Abstract Book Vol. 1 [International Conference on AIDS (16th: 2006: Toronto, Canada)]

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Page  i Abstract Book Volume 1 XVI International AIDS Conference 13-18 August 2006 * Toronto Canada www.aids2006.org

Page  ii The conference gratefully acknowledges the generous suport provided by the following donor! Conference Supporters Canada Ontario REG ERIN G SKAN SLI ET Swedish Ministry for Foreign Affairs HOJ~TRoNTo VSida Swedish International Development Agency (Sida) European Union B ILL)M ELI NDA GATES foundation Positive act l n 9 6OHTN BAbbott Virology (;:>Boehringer \iiIIi Ingeiheim BM S, firologyu ~joBrisol-Myer Squibb Comny mith~ine Roche G ILEAD Advancig T 000utc G ax "Irish Aid D~potnot o Foo goAfhROYAL NORWEGIAN MINISTRY OF FOREIGN AFFAIRS 'tibotec I1 virco 1~. sanoFi pstein. XVI INTERNATIONAL AIDS CONFERENCE " 13-18 AUGUST 2006 " TORONTO CANADA " ABSTRACT BOOK VOLUME 1

Page  iii SCHERING CANADA INC. Adnig Thrpeuti IpovigLives G L A Bristol-Myers Squibb Canada r WaaxoSmithK7i hire 0Riochem 0 ROGERS" Abbott Laboratories Canada, Roche Canada, Boehringer Ingelheim (Canada) Ltd, Ontario Nurses' Association, Toronto Community Foundation. lnnns THE LANCET CLINICAL CARE OPTIONS HIV CBC <iiE' Radio-Canada THE GLOBE AND MAIL THE GLOBE AND MAIL STAR ALLIAN( VIA Rail Canada Otticsa VVats Canada Trust S wpal8e oOfficia C n Supplier Roots ~.,........ U Alert Security Systems, Goodman Carr, Goodmans, Jolera, PhotoSensitive, Plazacorp Investments Inc., Tourism Toronto, Wellesley Central Health Corporation XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  iv INTERNATIONAL ABSTRACT REVIEW COMMITTEE The XVI International AIDS Conference broke a new record in abstract submissions, with almost 13,000 abstracts submitted to one of the five track categories. Given the volume and quality of abstracts, the peer reviewing process became an even more critical part of designing a strong Scientific Programme. Over 1,100 specialists from around the world in one or several fields of expertise volunteered to serve as peer reviewers, helping to ensure that the abstracts presented were selected on the basis of a rigorous review and of the highest scientific quality. We extend our special thanks to these individuals for the time they dedicated to the success of the conference: -AQuarraisha Abdool Karim, South Africa Abu Abdul-Quader, United States John Aberle-Grasse, Malawi Olaposi Olakunmi Isaiah Abiola, Nigeria Naeemah Abrahams, South Africa Donald Abrams, United States Elaine Abrams, United States Barry Adam, Canada Marina Adamyan, Armenia Sylvia Adebajo, Nigeria Alix Adrien, Canada Olayemi Agboola, Canada Simon Agwale, Nigeria Waheed Ahmad, Pakistan Angela Aidala, United States Martha Ainsworth, United States Campbell Aitken, Australia Atsushi Ajisawa, Japan Marvel Akamduwoh Cwaabe, Cameroon Ajaz Akhtar, Pakistan Arash Alaei, Iran, Islamic Republic of Kamiar Alaei, Iran, Islamic Republic of Jose Alcami, Spain Anna Aldovini, United States Grace Aldrovandi, United States Anna Alexandrova, Canada Sarah Alkenbrack, United States Ghalib Alkhatib, United States Robert Allard, Canada Dan Allman, Canada Charles Altman, Canada Dennis Altman, Australia Mary Grace Alwano, Botswana Milton Amayun, United States Joseph Amon, United States Gabriel Anabwani, Botswana Gail Andrews, South Africa Jonathan Angel, Canada Sylvia Anie, Ghana Francisco Antunes, Portugal Francis Anyona, Kenya Sevgi Aral, United States Keikawus Arasteh, Germany Chris Archibald, Canada Gabriele Arendt, Germany Radka Argirova, Bulgaria Eric Arts, United States Muhammad Aslam, Pakistan Habtam Asmeche, Kenya Clive Aspin, New Zealand Dini Nur Astari, United Kingdom Jana Atkins, Canada P Il Aukrust, Norway Maria Mercedes Avila, Argentina Gloria Aykroyd, Canada Ali Azizi, Canada -BDavid Back, United Kingdom Andrew Badley, Canada Andrew Ball, Switzerland Scott Bamber, Thailand David Bangsberg, United States Giuseppe Barbaro, Italy Benoit Barbeau, Canada Francis Barin, France Kevin Barlow, Canada Francoise Barre-Sinoussi, France Paulo Barroso, Brazil John A Bartlett, United States Francisco Bastos, Brazil Manuel Battegay, Switzerland Sharon Baxter, Canada Eduard Beck, Switzerland Richard Bedell, Canada Monica Beg, Bangladesh Georg Behrens, Germany Lizanne Beique, Canada Lynne Belle-Isle, Canada Jorge Beloqui, Brazil Reina Bendayan, Canada Marcos Benedetti, Brazil Serge Benichou, France Tarik Bereket, Canada Marge Berer, United Kingdom Philip Berger, Canada Erik Berggren, Sweden Ruth Berggren, United States Colm Bergin, Ireland Andreas Bergl6f, Sweden Ben Berkhout, Netherlands Nicole Bernard, Canada Petra Berrios, United States Stefano Bertozzi, Mexico Chris Beyrer, United States Kevin Bezanson, Malawi Sanjay Bhagani, United Kingdom Manisha Bharti, United States Mabel Bianco, Argentina Gunnel Biberfeld, Sweden Debbie Birx, United States Caroline Bishop, Senegal Victor Bittar, Argentina Derek Bodell, United Kingdom Ties Boerma, Switzerland Francesca Boldrini, Switzerland Tania Boler, United Kingdom Robert Bollinger, United States Clotet Bonaventura, Spain Vera Bongertz, Brazil Leonard Boniface, Tanzania, United Republic of Frikkie Booysen, South Africa Charles Boucher, Netherlands Frederic Bourdier, Cambodia James Bradac, United States Brian Bramson, Malawi Donald Branch, Canada James Bremer, United States Carlos Brites, Brazil Norbert Brockmeyer, Germany Barbara Broers, Switzerland Tim Brown, United States Fran;oise Brun-Vezinet, France Christopher Buchner, Canada Kristy Buck, Canada Michael Bukrinsky, United States Elizabeth Bukusi, Kenya Sandra Bullock, Canada David Burger, Netherlands Robert (Bob) Burgoyne, Canada Dennis Burton, United States Ines Bustamante, Peru Anne Buve, Belgium Ligaya Byrch, Canada Denise Byrd, United States -CLuisa Cabal, United States Robinson Cabello, Peru Samuel Cabrera Jr., Philippines Carlos F. Caceres, Peru Roy Cain, Canada Domenico Calla, Canada Alexandra Calmy, Switzerland Liviana Calzavara, Canada Cristina Camara, Brazil Irma Caplinskiene, Lithuania Alex Carballo-Dieguez, United States Dora Cardaci, Mexico Gloria Careaga-Perez, Mexico Giampiero Carosi, Italy Andrew Carr, Australia Henri Carrara, South Africa Jose Carvalheiro, Brazil Miguel Cashat-Cruz, Mexico Jorge Casseb, Brazil Jesus Castilla, Spain Christopher Castle, France Erika Castro, Switzerland Ward Cates, United States Rodrigo Cavalcanti, Canada Luca Ceccherini-Nelli, Italy Heather Cecil, United States David Celentano, United States Joana Chakraborty, United States Rana Chakraborty, United Kingdom Venkatesan Chakrapani, India Sofia Chalkidou, Greece Elaine Chase, United Kingdom Anindya Chatterjee, Switzerland May Chazan, Canada Claire Checkland, Canada Peter Chege, Kenya Yi-Ming Chen, China Genevieve Chene, France Cecilia Cheng-Mayer, United States Peter Cheung, Canada Tom Chin, Canada Nkechinyelum Chioneso, Canada Maureen Chirwa, Malawi Ian Chisholm, Canada Kyung-Hee Choi, United States Terence Chorba, United States Timothy Christie, Canada Paola Cinque, Italy Ken Clement, Canada Mario Clerici, Italy Nathan Clumeck, Belgium David Coetzee, South Africa Calvin Cohen, United States Eric Cohen, Canada Myron Cohen, United States Robert Colebunders, Belgium Ann Collier, United States Evan Collins, Canada Lynn Collins, United States Simon Collins, United Kingdom Alexandra Compagnucci, France Jerry Coovadia, South Africa Karen Copeland, Canada Gene Copello, United States Jacques Corbeil, Canada Liz Corbett, Zimbabwe Andrea Cossarizza, Italy Dominique Costagliola, France Helene Cote, Canada Pierre C6te, Canada Mark Cotton, South Africa Jose Carlos Couto-Fernandez, Brazil Frances Cowan, Zimbabwe Francois Crabbb, Cambodia Mia Crampin, Malawi Levinia Crooks, Australia Siobhan Crowley, Switzerland Maria Leticia Cruz, Brazil Joanne Csete, Canada Susanna Cunningham-Rundles, United States Matthew Curtis, United States -DEric Daar, United States Francois Dabis, France Luigino Dal Maso, Italy Gina Dallabetta, India Ronald D'Amico, United States Volker Daniel, Germany Emmanuel Danso Apau, Ghana Jean-Luc Darlix, France Antonella D'Arminio-Monforte, Italy Richard Davey, United States Yvonne Davis, United States Linda Day, Canada Varuni Dayaratna, United States Alina Maria De Almeida Souza, Spain Rafael De Andrbs-Medina, Spain Maria de Bruyn, United States Carmem Aparecida De Freitas Oliveira, Brazil Anita De Rossi, Italy Isabelle De Vincenzi, France John De Wit, Netherlands Isabelle de Zoysa, Switzerland Patrice Debre, France Naushaba Degani, Canada Laura Delany, Canada Eric Delaporte, France Jean-Francois Delfraissy, France Inge Derdelinckx, Netherlands Don Des Jarlais, United States Alice Desclaux, France Annabel Desgrees du lou, France Roger Detels, United States Beverly Deutsch, Canada Ygor Dias Moura, Brazil Sharon Diave, Papua New Guinea Carl Dieffenbach, United States Douglas Dieterich, United States Ursula Dietrich, Germany Melissa Ditmore, United States Vivek Divan, India XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  v Dawn Dixon, Canada Kate Dolan, Australia Le-Ann Dolan, Canada Antonina Dolei, Italy Pere Domingo, Spain Angela Dominguez, Spain Brenda Done, Canada Veronique Dore, France Daniel Douek, United States Robert Downing, Uganda Gary Dowsett, Australia Sonja Weinreich, Germany Joseph Drabo, Burkina Faso Stephan Dressier, Germany Geraldo Duarte, Brazil Michael Dube, United States Francoise Dubois-Arber, Switzerland Margaret Duckett, Australia Elizabeth Dudu, South Africa Sheila Dutta, United States -EMatthias Egger, Switzerland Maria Ekstrand, United States Jonathan Elford, United Kingdom Denielle Elliott, Canada Richard Elliott, Canada Joanne Embree, Canada Sean Emery, Australia Bissagnene Emmanuel, Cote d'Ivoire Gilbert Emond, Canada Jose Este, Spain Eka Esu-Williams, South Africa Emmanuel Etim, Nigeria Jesper Eugen-Olsen, Denmark Jean Louis Excler, India -FMartin-Mary Falana, Nigeria Pat Fast, United States Gerd Fatkenheuer, Germany Sylvie Faucher, Canada Eva Maria Fenyo, Sweden Guido Ferrari, United States Cristine Ferreira, Brazil Saviour Fianu, Ghana Sarah Fidler, United Kingdom Sarah Fielden, Canada Erin Finnerty, United States Susan Fiscus, United States Dennis Fisher, United States William Fisher, Canada Lisa M. Fitzgerald, United States Margaret Fitzgerald, Malawi Stuart Flavell, United States Douglas Fleming, Botswana Tom Fleming, Canada Markus Flepp, Switzerland Charles Flexner, United States Marise Fonseca, Brazil Rosemary Forbes, Canada Steven Forsythe, Mexico Pieter Fourie, South Africa Odile Frank, Switzerland Sandra Freire, France Martyn French, Australia Gerald Friedland, United States Sam Friedman, Canada Samuel Friedman, United States Vincent Frimpong Manu, Ghana Hayford Frimpong Otchere, Ghana Janet Frohlich, South Africa Stig Froland, Norway Jon Fuller, United States George Fast, Hungary Donna Futterman, United States Knut Fylkesnes, Norway -GDana Gabuzda, United States Massimo Galli, Italy Robert Gallo, United States Stephen Gange, United States Wen-Yi Gao, United States Homyar Gardin, India David Garmaise, Canada Hiroyuki Gatanaga, Japan Jose M. Gatell, Spain Joseph Gathe, United States Thomas Gegeny, United States Clemon George, Canada Haileyesus Getahun, Switzerland Grace Getty, Canada Peter Ghys, Switzerland Diana Gibb, United Kingdom Charlie Gilks, United Kingdom Noel Gill, United Kingdom Sue Gill, Canada James Gillett, Canada Albert Gimenez-Masat, Spain Adam Ginter, Canada Bethel Girma Shiferaw, Ethiopia Jean Claude Gluckman, France Frank Goebel, Germany James Goedert, United States Ron Gold, Australia Irene Goldstone, Canada Fabiano Gontijo, Brazil Alfredo Gonzalez, United States Ana Cristina Gonzalez-Velez, Colombia Frances Gotch, United Kingdom Matthias Gotte, Canada Kevin Gough, Canada Michael Grant, Canada Glenda Gray, South Africa Nicole Gray, United States Dirceu Greco, Brazil Daniel Gredig, Switzerland Minrie Greeff, South Africa Kim Green, Viet Nam Robert Greener, France Jeffrey Grierson, Australia Beatriz Grinsztejn, Brazil Howard Grossman, United States Kathie Grovit-Ferbas, United States Ian Grubb, Switzerland Andrew Grulich, Australia Sofia Gruskin, United States Mauro Guarinieri, Italy Rachel Guglielmo, United States Mark Guimaraes, Brazil Roy Gulick, United States Hema Gupta, Canada -HAlejandro Haag, United States Ibrahim Halkano, Tanzania, United Republic of Elizabeth Hamilton, United States Lisa Hansen, Canada Mary Haour Knipe, Switzerland Dave Haran, United Kingdom Alexandre Harari, Switzerland Deborah Hardwick, Canada Thomas Harrer, Germany Anthony Harries, Malawi Mark Harrington, United States Marianne Harris, Canada Steve Harris, Canada Jagdish Harsh, India Graham Hart, United Kingdom Trevor Hart, Canada Oliver Hartley, Switzerland Kenji Hattori, Japan Stephen Hawes, United States Norman Hearst, United States Hans Heiken, Germany Robert Heimer, United States Sarah Hendriks, Canada Philippe Hermans, Belgium Jaime Hernandez, United States Rosalinda Hernandez, Ghana Nancy Hessol, United States Alison Hickey, South Africa Hakima Himmich, Morocco Martin Hirsch, United States Bernard Hirschel, Switzerland Jennifer Ho, Thailand Mindy Hochgesang, Malawi Vida Hodara, United States Colleen Hoff, United States Margaret Hogan, Tanzania, United Republic of Robert Hogg, Canada Mark Holodniy, United States Mitsuo Honda, Japan Andrzej Horban, Poland Amy Horton, Canada Sean Hosein, Canada Moazzem Hossain, Bangladesh Mina Hosseinipour, Malawi Christine Hughes, Canada Michael Hughes, United States Joyce Hunter, United States Michael Hurley, Australia Winston Husbands, Canada Ingo W. Husstedt, Germany Nancy Hutton, United States -IChikwe Ihekweazu, United Kingdom Isaac Ikpekha, Nigeria Kazuyoshi Ikuta, Japan Catalina Iliuta, Romania Tomozumi Imamichi, United States Moses Imayi, Nigeria Silvia Inchaurraga, Argentina Cesar Infante, Mexico Elisabete Inglesi, Brazil Sheila Isoke, United States Aikichi Iwamoto, Japan Sujatha Iyengar, United States Helen Jackson, Zimbabwe Randy Jackson, Canada Mark Jacobson, United States Kuan-Teh Jeang, United States Richard Jefferys, United States Shirleen Jejeebhoy, India Ping Jia, China Shibo Jiang, United States Katarina Jiresova, Slovakia Nadine Job-spira, France Paul Johnson, United States Victoria Johnson, United States Grace John-Stewart, United States Heidi Jones, United States Peris Jones, Norway T. Stephen Jones, United States Ida Jooste, South Africa Gonzague Jourdain, Thailand Christian Junet, Switzerland Ralf JUrgens, Canada -KSandra Kabir, United Kingdom Auguste Kadio, Cote d 'Ivoire Olalekan Kaffo, Nigeria Fabiana Kakehasi, Brazil John Kaldor, Australia Pontiano Kaleebu, Uganda Kerstin KaII, Sweden Esper Kallas, Brazil Mitsuhiro Kamakura, Japan Anatoli Kamali, Uganda Lori E. Kamemoto, United States Claudes Kamenga, Ghana Elie Gaston Bertrand Kampoer Pfouminzhouer, Cameroon Franck Kamunga Cibangu, Congo, Democratic Republic of Aloys Kamuragiye, Djibouti Lai-yi Kang, China Elena Kanigan, Canada Phyllis Kanki, United States Anders Karlsson, Sweden Margaret Kaseje, Malawi Ahmed Kassem, Egypt Elly Katabira, Uganda Christine Katlama, France Shuaib Kauchali, South Africa Rupert Kaul, Canada Edna Kavuma, Canada Michel Kazatchkine, France Peter Kazembe, Malawi Michael Keefer, United States Kevin Kelly, South Africa Stephen Kent, Australia Thomas Kerr, Canada Ligia Regina Kerr-Pontes, Brazil Luc Kestens, Belgium Vuyiswa Keyi, Canada Constance Georgina Khaendi Walyaro, Kenya Chirasak Khamboonruang, Thailand Priyakamon Khan, Thailand Medha Khandekar, India Ayesha Kharsany, South Africa Ndunge Kiiti, United States Peter Kilmarx, United States Satoshi Kimura, Japan Sabine Kinloch, United Kingdom Maryselis Kioko, Zambia Susan Kippax, Australia Ole Kirk, Denmark Kamal Kishore, Fiji Dwip Kitayaporn, Thailand Marina Klein, Canada Thomas Klimkait, Switzerland Daniela Knauth, Brazil Renate Koch, Venezuela Steven Koch, South Africa Eiichi Kodama, Japan Jane Koerner, Japan Yasuhiro Koh, Japan Peter Kok, Netherlands Ryuichi Komatsu, Switzerland Marilena Komesu, Brazil Christine Kopp, Switzerland Richard Koup, United States Alejandro Krolewiecki, Argentina Natalie Kruse-Levy, Cambodia Don Kulick, United States Shobhna Kumar, India John Kumwenda, Malawi Chaiyos Kunanusont, Thailand Bernd Kupfer, Germany Takashi Kurimura, Japan Daniel Kuritzkes, United States -LMarie Laga, Belgium Renu Lal, India XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  vi Marc Lallemant, Thailand David Lalloo, United Kingdom Cosmas Lambini Kombat, Ghana Johan Lamprecht, South Africa Alan Landay, United States Randall Lanier, United States June Larkin, Canada Arielle Lasry, Canada Damian Lavarello, Argentina Taiwo Lawoyin, Nigeria Sophie Le Coeur, Thailand Roger Le Grand, France Carole Leach-Lemens, United States Andrea Leal, Brazil Susan Leather, Switzerland Marc-Andrb LeBlanc, Canada Michael Lederman, United States Krystal Lee, China Kira Leeb, Canada Olavo Leite, Brazil Luis Leiva, Costa Rica George Lemp, United States Jeffrey Lennox, United States Lori Leonard, United States France Lert, France Joan Lesmond, Canada Guido Levi, Brazil Jay Levy, United States Jennifer Levy, Canada Yves Levy, France Sharon Lewin, Australia Rene Leyva, Mexico Chen Liang, Canada Maria Lin Eng, United States Katarina Lindhal, Sweden Clifford Lingwood, Canada Narcisse Lokwa Mbunzama, Sweden Franco Lori, Italy Mona Loutfy, Canada Philips Lukwiya, Uganda Jens Lundgren, Denmark Chewe Luo, United States Peter Lurie, United States Paolo Lusso, Italy Katherine Luzuriaga, United States Chris Lyttleton, Australia -MGary Maartens, South Africa Kelly S. Macdonald, Canada Shauna MacEachern, Canada Daisy Machado, Brazil John Macleod, Canada Kenji Maeda, United States Rajendra Maharaj, Canada Carol Major, Canada Jennifer Major, Canada Harvey Makadon, United States Clement Malau, Australia Jaideep Mallick, United States Christoforos Mallouris, France Monica Malta, Brazil Miriam Maluwa, Jamaica Joanne Manchester, United Kingdom Justin Mandala, Ghana Enrico Mandarino, Cape Verde Purnima Mane, India Lisa Manhart, United States Janak Maniar, India Gordon Mansergh, United States Joanne Mantell, United States Simone Marcotullio, Italy Ulrich Marcus, Germany Shari Margolese, Canada Joseph Margolick, United States Martin Markowitz, United States Gayle Martin, United States Esteban Martinez, Spain Miguel Angel Martinez, Spain Michela Martini, Italy Neil Martinson, South Africa Bernard Masquelier, France Timothy Mastro, United States Takao Masuda, Japan Tetsuro Matano, Japan Arvind Mathur, India Masao Matsuoka, Japan John Maxwell, Canada Rafael Mazin, United States Chinyere Mbachu, Nigeria Kanjoo Ruth Mbaindjikua, Namibia Francine McCutchan, United States Francine Mccutchan, United States Marney McDiarmid, Canada Ann McDonald, Australia Scott McGill, United States Nuala McGrath, Malawi William McGreevey, United States James McIntyre, South Africa Chhi Vun Mean, Cambodia Nicolas Meda, Burkina Faso Michael Meegan, Kenya Sanjay Mehendale, India Shaun Mellors, South Africa Luis Menendez-Arias, Spain Alexandre Menezes, United States Jacqueline Menezes, Brazil Jonathan Mermin, Uganda Peter Messeri, United States Laurence Meyer, France Andreas Meyerhans, Germany Anna Meyer-Weitz, South Africa Giovanna Meystre-Agustoni, Switzerland Anne Lise Middelthon, Norway Anne Mijch, Australia Donna Mildvan, United States Per Miljeteig, Norway Ed Mills, Canada Peggy Millson, Canada Helen Miramontes, United States Jose M. Miro, Spain Mark Mirochnick, United States Claudia Mitchell, Canada Debjani Mitra, Canada Hiroaki Mitsuya, United States Koleka Mlisana, South Africa Jean-Paul Moatti, France Lynne Mofenson, United States Jean Michel Molina, France LaVerne Monette, Canada Julio S.G. Montaner, Canada Antonio Montero, Argentina Christiane Moog, France Neetha Morar, South Africa Amadou Moreau, Senegal Santiago Moreno, Spain Jan-Olof Morfeldt, Sweden Mariza Morgado, Brazil Hiroyuki Moriuchi, Japan Masako Moriuchi, Japan Gene Morse, United States Stephen Moses, Canada Jean-Francois Mouscadet, France Jack Moye, United States Graeme Moyle, United States Philippe Msellati, France Roland Msiska, South Africa Mark Muesing, United States Pierre Mugabo, South Africa Ayub Muhammad, Pakistan Esther Muia, Ethiopia Ya Diul Mukadi, United States Muhammad Mukhtar, United States Claire Mulanga, Switzerland Michaela Muller-Trutwin, France Mary Ann Mulvihill, Canada Edward Munene, Kenya Godfrey Mungazi, Zimbabwe MaAngeles Mufioz-Fernandez, Spain Michelle Munro, Canada Robert Murphy, United States Debra A. Murphy, United States James Murray, Canada Philippa Musoke, Uganda Marisa Mussi-Pinhata, Brazil Zablon Muthaka, Kenya Charles Mwansambo, Malawi Alwyn Mwinga, Zambia Lillian Mworeko, Uganda Landon Myer, South Africa Ted Myers, Canada Vicki Myers, Canada -NIndra Nadchatram, Malaysia Eknath Naik, United States Rakhi Nair, India Rafael Najera, Spain Tetsuya Nakamura, Japan Yasuhide Nakamura, Japan Hirotomo Nakata, Japan Emi Nakayama, Japan Devan Nambiar, Canada Priya Nanda, United States Filomena Nappi, Italy Heidi Nass, United States Lalit M. Nath, India Fortune Ncube, United Kingdom Chiratidzo Ndhlovu, Zimbabwe Cheikh Tidiane Ndour, Senegal Richard Needle, United States Graham Neilsen, Thailand Kenrad Nelson, United States Mark Nelson, United Kingdom Carole Neron, Canada Marie-Louise Newell, United Kingdom Peter A. Newman, Canada Ismael Ngnie Teta, Canada Minh Ly Nguyen, United States Patrice Nicholas, United States Karin Nielsen, United States Susanne D. Nielsen, Denmark Monique Nijhuis, Netherlands Khalil-ur-Rahman Nil, Pakistan Douglas Nixon, United States Stephanie Nixon, Canada Ephantus Njagi, Kenya Philip Norris, United States Nathan Nshakira, Uganda Philisiwe Ntshangase, South Africa Ugochukwu Nwosu, Nigeria -0 -Albert Yeboah Obeng, Ghana Kelly O'Brien, Canada William A. O'Brien, United States Dorothy Ochola-Odongo, Botswana Michael O'Connor, Canada Faith Odwaro, Ukraine Robert Oelrichs, Cambodia Dede Oetomo, Indonesia Mary O'Grady, South Africa Yewande Ogunnubi, Nigeria Shinichi Oka, Japan Takashi Okamoto, Japan Mutiu Okediran, Nigeria Desmond Okoro Onyebuchi, Nigeria Vincent Otieno Okullo, Kenya Olufemi Olugbemi, Trinidad and Tobago Francisca Isi Omorodion, Canada William Ongala, Kenya Nattawat Onlamoon, Thailand Ida Onorato, United States Gorik Ooms, Belgium Jan Orenstein, United Kingdom Eddy Orinda, Ukraine David Otiashvili, Georgia -PJulie Page, Switzerland Kimberly Page-Shafer, United States Vera Paiva, Brazil Anita Palepu, Canada Guiseppe Pantaleo, Switzerland Jean Pape, Haiti Michael Para, United States Warren Parker, South Africa Zahida Parveen, United States Carlos Passarelli, Brazil San Patten, Canada David Patterson, Canada Lauren Patton, United States Georg Pauli, Germany Bhatt Paurvi, United States Dorothy Pawluch, Canada Lynn Paxton, United States Richard Pearshouse, Canada Mario Pecheny, Argentina Miguel Pedrola, Argentina Martine Peeters, France Hector Perez, Argentina Jorge Perez, Cuba Michel Perreault, Canada Luc Perrin, Switzerland Rosalind Petchesky, United States Thomas Peterman, United States Jake Peters, Canada Audrey Pettifor, United States Fiona Pettitt, United Kingdom Peter Phillips, Canada Marie Pierre-Louis, United States Jose Pilotto, Brazil Steven Pinkerton, United States Jorge Pinto, Brazil Punnee Pitisititham, Thailand Marian Pitts, Australia Michel Pletschette, Luxembourg Daniel Podzamczer, Spain Pascal Poignard, France Nana Poku, Ethiopia Guido Poli, Italy Richard Pollard, United States Bruce Polsky, United States Melissa Popiel, Canada Kholoud Porter, United Kingdom Lane Porter, United States Cristina Possas, Brazil Jeff Potts, Canada Kathy Pouteau, Malawi Lisa Power, United Kingdom Jeff Powis, Canada Anton Pozniak, United Kingdom George Preez, United States Tracey Prentice, Canada Maria Prins, Netherlands Damian Purcell, Australia David Purcell, United States Anil Purohit, United States -QYusuf Qalib, Somalia Shuquan Qu, China Thomas Quinn, United States Miguel Quinones-Mateu, United States Obed Qulo, South Africa XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  vii Anital Rachlis, Canada Francois Raffi, France Allan Ragi, Kenya Khalil Rahman, Pakistan Syed Masiur Rahman, Saudi Arabia Bobby Ramakant, India Radhika Ramasubban, India Velia Aydee Ramirez-Amador, Mexico Arthi Ramkissoon, South Africa Luciana Ramos, Mexico Celso F. Ramos-Filho, Brazil Cristiane Rapparini, Brazil Suraiya Rasheed, Vanuatu Lucy Rasmussen, United States Silvia Ratto-Kim, Thailand Ramesh Babu Rayapu, India Myat Htoo Razak, Thailand Ali Razaque, Pakistan Jennifer Read, United States Thomas Rehle, South Africa Michael Rekart, Canada Robert Remien, United States Robert Remis, Canada Feliciano Reyna, Venezuela Rhon Reynolds, United Kingdom Giovanni Rezza, Italy Jorge Eurico Ribeiro, Brazil Ana Lucia Ribeiro de Vasconcelos, Brazil Doug Richman, United States David Rimland, United States Charles Rinaldo, United States Felipe Rios, Brazil Sidsel Roalkvam, Norway Marjorie Robert-Guroff, United States Lorraine Rock, Canada Juergen Rockstroh, Germany Benigno Rodriguez, United States Martha Romero, Mexico Allan Ronald, Canada Ana Maria Rosasco, Peru Sydney Rosen, South Africa Zeda Rosenberg, United States Ron Rosenes, Canada David Rosenthal, United States Mary Jane Rotheram-Borus, United States Sean Rourke, Canada Jean-Pierre Routy, Canada Christine Rouzioux, France Sarah Rowland-Jones, Gambia Willy Rozenbaum, France Erling Rud, Canada Juan Ruiz, United States Stefano Rusconi, Italy Roxana Rustomjee, South Africa George Rutherford, United States -SEster Sabino, Brazil Ximena Salazar, Peru Papa Salif Sow, Senegal Horacio Salomon, Argentina Robyn Salter, Canada Bernd Salzberger, Germany Paul Sandstrom, Canada Kamel Sanhadji, France Vonthanak Saphonn, Cambodia M6nica Saracco, Argentina Bachir Sarr, Senegal Solomon Saruni, Kenya Youssouf Sawadogo, United States Pathom Sawanpanyalert, Thailand Peter J.W. Saxton, New Zealand Fabio Scano, Switzerland Inon Schenker, Israel Rebecca Schleifer, United States Julia Schlossberg-Vinson, United States Reinhold Schmidt, Germany Helen Schneider, South Africa Robert Schooley, United States Erik Schouten, Malawi David Schwartz, United States Olivier Schwartz, France Jamie Scott, Canada Eric Seaberg, United States Hosein Sean, Canada Fernando Seffner, Brazil Aluisio Segurado, Brazil Shizuko Sei, United States Steven Seitz, United States Peter Selwyn, United States Robert Sember, United States Luisa Sen, Argentina Shanon Senefeld, United States Leslie Serchuck, United States Lena Serghides, Canada Evelyne Serima, Zimbabwe Meena Seshu, India Joyce Seto, Canada Daniel Seyoum, United States Iqbal Shah, Switzerland Eid Muhammad Shamas, Pakistan Kate Shannon, Canada Paul Shapshak, United States Suneeta Sharma, United States Mohammed Kamil Sherif, Botswana Avrom Sherr, United Kingdom Lorraine Sherr, United Kingdom Tatsuo Shioda, Japan Takuma Shirasaka, Japan Olive Shisana, South Africa Sheila Shyamprasad, Switzerland Elopy Sibanda, Zimbabwe Scott Sieg, United States Juan Sierra Madero, Mexico Guido Silvestri, United States Leickness Simbayi, South Africa Padam Simkhada, Nepal Jonathon Simon, United States Sally Simpson, Canada Ameeta Eshri Singh, Canada Sarman Singh, India Fiona Smaill, Canada Peter Smit, Netherlands Anthony Smith, Australia Don Smith, Australia Graham Smith, China Graham Smith, Canada Jes Smith, Canada Kimberly Smith, United States Marcelo Soares, Brazil Ricardo Sobhie Diaz, Brazil Suniti Solomon, India Anil Soni, United States Vincent Soriano, Spain Luis Soto-Ramirez, Mexico Stephen Spector, United States Paul Spiegel, Switzerland Bruno Spire, France Ron Stall, United States Janusz Stanczak, Poland Carl Stecker, United States Gail Steckley, Indonesia Alice Stek, United States Hans-Juirgen Stellbrink, Germany Liljana Stevceva, United States Mario Stevenson, United States Gerald Stimson, United Kingdom Matthias Stoll, Germany Steffanie Strathdee, United States Jeffrey Stringer, Zambia Vernon Stringer, Canada John Sullivan, Australia Patrick Sullivan, United States Ida Susser, United States Don Sutherland, Switzerland -TEllen't Hoen, France Negussie Taffa, Botswana Christianne Takeda, Brazil Masafumi Takiguchi, Japan Joan Tallada, Spain Giuseppe Tambussi, Italy Sadahiro Tamiya, Japan Darrell Tan, Canada Michael Tan, Philippines Kun Tang, China Frederic Tangy, France Placide Tapsoba, Ghana Carmen Tarrades, United Kingdom Patrick M. Tarwater, United States Shinobu Tatsunami, Japan Bernard Taverne, Senegal Ricardo Tawedi, Congo, Democratic Republic of Kate Taylor, United States Amalio Telenti, Switzerland Marleen Temmerman, Belgium Ghebrehiwet Tesfamicael, Switzerland Stephen Thagana, Kenya Ibou Thior, Botswana Usa Thisyakorn, Thailand David Thomas, United States Joe Thomas, Australia Kim Thomas, Canada Richmond Tiemoko, Nigeria Susan Timberlake, Switzerland Christopher Tindale, Canada Wesam Tohlob, Egypt Emil Toma, Canada Jose Toro-Alfonso, United States Maine Awa Toure, Senegal Graciela Touze, Argentina Robb Travers, Canada Cecile Tremblay, Canada Michel J. Tremblay, Canada Emmanuel Trenado, France Judith Tresidder, Canada Alcides Troncoso, Argentina Alice Tseng, Canada Amy Tsui, United States Mark Tyndall, Canada -UMikio Ueda, Japan Takamasa Ueno, Japan Chukwudi Ugwuja, Nigeria Eszter Ujhelyi, Hungary Charles Ukauwa, Nigeria Kumnuan Ungchusak, Thailand Willy Urassa, Tanzania, United Republic of -VRon Valdiserri, United States Linda Valleroy, United States Benoit Van Caloen, Canada Lut Van Damme, United States Philippe Van de Perre, France Janneke van de Wijgert, Netherlands Frits Van Griensven, Thailand Jan Van Lunzen, Germany Joep van Oosterhout, Malawi Carole Vance, United States Philippe Vanhems, France Ouk Vara, Cambodia Eftyhia Vardas, South Africa Maria Jose Vazquez, Spain Mariana Vazquez, Argentina Valdilea Veloso, Brazil Alain Venet, France Bernard Verrier, France Jean-Paul Viard, France Haran Vijayanthan, Canada Gabina Villagran, Mexico Surasing Visrutaratna, Thailand Robert Vitillo, Switzerland Jindrich Voboril, Czech Republic Bea Vuylsteke, C6te d 'Ivoire -WFred Wabwire-Mangen, Uganda Holly Wagg, Canada Bruce D. Walker, United States Sharon Walmsley, Canada Hauke Walter, Germany Constance Georgina Khaendi Walyaro, Kenya Ajay Wanchu, India Xin Wang, Japan Barbara Wanyoto, Uganda Judith Wasserheit, United States Arnaud Wasson-Simon, France David Watkins, United States Heather Watts, United States Adele Webb, United States Gundo Weiler, Switzerland Laurence Weiss, Gambia James Welsh, United Kingdom Katie West, United States Alan Whiteside, South Africa Matthias Wienold, Germany Peter Wiesner, France Flavio Wiik, Brazil Stefan Wiktor, Tanzania, United Republic of Paul Williams, Australia Carolyn Williamson, South Africa Lisa Williamson, United Kingdom Kinsley Wilson, Canada Wendy Wobeser, Canada Daniel Wolfe, United States Steven Wolinsky, United States Richard Wolitski, United States Loretta Wong, China Paul Wong, Japan Kate Wood, United Kingdom Ian Woolley, Australia Heather Worth, Australia Richard Wyatt, United States -YMukadi Ya Diul, United States Naoki Yamamoto, Japan Xiaojian Yao, Canada Robert Yarchoan, United States Sibili Yelibi, Senegal Sabine Yerly, Switzerland Philip Yin, United States Helene Yinda, Switzerland Benjamin Young M.D., United States Joseph Yu, Malawi -Z Basia Zaba, Tanzania, United Republic of Rony Zachariah, Luxembourg Christina Zampas, Sweden Richard Y. Zhao, United States Shengke Zhi, China Eduard Zijlstra, Malawi Chris Zink, Canada Jose M Zuniga, United States XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  viii Scientific Programme Committee Co-Chairs Liviana Calzavara, Canada Elly Katabira, Uganda Michel Kazatchkine, France Members Evan Collins, Canada, CPC Representative Lynde Francis, Zimbabwe, Track E Co-chair Ralf Jiurgens, Canada, Track E Co-chair Chewe Luo, Zambia, Track B Co-chair Ted Myers, Canada, Track D Co-chair San Patten, Canada, Track C Co-chair Frank Plummer, Canada, Track A Co-chair Horacio Salomon, Argentina, Track A Co-chair Gunnar Stalsett, Norway, LPC Representative Veriano Terto, Brazil, Track D Co-chair Ron Valdiserri, United States, Track C Co-chair Sharon Walmsley, Canada, Track B Cochair Alan Whiteside, South Africa, Track D Co-chair Scientific Programme Track Committees Track A: Biology and Pathogenesis of HIV Francoise Barre-Sinoussi, France Charles Boucher, Netherlands Emilio Emini, United States Julia Hasler Scott, UNESCO Eric Hunter, United States Richard Jefferys, United States Lai-yi Kang, China Constance Georgina Khaendi Walyaro, Kenya Michael Lederman, United States Kelly McDonald, Canada Amadou Moreau, Senegal Mariza Morgado, Brazil Khalil-ur-Rahman Nil, Pakistan Viola Onwuliri, Nigeria Ken Rosenthal, Canada Paul Shapshak, United States Anne Strauss, France Michel Tremblay, Canada Matthias Wienold, Germany Track B: Clinical Research, Treatment and Care Upton Allen, Canada Jonathan Angel, Canada Jorge Beloqui, Brazil Polly Clayden, United Kingdom Stig Froland, Norway Jon Fuller, United States Joseph Gathe, United States Charlie Gilks, WHO Glenda Gray, South Africa Anthony Harries, Malawi Christine Katlama, France Jorge Pinto, Brazil Vadim Pokrovsky, Russian Federation Anton Pozniak, United Kingdom Subhasree Sai Raghavan, India Jurgens Rockstroh, Germany Sean Rourke, Canada Mike Saag, United States Papa Salif Sow, Senegal Kun Tang, China Track C: Epidemiology, Prevention and Prevention Research Quarraisha Abdool, South Africa Michel Alary, Canada Mary Grace Alwano, Botswana Liz Corbett, Zimbabwe Kevin Frost, Thailand Thomas Kerr, Canada Daniela Knauth, Brazil Joanna Manchester, United Kingdom Purnima Mane, UNAIDS Kanjoo Ruth Mbaindjikua, Namibia Frank McGee, Canada Ngashi Ngongo, Congo, Democratic Republic of Jonathan Mermin, Uganda Ana Oliveria, United States Robert Remis, Canada Glora Sangiwa, United States Padam Simkhada, Nepal Saphonn Vonthanak, Cambodia Gail Wyatt, United States Track D: Social, Behavioural and Economic Sciences Peter Aggleton, United Kingdom Monica Beg, UNODC Frikkie Booysen, South Africa Carlos Caceres, Peru Gloria Careaga-Perez, Mexico Radhika Chandiramani, India Jacqueline Gahagan, Canada Christo Greyling, Norway Winston Husbands, Canada Randy Jackson, Canada Sue Kippax, Australia Katarina Lindhal, Sweden William McGreevey, United States Richard Parker, United States Nana Poku, Ethiopia Bruno Spire, France Michael Tan, Philippines Fantan Tsetsele, Botswana Jan Wijngaarden, UNESCO Track E: Policy Mabel Bianco, Argentina Jonathan Cohen, United States Margaret Duckett, Australia Catherine Hankins, UNAIDS Mark Harrington, United States Dabesaki Ikemenjima, Nigeria Modibo Kane, Mali Michael Kirby, Australia Anuar Luna, Mexico Per Miljeteig, Norway Jan-Olof Morfeldt, Sweden Stephanie Nixon, Canada Dasha Ocheret, Russia Darlene Palmer, Canada Fiona Pettitt, United Kingdom Meena Seshu, India Gail Steckley, Canada Christine Stegling, Botswana Roberto Vitillo, Norway XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  ix TABLE OF CONTENTS Monday 14 August Tuesday 15 August page page Oral Abstract Sessions Oral Abstract Sessions Track A Track B Track C Track D Track E Cross-Track MOAA0101 MOAB0101 MOAC0101 MOAD0101 MOAE0101 MOAX0102 1 3 8 12 16 18 Track A Track B Track C Track D Track E Cross Track TUAA0101 TUAB0101 TUAC0101 TUAD0101 TUAE0101 TUAX0101 259 261 265 271 273 277 Poster Discussions Poster Discussions Track A Track B Track C Track D Track E Key Challenges MOPDA01 MOPDB01 MOPDC01 MOPDD01 MOPDE01 MOKC101 24 25 27 28 29 31 Track A Track B Track C Track D Track E Key Challenges TUPDA01 TUPDB01 TUPDC01 TUPDD01 TUPDE01 TUKC101 280 281 283 285 286 287 Poster Exhibition Poster Exhibition Track A Track B Track C Track D Track E MOPE0001 MOPE0045 MOPE0271 MOPE0612 MOPE0870 36 45 95 173 230 Track A Track B Track C Track D Track E TUPE0001 TUPE0041 TUPEO277 TUPE0608 TUPEO875 293 301 353 427 485 Author Index 512 XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  x SESSION CODING Example: MO-AA-01-01 = (Day) MO - (session type) AA - (session order) 01 - (speaker order) 01 WEEKDAY SESSION TYPE SESSION ORDER 01, 02, 03, 04, etc SPEAKER ORDER MO TU WE TH (Monday) (Tuesday) (Wednesday) (Thursday) 01, 02, 03, 04, etc NON-ABSTRACT SESSIONS ABSTRACT SESSIONS OTHER SESSIONS BS CC LP SY (Bridging Session) (Controversy & Common Ground) (Learning from Practice) (Symposia) PL SS SB (Plenary Sessions) (Special Sessions) (Skills Building Workshops) I i I ABSTRACT ORAL PRESENTATIONS POSTER DISCUSSIONS POSTER EXHIBITIONS AA AB AC AD AE AX (Track A) (Track B) (Track C) (Track D) (Track E) (Cross track) PDA (Track A) PDB (Track B) PDC (Track C) PDD (Track D) PDE (Track E) KC (Key Challenge) PE Electronic abstract book composition by pharma service - a business unit of documediaS GmbH, Hannover, Germany www.pharmaservice.de Disclaimer No responsibility is assumed by the organisers for any injury and/or damage to persons or property as a matter of product liability, negligence or otherwise, or from any use or operation of any methods, products, instructions or ideas contained in the material herein. Because of potential inaccuracies on the part of authors or typists and because of the rapid advances in the medical sciences, we strongly recommend independent verification of all data, diagnoses and drug dosages. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  1 Oral Abstract Sessions Track A MOAA0101 Attachment in HIV entry process by electron microscopic tomography T. Goto1, T. Hasegawa2, N. Kajimura2, Y. Iwabu3, D. Yamamoto4, K. Ikuta3, A. Takaoka2. 1Kyoto University, School of Health Science, Faculty of Medicine, Kyoto, Japan, 2Osaka University, Research Center of Ultra-High Voltage Electron Microscopy, Osaka, Japan, 3Osaka University, Department of Virology, Research Institute for Microbial Diseases, Osaka, Japan, 4Osaka Medical College, Biomedical Computation Center, Osaka, Japan Background: After the interaction of viral spikes and receptors on the cell membrane, infection is established. It is important for the prevention and treatment of HIV infection to clarify the whole process of entry. Structural analysis at the nanoscale level is advancing using automated efficient electron microscopy and image analysis. In this study, we tried to clarify the attachment of HIV to the cell membrane in the entry process using electron microscopic tomography. Methods: HIV was inoculated into culture lymphocytes, and after a designated time the cells were harvested, fixed and embedded for electron microscopy. The sections were observed with an electron microscope attached to a tilting apparatus. Images were automatically recorded with a CCD camera. The recorded image data were subjected to 3-D construction processing for tomography. Results: In electron microscopic tomography, there are two competing conditions for obtaining a detailed restructuring image without any distortion: it is necessary to use a wide-range of observation angles with the tilting apparatus and to minimize electron beam damage. To meet these two requirements, we used a slit grid and an automated electron microscope. Although it is very difficult to find the point of contact of the virus and the cell (minimum distance) directly by conventional electron microscopy, with this technique we could easily find the point where the virus contacted the cell membrane. The detailed structure of the contact point is further analyzed and identified at the molecular level using molecular models with three dimensional position data from the Protein Database of HIV envelope and CD4 molecules. Conclusions: At the first contact point, the distance between the virus and the cell membrane corresponds very well to the length of the extended gp41 molecule. Further stages have been investigated and will be discussed. MOAA0102 Cell-to-cell HIV-1 transmission through a clathrindependent endocytic pathway B. Bosch1, B. Grigorov2, J. Senserrich', J. Blanco', B. Clotet', J.-L. Darlix2, D. Muriaux2, J. Este'. 'Fundacio IrsiCaixa, Retrovirology, Badalona, Spain, 2Ecole Normale Supdrieure de Lyon, LaboRetro, Unit INSERM de Virologie Humaine, Lyon, France Background: In the course of HIV infection and dissemination, the contact between HIV-1 producing cells and target primary T CD4+ cells, through a structure called the virological synapse, may induce the uptake of viral particles by target cells in a viral envelope gp120-CD4 receptor dependent manner while being coreceptor independent. Methods: Coculture of infected and non-infected CD4 T cells, flow cytometry analysis, confocal microscopy and western blot detection of expressed proteins. Results: Internalized virus particles were localized in large intracellular vesicles in cocultures of primary T CD4+ cells with T cells persistently infected by either one of three HIV-1 isolates observ, y Bal and a clinical isolate Cl-1-SI. Since non-stimulated T CD4+ cells have a very low metabolism, they only express residual levels of the early endosomal marker EEA-1 or the late endosomal marker CD63. Conversely, HIV-linfected cells are strongly CD63 positive. Coculture of infected and uninfected cells led to the translocation into T CD4+ cells of the HIV-1 Gag antigen and the CD63 marker, as seen by immuno-confocal microscopy. Internalized virus colocalised with the clathrinmediated endocytosis EEA-1 marker in primary CD4 T+ cells but not with the Caveolin-1 marker. CD63 staining was observed, by flow cytometry, in T CD4+ lymphocytes after cell-to-cell contacts and viral transmission. Moreover, CD63 was present in the transferred viral particles, explaining the presence of a late endosomal marker in EEA-1 positive, Gag positive endosomes. Analysis of CD4 and HIV envelope subcellular localization revealed their colocalization with Gag in the polarized phenotype, confirming the dependence on CD4 and the transmission of complete viral particles. Conclusions: Taken together these results suggest that HIV-1 cell-to-cell transmission probably occur through a caveolin-independent but clathrin dependent endocytic process leading to the formation of endosomal vesicles containing complete HIV-1 particles. MOAAO103 Role of the highly conserved LWYIK motif of the transmembrane protein gp41 of HIV in Env-mediated membrane fusion S.S.-L. Chen, W.-E. Chan. Academia Sinica, Institute of Biomedical Sciences, Taipei, Taiwan, Republic of China Background: It has been proposed that the highly-conserved LWYIK motif located immediately proximal to the membrane-spanning domain of the HIV-1 gp41 plays a role in gp41-mediated membrane fusion and Env association with lipid rafts. However, the significance of this domain in virus replication is still unclear. Methods: Virus mutants encoding deletions and substitutions in the LWYIK motif were constructed by site-directed mutagenesis. Virus infectivity was determined by continuous cell culture and one-cycle replication assays. The ability of Env proteins to mediate virus entry was assessed by an env trans-complementation assay. The membrane fusion ability of Env was assessed by the HIV1 LTR-Tat transactivation and three color transfer assays. Results: None of the mutants examined showed altered synthesis, precursor processing, CD4-binding, oligomerization, or cell surface expression of the Env, nor altered Env incorporation into the virus. However, all of the mutant viruses, in particular, the AYI, AIK, and ALWYIK mutants, significantly reduced their one-cycle viral replication and the trans-complementation ability of the mutant proteins. Nevertheless, all deletion mutant Env proteins were still localized in the lipid raft membranes. Furthermore, all of these mutants exhibited reduced membrane fusion ability, especially, the membrane fusion ability of the three deletion mutants were almost abrogated to the background level. Three color dye transfer assays showed that deletion of the entire LWYIK would arrest viral entry at hemifusion whereas deletion of the YI or IK two dipeptides impaired the step of fusion pore enlargement. Conclusions: Our study shows that localization of Env in lipid rafts is not sufficient for Env-mediated membrane fusion. The results also demonstrate that the immediate membrane-proximal LWYIK motif is not necessary for Env maturation or incorporation into the virus, but does play a critical role in membrane fusion by promoting formation of a functional fusion pore. MOAAO104 CXCR4 antagonist-induced coreceptor switch from X4 to R5 phenotype in vitro determined by a single amino acid substitution in the V3 region of human immunodeficiency virus type 1 gpl20 Y. Maeda, K. Yusa, S. Harada. Kumamoto University, Graduate School of Medical Sciences, Department of Medical Virology, Kumamoto, Japan Background: The disease progression of HIV-1 infection is largely associated with a switch of coreceptor usage by HIV-1 from CCR5 to CXCR4. However, the coreceptor switch has not been well reproduced in vitro under the selection pressure of CCR5 or CXCR4 antagonists. Methods: For the selection of coreceptor switch mutants, an R5X4 variant (89.6 strain) was passaged in the presence of a CXCR4 antagonist T140 using PM1/CCR5 cell line which is highly susceptible to R5 variants. Results: An isolated mutant harbored a single amino acid substitution in the V3 region of the Env (Arginine 308 to Serine, R308S). Luciferase-reporter HIV-1 pseudotyped with the mutant Env showed that the substitution totally conferred resistance to CXCR4 antagonists but increased sensitivity to a CCR5 antagonist TAK-779 in the infection of the cells expressing both CCR5 and CXCR4. Analyses using the cells expressing a single coreceptor showed that the virus with the mutation predominantly utilized CCR5 with retaining CXCR4 usage, and had higher affinity for CCR5 than CXCR4. Conclusions: These results indicated that the coreceptor switch from X4 to R5 MOAAO105 The mechanism of HIV-1 escape from small molecule CCR5 antagonists P. Pugach, S. Kuhmann, T. Ketas, J.P. Moore. Weill Medical College of Cornell University, Microbiology and Immunology, New York, United States Background: CCR5 is the principal coreceptor used by the strains of HIV-1 that dominate early infection, and is a major target for development of a new drug class. Two small molecule CCR5 inhibitors, Maraviroc and Vicriviroc, are now in advanced clinical trials in HIV-infected people, and have demonstrated antiviral efficacy. To date, escape from them has not been demonstrated in vivo, but it can be anticipated. Methods: We have studied how HIV-1 escapes from small molecule CCR5 inhibitors in vitro, by creating resistant viruses and studying their properties. Results: We report that the drug-resistant viruses have acquired the ability to utilize CCR5 in its inhibitor-bound form. Thus the viruses resistant to the small molecule inhibitors are sensitive to inhibition by PSC-RANTES, but they become significantly resistant to this chemokine derivative when a small molecule inhibitor is also present. In single-round replication assays the drug escape variants exhibit characteristic resistance "plateaus" (e.g., at a maximum of 80% inhibition). Conclusions: We interpret these findings to indicate that the resistant viruses are utilizing CCR5 receptors to which the small molecule have already bound XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  2 Monday 14 August rat bstract Sessions in a way that blocks PSC-RANTES binding. The appearance of "plateaus" of incomplete resistance suggests that these viruses utilize drug-bound CCR5 less efficiently than drug-free receptors. MOAAO201 Probing the promiscuity of the HIV-1 neutralizing 2F5 antibody J.-P. Julien', Bryson S., Pai E.F.. University of Toronto, Biochemistry, Toronto, Canada Background: The HIV-1 neutralizing antibody 2F5 recognizes an epitope consisting of amino acids 662-668 located at the membrane-proximal region of the gp41 protein, which is responsible for the membrane fusion mechanism of HIV-1. Thus far, efforts to induce an immunologic response by stimulating 2F5 antibody production from peptide-like molecules mimicking the B13-turn structure of the antigen ELDKWAS have failed. Methods: In this study, the crystal structures of peptide molecules mutated, elongated and constrained at key positions of the ELDKWAS antigen in complex with the 2F5 antibody are studied. Results: It is observed from structures with and without peptide that three key waters are present around the epitope, which are thought to be important for antigen-antibody interaction. In addition, interpretation of the interactions at the C-terminus of the elongated antigen with the 2F5 antibody is limited because of crystal packing interactions that are present in that region. Finally, significant interactions of the side chains in the 3-turn are identified from the mutated antigen structures, and results from mutations at the alanine 667 position are particularly interesting because they help in partially understanding the escape of clade C HIV-1 isolates from 2F5 neutralization. Conclusions: The results presented here give new insights in the structurebased design of a peptide-like molecule potentially capable of stimulating 2F5 antibody production and help in the bigger quest of creating a potent vaccine for HIV-1. MOAAO203 The E2DISP antigen display system: a novel HIV vaccine approach D.N. Lauman'1, A. Caivano2, G. Domingo3, L. Meoli2, S. Thomas4, W.F. Sutton5, M.-K. Kaja4, N.L. Haigwood', P. De Berardinis2, N. Doria-Rose5. 'University of Washington, Molecular and Cellular Biology Program, Seattle, United States, 2National Research Council, Institute of Protein Biochemistry, Naples, Italy, 3Program for Appropriate Technology in Health (PATH), Seattle, United States, 4University of Washington, Department of Immunology, Seattle, United States, sSeattle Biomedical Research Institute, Seattle, United States Background: It is widely accepted that an ideal HIV vaccine should elicit broad and robust cytotoxic T lymphocyte (CTL) and neutralizing antibody (NAb) responses. The E2 protein from Geobacillus stearothermophilus selfassembles into a virus-like 60-mer particle (1.5 MDa). Preliminary evidence from our group has shown that a novel antigen display system, E2DISP, can be engineered to display the HIV Gag-p17 protein or a T helper epitope from reverse transcriptase (pep23). Both self-assembling particles elicited both antibodies and CTL in HLA-A2 transgenic mice. Methods: E2DISP was engineered to display HIV peptides or proteins as N-terminal fusions to E2, with up to 60 copies of one ("pure") or multiple ("hybrid") antigens on a single particle. We have expressed as stable E2DISP fusion proteins large domains of HIV Env, Gag, Pol, Nef and Rev ranging in size from 5 to 20 kDa. Purification by ion-exchange chromatography and gel filtration yields up to 3 mg of E2DISP-HIV fusion protein per liter of bacterial culture. Results: E2Gag-p17 particles elicit robust anti-HIV antibody responses in C57BL6XBalb/C mice following immunization with either pure E2Gag-p17 or hybrid E2Gag-p17-pep23 particles adjuvanted with IFA. Responses were effectively boosted after two doses. Cellular responses were undetectable using intracellular cytokine staining following stimulation of splenic cells with pooled Gag peptides. Conclusions: Both pure and hybrid E2DISP-HIV particles are immunogenic in non-transgenic mice. The successful boosting of HIV-specific antibodies despite the presence of antibodies to the E2DISP backbone suggests that higher titer responses may be elicited with additional immunizations. Future studies will evaluate the immunogenicity of E2Env, E2Nef and E2Rev constructs, and alternative adjuvants will be used to enhance CTL responses. Generation of NAbs will be evaluated following immunizations with E2Env constructs, such as E2Env-gp41EC, which contains a target of broad NAbs, the Membrane Proximal External Region. MOAAO204 Vaccine-relevant mimotopes selected with neutralizing IgG present in plasma from long-term non-progressors (LTNP) by phage display *M. Humbert', S. Antoni', M. Landersz', B. Rodes2, V. Soriano2, H. Knechten3, S. Staszewski4, D. von Laer', M. Dittmar', U. Dietrich'. 'Georg-Speyer-Haus, Molecular Virology, Frankfurt, Germany, 2Instituto de Salud Carlos III, Madrid, Spain, 3Praxiszentrum Blondelstr., Aachen, Germany, 4JW Goethe University Hospital, Division of Infectious Diseases, Frankfurt, Germany, 5Hygiene Institute, Virology, Heidelberg, Germany Background: Non-progressive disease is a hallmark of LTNPs and the underlying control mechanisms are multifactorial including viral, cellular and immunological factors. Here we focus on the role of neutralizing antibodies for the LTNP status and aim at the identification of the corresponding epitopes as potential vaccine candidates. Methods: Neutralizing antibodies in our LTNP sera were detected by in vitro neutralization assays using recombinant repoter HIV-1 and U87-CCR5/CXCR4 cells. For the biopannings, LTNP IgG were immobilized and screened with 3 phage displayed peptide libraries. After several rounds of positive and negative selection, mimotopes were tested by ELISA for specificity. Sequences of peptide inserts were determined and analyzed for homology to HIV-1 proteins by 3DEX, a program we developed for the identification of conformational epitopes. Phages grouped according to peptide similarity were used for immunizations of mice to prove the induction of neutralizing antibodies against HIV-1 by the selected mimotopes. Results: Our LTNP sera contained broadly neutralizing antibodies against HIV1 with titers significantly higher than those in control sera. More than 1400 phage clones selected with LTNP IgG were analyzed by ELISA, more than 700 phage inserts were sequenced. We could identify motifs corresponding to the immunodominant epitopes in HIV-1 Env, but also interesting conformational epitopes overlapping with receptor binding sites on the surface of gp120. Sera from mice immunized with ceratin phage groups showed neutralizing activity against HIV-1 in vitro proving that the phage mimotopes indeed mimic epitopes for neutralizing antibodies. Conclusions: The phage display technology was successfully applied to identify HIV-1 specific mimotopes for neutralizing antibodies supposed to have a protective role in LTNP. These mimotopes represent candidates for the derivation of vaccine-relevant immunogens. This work is supported by the Deutsche Forschungsgemeinschaft, the German AIDS research award and the Dr. Bodo Sponholz-Stiftung. MOAAO205 Maternal neutralizing antibodies to a CRF01_AE primary isolate are associated with low intra-partum transmission of HIV-1 in Thailand T. Samleerat', G. Jourdain2, M. Braibant', N. Ngo-Giang-Huong', M. Lallement2, P. Leechanachai4, S. Sirithadthamrong', V. Surasaerneewongse6, B. Warachit', S. Hotrawarikarn8, F. Barin3. 'University F Rabelais, Tours, France; Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand, 'Harvard University, IRD 054; Institut de Recherche pour le Developpement, UMI 174, Chiang Mai, Thailand, 3Universite F Rabelais, Tours, France, 4Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand, 5Banglamung Hospital, Chonburi, Thailand, 6Bhumibol Adulyadej Hospital, Bangkok, Thailand, 'Hat Yai Hospital, Songkla, Thailand, 'Klaeng Hospital, Rayong, Thailand Background: Mother-to-child transmission of HIV-1 (MTCT) may provide a model to study the role of passively-acquired antibodies in preventing HIV infection. We previously found an association between high levels of neutralizing antibodies (NAb) toward a CRF01 AE primary isolate (MBA) and a lower rate of intra-partum transmission of HIV-1 in Thai women (Barin et al., JID 2006, in press). The present study was conducted in order to confirm this observation. Methods: We used sera collected in a clinical trial assessing various zidovudine durations for the prevention MTCT in Thailand (no breastfeeding). We matched 45 transmitting (cases) to 45 non-transmitting mothers (controls) on baseline maternal viral load and duration of maternal zidovudine prophylaxis, the two main independent factors associated with MTCT. Neutralization titers towards 6 primary isolates of clades B (FRO, BIG, CHA) and CRF01 AE (MBA, LEA, C1712) were determined by a neutralization assay using CD4+CXCR4+CCR5+ HeLa cells. Results: MTCT was only associated with undetectable or low NAb titers against MBA (p=0.009). When restricting the analysis to intra-partum or in utero transmitters and their controls, the only association that remained significant was between low level of Nab to MBA and risk of intra-partum transmission (p=0.046). Conclusions: Our analysis confirmed our previous observation that high levels of NAb to MBA were associated with low risk of MTCT, and this was mainly due to a lower risk of intra-partum transmission. Such data support the hypothesis that passive immunization could be efficient in preventing MTCT. Further studies are needed to understand why levels of Nab to MBA are more relevant to MTCT than other Nab. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  3 MOAAO206 MOAB0102 Loop deletions in gpl20 expose the CD4 binding site Characteristics of people living with HIV-1 (PLWH) for improved binding of 1b12 and F105 antibodies screened for isoniazid preventive therapy (IPT) - Botswana, 2004-2005 I. Berkower, Y. Ni, C. Patel, A. Spadaccini. Center for Biologics, FDA, Division of Viral Products, Office of Vaccine Research, Bethesda, MD, United States Background: HIV-infected humans make broadly crossreactive neutralizing antibodies specific for the CD4 binding site on gpl20. Vaccines based on native gpl20 fail to elicit similar antibodies. Native gpl20 may cover up this site to prevent antibody induction. Methods: Based on the 3D structure of gpl20, we have identified four conserved loops that project into the CD4 binding site and may partially block antibody binding or may interfere with induction of antibodies to this site. Each loop was deleted by quick change PCR, expressed as virus-like particles in a baculovirus system, and partially purified by sedimentation through sucrose. The amount of antigen was normalized by 2G12 binding, and exposure of the CD4 binding site was determined with a panel of monoclonals and CD4-Ig. Results: Three phenotypes were observed: one mutant abrogated binding of both 1b12 and CD4-Ig, one removed 1b12 completely but had no effect on CD4-Ig, and one enhanced 1b12 binding, with minimal effect on CD4-Ig. F105 binding was enhanced even more. Conclusions: These results suggest that naturally occurring features of the gpl20 structure may inhibit antibody binding and reduce the induction of antibodies to the CD4 binding site. These structures can be removed without upsetting the overall conformation. Exposure of the CD4 binding site could occur by reducing steric hindrance or through an allosteric effect on the excursion between open and closed forms of the protein, as occurs during CD4 binding. Open forms of gpl20 bearing an exposed CD4 binding site may favor the induction of broadly cross-reactive neutralizing antibodies. Track B MOAB0101 ELISPOTs in the detection of Mycobacterium tuberculosis infection in a population with high prevalence of HIV and high exposure to BCG and environmental mycobacteria 3. Mutsvangwal, E.L. Corbett2, K. Chaka-Boyd3, R. Vundla4, J. Muzangwa4, T. Mavhudzi4, Y. Cheung5, P.R. Mason6, K. Millington', K. Ewer', A. Lalvani7, A.E. Butterworth'. 'Biomedical Research and Training Institute, Harare, Zimbabwe, 2London School of Hygiene and Tropical Medicine & Biomedical Research and Training Institute, Department of Infectious Diseases, Harare, Zimbabwe, 3Biomedical Research and Training Institute, Laboratories, Harare, Zimbabwe, 4Biomedical Research and Training Institute, DetecTB, Harare, Zimbabwe, 5London School of Hygiene and Tropical Medicine, London, United Kingdom, 'Biomedical Research and Training Institute & University of Zimbabwe, Harare, Zimbabwe, 'Nuffield Department of Clinical Medicine, University of Oxford, Clinical Medicine, Oxford, United Kingdom, 8Biomedical Research and Training Institute & London School of Hygiene and Tropical Medicine, Department of Infectious Diseases, Harare, Zimbabwe Background: The tuberculin skin test (TST) remains the gold standard for the detection of new or latent infections with Mycobacterium tuberculosis (MTB), but has low sensitivity in HIV-infected subjects and lacks specificity in individuals vaccinated with BCG or exposed to environmental mycobacteria. The interferon-gamma ELISPOT response to peptides of defined MTB antigens has shown superior sensitivity and specificity in a number of settings. In this study we have compared TSTs and ELISPOTs among factory workers and their household contacts. Methods: Index cases (IX, n=75) and their household contacts (IXC, n=114) were recruited through a site-randomised study of VCT and health care delivery in factories in Harare. Index controls (CT, n=71) and their household contacts (CTC, n=85) were randomly selected from the same factories. TSTs were compared with ELISPOT responses to peptides and recombinant antigens of ESAT-6 and CFP10 (RD1 responses) and to PPD. Results: Positive TSTs and PPD responses were significantly more frequent than positive RD1 responses, both overall (TST 71%, PPD 83%, RD1 59%, p<0.001) and by case status. HIV prevalence was 79%, 32%, 18% and 9% among IX, IXC, CT and CTC respectively. TST and PPD responses were significantly lower among HIV+ than HIV- subjects, both overall (TST, 46% vs 79%, p<0.001: PPD, 61% vs 94%) and by case status. In contrast, RD1 responses were not affected by HIV status (overall, 59% positive for both HIV+ and HIV-). Conclusions: A proportion of positive TSTs and PPD responses may be attributable to exposure to organisms other than MTB. Both TSTs and PPD ELISPOTs are substantially reduced in HIV-infected individuals, whereas RD1 ELISPOTs are unaffected. Thus, this study supports that the RD1 ELISPOT is a useful marker of MTB infection in individuals from areas with a high prevalence of HIV infection and high exposure to BCG or cross-reactive environmental mycobacteria. T. Samandari', B. Mosimaneotsile2, S. Nyirenda3, T. Agizew2, O. Motsamai4, P.H. Kilmarxs, E.A. Talbot', C.D. Wells'. 'CDC/BOTUSA, Division of TB Elimination, Gaborone, Botswana, 2BOTUSA, Gaborone, Botswana, 3BOTUSA, Francistown, Botswana, 4Ministry of Health, National TB Programme, Gaborone, Botswana, 5CDC, Division of HIV/AIDS Prevention, Atlanta, United States, 6CDC, Division of TB Elimination, Atlanta, United States Background: IPT aims to prevent active tuberculosis (TB) among PLWH in TB-endemic countries. Because of high rates of both TB and HIV, Botswana rolled out an IPT program nationwide by mid-2004. This analysis aims to better inform national IPT programs about characteristics of PLWH seeking IPT from data derived from an ongoing clinical trial that recruited at the same sites as the Botswana National IPT Program. Methods: PLWH were referred largely from local clinics and voluntary counseling and testing centers, and were screened in two parts. First-round screening followed guidelines set by Botswana's National IPT Program; exclusion criteria included any current illness, terminal AIDS, or recent TB treatment. If not excluded, candidates underwent second-round (trial-related) screening: exclusion criteria included abnormal chest radiographs (CXRs), elevated hepatic enzymes, significant neutropenia, or anemia. Results: Between January-December 2005, 3,458 persons (65% female; median age 33 years) underwent first-round screening. Of these, 987 (28%) were excluded; the most frequent reasons were current illness (51%) and recent TB treatment (8%). Of the PLWH who underwent first-round screening, 2,261 persons (65%) proceeded to second-round screening. Of these 511 (23% of second-round subjects) were excluded; the most frequent reasons were abnormal CXRs (50%) and neutropenia (20%). Of the original 3,458 who underwent first-round screening, 1,499 (43%) were enrolled for the trial. Among enrollees, 25% had tuberculin skin tests with >5 mm induration, median CD4 lymphocyte count was 313 cells/mm3 and 18% were already receiving highly active antiretroviral therapy. Conclusions: Many PLWH seeking IPT in Botswana have advanced HIV disease, and were ineligible for IPT due to current illness at first-round screening or an abnormal CXR in second-round screening. As these exclusions were most likely related to advanced HIV disease, national IPT programs may best target candidates for IPT by targeting HIV screening to healthier individuals. MOAB0103 Factors associated with multidrug-resistant tuberculosis in HIV-infected patients, Peru D. Vargas'1, A. Bernab&2, R.H. Gilman3, V. Kawail, G. Soto1, D.A. Moore', L. Caviedes4, C.T. Bautistas, M. Tovar', V. Chavez', L. Huaroto6, E. Ticona6, C.A. Evans'. 1NGO PRISMA, Research, Lima, Peru, 2Cayetano Heredia University, Epidemiology, Sexually Transmitted Diseases and HIV Unit, Lima, Peru, 3NGO PRISMA, Public Health School, Lima, Peru, 4NGO PRISMA, Laboratory, Lima, Peru, sNGO PRISMA, Statisitics, Lima, Peru, 6Dos de Mayo Hospital, Lima, Peru Background: To evaluate factors associated with multidrug resistant tuberculosis (MDR-TB) in patients with HIV infection. Methods: A longitudinal observational study was undertaken at the Dos de Mayo Hospital (Lima) between May 1999 and December 2004. All patients were HIV positive adults and had tuberculosis cultured from sputum. Tuberculosis susceptibility to isoniazid and rifampicin was determined by testing the diagnostic, pre-treatment sample. The factors associated with MDR-TB at the time of diagnosis were calculated using logistic regression analysis. Results: A total of 209 subjects were enrolled, 165 (79%) were males and the mean age was 32 years (standard deviation 8.0). CD4 was measured for 166 (79%) and the median was 44 cells/pl (inter-quartile range 15-118). The MDR-TB prevalence in these patients was 34% and an additional 20 (9.6%) of patients had tuberculosis resistant only to isoniazid. 180 (81%) were sputum microscopy positive but this was not associated with MDR-TB (P=0.8). In the multivariate analysis, the risk factors significantly associated with MDR-TB were: previous anti-tuberculosis chemoprophylaxis, odds ratio (OR)= 4.8 (95% confidence intervals (CI), 2.2 - 11), hospital admissions during the two years prior to this episode, OR= 2.9 (95% CI, 1.2 - 6.9) and known close contact with another tuberculosis patient, OR= 3.9 (95% CI, 1.6 - 9.9). MDR-TB was not significantly associated with the presence of a BCG scar, OR= 0.65 (95% CI, 0.30 - 1.4), past tuberculosis therapy, OR= 1.8 (95% CI, 0.91 - 3.4) or CD4 count, OR= 1.9 (95% CI, 0.77 - 4.6). Conclusions: Amongst this population of HIV-positive subjects, the risk factors associated with MDR-TB were previous anti-tuberculosis chemoprophylaxis with isoniazid, recent hospital admission and the close contact witn another tuberculosis patient. These results emphasize the importance of ruling-out active tuberculosis before administering isoniazid preventive therapy and optimizing infection control practices to prevent nosocomial and domiciliary dissemination of MDR-TB. Monday 14 August Oral XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  4 MOAB0104 MOAB0106 Tuberculosis incidence and risk factors among adult Blood based methods of identifying tuberculous patients receiving HAART in Senegal: infections in high HIV/TB incidence areas a 7-year cohort study A. Diouf', J.-F. Etard2, I. Ndiaye3, N.F. Ngom Gueye4, P.M. Gueye5, K. Ba Fall5, M. Thierry-Mieg2, A.B. Dieng', V. Cilote6, I. Laniece6, L. Christian2, P.S. Sow3, I. Ndoye6, E. Delaporte2, ANRS 1290. 'Centre Hospitalier National de Fann, Centre rdgional de recherche et de formation VIH/sida-ANRS, Dakar, Senegal, 2Institut de Recherche pour le Ddveloppement, UMR 145, Montpellier, France, 3Centre Hospitalier National de Fann, Service des maladies infectieuses, Dakar, Senegal, 'Centre Hospitalier National de Fann, Centre de traitement ambulatoire, Dakar, Senegal, 5Hopital Principal de Dakar, Service Jamot, Dakar, Senegal, 6Conseil National de Lutte contre le Sida, Dakar, Senegal Background: tuberculosis is a leading cause of death among HIV-1 infected adults receiving HAART in Senegal. Methods: tuberculosis incidence was assessed in the patients enrolled between August 1998 and April 2002 in the Senegalese antiretroviral drug access initiative. Patients were included according to the consensus reports on HAART in Africa issued in 1997 and 2000. First-line regimen combined two NRTIs and either a NNRTI or a PI. Follow-up visits were done every two months with a complete biological assessment every six months. Cases of tuberculosis were ascertained by examining the patient clinical files. Survival analysis were performed. Results: 397 patients (54.7% women) were enrolled in the study and were followed for a median of 46 months (interquartile range: 32-57 months) after HAART initiation for a total of 1403 person-years as of September 30, 2005. At baseline, 5% were ART non-naive, 39% and 55% were respectively at CDC stage B and C, median age, CD4 count and viral load were respectively 37 years, 128 cells/ L and 5.2 log cp/mL. More than a fourth of the patients had a previous history of tuberculosis and 47 incident cases of tuberculosis were recorded after HAART initiation, yielding to an overall incidence rate of 3.2/100 person-years [95%CI 2.4 - 12.4]. Incidence rate decreased with time after starting HARRT from 6.4/100 person-years [4,2-9,6] for the first year to 3.5 [1.9-6.3] for the second year and 1,4/100 person-years [0,5-3.7] for the third year. It was associated with anaemia at baseline (haemoglobin level < 10 g/ dL). Conclusions: this study provides the first estimates of tuberculosis incidence following HAART initiation in Senegal. MOAB0105 Unmasking of mycobacteria tuberculosis in patients initiating free ARVs in an urban HIV clinic in Kampala Uganda B. Wanderal, C. Kigonya2, A. Kambugu3, D. Thomas4, M.R. Kamyas. 'Infectious Diseases Institute, Makerere University Medical School, Adult Infectious diseases institute, Kampala, Uganda, 2Infectious Diseases Institute, Makerere University Medical School, Adult Infectious diseases institute., Kampala, Uganda, 3Infectious Diseases Institute, Makerere University Medical School, Adult Infectious diseases Clinic, Kampala, Uganda, 41Johns Hopkins Medical Institutions, Baltimore, United States, 5Makerere University Medical School, Department of Medicine, Kampala, Uganda Background: Despite a high prevalence of TB/HIV co-infection in Sub-Saharan Africa, there is insufficient data on the incidence of TB in patients on ARV in this region. This information is important in designing effective TB/HIV control programs. Methods: Between June2004 to March 2005, 538 ARV na/ve adults, eligible to start ARVs, without evidence of TB were consecutively enrolled into a cohort and started on a free efavirenz or nevirapine based regimen in addition to stavudine/ lamivudine or zidovudine/lamivudine. At enrollment and monthly follow-up a detailed questionnaire and physical examination were done. Immunological and virological testing was done at baseline and every 12 weeks. Diagnosis and management of TB was according to national guidelines. Results: Of the 538 patients, 25 developed TB in the first year of followup while on ARVs, incidence of 46.5/1000 persons/year. Of those who developed TB, mean age was 36.9 years, 76% were females. Median baseline CD4 count was 53 cells/pl and median viral load was374025copies/ml.Median duration between start of ARVs to TB diagnosis was 17 weeks (range 3-50 weeks). 48% were pulmonary while 52 were extra pulmonary TB cases. At the time of TB diagnosis, median CD4 count was. At the time of TB diagnosis, median CD4 count was 133 cells/pI, and only 11 patients had a detectable viral load with a median of 213206 copies/ml. 19 of the 25 (78%) TB patients had their ARV regimen either discontinued or changed due possible drug-drug interactions between antiTB drugs and ARVs. Conclusions: There is an appreciable risk of unmasking of TB in patients starting ARVs in this urban HIV clinic and therefore TB and HIV treatment programs in sub Saharan Africa need to be designed in partnership. Innovative interventions are needed to control TB in HIV-infected populations. Detailed analyses and results will be discussed. M. Rangaka'1, K. Wilkinson', M. Shey2, R. Seldon', P. Mouton2, G. van Cutsem3, E. Goemare3, G. Meintjes4, G. Maartens5, R. Wilkinson6, Mycobacterial Immunology Group. 'Institute of Infectious Diseases and Molecular Medicine, Mycobacterial Immunology Group, Cape Town, South Africa, 2Institute of Infectious Diseases and Molecular Medicine, Mycobacterial Immunology Unit, Cape Town, South Africa, 3Medecins Sans Frontieres-Cape Town, Ubuntu Clinic, Site B, Cape Town, South Africa, 4GF Jooste Hospital, Department of Infectious Disease Medicine, Cape Town, South Africa, 5Groote Schuur Hospital, Department of Pharmacology, Cape Town, South Africa, 6Wellcome Trust/Institute of Infectious Diseases and Molecular Medicine, Mycobacterial Immunology Unit, Cape Town, South Africa Background: TB infection in the HIV-infected presents unique diagnostic challenges.The aim of this study was to determine in vitro reactivity to Mycobacterium tuberculosis antigens in healthy people with and without HIV infection as well as to compare in vitro reactivity with PPD TST (mantoux). Methods: In a cross-sectional design, 80 people, similar numbers being HIVinfected and uninfected, were recruited for a study that has 80% power to detect a 25% difference (or > 99% power to detect a 40% difference) in RD1 positivity at 5% significance level. The study was conducted at Ubuntu Clinic in Khayelitsha, Cape Town. VCT was the entry point for recruitment. Active TB was exclusory. Skin testing and phlebotomoy for laboratory assays were done on the first visit. Skin reactions were measured 48-72hours later. Diluted whole blood was cultured for 72 hours in the presence of various antigens of M. tb. The Interferon-gamma content of supernatants was determined by ELISA. HIVinfected participants with reactions >5mm were offered isoniazid. Results: Figurel showing percentage of individuals with positive IFN-gamma responses to ESAT6 family of antigens by TSI cut off point z~ 1.i " PSPD 0 E AT6 ~] T"BIO. 53% were positive by skin test and the high rate of in vitro reactivity to M. tuberculosis antigens accords well with likely latent infection in this group. In the skin test negative group, 83% HIV infected persons reacted to either ESAT-6 or CFP-10, a similar rate to that found in the HIV uninfected group. Figure 2: Interfron-gamma secretion in response to PPD and to three antigens secreted by replicating Mycobacterinmn tuberculosis. PPD ESAT6 a v y E Rsy a v a innu a. HIV non-HIV HIV no"nIV Group p=0.0004 oroup CFP0O TB10.3 ~*. 4i - H non-I 1-- V non-IV Group Group The results show that whilst the in vitro response to PPD is clearly depressed in HIVinfected people, the response to antigens actively secreted by replicating M. th. is less affected [Median IFN-gamma responses] Conclusions: Compared to HIV uninfected, the recall response to PPD in HIVinfected people is impaired. By contrast, the responses to antigens secreted by dividing M. tuberculosis are well preserved. This has implications for immunodiagnosis: There is a role for RD1 assays in the HIV context and these tests may identify more people for TB prophylaxis. HIV may not quite be the Achilles' heel of T cell based assays! XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  5 MOAB0201 MOABO203 Children enrolled in a public HIV care and treatment Outcomes of children, stratified by immune status, program in Lusaka, Zambia: rapid scale-up and first- receiving antiretroviral therapy (ART) in Medecins year clinical outcomes Sans Frontieres (MSF)-supported projects in resource-poor countries (RPCS M. Mbewel, C. Bolton', J. Levy', M. Sinkala2, M. Bultery J. Stringer', A. Dumas', N. Chintu', E. Stringer'. 'Centr Disease Research in Zambia, Lusaka, Zambia, 2Lusaka Management Team, Lusaka, Zambia, 3U.S. CDC-GAP, L 4Elizabeth Glaser Pediatric AIDS Foundation, Washingto Background: Access to and uptake of pediatric HIV can resource-limited settings remain inadequate, with few WHO target that 10% of patients on antiretroviral thera Methods: Pediatric ART services are provided in prim ART eligibility is based on WHO staging and age-based diagnosis is limited; most children <18 months start ti nria. Results: Between May-04 and Oct-05, 1815 childrena 1319 (629 girls, 690 boys) initiated ART. Median age wa <5% weight-for-age. Mean CD4+ at ART initiation was <1 year; 484 (+390) for children age 1-5 years; and 2 >6 years. Initial regimens included: 545(41%) ZDV+ D4T+3TC +NVP; 48(3.6%) ZDV+3TC +EFV; 68(5.2% 48(3.6%) other regimens..- - m lr-L-: 1 - - -- W'%FqbGffmm EWk.P lksko %0%.Fo,s, B. Chi, C. Wilfert4, e for Infectious Urban District Health usaka, Zambia, n, D.C., United States D. Olson', D. Sauvageot2, L. Ferradini2, D. O' Brien3, P. Humblet4, The MSF AIDS Working Group. 'Medecins Sans Frontieres, New York, United States, 2Epicentre, Paris, France, 3Medecins Sans Frontieres, Amsterdam, Netherlands, 4Medecins Sans Frontieres, Brussels, Belgium e and treatment in most Background: Despite scale-up of ART in RPCs, treatment of children lags programs meeting the behind that of adults. Globally, less than 5% of eligible children receive ART. py (ART) be children. Those who do tend to be older and data on treatment outcomes of younger ary government clinics, children in RPCs remain scarce. i CD4 criteria. Virologic Methods: A retrospective analysis was performed of baseline characteristics herapy on clinical crite- and treatment outcomes in MSF-supported HIV-treatment projects collected with FUCHIA database software (Epicentre, Paris). There were 15 projects in sere enrolled. Of these, Africa, Asia, and Central America. Results for children aged 18 to 59 months as 6.5 years; 74% were were grouped according to pre-ART immunosupression (IS): Profound IS (CD4 650 (+520) for children < 5%) or Severe IS (5% < CD4 < 15%). 254 (~234) for children Results: Data on 195 children were available for analysis. 98% were ART-naive 3TC +NVP; 610(46%) and 95% received an NNRTI-based regimen. 49 (45% female) had baseline ) D4T+3TC +EFV; and Profound IS with median age of 45.6 months (IQR: 36-52); 28.6 and 54.8% were CDC clinical stage B and C, respectively. There were 146 (41% female) with Severe IS, with median age of 37.3 months (28.9-48.5); 30.8 and 35.3% were clinical stage B and C, respectively. Two-thirds of each cohort had received >6 years (n=742) ART less than 12 months, while 14 and 20% in the Profound and Severe IS groups, respectively, had been on ART for 12-24 months. Probability of survival 6 months 12 months (not deceased or lost to follow-up) was 0.85 (0.71-0.93) at both 6 and 12 months in the Profound IS group, and 0.95 (0.93-0.99), 0.94 (0.88-0.97), 0.85 242 305 (0.69-0.83) at 6, 12, and 24 months in the Severe IS group. At 6 months, (+310) (+370) median CD4% was 11.8 (9.9-17.4) and 20.6 (15.2-25.7) and median CD4% gain was 11.5 (8.1-14.9) and 11.5 (7.4-15.4) in the two groups, respectively. <1 year (n=53) 1-5 years (n=524) 6 months 12 months 6 months 12 months Mean change in (422348) CD4 count (448) Mean change in hemoglobin 393 337 (+581) (+516) 0.27 0.00 1.12 1.25 (+2.27) (+3.76) (+2.28) (+1.70) Over 664 child-years on ART, 60 children died (9.0/100 child-years). In Cox proportional hazard modeling, WHO stage III or IV (HR 3.0; CI 1.7-5.7) and low CD4 (HR 2.4; CI 1.1-5.4) were predictors of mortality on ART. Weight-forage <5%, adherence, gender, and TB at enrollment were not associated with death. The proportion of total ART program enrollment comprising children increased modestly from 5.8% in the first 6 months to 7.3% in the last 6 months (p<0.001). Conclusions: In this population without full access to infant HIV diagnostics, more than two-thirds of HIV-infected children presenting for care were eligible for ART. Providing quality HIV care and treatment to children on a large scale in a resource-limited setting is feasible but requires a strong commitment to pediatric care. MOABO202 Impact of free and universal access to antiretroviral treatment on the survival among Brazilian children with AIDS L.H. Matidal, A. Novaes2, J.E.C. Moncau', L.F. Marcopito', H.H.S. Marques', R.C.M. Succi3, M. Della Negras, N. Hearst', Brazilian Group of Survival Study in Children with HIV. 'National Program of STD/AIDS, Sao Paulo, Brazil, 2Federal University of Ceara-Brazil, Fortaleza, Brazil, 3Federal University of Sao Paulo, Sao Paulo, Brazil, 4University of Sao Paulo, Sao Paulo, Brazil, 5sInstitute of Infectology Emilio Ribas, Sao Paulo, Brazil, 'University of California, San Francisco, United States Issues: Besides the existing social inequality and the differences on access to health services, Brazil with his vast geographical area, offers free and universal access to antiretroviral treatment (ART) for AIDS patients. This technical and political attitude has brought substantial improvement in survival among pediatric patients with HIV, in Brazilian regions; Description: We obtained data on retrospective cohort study in 10 Brazilian cities to examine trends in diagnostics and survival with a representative sample of AIDS cases in persons younger than 13 years old listed in the Brazilian national AIDS registry with years of diagnosis between 1983 and 1998 and followed until 2002 (N for analysis = 1,154). Date of last clinical contact was used as a censor date for children not known to have died; Lessons learned: Survival time increased steadily and substantially in all regions despite the observed differences. The survival probability on 60 months after the diagnosis for the period from 1988 to 1992 was 0.246 (CI 95%: 0.150 -0.356) and it increased to 0.605 (CI 95%: 0.521-0.680) for the 1997 to 1998 period in children followed up to 2002. Among children infected by maternal transmission, the median time since birth to diagnosis was 12.2 months, and in the Northeast region this time was 18.3 months, and in the Southeast region belonged to 4.7 months. The Brazilian experience thus provides the first evidence regarding the impact of such treatment on the survival of perinatally acquired AIDS cases in the developing world; Recommendations: A free and universal access to ART, even in 4a country that lacks an ideal health infrastructure, can make a substantial difference in survival. These results argue strongly for making such treatment available to children elsewhere in the developing world. Female, % Median age (IQR), m CDC clinical stage % N A B C Duration of ART: < 12 m 12-24 m Probability of Success*: At 6 months (n, IQR) At 12 months (n, IQR) At 24 months (n, IQR) Immunologic Evolution at 6 months Median CD4% (IQR) Median gain CD4% (IQR) Profound IC (N=49) 45 45.6 (36-52) N= 42 9.5 7.1 28.6 54.8 Profound IC (N=49) 65% 14% 0.85 (31, 0.71-0.93) 0.85 (18, 0.71-0.93) N=11 11.8 (9.9-17.4) 11.5 (8.1-14.9) Severe IC (N= 146) 41 37.3 (28.9-48.5) N=133 12.0 21.8 30.8 35.3 Severe IC (N=146) 66% 20% 0.95 (91, 0.93-0.99) 0.94 (51, 0.88-0.97) 0.85 (22, 0.69-0.83) N=43 20.6 (15.2-25.7) 11.5 (7.4-15.4) Conclusions: Young children can be successfully treated with ART in RPCs, as measured by treatment continuation and immunologic criteria. Extent of baseline IS does not appear to impact on treatment outcome by month 12. MOABO2O4 Antiretroviral therapy (ART) outcomes in children < 13 years of age in resource-poor countries (RPCs): a medecins sans frontieres (MSF) cohort D. Olson', D. Sauvageot2, L. Ferradini2, P. Humblet3, the MSF AIDS Working Group. 'Doctors Without Borders/MSF, New York, United States, 2Epicentre, Paris, France, 3Medecins Sans Frontieres, Brussels, Belgium Background: Initiatives to increase the number of people under ART in RPCs (WHO 3 x 5, PEPFAR) have tended to focus on the adult AIDS patient. Globally, less than 5 % of eligible children are on ART and data on outcomes for pediatric therapy in RPCs are limited. Methods: A retrospective analysis was performed for baseline characteristics and treatment outcomes in MSF-supported HIV programs, using FUCHIA database software (Epicentre, Paris, France). 22 projects in Asia, Africa, the Caribbean, and Central America are represented. Results: Data on 1824 children < 13 years of age (48.4% female) were analyzed. At ART initiation, median age was 5.9 years, 84.5% (652/772) had a CD4 < 15%, and 35.7% and 43.2% were CDC clinical stages B and C, XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  6 Monday 14 August O-al ALstr ct Sessioris respectively. > 98% received NNRTI-based ART. 71.1% had been on ART < 12 months, while 22.2% and 6.8% were under therapy for 12-24 months and > 24 months, respectively. Overall, mortality on ART was 6.0% and lost to follow-up (LFU) was 4.3%. Probability of survival on ART (not deceased or LFU) at 6, 12, 18, and 24 months was 0.91 (IQR: 0.90-0.93), 0.88 (0.86-0.90), 0.86 (0.84 -0.88), and 0.84 (0.80-0.87), respectively. Median CD4% and CD4% gain at 6 months were 17.5 (11.1-24.5) and 8.9 (5.4-13.6); at 12 months: 20.2 (14.2 -27.7) and 11.4 (4.4-16.9); at 18 months: 21.5 (12.2-28.4) and 13.8 (5.7 -20.0); and at 24 months: 19.8 (11.2-27.6) and 12.5 (5.2-19.1), respectively. 4.3% (79/1824) had at least one drug stopped due to side effects. Conclusions: In RPCs, children < 13 years of age appear to do well on ART, based on survival and immunologic criteria, with a low incidence of significant adverse side effects. Continuing efforts at treatment scale-up should include increased attention on ART for children. MOABO205 Forecasting HIV treatment needs in children to guide policy, planning and scale up: a multi-country experience from India, Malawi, Cameroon, Rwanda and Cote d'Ivoire N. Ngashi', C. Luo1, D. Mulenga2, K. Little3, R. Gass'. 'United Nations Children's Fund (UNICEF), Health, New York, United States, 2United Nations Children's Fund (UNICEF), HIV/AIDS, New York, United States, 3Institute of Child Health, Epidemiology, London, United Kingdom Background: Globally, less than 5% of people receiving ART are children (WHO 2005). Factors of low access include lack of appropriate drug formulations, diagnostic technologies and competencies to treat children. Furthermore, countries lack estimates of the number of HIV-infected children eligible for HIV treatment from a life cycle approach. UNICEF supported the estimation of disease burden and treatment needs in five countries. Methods: The London Institute of Child Health developed for UNICEF, a model for estimating the number of children eligible for HIV treatment, based on WHO clinical criteria, HIV prevalence in ANC settings, MTCT rates, infant and child mortality rates, and access to PMTCT services, cotrimoxazole prophylaxis and ART. The model was validated in Rwanda, Cameroon, Cote d'Ivoire, Malawi and India, in collaboration with country epidemiologists, WHO and UNAIDS. Results: In India, 2% (616) out of 27,300 children requiring ART receive it, 4% (1,149/28,000) children in Malawi, 5% (427/9,000) in Cameroon, 11% (710/6,400) in Rwanda and 13% (2,309/18,400) in Cote d'Ivoire. With the exception of Cote d'Ivoire and Malawi, cotrimoxazole prophylaxis is not included in the package of scaled up care interventions for children in all countries. The model demonstrated that cotrimoxazole prophylaxis could reduce child mortality by 43% (36.8% vs. 21%). Where early infant diagnosis is available, further mortality reductions could be achieved with a combination of cotrimoxazole and ART: from 36.8% to 12.4% by year one and 75% to 26% by year 10. Conclusions: National programs have started using this information to revise national policies on pediatric care and to define realistic population-based targets, scale up plans and strategies for achieving these targets. The estimation of country-specific burden of disease and treatment needs is a powerful tool for advocacy and scale up planning and should be roll out. MOABO301 by decreasing differences in developmental functioning between HIV+ and HIVchildren during the first three years of life. MOABO302 Neurocognitive impairment, symptomatic peripheral neuropathy and depression are highly prevalent in HIV-infected outpatients within the Asia Pacific region: findings of the Asia Pacific NeuroAIDS consortium (APNAC) study E. Wright', B. Brew2, S. Kongsaengdao3, A. Arayawithchanont4, K. Samintarapunyas, D. Imran', W. Lun', A. Kamarulzaman', P. Li', G. Tau", S. Vonthanak", C. Sarim", S. Huffam", K. Kishore2, S.T. Ali'3, K. Robertson4, L. Lals, M. Lim"s, D. Devadsons, P. Bain2, R. Dwyer'16, G. McCormack', C. Scholten', C. Cherry", J. McArthur'', S. Wesselingh". 'The Alfred Hospital, Melbourne, Australia, 2St Vincent's Hospital, Sydney, Australia, 3Rajavithi Hospital, Bangkok, Thailand, 4Sappasithiprasong Hospital, Ubon Ratchathani, Thailand, sLampang Hospital, Lampang, Thailand, 6Cipto Mangunkusomo Hospital, Jakarta, Indonesia, 7Ditan Hospital, Beijing, China, "University of Malaya Medical Centre, Kuala Lumpur, Malaysia, 9Queen Elizabeth Hospital, Hong Kong, Hong Kong, "Port Moresby Hospital, Port Moresby, Papua New Guinea, "National Centre HIV/AIDS, Dermatology and STD, Phnom Penh, Cambodia, 2Fiji School Medicine, Suva, Fiji, "3Ministry of Health, Suva, Fiji, 14University of North Carolina at Chapel Hill, Chapel Hill, United States, "Burnet Institute, Melbourne, Australia, 16Monash University, Melbourne, Australia, "Johns Hopkins School Medicine, Baltimore, United States Background: The prevalence of HIV-related neurocognitive impairment (NCI) in the AP region is unknown. HIV dementia and symptomatic peripheral neuropathy (PN) are reportedly uncommon. APNAC undertook a cross-sectional study in 8 countries of the region to determine prevalence of NCI and PN. Study hypothesis: NCI and PN are prevalent but under-diagnosed. Results from sites in Thailand, Indonesia, China and Malaysia are presented. Methods: HIV positive outpatients were screened for NCI, PN and depression. The neurocognitive test battery comprised grooved pegboard, finger tapper, timed gait and category fluency. NCI definition: normal: all tests > -1SD; equivocal: <-1SD on 1 test; mild-moderate: <-ISD on 2 tests, or <-2SD on 1 test, up to -4SD total; severe: >-4SD. Results were analysed using US and APNAC site control norms. The ACTG PN screening tool was used. Definite PN: symptoms + vibration at great toes <10 seconds + absent ankle reflexes; probable PN (pPN): symptoms + one of remaining 2 criteria. CES-D 20 was used for depression screening. Student t-tests and tests for comparison of proportions were used. Results: 504 outpatients were enrolled and 220 evaluated: median age 33 years; male 73%; median CD4 cell count 177/mL; prior AIDS 61%; 148/220 patients (67%) were receiving HAART with 37% receiving didanosine, stavudine, or both. Mild-moderate and severe NCI were found in 24% and 64% patients, respectively. PN and pPN were found in 6.3% and 52% patients, respectively. 32% of patients reached the CES-D cutoff. Patients with severe NCI were older and had lower nadir CD4 counts than those without NCI (p<0.05). Patients with pPN were significantly likelier to have used dideoxynucleosides than those without PN (p<0.05). <5% of patients received pain relief or antidepressants. Conclusions: HIV-related NCI, symptomatic PN and depression are common under-diagnosed conditions in HIV-infected outpatients at sites in Thailand, Indonesia, China and Malaysia and require further study Neurodevelopmental functioning in HIV-infected children before and after the introduction of highly active antiretroviral therapy (HAART) OAB303 Trends and risk factors for community-acquired J. Lindsey', K. Malee2, P. Brouwers3, M. Hughes'. 'Center for Biostatistics in AIDS Research, Biostatistics, Harvard School of Public Health, Boston, United States, 2Children's Memorial Hospital/Northwestern University Feinberg School of Medicine, Infectious Diseases/Child and Adolescent Psychiatry, Chicago, United States, 3Division of AIDS & Health and Behavior Research NIMH, NIH, Center for Mental Health Research on AIDS, Rockville, United States Background: Recent investigations suggest a reduced prevalence of encephalopathy in HIV-infected (HIV+) children. Howeverthe factors responsible for this decline remain unclear. Early use of highly active antiretroviral therapy (HAART) in children has improved survival and immunologic status. The purpose of this investigation was to determine the impact of protease inhibitor (PI)-containing HAART regimens on neurodevelopmental functioning during the first three years of life. Methods: This study examined profiles of neurodevelopmental functioning, as measured by the Bayley Scales of Infant Development, in children participating in a cohort of long-term outcomes (PACTG 219C). Random effects models were used to compare mental and motor functioning during the first three years of life by HIV infection status and before and after initiating HAART with a PI. Results: In the pre-HAART era (before 6/1997), mean mental (85) and motor (77) scores in HIV+ (n=54) infants less than one year of age were significantly lower than among HIV- infants (105 and 107, n=221) and remained lower up to two years, with similar negative trajectories. After HAART became available, the mean mental (85) and motor (83) functioning of HIV+ infants (n=91) before one year of age were still significantly lower than that of HIV- infants (92 and 90, n=838). However, against a not unexpected background of declining scores among the HIV- infants (-6.2 points/yr for mental scores and -1.4 points/yr for motor scores), there was evidence of limited improvement in the HIV+ infants relative to their un-infected peers (declines of only -3.2 points/yr for mental scores (p=0.01) and increases of +1.2 points/yr for motor scores (p=0.03)). Conclusions: Suppression of HIV-1 RNA levels and subsequent benefits in survival and immunologic status brought about by HAART have been followed pneumonia among HIV-lnfected and HIv-unlnTected intravenous drug users K. Stein', J. Astemborski2, S. Mehta2, D. Vlahov3, N. Galai2, G. Kirk2. 'Johns Hopkins University, Department of Medicine, Baltimore, United States, 2Johns Hopkins University, Department of Epidemiology, Baltimore, United States, 3New York Academy of Medicine, New York, United States Background: Both HIV infection and injection drug use increase risk for community-acquired pneumonia (CAP). We examined CAP diagnoses among HIV-infected and uninfected injection drug users (IDUs) in the ALIVE study. Methods: From1988 to 2004, bacterial CAP diagnoses were confirmed through record abstraction to have radiographic infiltrates and at least 1 finding of productive cough, fever, or leukocytosis; 38% had positive sputum or blood cultures. Cox time-dependent regression models were used to estimate risk for initial CAP diagnosis. Results: Among 2,833 IDUs (1,150 HIV-infected and 1,683 HIV-uninfected), 346 developed CAP; 273 were HIV-infected and 73 HIV-uninfected. CAP incidence rates declined from the pre-HAART (1988-1996) to early (1997-2000) and current (2001-04) HAART periods (2.2/100p-yrs, 1.6/100p-yrs, 0.8/100pyrs, respectively); similar trends were observed stratified by HIV status or CD4 levels. In multivariate analyses, time-period was not significantly associated with CAP but smokers (adjRH 1.9; 95% CI, 1.3-2.8) and females (1.3; 1.0 -1.7) had increased risk. Recent injection drug use (1.5; 1.2-1.9) and related complications including prior sepsis/bacteremia (4.6; 3.1-6.8) or endocarditis (2.7; 1.8-4.1) were strongly associated with CAP, while inhaled drugs had limited effect. HIV infection was strongly associated with CAP (8.5; 6.5-11.1) with increasing risk observed with progressively lower CD4 counts. Further, HIV-infected with CD4 >500 still had significantly increased risk compared to HIV-uninfected (4.1; 2.7-6.1). CAP predictors among pre-HAART HIV-infected participants were similar to HIV-uninfected (female, smoking, heavy drug use, endocarditis/bacteremia) except for the strong CD4 effect seen in all time XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  7 periods. HAART conferred a 65% reduction (0.34; 0.17-0.69) in CAP risk. Sexual behavior variables were associated with CAP but had discordant effects by HIV status. Conclusions: CAP incidence is declining among IDUs. Among HIV-infected IDUs, CAP risk from lifestyle-related factors has diminished while effects of HIV disease status predominate. HAART greatly reduces CAP risk, but HIV-infected IDUs remain at high risk even with relatively intact immune function. MOAB0304 Increasing rates of community-acquired MRSA infections among HIV-infected persons N. Crum-Cianflone1, B. Hale2, A. Burgi, G. Utz2, A. Truett2, H. Chun2, M. Bavaro2, TriService AIDS Clinical Consortium. 'TriService AIDS Clinical Consortium, San Diego, United States, 2Naval Medical Center San Diego, San Diego, United States Background: Community-acquired (CA)-MRSA rates are rapidly increasing in the general population, but there are few data regarding the rates among HIVinfected patients and the risk factors in this population. Methods: We assessed the incidence of CA-MRSA infections from 1993-2005 in a large HIV clinic. We collected data on all patients with CA-MRSA infections receiving care at our facility. Cases were defined as patients with a positive MRSA culture without a history of recent (<1 year) hospitalization. We compared HIV patients with MRSA to HIV patients without MRSA in terms of demographics, antibiotic and antiretroviral history, CD4 counts, viral loads, and STDs using Fisher's exact and rank-sum testing. A backward stepwise multivariate logistic regression model was constructed to determine risk factors for CA-MRSA. Results: Among 425 HIV patients, 25 (5.9%) developed CA-MRSA. All cases occurred after 2002, with a 17-fold increase from 2003 to 2005 (Chi-square test of trend 15.7, p<0.001). The annual incidence in 2005 among HIV patients was 40 cases/1000 person-years compared to 741 cases/325,000 (or 2.28/1000) among HIV-negative persons (18 fold higher rate). All HIV-infected patients developed soft-tissue infections, 16% required hospitalization, 67% had a positive nares cultures, 0% were taking Septra prophylaxis, and 56% HAART. Sixteen percent had relapsing MRSA infections despite appropriate initial antibiotics. In the univariate analyses, lower current CD4 count, CDC stage C, history of syphilis, and B-lactam antibiotics in the past year were predictive of MRSA; there were no associations with demographics, diabetes, or HAART. In the multivariate analysis, recent use of B-lactam antibiotics (p=0.04) and syphilis (p=0.02) predicted CA-MRSA infections in HIV patients. Conclusions: Community-acquired MRSA infections are rapidly increasing among HIV-infected patients. HIV patients have a 18-fold higher risk for CAMRSA than the general population. Risk factors for CA-MRSA include recent use of B-lactam antibiotics and high-risk sexual activity as demonstrated by syphilis infection. MOABO305 Study of immune reconstitution inflammatory syndrome (IRIS) in resource limited settings M. Bhrushundi, P. Mishra. Lata Mangeshkar Hopital, Nagpur, India Background: With increase access to ARTthere is going to be rise in cases of IRIS. Methods: The study was carried out at private set up in Central India. ART was initiated as per WHO guidelines after treating suspected and diagnosed opportunistic infections. During the follow up, cases that showed signs of deterioration after starting ART were carefully examined and investigated. Those cases that had significant increase in CD 4+T-helper cells were included in the study. All the cases were counseled specifically for symptomatology of IRIS. Results: Of 720 who was started on ART 68(9.44%) had IRIS. Mean CD+Thelper cell count in these cases was 45/cmm as against 125cell/cmm in those who did not develop IRIS. Mean CD4+ increase was 50/cmm. Of 68 IRIS cases 42(61.76%) had TB IRIS, 10(14.7%) cases had PCP, 8(11.76%) had Cryptococcal meningitis, 4(5.88%) cases had CMV retinitis, 2(2.94%) had Toxoplasma encephalitis and each case (1.47%) of Hepatitis C and Progressive multifocal leukoencephalopathy. Of 42 cases of TB IRIS, 36 had extra-pulmonary TB. One each case of PCP and Cryptococcal meningitis died during the study. Conclusions: After initiating ART in individuals with low CD4+T-helper cells, meticulous follow up and patients awareness can detect the IRIS early. TB IRIS tops too followed by PCP. IRIS increases cost of the treatment especially with CMV, Hepatitis C and Cryptococcal meningitis IRIS.IRIS can have fetal outcome also. MOAB0401 A pilot randomized trial of nutritional supplementation in food insecure patients receiving antiretroviral therapy (ART) in Zambia K. Megazzini', S. Washington', M. Sinkala2, S. Lawson-Marriott', E. Stringer', D. Krebs', J. Levy', B. Chi', R. Cantrell', I. Zulu4, L. Mulengal, J. Stringer'. 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia, 2Lusaka Urban District Health Management Team, Lusaka, Zambia, 3World Food Programme, Lusaka, Zambia, 4University Teaching Hospital, Medicine, Lusaka, Zambia Background: In many parts of sub-Saharan Africa, where the need for ART is most urgent, there is also widespread hunger. Whether food supplementation can improve clinical and adherence outcomes of food insecure populations on ART has been widely debated, but not yet tested. Methods: In the context of a home-based adherence support program attached to 8 government clinics in Lusaka, we randomly assigned 4 clinics to provide a monthly household food ration (micronutrient-fortified corn-soya blend, from World Food Programme) to food insecure patients starting ART; 4 clinics served as controls. Weight and CD4+ change were measured at 6 and 12 months. Adherence was assessed by timeliness of pharmacy visits. Results: At baseline, the median age, BMI, CD4+ count, WHO stage, hemoglobin, or gender distribution did not differ significantly between 375 food recipients versus 161 non-recipients. For those receiving food, median number of rations received was 9 (IQR: 6-10); median time between starting ART and first ration was 70 days (IQR: 44-125). We observed negligible differences in weight gain (kg) at 6 months (+5.6 vs. +5.0; p=0.48) and 12 months (+6.2 vs. +5.5; p=0.44) between food recipients and non-recipients. However, food recipients had a substantially greater increase in CD4+ count at 12 months than did non-recipients (+185 vs. +113; p=0.017). The mean number of days late for pharmacy visits per month was lower among food recipients versus non-recipients (2.4 vs. 3.4; p=0.008). Both the CD4+ and adherence findings remained statistically significant in multivariate analyses adjusting for sex, WHO Stage, and BMI at entry. Conclusions: In this pilot study, a monthly household food ration for food insecure patients commencing ART improved adherence by 40% and resulted in a better CD4+ response at 12 months of therapy. Further study is warranted of food supplementation as an adjunct to ART in food insecure patients. MOABO402 Micronutrient supplementation increases CD4 count in HIV-infected individuals on HAART: a prospective, double-blinded, placebo-controlled trial J. Kaiser', M. Baum2, A. Campa2, J. Ondercin3, G. Leoung4, R. Plesss. 'University of California at San Francisco Medical School, Medicine, San Francisco, United States, 2Florida International University, Nutrition, Miami, United States, 'The Jonathan Lax Treatment Center, Philadelphia, United States, 4Saint Francis Memorial Hospital, HIV Care, San Francisco, United States, sOvation Research Group, Highland Park, United States Background: This is a prospective, randomized, double-blinded, placebocontrolled trial designed to examine the immunologic, metabolic, and clinical effects of a micronutrient supplement in HIV-infected patients currently taking highly active antiretroviral therapy (HAART). Methods: Forty HIV-infected patients taking a stavudine and/or didanosinebased HAART regimen were prospectively randomized to receive micronutrients or placebo twice daily for 12-weeks. Data was collected at 4-week intervals including immunologic, metabolic, and clinical measurements. Endpoints included measuring the micronutrient's effect on several immunologic, metabolic, and clinical parameters, as well as on the symptom of distal symmetrical polyneuropathy (DSP). 7O 6as 7,0 -0 the micronutrient group versus a 6 cell decline in the placebo group at 12 -va. 1 30 - weeks (P=0.029 IT-). The absolute CD4 count rose by an average of 240/a in the micronutrient group versus a 0% change in the placebo group (P=0.01 ITT). Peripheral neuropathy symptoms also declined to a greater extent in the micronutrient than placebo groups though this difference was not statistically significant at 12-weeks. Fasting serum glucose, insulin, and lipids were not adversely affected in the patients taking the micronutrients. Conclusions: Micronutrient supplementation can significantly improve CD4 cell count reconstitution in HIV-infected patients taking HAART. The micronutrient supplement tested was well-tolerated and may hold promise as an adjuvant therapy in the treatment of HIV. Further investigation is warranted. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  8 Monday 14 August Oral Abstract Sessions MOABO403 MOABO405 The role of selenium as adjunct to haart among Impact of HIV status on patterns of mortality HIV-infected individuals who are advanced in their in HIV-infected severely malnourished children, disease admitted to 3 nutrition rehabilitation units in the central region of Malawi N.N. Odunukwel, D. Onwujekwel, O.O. Ezechi', P. Ezobi', T. Gbajabiamila', R. Anyanwu', E. Iloka1, R. Adu', O. Nwogbe', R. Audu', E. Herbertson', E.O. Idigbe', P. Kanki2. 'Nigerian Institute of Medical Research, Clinical Science Division, Yaba, Nigeria, 2Harvard School of Public Health, Boston, United States Background: In developing countries, HIV-1 infection impact on people is devastating. Poor nutrition and HIV-related adverse health outcomes contribute to a vicious cycle that should be slowed down by nutritional supplements. Past studies document decreased levels of antioxidants and selenium in people living with HIV/AIDS. Low serum micronutrient levels in HIV-positive individuals have been associated with immune impairment, disease progression, and increased mortality. This study examined the role of selenium supplement among HIV-positive individuals who were advanced in their disease and are receiving HAART. Methods: A follow-up study of all HIV positive individuals with advanced disease recruited for HAART programme between February 2002 and June 2005. One hundred and seventy were on HAART plus Selenium supplement and 170 were on HAART only. Their viral load, CD4 cell count, Haematological and Biochemical indices were analysed at base line and 12 weekly intervals. At each visit adherence and nutritional counselling were given. Data generated were analysed using SPSS statistical software Results: Of the 340 subjects recruited, 66% had CD4 cell counts < 50cells/pl. A comparison between those on HAART plus Selenium and those on HAART only showed that the rate of CD4 cell recovery was higher among the HAART plus Selenium group. The median CD4count increments from baseline to 64 weeks were +120cells/pl and +50cells/pl (P=0.02). Less hospital visits for treatment of Ols were recorded for individuals on HAART plus Selenium compare to those on HAART only. Weight gain was significantly higher in Selenium group (P 0.004). Median Haemoglobin increments from baseline to 64 weeks were +30g/l and +10g/I (Plus Selenium and non Selenium groups respectively).The median time for undetectable viral load was similar for the two groups (P 50.2). Conclusions: Selenium supplementation resulted in higher CD4. This supports Selenium supplement as an adjunct to HAART in HIV positive individuals with severe immune suppression. MOABO404 Growth and body composition in children beginning or changing antiretroviral therapy C. Chantry', M. Hughes2, C. Alvero2, J. Cervia3, J. Hodge4, P. Borum5, J. Moye6, PACTG 1010. 'University of California Davis Medical Center, Pediatrics, Sacramento, California, United States, 2Harvard School of Public Health, Center for Biostatistics in AIDS Research, Boston, Mass, United States, 3Albert Einstein College of Medicine, Clinical Medicine and Pediatrics, East Hills, New York, United States, 4Frontier Science & Technology Research Foundation, Amherst, New York, United States, 5University of Florida, Food Science and Human Nutrition, Gainesville, Fla, United States, 6NIH, NICHD, Bethesda, Maryland, United States Background: Determinants of growth and body composition in HIV+ children on antiretroviral therapy (ART) are poorly understood. Objectives of this study were to describe changes in growth and body composition in HIV+ children after initiating or changing ART and correlate these changes with viral load (VL) and CD4%; and to describe changes in and correlates of insulin-like growth factor-1 (IGF-1) and binding proteins-1 and - 3 (IGFBP-1 and -3). Methods: A prospective, observational study of 100 HIV+ children ages 1 mo to <13 yrs over 48 wks upon beginning or changing ART. Criteria included: a) beginning any ART if nalve, b) beginning protease inhibitor (PI) if PI naive, or c) changing ART with 2 new drugs. Anthropometry and bioelectrical impedance analysis at wks 0-48 were compared to age/sex/race-matched controls from NHANES to generate z-scores. Plasma VL, CD4%, IGF-1 and IGFBP-1 and -3 were measured. Multivariable stepwise regression identified significant correlates of z-score changes. Results: All anthropometric and BIA measures of lean and fat mass were significantly below age/sex/race-adjusted norms; weight, height, and total body water (TBW) z-scores increased significantly over the study. In multivariate analysis, both lean and fat mass measures increased more with lower entry CD4% [wt, p=0.003; triceps skinfold, p=0.010; body mass index (BMI), p=0.002; TBW, p=0.049]. BMI and % body fat z-scores increased more in PI-naive children. Body composition changes were not associated with virologic response, increase in CD4%, or current ART class. IGF-1 increased (p=0.020) while IGFBP-i decreased (p=0.007). Conclusions: HIV+ children beginning or changing ART demonstrate greater gains in weight, height and lean mass than age/sex/race-adjusted norms. Baseline characteristics, but not virologic response to therapy, immune reconstitution nor specific ART class(es) in the new regimen are associated with growth or body composition changes. IGF-1 increases and IGFBP-1 decreases in these children may relate physiologically to growth and body composition changes. J. Chinkhumbal, P. Fergusson2, S. Thurstans', G. Nyirendal, H. Mafupal, A. Tomkins4. 'Action Against Hunger, HIV research, Lilongwe, Malawi, 2Action Against Hunger, University of Chester, HIV and nutrition, Chester, United Kingdom, 3Action Against Hunger, HIV and nutrition, Lilongwe, Malawi, 4Institute of Child Health, London, United Kingdom Background: The objective of the study was to ascertain the impact HIV status has on death patterns in severely malnourished children admitted for therapeutic feeding in Nutrition Rehabilitation Units (NRUs). Methods: A nested study auditing deaths in a cohort of 295 severely malnourished children recruited over a ten month period. Upon admission, all severely malnourished children were treated with F75/F100. Routine medical care including systematic antibiotics and anti- malarials was provided. Upon discharge, the children received supplementary rations for 16 weeks. Results: Overall mortality was 15.9% (47/295). Mean age on admission was 22 months (range 7-52), Average number of days from admission to death was 19 days (range 0-170). HIV positive children had a mean admission of 20 days (SD39.6) compared with 11.7 days (SD22) for HIV negative children. Overall HIV prevalence was 17%. 50% of children who died were HIV positive: 65% male and 38% female. 67% of HIV positive children were marasmic compared to 33% in HIV negative children (P<0.05). 47% of HIV positive children had Kwashiorkor compared to 53 % of HIV negative children (P >0.05). 67% of the HIV positive children died in phase 1 compared to 33% HIV negative (P<0.05). No marked differences existed among transitional and phase two nor was there a significant difference as to whether a child died in the hospital or home. Conclusions: HIV positive severely malnourished children have a greater risk of dying in early rehabilitation and the average admission in the NRU is nearly twice as long in HIV positive children than HIV negative. There is need for prompt referral of malnourished children to NRUs and need for early identification of HIV status in children and caretakers for essential access to HIV treatment. More effective treatment regimes for HIV positive children in early rehabilitation need to be developed and tested. Track C MOACO101 Surveillance of HIV prevalence among populations of men who have sex with men in Thailand, 2003-2005 F. van Griensven', A. Varangrat2, S. Naorat2, C. Sinthuwattanawibool2, J.M. McNicholl', P.A. Mock2, T. Siraprapasiri2, R. Jommaroeng3, P. Phanuphak4, J.W. Tapperos, the Thailand MSM Study Group. 'Thailand MOPH-U.S. CDC Collaboration, Nonthaburi, Thailand; Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States, 2Thailand MOPH-U.S. CDC Collaboration, Nonthaburi, Thailand, 3Thai Red Cross Society; Rainbow Sky Association of Thailand, Bangkok, Thailand, 4Thai Red Cross Society, Bangkok, Thailand, 5Thailand MOPH-U.S. CDC Collaboration, Nonthaburi, Thailand; Global AIDS Program, Centers for Disease Control and Prevention, Atlanta, GA, United States Background: HIV prevalence among Thai populations of men who have sex with men is not well described. This information is important to target and inform HIV preventive interventions. Methods: Identical cross-sectional surveys, using venue-day-time sampling, enrolled 1,121 men from Bangkok in 2003 (response rate: 90.2%) and 2,049 from Bangkok, Chiangmai and Phuket in 2005 (response rate: 97.3%). Participants were Thai, _15 years old, and had had sex with another man in the past 6 months. Palmtop computer-assisted self-interviews collected demographic and behavioral data; EIA tested oral fluid for HIV infection. Our study population consisted of general men who have sex with men (MSM), male sex workers (MSW) and transgendered persons (TG). Results: 1,121 MSM enrolled in 2003; and 821 MSM, 754 MSW, and 474 TG in 2005. In Bangkok, HIV prevalence among MSM increased from 17.3% in 2003 to 28.3% in 2005; among 22 year olds it increased from 12.9% to 22.3% and among those older from 19.1% to 30.2% (all p<0.05). Prevalence at bar/disco's increased from 13.0% to 23.0%, at parks from 16.9% to 29.6% and at saunas from 22.0/o to 319% (all p<0.01). In 2005, HIV prevalence among MSM in Chiangmai was 15.3%/ and in Phuket 5.5%/. Among MSW, HIV prevalence was 18.9% in Bangkok, 11.4% in Chiangmai and 14.4% in Phuket. HIV prevalence in TG was 11.5% in Bangkok, 17.6% in Chiangmai and 11.2% in Phuket. Conclusions: Data show that by 2005, HIV was widespread in Thai populations of men who have sex with men. Among MSM in Bangkok, HIV prevalence increased over 50% between 2003 and 2005. In 2005, more than 20%0/ of Bangkok MSM <22 years old were HIV-infected, suggesting high underlying HIV incidence. Thai populations of men who have sex with men should be considered for the implementation and evaluation of preventive interventions. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  9 MOAC0102 MOAC0104 Being positive about staying negative; the power of A theory-based, tailored, interactive intervention first person narrative in HIV prevention directed at MSM who meet sexual partners through Internet chat sites: effective for MSM who practice J. Grierson', C. Batrouney2, M. Mclean3, M. Kennedy4. '1Australian Research Centre in Sex, Health and Society, Living With HIV Program, Melbourne, Australia, 'Victorian AIDS Council/ Gay Men's Health Centre, Health Promotion Program, Melbourne, Australia, 3Victorian AIDS Council / Gay Men's Health Centre, Health Promotion Program, Claremont Street South Yarra, Australia, 'Victorian AIDS Council / Gay Men's Health Centre, Melbourne, Australia Issues: After 20 years of providing Victorian MSM with HIV prevention information, and in response to rising HIV notifications, the Victorian AIDS Council / Gay Men's Health Centre developed a multi-faceted, integrated health promotion program which included the Staying Negative campaign. Based on the aspirational and emotive techniques of advertising and social marketing, this approach moves beyond the provision of HIV prevention information and aims to motivate HIV negative MSM to value and preserve their HIV negative status. Description: Staying Negative is an integrated multi-faceted program that directly addresses the aspirational value of remaining HIV negative. Initial focus testing suggested that emphasising the benefits and positive value of HIV negativity was more effective than an approach emphasizing the negative aspects of being HIV positive. Names and faces of HIV negative men appeared in press ads, on billboards, postcards and other health promotion material with a minimum of explanatory detail. A website featuring first person narratives of the sexual histories of these men has both highlighted factors that reinforce individual decision making and strategies that have enabled them to remain HIV negative as well as those factors that compromise MSM's HIV prevention efforts (including depression, drug and alcohol use and misconceptions around sexual health). Lessons learned: An approach that promotes the aspirational value of HIV negativity has the potential to generate productive discourse and reflective practices both within the gay community and the HIV sector. Promoting HIV negativity does not stigmatise HIV positive gay men but rather creates a discursive space where multiple experiences of living within the HIV/AIDS epidemic can be expressed. Recommendations: This approach will continue informing our thinking in relation to the work of the program while allowing us a 'snapshot' of current issues facing homosexually active men (both HIV positive and negative) living in the midst of an ongoing epidemic. MOAC0103 Evaluation of a community-level peer-based HIV prevention intervention adapted for young black men who have sex with men (MSM) K. Jones', P. Gray2, T. Wang', W. Johnson', E. Foust2, E. Dunbar', The North Carolina Men's Health Initiative. 'Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention, Atlanta, GA, United States, 2North Carolina Division of Public Health, HIV/STD Prevention and Care Branch, Raleigh, NC, United States Background: Few interventions have been tested exclusively among black MSM, the group at highest risk for HIV in the US. In response to increasing HIV rates among black MSM, an adapted version of Popular Opinion Leader (POL) was evaluated. POL is a rigorously evaluated community-level intervention in which recruited opinion leaders have risk reduction conversations with their peers. The intervention has been shown effective in reducing unprotected anal intercourse (UAI) by 15-29%. Methods: To ensure that POL reflected experiences of black MSM, we conducted focus groups in September 2004. While maintaining core elements of POL, we then modified the intervention to include discussions and images, and address topics, relevant to black MSM. Using a quasi-experimental pre/ post test design without control group, we conducted quarterly cross-sectional surveys in nightclubs across North Carolina from December 2004 to December 2005. Black men, ages 18-30, reporting sex with another male in the past year were eligible for participation. We used logistic regressions to examine changes in UAI. Results: At baseline (n=284), 32.4% of the sample reported unprotected receptive anal intercourse (URAI), 29.3% reported unprotected insertive anal intercourse (UIAI), and 42.0% reported any UAI. We found significant reductions for URAI at 4 months (n=287) and 8 months (n=307) and for all 3 outcomes at 12 months (n=278). URAI decreased by 23.6% [to 24.7%; OR=.69, 95% Confidence Interval [CI]=(.48,.99); p=.0433] at 4 months, by 24.6% [to 24.4%; OR=.67, CI=(.47,.97); p=.0330] at 8 months, and by 44.5% [to 18.0%; OR=.46, CI=(.31,.68); p=.0001] at 12 months. At 12 months, UIAI decreased by 36.5% [to 18.6%; OR=.55, CI=(.37,.82); p=.0033] and any UAI decreased by 32.3% [to 28.5%; OR=.55, CI=(.38,.78); p=.0009]. Conclusions: We observed significant decreases after implementing the adapted intervention. We concluded that adapting evidence-based interventions is a key step in increasing the number interventions for black MSM. UAI with casual partners P. Harterink', H. Hospers2, P. Vriens', G. Kok2, O. De Zwart1. 'Municipal Public Health Service Rotterdam, Infectious Diseases Control, Rotterdam, Netherlands, 2Maastricht University, Psychology, Maastricht, Netherlands Background: Almost half the Dutch MSM use the Internet for chatting and dating. Current Internet interventions for HIV prevention are seldom linked to popular commercial chat sites, hardly ever make use of interactivity and are rarely theory based. We therefore developed and evaluated a theory-based tailored interactive intervention that was linked directly to Chatboy, the most popular Dutch gay chat site. Methods: Using the Intervention Mapping protocol, we developed the intervention "GAY CRUISE", tailoring it to age and sexual experience and focusing on psychosocial determinants. Participants registered with their email address through Chatboy and were randomised to the intervention group or control group. Virtual agents guided participants through the intervention, giving personalised feedback. Follow-up was at three months. Results: The intervention group contained 2,886 respondents; the control group had 2,731. Response at follow-up was high: 39% (intervention group) and 44% (control group). The mean age was 33 years, 14% was of mixed or non-Dutch ethnicity, and 49% had a steady partner. 57% had met casual sex partners online in the previous three months. Of those, 66% had anal sex in that period, of whom 64% used condoms consistently. A comparison of the intervention group with the control group in the full sample shows no significant effects on condom use with casual sex partners. However, the intervention was effective for men who had been having unprotected anal intercourse (UAI) with casual partners at pre-test. The level of UAI at post-test was significantly lower in the intervention group than in the control group (45% versus 55%, respectively; p<0.05). 93% of the participants indicated they would appreciate having a tool within the chat programme that could indicate their wish to have safer sex. Conclusions: Interactive tailored interventions linked to chat sites can be an effective instrument in HIV prevention for MSM who practice UAI with casual partners. MOACOIO5 HIV serosorting? Increases in sexually transmitted infections and risk behavior without concurrent increase in HIV incidence among men who have sex with men in San Francisco H.M. Truong', T. Kellogg2, J. Klausner2, M. Katz2, J. Dilley2, K. Knapper3, S. Chen2, R. Prabhu2, R. Grant4, B. Louie2, W. Mc Farland2. 1University of California, San Francisco, Center for AIDS Prevention Studies, San Francisco, United States, 2San Francisco Department of Public Health, San Francisco, United States, 3The STOP AIDS Project, San Francisco, United States, 4Gladstone Institute of Virology and Immunology, San Francisco, United States Background: Sexually transmitted infections (STI) and unprotected anal intercourse (UAI) have been increasing among men who have sex with men (MSM) in San Francisco. However, HIV incidence has stabilized. We evaluated recent trends in sexual risk behavior, STI, and HIV incidence to assess whether increases in HIV serosorting (i.e., selective unprotected sex with partners of the same HIV serostatus) may contribute to preventing further expansion of the epidemic. Methods: The study applies an ecological approach and follows the principles of Second Generation HIV Surveillance. Temporal trends in biological and behavioral measures were assessed using multiple pre-existing data sources: STI case reporting, prevention outreach programmatic data, and voluntary HIV counseling and testing data. Results: Reported STI cases rose from 1998 through 2003. Rectal gonorrhea cases increased from 158 to 311 while early syphilis increased from 8 to 314. UAI increased overall from 1998 to 2004 (p<0.001) in community-based surveys; however, UAI with partners of unknown HIV serostatus decreased overall (p<0.001) among HIV-negative MSM, and among HIV-positive MSM declined from 30.7% in 2001 to a low of 21.0% in 2004 (p<0.001). UAI (any, receptive, insertive) with a known HIV-positive partner decreased overall from 1998 to 2004 (p<0.001) among MSM at HIV testing programs. HIV incidence using the serological testing algorithm for recent HIV seroconversion (STARHS) peaked in 1999 at anonymous testing sites (4.1%) and the STI clinic confidential testing program (4.8%), with rates leveling off through 2004. Conclusions: HIV incidence among MSM appears to have stabilized at a plateau following several years of resurgence. Increases in the selection of sexual partners of concordant HIV serostatus may be contributing to the stabilization of the epidemic. However, current incidence rates of STI and HIV remain high. Moreover, a strategy of risk reduction by HIV serosorting can be severely limited by imperfect knowledge of one's own and one's partners' serostatus. Monday 14 August Oral Abstract Sessions XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  10 MOACO201 MOACO203 Assessing a national HIV behavior change campaign An evaluation of a quasi-experimental community focusing on multiple concurrent partnerships in level HIV intervention among out-of-school youth in Swaziland 26 communities in Nigeria D. Halperin', N. Andersson2, M. Mavuso3, B. George4. IUSAID, Southern Africa HIV-AIDS Program, Mbabane, Swaziland, 2Centro de Investigaci6n de Enfermedades Tropicales (CIET), Acapulco, Mexico, 3United Nations Family Planning Association, Mbabane, Swaziland, 4Centers for Disease Control (CDC), Monitoring and Evaluation, Pretoria, South Africa Background: Swaziland is currently experiencing the world's most severe HIV epidemic, at over 40% in pregnant women (2004 survey). Researchers, planners and donors increasingly consider the pervasive pattern of concurrent multiple partnerships to be a key epidemiological driver in the spread of HIV, especially in such high prevalence, generalized epidemics (Halperin and Epstein, Lancet 2004). A government national multi-media campaign proposed to generate increased awareness on this issue in the hope of eventually reducing HIV risktaking behavior and associated social norms. Methods: A baseline survey was conducted to explore sexual attitudes and social norms of behavior among over 2000 adults in 12 randomly selected communities (4 urban and 8 rural), just prior to the launch in June 2005 of the government (NERCHA)-led behavior change communication campaign. A follow-up survey of over 2000 adults in the same communities in June 2006 measured the potential contribution of and processes involved in the campaign (recognizing that other significant behavior change efforts may also have impacted on behavioral patterns and norms). In addition, three rounds of intensive focus group discussions were held in each of the 12 communities (one for each gender, or 72 groups in total). Results: The large majority of respondents in the baseline survey and the first two focus group rounds reported that "lishendes", or multiple concurrent partners, were "very common" or "common" in their communities. Over the course of the study, a substantial number of people reported that such behaviors were detrimental for the HIV-AIDS crisis, and considerable numbers of them, especially females, felt that "choosing to have only one partner" could/ should be an important prevention approach for the country's fight against the deadly epidemic. Conclusions: The study ended up helping guide the development of the government BCC campaign, and could also help inform similar such behavior change interventions carried out elsewhere in the region. MOACO202 Exposure to a community-mobilization intervention and HIV-related knowledge, attitudes, and practices, Botswana, 2003 T. Koppenhaver', D. Fleming2, B. Meyerson3, A. Robbins3, G.S. Kebonang4, T.H. Roels', P.H. Kilmarxs. 1BOTUSA Project, Global AIDS Program, Gaborone, Botswana, 2BOTUSA Project, Gaborone, Botswana, 3National Alliance of State and Territorial AIDS Directors (NASTAD), Washington, United States, 4Humana People to People / Total Community Mobilization, Gaborone, Botswana, 5Centers for Disease Control and Prevention (CDC), Atlanta, United States Background: The Total Community Mobilization (TCM) program is a doorto-door intervention which delivers HIV prevention and treatment-related information to households in Botswana. We examine the association of exposure to TCM with selected indicators of HIV/AIDS-related knowledge, attitudes, and practices (KAP). Methods: Our data come from a cross-sectional household survey, which interviewed 807 15-to 49-year-old Batswana in seven of Botswana's 22 health districts in 2003. At this time, TCM was operating in five of these seven health districts. We used bivariate and multivariate analyses to compare KAP outcomes among those individuals with reported TCM exposure (defined as having ever spoken with someone from TCM, either in a group or individually) to those without. Results: In the five TCM-active health districts, 23% of respondents reported exposure to TCM. Controlling for demographics and regularly listening to an HIV/AIDS education-entertainment radio drama, TCM exposure was significantly (p<.05) associated with spontaneously mentioning abstinence (adjusted odds ratio (AOR) 1.99) and condom use (AOR 2.96) as HIV prevention methods. TCM exposure was similarly associated with knowing that it's possible to prevent mother-to-child transmission (MTCT) and that AZT is a means of preventing MTCT, but not with spontaneously mentioning the three modes of transmission (pregnancy, delivery, and breastfeeding). On four of six separate questions about stigma, TCM exposure was significantly associated with non-stigmatizing responses (AORs from 1.44 to 9.12). Further, TCM-exposed individuals were twice as likely as the unexposed to report having been tested for HIV (AOR 1.96, p<.01). However, TCM-exposed individuals were no more likely to report abstaining, not having concurrent sex partners, or using condoms with noncohabiting partners. Conclusions: These findings suggest that TCM has helped to improve HIVprevention knowledge, reduce stigma, and encourage testing in Botswana. The lack of association between TCM exposure and targeted sexual behaviors indicates that important behavior-change challenges remain. J. Anyanti, G. Omoregie, A. Ankomah, S. Adebayo, A. Buba-Vaganda. Society for Family Health, Research and Evaluation, Abuja, Nigeria Background: In developing countries, a major issue with HIV interventions is the failure to attribute programme success to programme interventions. Promoting Sexual and Reproductive Health and HIV/AIDS (PSRHH) is a seven year DFID and USAID funded programme, which was designed as an 18 -month quasi experimental design to test whether young persons (15-24) at intervention sites were more likely to use condoms compared with the control sites. This paper presents the key findings from the study. Methods: Thirteen most at risk intervention sites spread across Nigeria's six health zones were purposively selected along with 13 matched controls. Data were collected from 1741 respondents prior to implementation and from 1713 respondents 18 months later based on multistage probability sampling design. The main intervention was the Peer Education Plus (PEP) model consisting of innovative peer education, edutainment and special interventions among 'influencers' of young persons. Multivariate statistical methods were used to investigate whether changes in condom use will be significantly higher at intervention than control sites even after controlling for selected population characteristics. Results: While there was no significant change at the control sites, (from 58% in 2002 to 55% in 2004, p > 0.05), at the intervention sites the proportion of females that used condoms in last non-marital sex increased significantly from 54% to 69% (p< 0.05). For males too, the programme was effective in significantly increasing the proportion of young males who used condoms in last risky sex from 64% to 75% (p< 0.05). The change in control communities was not significant. Conclusions: For both males and females, the PEP interventions were effective in increasing condom use at the intervention but not the control sites. The model is therefore recommended as an effective tool and can be scaled up at similar sites throughout Nigeria and elsewhere. MOACO204 Changes in sexual behavior and risk of HIV transmission after two years of antiretroviral therapy and prevention interventions in rural Uganda R. Bunnell', N. Wamai2, J.P. Ekwaru1, D. Moore2, W. Were2, S. Bechangel, A. Coutinho3, E. Madraa4, J. Mermin'. 'CDC-Uganda, Global AIDS Program, CDC/HHS, GAP-Uganda, Entebbe, Uganda, 2CDC-Uganda, HBAC, Tororo, Uganda, 3The AIDS Support Organisation (TASO), Kampala, Uganda, 4Ministry of Health, AIDS Control Programme, Kampala, Uganda Background: The long-term impact of antiretroviral therapy (ART) on sexual HIV transmission risk among HIV-infected persons in Africa is unknown. We assessed changes in sexual behavior and estimated HIV transmission from HIVinfected adults after 2 years of ART in Tororo, Uganda. Methods: Between May 2003 and December 2004 we enrolled and followed 926 drug-naive HIV-infected adults in a home-based AIDS care program that included HIV prevention counseling, voluntary counseling and testing (VCT) for cohabitating partners and condom provision. At baseline and follow-up, we assessed participants' HIV plasma viral load and partner-specific sexual behaviors. We defined risky sex as intercourse with inconsistent or no condom use with partners of HIV-negative or unknown serostatus in the previous 3 months. We compared risky sex rates using a Poisson regression model and estimated transmission risk per partner based on established viral load-specific transmission rates. Sero-conversion rates among cohabitating sero-discordant partners with laboratory results were assessed at 24 months. Results: By January 2006, 454 (49%) participants had reached 24 months of follow-up. Sexual activity increased from 28% at baseline to 38% (p<0.001) (women: 21%-31%; men: 47-61%) at 24 months. The proportion of sexually active participants reporting any risky sex decreased from 22% to 15% (p=.062). Median viral load among those reporting risky sex was 122,500 copies/ml at baseline and undetectable at follow-up. At 2 years, the reduction in estimated risk of HIV transmission from cohort members was 98%, from 45.7 to 1.0 per 1000 person years. One sero-conversion occurred within 62 cohabitating sero-discordant partners during 1st year of therapy; no seroconversions occurred in the second year. Conclusions: Providing ART and on-going prevention interventions was associated with a reduced estimated risk of HIV transmission among HIVinfected Ugandan adults after two years of therapy, despite an increase in overall sexual activity. Integrated ART and prevention programs may reduce HIV transmission in Africa. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  11 MOACO205 MOACO302 Life in the fastlane: testing the efficacy of a The Abidjan - Lagos transport corridor project: behavioral intervention to reduce high risk sexual a regional strategy to combat STIs/HIV/AIDS behaviors among HIV-negative, heterosexual spread by mobile population along migratory routes methamphetamine users T.L. Patterson1, B. Mausbach', S.J. Semple', J. Zians', S. Strathdee2. 'University of California, San Diego, Department of Psychiatry, La Jolla, California, United States, 2University of California, San Diego, Department of Family and Preventive Medicine, La Jolla, California, United States Background: Methamphetamine use has become widespread in the U.S. and is associated with high risk sexual behaviors. We examined efficacy of a psychosocial intervention to reduce unprotected sex among HI\-negative, heterosexual methamphetamine users in San Diego, CA. Methods: HIV-negative, heterosexual men or women aged >18 years who reported unprotected sex during the past two months and had snorted/smoked methamphetamine at least twice in the past two months completed ACASI surveys and were randomized to either: 1) four weekly 90-minute individual counseling sessions based on motivational interviewing with theory-based principles (i.e., social-cognitive theory, theory of reasoned action) to develop insights into motivations/triggers for unsafe sex and methamphetamine use; 2) condition 1 above plus four monthly 90-minute safer sex "maintenance" counseling sessions; and 3) diet-nutrition attention-control condition (DNT). Linear regression was used to compare individual counseling (i.e., Fastlane) to DNT on change for both intentions for safer sex and the ratio protected sex acts to total sex acts between baseline and six months. Results: Of 383 participants, 255 were randomized to individual counseling and 128 to DNT; 33% were female, 26% were African-American, 13% were Hispanic; mean age was 36; mean monthly methamphetamine used was 10 grams. No differences emerged between intervention and control subjects or those who completed the 6 month follow-up versus those who did not (p>0.05). Although only 209 subjects (56%) completed the 6 month follow-up, pre-post intervention change in protected sex acts indicated a significant intervention effect (t=2.8, df=202, p=0.006). Relative to the DNT, Fastlane subjects also had significantly greater changes in intentions for safer sex (t=3.2, df=202, p=0.001). Conclusions: Our behavioral intervention was associated with significant increases in intentions for safer sex and the percentage of total sex acts that were protected, indicating that heterosexual methamphetamine users can learn to engage in safer sex behaviors in the context of methamphetamine use. M OACO301 Experiences and reflections on delivering an HIV/AIDS programme with, and for, immigrants and mobile populations in Australia E. Katsaros, M. Eisenberg, W. Sabri, T. McMahon, S. Paljor, R. Yaman, B. Luisi, L. Kerr. Multicultural HIV/AIDS and Hepatitis C Service, Sydney, Australia Issues: Immigrants and mobile populations present challenges for delivering HIV/AIDS responses at global and national levels. In Australia, immigrants now represent 21% of HIV notifications. Among immigrants there are higher proportions of women and heterosexual men, generally lower proportions of MSM, and an over-representation of people from high HIV prevalence countries. There is increasing evidence of HIV inequalities in access to services, health literacy and health outcomes among immigrants. Description: The Multicultural HIV/AIDS and Hepatitis C Service has endeavoured to address these inequalities since 1991. The programme includes initiatives in community development, work with immigrant media, and bilingual/bicultural support for PLWHA within a health promotion framework implemented by a workforce from 20 cultural backgrounds. The paper will outline research among Australian immigrants and explore the strengths and weaknesses, using programme examples, of approaches to address HIV/AIDS among immigrants. Lessons learned: The programme strengths include employing a casual multicultural workforce to implement initiatives with, and for, their respective communities with cultural and linguistic appropriateness delivered "in-house", while the support provided to PLWHA feeds into broader health promotion activities. The programme has also developed a framework for prioritising specific immigrant communities within cultural diversity of Australia's population. Weaknesses include the trade-off between cultural specificity and efforts to reach multiple communities - as the programme cannot sustain intensive work with each of the 20 communities. The programme is also largely unable to address the wider social context impinging on immigrants' health such as gender issues, immigration status, and racism. Recommendations: The programme experience points towards a pragmatic and sustainable response to HIV/AIDS among multiple immigrant populations, working within the constraints of (comparatively) limited resources to deliver on the rhetoric of a "cultural and linguistic appropriate" response to HIV/AIDS. This experience may be particularly relevant to delivering HIV/AIDS responses in national programmes among immigrants and mobile populations. J. Koffi', A. Abu2, L. De Souza Padonou3. 'Abidjan-Lagos Transport Corridor Organization, Executive Secretariat, Cotonou, Benin, 2Abidjan-Lagos Transport Corridor Organization, Environment and WRHC Management, Cotonou, Benin, 3Abidjan-Lagos Transport Corridor Organization, Health, Cotonou, Bermuda Issues: Frequent movements especially across international borders expose people to the risks of contracting STI and HIV/AIDS because of their separation from spouse and usual sex partners. These mobile populations are bypassed by country specific efforts. Although regional efforts are to be preferred they are very rare. The aim of this paper is to illustrate how a multi-country and multisectoral initiative contributes towards the effective reduction of the spread of STI/HIV/AIDS along transport corridor. Description: The Abidjan - Lagos Transport Corridor is the initiative of five countries of Nigeria, Benin, Togo, Ghana and C6te d'Ivoire with the financial support of the world bank and technical assistance of UNAIDS. The project is intended to reach a population of 14 million migrants largely underserved, vulnerable groups-including transport sector workers and their clients in constant flux over an 1022 km road. The project has three components: (i) HIV/AIDS prevention services; (ii) treatment, care, support; and safe disposal of medical wastes and (iii) project coordination. Lessons learned: Regional efforts are very effective in reaching difficult population. Specifically, over 200 outlets have been established for the social marketing of condoms at every border site. Over 16 662 people have been reached by VCCT programme while the continuum of care initiative ensures that truckers and traders have access ARV and STIs treatment even when outside their country of origin. The programme gives food and educational support to 591 orphans. The average time spent at border sites has been profoundly reduced. There is a revolution in medical waste management along the corridor. Recommendations: Country specific programmes on STIs/HIV/AIDS are not suitable to reach mobile populations that traverse transport corridors. The Model described in this paper should be replicated in other transport corridors and among high risk and mobile population whose peculiar needs for prevention, care and support are beyond single country ability. MOACO303 The impact of HIV/AIDS programming for truckdrivers in Cameroon from 1997 to 2004 J.-A. Onana Ekembene', A. Dillow2, B. Cisse3, M.C. Beauchamp4. 'CARE International in Cameroon, Program, Yaounde, Cameroon, 2CARE Cameroon, Program, Yaounde, Cameroon, 3CARE Mali, Program, Bamako, Mali, 4CARE Canada, HIV/AIDS specialist, Ottawa, Canada Issues: Cameroon, located in central Africa, is a country of intense migratory movement, mostly of truckdrivers, commercial sex workers. Despite HIV prevention programs targeting mobile populations over the past decade, the HIV prevalence among truckdrivers remains high, 16% in 2004, while HIV prevalence in the general population that same year was 5.5% (truckdriver study conducted by Centre de Recherches et d'Etudes en Economie et Sondages, general population figures from DHS 2004). Description: Since 1997, CARE Cameroon has implemented two HIV/AIDS and STI prevention projects targeting truckdrivers and their sexual partners. Both projects applied the following strategies: 1. Peer education to encourage reduced-risk sexual practices including STI treatment 2. Syndromic management of STIs by health centers along key routes 3. Condom promotion at truckstops Lessons learned: Lessons Learned: Despite the challenges these projects faced, like a highly mobile and difficult-to-track target population, frequent medicine stockouts for STI treatment, and insecurity in project zones, CARE is able to show impressive results. Evaluations have shown that 49,148 persons (17,200 were truckdrivers) participated in group and individual education from 1997 to 2004. Evaluation results for activities in the east of the country show behavior change between 1997 and 2000; during this period the percentage of truckdrivers who had at least two occasional sexual partners dropped from 39.5% to 26.3% and that percentage faithful to one partner increased from 33.5% to 57.3%. Recommendations: CARE's experience working for STI and HIV prevention among mobile populations was applied recently when CARE designed a scaleup project intended to target truckdrivers and roadside communities across the country. In addition to the aforementioned strategies, this new project, to be implemented from 2005-2009 with CIDA and CARE funding, will focus on community mobilization and VCT promotion. It will work in line with updated national AIDS policies and will support recent improvements in VCT and ART availabilty. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  12 Monday 14 August Orall Abstract Sessions MOACO304 Sexual networking and HIV risk in migrant workers in India L. Gelmon', K. Singh2, P. Singh2, P. Bhattacharjee3, S. Moses4, A. Costigan2, J. Blanchards. 'Univ. Nairobi/Univ Manitoba, Medical Microbioloy, Nairobi, Kenya, 2ICHAP Project, Jaipur, Rajasthan, India, 3ICHAP Project, Bangalore, India, 4Univ Manitoba, ICHAP project, Medical Microbioloy, Winnipeg, Canada, 5Univ Manitoba, ICHAP project, Medical Microbioloy, Bangalore, India Background: The Hamara sub-project is part of the India-Canada HIV/AIDS Project (ICHAP), working with rural migrants from Rajasthan, providing prevention/care from places of origin, while in transit, and in destination places. A biological baseline in fifteen villages in 2004 revealed high levels of medically-confirmed STIs with HIV prevalences of approximately 1% (four times the state average) in migrants, non-migrants and their spouses. Further, there was evidence of high rates of sexual networking. A follow-up study documented the sexual behavior of migrants (actual, potential, returned, visiting), their spouses, sex workers and MSMs. Methods: All 133 villages in three districts of Shekhawati Region were canvassed, primary and secondary stakeholders identified, and detailed questionnaires developed, enquiring into perceptions of what was occurring in the villages. Data was collected through key informants (793), focus groups (318) and "polling booth" questionnaires (3,166). Results: There are high levels of sexual networking in the home villages as well as the places of destination, with 40%-70% of the respondents acknowledging evidence of premarital and extramarital sex by both women and men, the presence of village sex workers and MSMs. Married and unmarried migrant workers visit sex workers and/or have liaisons with local women both at home and at their places of destination. There is a relatively high rate of knowledge of STIs and HIV/AIDS but a low rate of condom utilization. Conclusions: Migration intensifies risk for contracting HIV/STIs, but the key finding is that the determinant of risk for migrant workers is prior behaviour. Migrating does not change sexual behavior, migrants take their established behavior into an environment where there is a higher rate of HIV/STIs. This is different from the commonly-accepted wisdom that being a migrant leads one to assume high-risk behaviour. Therefore migration programming has to address both the points of origin as well as the points of destination. MOACO305 HIV-related risk behaviors and history of sexually transmitted diseases among male migrants who patronize commercial sex in China B. Wang', X. Li', B. Stanton', X. Fang2, D. Line, R. Mao3. 'Wayne State University, Pediatrics, Detroit, United States, 2Beijing Normal University, Institute of Departmental Psychology, Beijing, China, 3Nanjing University, Institute of Mental Health, Nanjing, China Background: Men who pay for sexual services are at increased risk for HIV/ STD. Data on the socio-demographic and behavioral characteristics of such men in China are limited. Methods: Two cross-sectional surveys, using similar instruments, were completed among Chinese migrants in Beijing, Shanghai, and Nanjing in 2002. 1304 rural-to-urban migrant men from community settings ("community sample") and 465 migrant men attending STD clinics ("STD clinic sample") were included in the current study. Results: Ten percent of men in the community sample and 32.7% of men in the STD clinic sample reported having ever paid for sex. Nearly 20% of clients from the community sample and 60% of clients from the STD clinic sample reported a history of STDs. For both the community and STD clinic samples, working at industrial or construction sectors, multiple sexual partners, regular sex partner having sex with others, and a history of drug use were associated with being a male client. In addition, perceived peer sexual risk and perceived vulnerability to STD were associated with being a male client in the community sample, and history of STD and being tested for STD/HIV were associated with being a male client in the STD sample. Conclusions: Male migrants who paid for sex in China were vulnerable to HIV/STDs. HIV prevention efforts should target young migrant men who work at factory and construction sectors. STD clinics may be important sites for outreach and intervention efforts among male clients. MOACO3O6 Trucking against AIDS: a unique and sustainable response to HIV/AIDS by the South African road freight industry P. Matthew, B. Watson. National Bargaining Council for the Road Freight Industry, Trucking Against AIDS, Johannesburg, South Africa Issues: In South Africa, the road freight industry employs 70 000 people, of which truck drivers constitute roughly 35 000. It forms a vital part of the economy, responsible for transporting 80% of goods. Although HIV/AIDS prevalence studies vary, the impact of the disease on the industry's mobile workforce is indisputable. To prevent the spread of the disease, Trucking Against AIDS (TAA) was introduced in 2000 offering preventative and healthcare programmes to the industry. Description: TAA pioneered the concept of establishing Roadside Weliness Centres (converted shipping containers) at high-risk areas such as truck stops situated along national routes. It's a targeted industry initiative, mostly open at night and focusing mainly on drivers and commercial sex workers. Services are free and include awareness education, primary healthcare, STI treatment, VCT, food supplements and condom distribution. A partnership approach is followed, with transport companies, unions, government and international organisations (Sida) collaborating to enhance the impact of the project. The project also offers Mobile Wellness Centres, which expand its services to transport companies. Since 2000, eleven centres have been opened and three mobile centres introduced. 172937 people received awareness education; 63955 patients were treated; 27651 STIs treated and 4.8 million condoms distributed. Due to the project's success, WFP decided to use it as a model for a similar project in Malawi. Lessons learned: (1) Using "wellness centre" vs "AIDS clinic" is central to drawing the target market to utilise services. (2) Interventions that are focused and partnership-based are more effective and sustainable. (3) Employing staff from the communities around the truck stops is key to building trust and ensuring effective delivery. (4) Accessibility and convenience of services are central to the success of the project. Recommendations: (1) Services expanded to include treatment. (2) Scale up network of Roadside Wellness Centre and Mobile Wellness Centres. (3) Continual staff training. Track D MOADOI01 A qualitative study into the impact of HIV disease progression on initial HIV-serostatus disclosure to significant others C. Almeleh. AIDS and Society Research Unit, Centre for Social Science Research, University of Cape Town, Cape Town, South Africa Background: This study explores the bio-psychosocial context of HIV/AIDS in which eleven HIV-positive women negotiate the process of disclosing their positive serostatus to significant others, specifically biological household members. The study is based on the personal experiences of a group of HIV-positive peereducators in Cape Town, South Africa. Methods: The data was generated through in-depth interviews, two focusgroup discussions, ethnographic observation, and a self-administered questionnaire with eleven HIV-positive African women. The study uses data from a longitudinal-survey of people on HAART for a minimum period of one year (n = 247). Results: 72% of the sample disclosed their HIV-positive status to a close biological household member (significant-other) as significant-others provided, or had the potential to provide the necessary health-related social support. 50% of the sample did not disclose until they were sick in the later stages of HIV-disease. At this time, concerns regarding health and mortality superseded fears of rejection and discrimination due to AIDS-related stigma. The perceived potential benefits (social and health-related support) outweighed the perceived risks (ostracism and discrimination). When participants had never been sick, they disclosed in order to educate loved-ones and challenge HIV/AIDS-stigma. Conclusions: The results suggest that the unique and changing biophysical nature of HIV/AIDS lends itself to possible social and individual confusion which in-turn facilitates false popular perceptions of HIV/AIDS. HIV-positive individuals have to negotiate through the disclosure process in this particular social context. Consequently, the motivations for disclosure and the choice of recipients are based on a complex and subjective combination of countering false popular perceptions of HIV/AIDS, and accessing appropriate treatment, care and support. Further research on HIV-status disclosure in Africa needs to be conducted and theoretical models developed, where HIV/AIDS is viewed as a dynamic and changing bio-psychosocial experience in which the HIV-positive person simultaneously negotiates their way through and reproduces their individual and social contexts. MOADOIO2 Getting around disclosure: social status and support of patients enrolled in an ART programme in rural South Africa M. Fitzgerald', M. Collumbien', Z. Gumede', V. Hosegood'. 'London School of Hygiene and Tropical Medicine, Centre for Population Studies, London, United Kingdom, 'Africa Centre for Health and Population Studies, Population Studies Group, Mtubatuba, South Africa Background: Disclosure is strongly associated with the uptake of ART, adherence and HIV prevention. The ability of individuals to disclose is embedded within an emotional, social and economic context. Methods: Two in-depth interviews were undertaken with thirty patients enrolling into an ART program, the first at the onset of treatment, the second after four months. To explore the community context to participant experiences interviews were undertaken with nine lay people reported to be providing support to each of these participants in order. For an understanding of the institutional context within which treatment occurs, seven health care providers and two traditional healers were interviewed about attitudes of health staff towards patients seeking ART. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  13 Results: Individual factors associated with disclosure and support echo those previously reported; positive state of mind, sense of personal responsibility and agency, belief in treatment efficacy, and lower AIDS-related stigma. This study suggests that these determinants are inextricably linked to deep-seated social inequalities. Patients' marital status, gender and age shape their social networks, imposing constraints on disclosure, and in turn, access to support. People tailor disclosure strategies to meet their support needs and navigate around social and economic barriers. Strategies include for example using a confidante to negotiate on the patient's behalf without explicit disclosure. However, patients were more likely to disclose to personal carers in order to secure continued support. Conclusions: What we know about disclosure and adherence in government ART programmes in South Africa comes from early initiators. Such people are expected to have strong material or social capital, or be skilful in securing support and avoiding social approbation. Programs and policies need to be cognizant of, and responsive to, the pervasive social inequalities that strongly restrict the lives of the majority of people who have not yet sought treatment and those having difficulty with adherence. MOADO103 Disclosing your HIV status: the role of ethnicity among people living with HIV in London J. Elford', J. Anderson', C. Bukutu', F. Ibrahim'. 'City University, London, United Kingdom, 2Homerton University Hospital, London, United Kingdom Background: For people diagnosed with HIV, disclosing your HIV status to your partner, family and friends is not always easy. In the UK the two groups most affected by HIV are gay men (mostly white) and black African heterosexual men and women. This paper examines the extent to which people diagnosed with HIV, living in London, disclose their status and to whom. Methods: Between June 2004-June 2005, 1687 people living with HIV (73%o response) receiving treatment and care in London NHS outpatient clinics completed a confidential self-administered questionnaire. Respondents were asked whether they had told anyone else that they had HIV and if so, whom. Results: 480 Black African heterosexual women, 224 black African heterosexual men and 758 gay men (646 white, 112 ethnic minority) returned a questionnaire. While the majority of respondents (87%) had told at least eot esone other person about their HIV infection this varied between groups; gay men (white and ethnic minority) 95%, African women 83%, African men 77% (p<0.001). White gay men were more likely to have told their parents that they were HIV positive than ethnic minority gay men, African women or African men (42%, 19%, 19%, 17%, p<0.001), as well as telling their siblings (44%, 37%, 33%, 27%, p<0.001) other relatives (34%, 24%, 18%, 21%, p<0.001) and friends (81%, 67%, 31%, 22%, p<0.001). Three-quarters of the respondents who were in a relationship (married, cohabiting or "living apart together") had told their partner about their HIV status. However, African men (65%) and women (60%) were less likely to have told their partner than white or ethnic minority gay men (86%) (p<0.001). Conclusions: In London, there were striking differences, by ethnicity, in the extent to which people told their family, friends and partners that they have HIV. African men and women in particular may require support in disclosing their HIV status. MOADOIO4 Calculated strategies on how clients decide to disclose HIV test results: exploring gender dimensions in Uganda X. Nsabagasani', N. Orobaton', S. Kironde', S. Yoder', L. Kateebire', N. Nakamatte'. 'Uganda Program for Human and Holistic Development, Kampala, Uganda, 'MACRO International, Kampala, Uganda Background: The disclosure of the HIV test results to at least a service provider including a family member is crucial if the benefits of positive, healthy living and early access to anti-retroviral therapy are to be realized. In 2005, a study on how clients disclosed HIV test results with spouses was conducted in two districts in Uganda John Snow, Inc. and Macro International. Methods: 105 in-depth interviews were conducted with VCT clients to explore their social relations and family, their social activities, how they decided to test for HIV, and discussions of test results with spouses. VCT Counselors at testing sites aided in the selection of respondents. Respondents' responses were analyzed for content and recurrent themes. Results: Respondents approached disclosure of test results in a variety of ways depending on situations. Men who were not overtly ill-looking chose not to share test results with their wives, to avoid rumors, blame and disruptions in family relationships. Critically ill men chose to disclose results to their wives whose care and support were needed. Critically-ill women feared their husbands might blame them for unilaterally taking the test thus implying husbands were guilty of "misbehavior". Women who had lost trust in their husbands also saw no value in sharing their status with their husbands. Conclusions: The pattern of disclosure discussed above raises important gender implications for couple communication. There is a need to pay program attention on gender dimensions to communication to better address timely and effective disclosure among couples. MOADO105 The relational context of non-disclosure of HIV+ serostatus to main sexual partner among women living with HIV S.H. Peterson, R.J. DiClemente, G.M. Wingood, D. Lang. Emory University, Behavioral Science and Health Education, Atlanta, United States Background: In this study we sought to explore the context of sexual relationships in HIV+ women who do or do not disclose their serostatus to their sexual partners. Methods: We recruited 366 HIV+ women from health clinics across the southeastern U.S. Participants completed a series of surveys that assessed disclosure history, sexual history, sexual attitudes, and relationship quality. The majority of participants were African-American (84%) and the average age was 34.7. Results: Eleven percent of participants (n=37) did not disclose their HIV serostatus to their main sexual partner. A series of bivariate analyses were used to identify significant associations between disclosure and relationship characteristics. Women who did not disclose their HIV serostatus reported lower overall faith in the stability and longevity of their relationship (6.12 versus 8.4, p=.001), experienced more threats and/or violent partner responses to requests for condom use (.21 versus.07; p=.012), and had a shorter average length of relationship (34 months vs. 56.7 months, p=.07) than women who did disclose. However, non-disclosers were more likely to communicate their sexual preferences and refuse to engage in unwanted sexual practices as opposed to women who had disclosed their serostatus (4.1 vs 3.2, p=.001). To explore the relation between disclosure history and relationship characteristics, a linear regression was estimated. Women reporting higher faith in their relationship and more positive attitudes towards condoms were more likely to disclose to their sexual partners (F(4,244)=4.825, p=.000, r2=.123). Conclusions: Women who chose not to disclose were more likely to report unsupportive and threatening sexual relationships. These factors may impede their ability to safely disclose their serostatus, and may negatively effect their health and that of their sexual partners. It is important that clinicians, counselors, and health educators engage women in the process of identifying healthy relationships as well as safe alternatives to unhealthy relationships. MOADO201 Enhancing the process of informed consent in crosslinguistic research trials C. Penn. University of the Witwatersrand, School of Human and Community Development, Johannesburg, South Africa Background: Informed consent in treatment and research trials is jeopardized in many of the contexts in which research is taking place on HIV, because of a range of cultural and linguistic factors. The majority of health care encounters in the multilingual context of South Africa require the presence of a third party who serves in the multiple roles of counselor, interpreter and cultural broker. These unique communication challenges have been largely unexplored. This paper will present the preliminary results of a series of studies, which have been conducted on counselor-mediated interviews in different sites and with different types of medical encounter (including voluntary counseling and testing and enrolment in antiretroviral therapy treatment and vaccination trials). Methods: The aim of this research was to compare the use of a standard informed consent protocol and one modified specifically for a South African population, drawing on a body of research informing cultural and process variables which assist communication. Preliminary trends from 23 recorded interviews between physicians and patients living with HIV/AIDS will be presented. Methods of analysis included Conversation Analysis as well as the measurement of the perceptions of the participants (patients, counselors and physicians) regarding content and process factors. Results: The paper will identify potential facilitators and inhibitors to the clinical interaction and will consider the influences of variables such as poverty, gender and education on the process. Results of trial interventions with counselors will be presented demonstrating capacity development and improved protocols of service delivery. Conclusions: A series of recommendations are offered with regard to facilitating aspects of communication and ensuring true informed consent in the multilingual health care setting. A culturally attuned model for effective health communication will be proposed for the development and implementation of appropriate guidelines for training health professionals who work in crosscultural and cross-linguistic contexts. MOAD02O2 Exploring communication in the informed consent process of an HIV/AIDS vaccine trial J. Watermeyer. University of the Witwatersrand, School of Human and Community Development, Johannesburg, South Africa Background: South Africa is a multilingual, multicultural context that poses challenges for health professionals when trying to successfully convey information to patients. In a clinical trial, it is imperative that information is fully understood by participants in order for consent to be truly informed. Unfortunately, this is often not the case. This paper will describe a study which analyzed informed consent interactions between potential trial participants and health professionals to identify communication successes and failures. Methods: The study was conducted at an HIV research unit in South Africa. I Monday 14 August Olral Ahs'D-ae;: Sessions --- - ------------------------------ XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  14 Two interactions between a health professional and potential trial participants were recorded during the pre-screening informed consent process of an HIV/ AIDS vaccine trial. Data was qualitatively analyzed using Conversation Analysis techniques and quantitatively examined according to essential components of informed consent protocols. Post-interaction interviews with trial participants were conducted to determine understanding of crucial information. Results: A general lack of understanding and recall of information by trial participants was noted, indicating that consent was not truly informed. Interactions were dominated by the health professional and trial participants contributed minimally. Participants' understanding of content was not completely assessed by the health professional. Some blatant errors in explanations and terminology were made by the health professional. Interactions were conducted in English, which was not the first language of the participants. A linguistically and culturally inappropriate protocol form was used in the trial. Conclusions: The study highlights the need for monitoring and review of informed consent protocols currently utilized in clinical trials, and implementation of measures to ensure thorough understanding of information by patients and trial participants. Such protocols need to be culturally and linguistically modified for the target population, and health professionals need to receive communication skills training in obtaining informed consent from trial participants and patients. MOAD0203 Web-based community research on sexual venues in Mexico city O. Feliciano', V. Montiel2, M. Lopez2'. 'La Manta de Mexico, Targeted Interventions, Mexico city, Mexico, 2La manta de mexico, Mexico city, Mexico Background: Mexico City has a connectivity level similar to some European cities (50% of the population); therefore the internet has become an important resource for MSM to cruise and to gather information about sexual venues. Methods: We performed a community research based in a web-based data base and in a email listing. We applied speech analysis creating a table were we split what the users wrote about the venue, interaction, sexual scripts, description of the users, kind of sexual act performed and other observations. We create another table where we compared the venues by source to remove those which had only incidental cruising, to be included the venue must be in both sources. Results: We identified 147 sexual venues described in 252 messages by 10 categories: 68 public toilets (89 messages), 25 saunas (55 messages), 17 public transport (32 messages), 13 parks (16 messages), 9 movie theatres (14 messages), 8 sex clubs (21 messages), 7 bars (8 messages), 4 private parties (5 messages), 4 hotels (6 messages), 4 sex shops (7 messages). In the sexual narratives we profiled 3 kinds of users: calculated risk takers, no risk takers and no calculated risk takers. We identified five interactions (group sex, private sex, limited oral sex, limited anal sex & voyeur) and three kinds of safe practices (no anal sex, condoms 100% and negotiated safety); these shaped by the level of intimacy of the place and sexual script. Conclusions: The recognition of the principal trends in the cruising scene allows to design site-specific interventions or to address specific users. The cruising scene is a network woven by the sexual scripts, interactions and homophobia. The more risky activities happened in the limited anal sex and in the private sex interactions among no calculated risk takers. Anal sex in the subway and the sex-shops cabins are an example. MOADO2O4 Perspectives of minors and caregivers on the rights of minors to be involved in decision making about research participation: findings from formative research on assent and disclosure for HIV-positive children in Kinshasa, Democratic Republic of the Congo A. Corneli', S. Rennie2, L. Vaz', J. Dulyx', S. Omba3, J. Kayumba Baye4, T. Badinga4, N. Kutumbakana4, O. Daiku4, M. Ilaka4, J.-S. Kalengi Kukemfuka4, S. Callens', A. Van Rie', F. Behets'. 'University of North Carolina, Department of Epidemiology, Chapel Hill, United States, 'University of North Carolina, Department of Dentistry, Chapel Hill, United States, 'UNC-CDC/GAP-DRC Project, Kinshasa, Congo, the Democratic Republic of the, 'Independent Contractor, Kinshasa, Congo, the Democratic Republic of the Background: Operational research is being conducted in Kinshasa, DRC, to develop a context-appropriate, reproducible model of comprehensive HIV care, including antiretroviral treatment, for children and their family members. Little is known about the cultural appropriateness of obtaining assent for health care or research in this setting, and there are no known local guidelines on assent in biomedical research or clinical care. Methods: As part of a larger formative study, semi-structured interviews were conducted with 19 minors aged 8 years old who had been previously told their HIV status and 15 caregivers of HIV-positive children aged 8 years old. Questions explored minors' rights related to decision making on research participation and contextual factors surrounding assent. Participants were purposively selected from three HIV care centers. Content analysis was used to identify themes and patterns related to research questions. Results: Most minors indicated that minors have the right to be told what will happen if they join a research study and believed they could sign an assent form to indicate they agree to take part in the research. Only a few minors believed that minors' opinions need not be considered when decisions are made about their participation in research. Many minors believed that minors cannot refuse research participation if their caregivers want them to participate. Caregivers agreed that minors should be provided information about the research and several said it was permissible for minors to sign an assent form. Most caregivers, however, believed that research participation among minors was the caregivers' decision alone. Conclusions: Involving minors in discussions about research participation and obtaining their assent is considered acceptable; however, in this context, caregiver decisions are regarded as final. Understanding minors' and caregivers' perspectives can inform the development of guidelines on assent in this setting. MOAD0205 Increasing access to voluntary counselling and testing (VCT) through mobile VCT services; case study of 6 communities in Oyo state U.R. Okeke', T. Ogungbenro2, A. Faloye2. 1Centre for Reproductive Health, Aromatherapy and Development, Non-Governmental Organisation, Ibadan, Nigeria, 2Society for Family Health, Ibadan, Nigeria Issues: Challenges experienced from using designated centres for VCT services and community perception and response to mobile VCT services. The impact on HIV screening response from the community. Description: The Mobile VCT service was initiated as a vital and effective approach in combating HIV infection rate in the poor resource community settings where designated centres are seriously stigmatized. The awareness being created by the Promoting Sexual Reproductive Health and HIV Reduction (PSRHH) nationwide programme on HIV, have created more response to HIV screening and in time past, indulged in giving referrals to designated centres across the state, of which recorded only 2% response in designated centres. The process, involved monitoring of designated centres to collect referral stubs of which out of 140 referrals given in 2nd and 3rd Quarter of 2004 only 9 persons accessed VCT due to clinical complications. In the 4th quarter of 2004 and through 2005, a total number of 1,245 persons were tested at the community level by the Mobile VCT team of implementing CSO partners of the PSRHH programme in Oyo state. Community perception survey was carried out and it was discovered that people in poor communities refuse to associate with designated centres because of stigma and fear of being ostracize, even though they understand the benefits of VCT services. Achievements and successes were evident in this process that incorporated both community perception and financial constraints. Lessons learned: - Records show high turn out in accessing services of both sex. - VCT could be accessed without spousal consent especially in high stigmatized communities. - Clients seeking VCT are self motivated and in desperate need of it. Recommendations: Mobile VCT services should be encourage in reducing access barriers and stigmatization. Community Based Initiatives should be encouraged and funded to create linkages for service providers. MOADO301 Gender discriminatory beliefs are associated with vulnerability to HIV among women and men in Botswana K.S. Leiter', S. Weiser2, M. Heisler', F. Percy-de Kortel, S. DeMonner', S. TIou4, N. Phaladze4, M. Dandu3, V. Iacopino'. 'Physicians for Human Rights, Cambridge, Massachusetts, United States, 2University of California, San Francisco, Epidemiology and Prevention Interventions Center, San Francisco, California, United States, 3University of Michigan, Division of General Medicine, Department of Internal Medicine, Ann Arbor, Michigan, United States, 4University of Botswana, Department of Nursing Education, Gaborone, Botswana Background: In southern Africa, inequitable and discriminatory economic and social conditions drive the epidemic and disproportionately affect women. This study sought to assess the prevalence and correlates of gender discriminatory beliefs and to quantify the association of such attitudes with risk-taking sexual practices or circumstances. Methods: We conducted a cross-sectional, population-based study of 1,268 individuals in five districts in Botswana, using a two-stage probability design. Descriptive statistics characterized the study populations and distribution of responses and multivariate logistic regression analyses examined factors associated with holding gender discriminatory beliefs and with sexual risk. Results: Ninety-five percent of women and 90% of men in Botswana held one or more gender discriminatory attitudes. The most commonly held beliefs among participants were that it is more important for a woman to respect her partner than for a man (19%) and that a man may beat his partner if he believes her to be having sex with other men (17%). Behavioral factors (refusal to use condoms (29%), multiple sexual partnerships (25%) and alcohol abuse (37%)) were identified as the most important reasons men were at risk for HIV. Risk factors for women were related to lack of power in their relationships with men, e.g., economic dependence (8%), lack of control in sexual relations (9%) and domestic violence/rape (11%). Holding gender discriminatory attitudes also predicted sexual risk. For example, participants having three or more discriminatory attitudes were 2.7 times as likely to have unprotected sex with a non-primary partner in the past year (95% CI=1.01-7.01). Conclusions: For women in Botswana, risk-taking sexual behavior is often not chosen but compelled by social and economic inequality. In order for HIV/ AIDS interventions to be effective for women, not only individual behaviors but XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  15 attitudes that perpetuate socially-sanctioned discrimination must be addressed through policies that promote women's equality and protect human rights. MOAD0302 Social silence and the transport sector, conspire in-school girls' vulnerability to HIV N.D. Bulawo1, K. Zulu2, W. Zulu3, M. Daka4. 'ZAPHIT, Director of Programs, Lusaka, Zambia, 2AVOCHILD, Executive Director, Lusaka, Zambia, 3AVOCHILD, Projects Manager, Lusaka, Zambia, 4AVOCHILD, Deputy Executive Director, Lusaka, Zambia Background: Objectives were to examine the sexual relationships between in-school girls and Bus Drivers and Conductors (BDCs) and the frequency with which they engage in unprotected sex. Analyse factors propelling HIV/ STI transmission and assess vulnerability of girls and BDCs to HIV/AIDS in Zambia. Methods: The study instrument was a questionnaire in which some answers were given orally and others in writing. The sample consisted of 1200 in-school girls aged 14-18 and 840 BDCs aged 15-35 in six cities of Zambia. (Lusaka, Ndola, Kitwe, Mufulira, Kabwe and Luanshya) Results: 61% of BDCs reported having unprotected sex with in-school girls and their wives in the last twelve months, 38%h reported having had an STI, but blamed sex workers for it. 18% reported having sex with in-school girls only. 73% thought in-school girls are a "safe sex zone". 34% did not use a condom at last sex. In contrast, in-school girls reported having multiple BDCs sex partners in classes of lunch, "free transport" and for pleasure. 12% reported having an STI. 37% reported having unprotected sex with fellow in-school peers. 78% reported initiation through peers and 17% by choice. 41% did not use a condom at last sex. Below 1% attempted to seek VCT services. Conclusions: The analysis of data suggests that the transport sector is at the core of the vicious circle of STIs and HIV transmission from adults to children below the age of 17. Data further suggest unreported child defilement and molestation which constitute a moral and child health crisis in Zambia if not in Africa. Social conspiracy of silence is undoing achievements in children's rights, health and welfare in the past decade. On the flip side of child defilement and molestation is the local transport industry and its staff who have been left unattended to by HIV prevention programs. Sexual risk behavior and HIV prevalence among male-to-female transgendered people seeking voluntary counseling and testing services in Mumbai, India S. Kumta', M. Lurie', A. Gogate2, H. Jerajani', S. Weitzen4, A. Row Kavi5, V. Anand5, H. Makadon6, K. Mayer7. 'Brown University, Community Health, Providence, United States, 2UNAIDS Project, Mumbai, India, 3LTM Medical College and Hospital, Dermatology and STIs, Mumbai, India, 4Brown Medical School and Woman and Infants Hospital, Department of Obstetrics and Gynaecology and Community Health, Providence, United States, 5The Humsafar Trust, Mumbai, India, 'Harvard Medical School, Boston, United States, 'The Miriam Hospital, Brown University, Biomed, Community Health, Providence, United States Background: The transgendered community in Mumbai, India is marginalized, lacks knowledge about HIV, lives in poverty and has minimal access to health care services. This study describes sociodemographics, risk behavior, sexually transmitted disease and HIV prevalence among 205 transgendered people accessing Voluntary counseling and testing services (VCT) at the Humsafar Trust in Mumbai. Methods: All consenting transgendered people accessing VCT services received pretest counseling, a behavioral questionnaire and blood draw for VDRL and rapid HIV tests. They received posttest counseling before collecting their reports. Data was entered using Epi Info and analyzed using STATA software version g.i. Data output included basic frequencies and Pearson's chi square test or Fischer's exact test for dichotomous outcomes. Results: Mean age of transgendered people was 24.5 years, 77%/ (157/205) were not castrated and 67%/ (137/205) were educated up to secondary school or higher. 96.1%/ (197/205) had their first sexual encounter with a male, 490/ had greater than 10 partners in the past 1 month and 85%/ preferred practicing receptive anal sex yet only 14.2%/ (29/205) perceived risk from HIV. VDRL and HIV prevalence among transgendered people was 250/ (27/108) and 40% (80/200) respectively. 640/ of transgendered people reported sex work as occupation and did not differ significantly from other transgenders by sexually transmitted diseases, VDRL and HIV prevalence (p>0.05). Transgendered people differed from other MSM, as they had lesser education, reported sex work as an occupation, had higher number of sexual partners, preferred male partners and had high prevalence of STIs and HIV (p<0.05). Conclusions: Transgendered people accessing VCT services in Mumbai, India have high rates of STIs and HIV. They are in urgent need of HIV education, risk reduction counseling and culturally sensitive behavioral interventions to prevent HIV acquisition. MOAD0304 Rape, violence and HIV transmission among men who have sex with men P. Reynolds', C. Aspin2. 'University of Auckland, Nga Pae o te Maramatanga, Wanganui, New Zealand, 2University of Auckland, Nga Pae o te Maramatanga, Auckland, New Zealand Issues: Recent research has established that rape and sexual violation occurs among men who have sex with men (MSM), contrary to a prevailing belief that this was not a problem within the communities of MSM (McMullen, 1990). In fact, more recent research has shown that MSM are significantly more likely to be the victims of rape or sexual coercion than their heterosexual counterparts (de Visser et al, 2003). Description: This study scoped and highlighted the problem of rape and violence and HIV transmission in the Maori MSM community. Recent research among Maori MSM in New Zealand has shown that rape by other men can have a devastating impact on these men and their communities. Interviews were conducted with a small convenience sample of Maori men (n=8). Although small, the sample provides ample evidence on which to make significant recommendations. Lessons learned: Eleven cases of forced sex were reported with eight of these cases involving forced anal penetration or rape by the perpetrator, which included violent assault for some. Condoms were not used in any of these cases. The men also reported serious health impacts such as long-term anxiety, compulsive disorders and social isolation. The lack of an appropriate social support service was a major issue for all participants. Recommendations: This study raises serious concerns about the HIV risk of men who are raped by other men. The risk of HIV transmission is significant given that condoms were not used. This pape r calls for ongoing research in order to ascertain the extent of the problem so that it can be factored into HIV health promotion campaigns for MSM. As well, it is vital that the silence around this issue be eliminated so that appropriate support services can be provided. Recommendations from this study will contribute towards reducing the risk of HIV among MSM. Correlates of sexual coercion among populations of men who have sex with men in Thailand T.E. Guadamuz', S. Naorat', A. Varangrat', P. Phanuphak2, R. Jommaroeng3, P.A. Mock', J.W. Tappero4, F. van Griensvens, T. Siraprapasiri', Thailand MSM Study Group. 'Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand, 2Thai Red Cross Society, Bangkok, Thailand, 3Thai Red Cross Society; Rainbow Sky Association of Thailand, Bangkok, Thailand, 4Thailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand; Global AIDS Program, Centers for Disease Control and Prevention, Atlanta, GA, United States, SThailand Ministry of Public Health - U.S. Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand; Division of HIV/AIDS Prevention, Centers for Disease Control and Prevention, Atlanta, GA, United States Background: Although sexual coercion is believed to increase vulnerability to HIV infection, prevalence and correlates of sexual coercion are not well described. In 2005, we assessed the prevalence of sexual coercion and associated factors among populations of men who have sex with men in Thailand. Methods: Between March-October 2005, cross-sectional surveys, using venueday-time sampling, enrolled 2,049 men (response rate 97.3%) from Bangkok, Chiangmai, and Phuket. Participants were Thai, aged _15 years and had had sex with a man in the past 6 months. Palmtop computer-assisted self-interviews collected demographic and behavioral data. Our study population consisted of general men who have sex with men (MSM), male sex workers (MSW), and transgendered persons (TG). Logistic regression evaluated factors associated with sexual coercion (defined as ever being forced to have sex against one's will). Results: Df participants (mean age 24.8 years), 821 (401%) were MSM, 754 (36.8%/) MSW, and 474 (23.1%/) TG. History of coerced sex was reported by 377 (l8.4%/), and of these, 253 (67.3%/) were coerced more than once (median=2 times). Median age of first coerced sex was 17 years. In bivariate analysis, female/gay sexual identity (vs. male), receptive anal sex role (vs. insertive/dual role), recruited from street/park (vs. saunas/bars), recruited from Phuket (vs. Bangkok/Chiangmai), being TG (vs. MSM/MSW) and ever having received valuables/favors for sex were significantly associated with coerced sex (p<0.0001). Multivariate analysis (ORs; 95%/Cis) showed that identifying as female/gay (1.86;1.39,2.48), receptive anal sex role (1.49;1.11,2.01), recruited from street/park (1.50; 1.18,1.92) and ever having received valuables/ favors for sex (2.18; 1.69,2.81) were significantly and independently associated with coerced sex. Conclusions: Sexual coercion was common in Thai populations of men who have sex with men. Risk factors associated with sexual coercion as documented in our analysis may help identify those at higher risk and inform preventive interventions for them. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  16 Monday 14 August Oral str ct Abstract Sessions Track E MOAE0101 The SMARTWork program's experience with stakeholders and decision-making processes in designing workplace HIV/AIDS programs and policies: a blend of working smart, "muddling through" development, and "all I really need to know I learned from PEPFAR M. Roberts'. Academy for Educational Development (AED), Center on AIDS and Community Health, Washington, United States Issues: Managing international projects and developing effective HIV/AIDS workplace policies and programs depend on successfully engaging various key stakeholders in critical decision-making processes. However, stakeholders often have existing, complex, or even conflicting roles, responsibilities and relationships that make this process challenging. Description: Internationally funded workplace HIV/AIDS projects - like many other development programs - have numerous stakeholders, including: international funding agencies, host governments, implementing bodies, business managers, labor representatives, community opinion leaders, and affected workers. Funded by the U.S. Department of Labor, AED's SMARTWork program in Dominican Republic, Haiti, Nigeria, Ukraine, Vietnam, and Zimbabwe works to assist stakeholders to engage constructively in establishing sustainable workplace interventions. The proliferating number, and sometimes unpredictable nature, of key stakeholders - who may also have differing levels of experience, expertise, values, and approaches - make the design of HIV/AIDS workplace programs and overall development process increasingly difficult. This paper will use the experiences of SMARTWork, political science theories of decision-making and international development models to explore these challenges and make recommendations on overcoming them. Lessons learned: Successful implementation of HIV/AIDS workplace programs requires understanding, engaging, and institutionalizing sustainable relationships between a myriad of stakeholders, not all of whom are obvious, familiar to each other, or team oriented. Often this is more of an art than science - requiring diplomacy, flexibility, knowledge of international development and decision-making processes, and good brokering skills more than HIV/AIDS health expertise. SMARTWork has achieved considerable success using these strategies, having assisted over 100 companies, employing some 1.6 million employees, to adopt workplace HIV/AIDS programs and policies. Recommendations: To promote comprehensive and effective HIV/AIDS workplace policies and programs, implementers should carefully identify and involve the key stakeholders, assisting them to forge common sustainable ground. For their part, stakeholders can assist the development process by focusing more on evidence-based interventions affecting the workplace as well as sound development models, rather than on externally derived, values-driven approaches. MOAEO102 The Debswana antiretroviral therapy programme B. Mbakile', O. Johnson'. Debswana Diamond Company, HIV/AIDS Impact Management, Gaborone, Botswana Issues: This abstract describes Debswana's Disease Management Programme (DMP) as part of the Company's Workplace HIV/AIDS Strategy. It describes its beneficiaries, benefits and also provides outcome data. Description: In order to extend productive lives of employees living with HIV/AIDS, Debswana in May 2001, established an Anti Retroviral Therapy (ART) programme administered through a comprehensive DMP. Through this programme, Debswana provides free ART and related monitoring tests including viral load and CD4 count to the defined beneficiaries. The DMP, through stipulated guidelines, ensures use of correct drug combinations, at the right stage and with appropriate monitoring and follow-up. The beneficiaries of the DMP are HIV-infected permanent employees of Debswana and their legally married spouses. Registration into the programme is done via internet by doctors and clinical consultants. The programme currently has 788 registered patients, their age disrtibution concentrated around 30 to 40 years and with a majority being on stages 3 and 4 of the disease. Lessons learned: (a) The tracked indicators of the DMP, i.e. deaths, ill-health retirements and absenteeism have shown negative growths since the provision of ART, a clear indication that the programme is bearing positive results. (b) Patients tend to register on the DMP rather late, resultanlty, quite a number of deaths on the programme have occured. Therefore, early registration into the programme is vital. (c) Fear of discrimination, coupled with inadequate publicity of the DMP amongst beneficiaries has resulted in its sub-optimal utilisation. It is important to have a robust information, education and communication programme. (d) To ensure high levels of adherence to treatment, a DMP should have a strong patient follow-up component, provision of ART alone is insufficient. Recommendations: All businesses should have a workplace programme that facilitates access to treatment, care and support as a way of minimising the negative impact of the epidemic on the business. MOAEO103 Building a sustained private-public partnership to address HIV/AIDS and reduce stigma and discrimination in the workplace: the case of Mexico M.J. Negroni Belen', E. Hoadley', M. Kincaid2, J. Moody3. 'Futures Group, Mexico City Offce, Mexico City, Mexico, 2Futures Group, Chapel Hill, United States, 3Independent Consultant, Mexico City, Mexico Issues: Two key elements have been shown to be important in an effective response to HIV/AIDS in the past few years: reduction and stigma and discrimination and building a sustained multi-sectoral response. One important player in this response is private enterprise. Few successful strategies, however, for scaling up the response of the private sector have been given international attention. Description: A survey of 20 key multinational companies in Mexico illustrated a willingness to respond to issues of HIV in the workplace and highlighted inconsistencies in international and national policies. With external technical support, CONAES (Consejo Nacional Empresarial sobre SIDA) was formed in 2004. By the end of 2005, there were 28 member companies who agreed to review and rewrite their HIV-related policies and make public presentations on concrete action they undertake to address HIV/AIDS. A conglomerate of NGOs acts as technical resource persons for the process. This group has begun providing technical assistance to private companies as well as to the public sector in Mexico. Lessons learned: An independent business council is a successful means of improving workplace policies and creating supportive environments for dialogue and prevention. It can also provide a means to generating political will to more openly address HIV as well as providing a medium for media coverage that illustrates successful endeavours to addressing HIV/AIDS as opposed to negative stories of decline and omission. The reduction of HIV-related stigma and discrimination can be dealt with through such a broad-based project. By 2006, over 130,000 Mexican workers would be directly covered by HIV-specific workplace company policies. Recommendations: The next challenge is to bring this approach to a local level so as to build better private-public partnerships at a state and municipal level. MOAE0104 An innovative private sector led response to HIV/AIDS, targeting seasonal and permanent farm workers J. Hill-Mlatil, P. Craviolatti2. 'International Organization for Migration, Migration Health Department, Pretoria, South Africa, 2ECI Africa, Trade Competitiveness Project, Southern Africa Competitiveness Hub, Johannesburg, South Africa Issues: Development of an innovative private sector-led comprehensive response to HIV/AIDS for small and medium size agri-businesses that employ large numbers of migrant and mobile workers in Limpopo Province, South Africa. Description: The commercial agricultural sector in South Africa faces a number of challenges; a high HIV prevalence environment exacerbates the situation. In 2005, a partnership against HIV/AIDS was born out of the need to address the HIV impact on business and to reduce the HIV vulnerability of farm workers. 16 local agri-businesses are organised into a single cluster, coordinated by a local NGO and supported by technical experts on issues such as migration, workplace policy development, Behavioural Change Communication (BCC), capacity building and access to care and treatment. The advantage of a cluster approach is that it brings into play economies of scale (increases cost-effectiveness of interventions) and resource pooling (all agri-businesses contribute to the cluster's HIV/AIDS programme). The project tackles HIV from a structural, environmental and individual level and includes the provision of home based care, peer education, development of workplace policies/programmes, evidence-based BCC campaign and a gender intervention. Each intervention in the workplaces is designed and implemented with the objectives of: (i) reducing the HIV impact on the businesses (trade competitiveness erosion), (ii) improving the wellbeing of farm workers whether permanent or seasonal, and (iii) investing into the surrounding communities where farm workers come from. Lessons learned: The buy-in of the business owners is fundamental for the success of the clustering, design and implementing of HIV/AIDS interventions. Ensuring interventions are relevant to address the vulnerabilities associated with seasonality and migrant workers. Clustering of medium size businesses appears a viable option for cost sharing and resource pooling. Recommendations: Although this is work-in-progress it is hoped that it will be replicated in the Southern Africa Region. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  17 MOAE0105 Sexual harassment and HIV/AIDS at the workplace L. Bakaki. Women's Interculcural Network, Uganda Women's Land Poject, Cleveland Heights, United States Issues: There are pockets of HIV AIDS in many workplaces. At the same time there has been a lot of outcry regarding sexual harassment at the workplace. Workplace HIV programs are also emerging. Most of these programs are centered on sporadic activities rather than policy interventions. Description: A cross sectional study was carried out in Kampala to evaluate the nature of interventions that organizations were using to address the issue of Sexual Harassment at the workplace. The participants were recruited from organizations in Kampala, Uganda. Personal interviews carried out with support staff, middle managers and executive staff using research schedules: Lessons learned: Several employees suffered sexual harassment including utterance of suggestive words, indecent touching, and forced sexual intercourse. The most affected were women, regardless of employment level in the organization. Forced sexual intercourse was more common among young single fresh employees. Many women did not report sexual harassment for fear of stigmatizations and loss of employment. Most workplaces did not have policies on sexual harassment or HIV control. A few organizations conducted HIV education seminars. Recommendations: There was rampant workplace sexual harassment including forced sex with minimal policies to deal with the problems of sexual harassment and HIV/AIDS. Employers should develop policies to address the problems of HIV and sexual harassment at the workplace. MOAEO106 AIDS education for medical personnel: does it make a difference? A. Malek, S. Sallam, A. Hassab, A. Mahfouz. High Institute of Public Health, epidemiology, Alexandria, Egypt Background: To assess the impact of AIDS education on HIV related attitudes, perceived occupational risk and practice of professional medical personnel. Methods: In a prospective randomized controlled study 500 professional medical personnel providing different services were enrolled. They were divided into two groups; a control group (100) and intervention group, the latter was subdivided into 4 equal subgroups and assigned to 4 different AIDS education; lectures, group-discussions, hypothetical cases and booklets. Groups were assessed in pre/post/post-post test using self administered questionnaire. Results: Nearly 2/3 of study subjects had postgraduate degree, only 18.4% attended before a training on HIV, their overall mean HIV knowledge score was less than 1/3 of the high (8.6 of 27), with serious misinformation on issues related to modes of transmission. Almost all over estimated risk of "low-tono risk" while 2/3 missed the risk of needle recapping after its use. 4/5 had unfavorable attitude towards person infected through MSM practice (89%) and IDU (84.4%). 2/3 (41%) had reservation to care for AIDS patients, 4/5 (84%) were not willing to work in facilities caring for AIDS. 2/3 want to isolate the patient and 1/4 (27.2%) would inform the police. Only 1/10 (9.4%) always comply with universal precautions, 85.8% identified lack of training as the main barrier. Significant increase in the mean knowledge score was observed in the intervention group, with significant increase and improvement in the mean score of AIDS specific attitude, attitude towards AIDS patient and in preventive practice, besides significant drop in the mean perceived occupational risk. Group-discussion was the leading approach. Conclusions: Yes, AIDS education program could make a difference, by allaying medical personnel anxiety, alleviating attitudinal barriers and improving their practice. It is strongly recomended to be incuded as an essential component in medical personnel in-service training program. MOAEO201 The perpetual battle of the better half S. Singh, S. Prathibha. Lawyers Collective HIV/AIDS Unit, Mumbai, India Issues: The increased vulnerability of women to HIV and social stigma is welldocumented. HIV positive women in India occupy a threatened space. Their HIV status may open them to abuse by partners and extended family. Given their often precarious legal claim to property, they also face eviction, destitution and loss of child custody. A review of cases brought by HIV positive women shows a predominant concern with inheritance, property, maintenance and custody rights. These are areas governed by personal law based on religion, and often lead to difficult disputes. India's newly enacted Domestic Violence Act contains provisions that may help. Description: This paper discusses how the Domestic Violence Act might help protect the rights of HIV positive women. The Act contains a broad definition of domestic violence, encompassing harm and threats - physical, sexual, verbal or emotional - by anyone in a household. The Act also encompasses economic abuse, committed through deprivation of resources, disposal of household assets or restricted access to facilities. Importantly, the Act recognizes a full right of all women in domestic relationships to reside in the shared home, regardless of legal title. It also applies to all women in all areas, regardless of religion, creating uniformity of rights. These are important steps toward creating legal entitlements for women reflecting social reality. The paper discusses the legal gaps that past cases expose, how provisions of the Act address these and whether the Act can assist HIV positive women. Lessons learned: Legal lacunae make it difficult to realize the rights of HIV positive women. Legal title often does match social reality, and real claims are left unenforceable. Recommendations: The gap between law and social context is breached only by re-conceptualising our interpretations of legal definitions. Use of the Act should be monitored to see if it can address HIV issues. MOAEO202 Gender violence & HIV D. Sorley. Nairobi Womens Hospital, Gender Violence Recovery Center, Nairobi, Kenya Issues: Kenya's Attorney General and the police continue to report that cases of rape have steadily increased in the last 5 years. Due to the HIV epidemic this is abig concern. At the moment HIV prevalence in Nairobi is 11.9% in women and 7.8% in men. Therefore survivors of rape are at significant risk of becoming infected with HIV. Description: A. Project Because of a recognized gap in medical and psychological care for survivors, the Nairobi Womens Hospital opened the Gender Violence Recovery Center (GVRC) in March 2002. This is a community service arm of the Hospital and offers free medical management, including 28 days of ARV PEP and psychological support to survivors who report within 72 hours of the assault. B. Experience April 2002 -March 2005 Rape cases seen - 2,425 Sodomy cases - 8 Lessons learned and recommendations: A.Testing Total number of HIV tests done - 1,633 Number testing negative at time of rape - 1,536 Number who seroconverted after 3 months - 1 B.ARV Intervention: Survivors put on ARV PEP -1,239 Survivors returning for HIV follow up test - 292 C. Counselling: Counselling and support groups were helpful in survivors finding healing from their trauma. D. Public Awareness: The GVRC of the Nairobi Womens Hospital, along with the media, have done a lot to create public awareness of this social problem. Survivors no long need to suffer in silence as there is a place they can go for help. E. In areas where is a high prevalence of HIV, in addition to counseling, ARV PEP should be given to survivors to prevent HIV infection. F. With the high demand for this service, a better follow up system needs to be put in place to monitor the 80% of clients who did not return for follow up HIV testing. We recognize that our program is 5 years old and at first we did not have an adequate data collection system to follow our clients. That system is now in place. MOAEO203 Research on reproductive rights of women living with HIV in Russia M. Rukavishnikov1. Regional Public Organisation, Community of People Living with HIV/AIDS', Moscow, Russian Federation Issues: Increase in sexually transmitted infections and in the rate of HIV infection among women in Russia leads to the growth of potential vertical transmission cases. Women living with HIV/AIDS (WLWHA) are faced with the choice of giving birth or aborting. In Russia the reproductive rights of WLWHA are often violated. Contributing to this violation are factors including: lack of knowledge on reproductive rights and the means of preventing vertical transmission; stigma towards HPW reproduction; and a widespread negative attitude among doctors to safe childbearing despite the existing methods to lessen the risk of transmission to 2%. Description: The NGO, The Community of PLWHA conducted sociological research, supported by UNESCO and UNFPA, among the Russian population, doctors working in HIV-service and WLWHA. The project was aimed at investigating the situation with women's reproductive rights and improving knowledge among WLWHA about childbearing. Lessons learned: The research revealed that the majority of the general population had a negative attitude toward WLWHA reproduction: more than a half support prohibition of WLWHA childbirth. Most were not aware that WLWHA can bear healthy children. Fear and stigma was common among medical personnel which led them to provide inadequate information to WLWHA. WLWHA have low knowledge of HIV, reproductive rights, and safe childbearing possibilities. Recommendations: To increase awareness among health professionals, legal professionals and PLWHA, especially WLWHA, of medical and legal aspects of PLWHA reproductive health issues. To promote public monitoring and control of the implementation of legal instruments in HIV context. To inform the general public about legal rights related to HIV. To reduce stigma and discrimination both within the general public and medical personnel through work with the mass media. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  18 MOAE0204 The need for AIDS feminism S. Mthathi', M. Richter2'. 1Treatment Action Campaign, Cape Town, South Africa, 2AIDS Law Project, Johannesburg, South Africa Issues: The women's movement in South Africa has failed to take up the challenge of HIV/AIDS in an urgent, comprehensive and far-reaching manner. This paper explores a new conception of feminism that relates specifically to the AIDS epidemic in developing and middle-income countries. Description: While feminism has traditionally focused on a range of issues relating to gender relations, in South Africa it has not concentrated on the critical issues facing poor, black women in a rapidly expanding epidemic. "AIDS feminism" is proposed as a conceptual tool to re-focus energy and resources on issues such as the burden of care, access to anti-retroviral therapy, postexposure prophylaxis after rape, prevention of mother-to-child transmission programmes, the oppressive role of a number of aspects of customary law and tradition, inadequate HIV prevention programmes, and access to social security. Drawing on the experiences of the Treatment Action Campaign and women with HIV/AIDS in South Africa, a new direction for feminism is proposed. Lessons learned: General feminist concerns and programmes have lacked the urgency and dedication necessary to effect dramatic change to the lives of a myriad of women who lack the resources and power to practically negotiate the consequences of the AIDS epidemic. A different and more powerful approach is essential. Recommendations: AIDS feminism emphasizes women's empowerment and agency, while focusing on the root causes of gender inequality that ultimately give rise to the increased vulnerability of women to the epidemic. It proposes a number of strategies that will make feminism more relevant and appropriate to the lives of women with HIV/AIDS. MOAE0205 HIV treatment for women in Uganda: increasing access through integrated service provision J. McGrath', S. Rundall', D. Kaawa-Mafigiril, N. Kakande2. 'Case Western Reserve University, Anthropology, Cleveland, Ohio, United States, 2Makerere University, Uganda-CWRU Collaboration, Kampala, Uganda Background: As HIV treatment is "scaled up" public policy must address both the availability of medications and accessibility of these drugs in different social contexts. This study examined issues related to accessing available HIV treatment for women in Kampala, Uganda. Methods: Women (n=101) receiving HIV care at the Joint Clinical Research Centre (JCRC) in Kampala, Uganda were interviewed regarding their experiences in seeking HIV care. In addition, providers (n=22) from around Kampala were interviewed about their perceptions of barriers patients experience accessing HIV care. Results: Providers and patients identified several issues with implications for policies promoting HIV care and services. First, providers report that patients often delay seeking care until late in the disease process, therefore limiting success of subsequent treatments. Additionally, they support a holistic approach to HIV care which addresses an array of patient needs, including the need for food, sexual partners, and material assistance necessary to remain in treatment. Women report delaying up to 5 or more years after suspecting they might have HIV before seeking treatment. The primary factor driving women to seek care is the appearance of visible symptoms, often severe, which they can no longer disregard. The focus on symptoms persists even after women have tested HIV positive. Women express concern about their ability to maintain long term access to care. Together, providers and women identify the need for a broad-based approach to care which integrates needed services. Conclusions: These data demonstrate the urgent need to create integrated programs to deliver HIV care. Because women are driven by symptoms to seek care, integrating HIV care into other health care will increase the likelihood women receive appropriate treatment earlier in the disease process. This study was funded as a supplement to the Center for AIDS Research (CFAR), Case Western Reserve University, Michael Lederman, M.D., PI (NIH grant number AI36219). Cross-Track MOAX0102 Clinical correlations of inflammatory cytokines in the female genital tract during acute HIV-1 infection L. Bebell', J.-A. Passmore2, C. Williamson', K. Mlisana4, I. Iriogbe4, Q. Abdool Karim4, S.A. Karim4, and the CAPRISA Acute Infection Study Team. 'Columbia University College of Physicians and Surgeons, Centre for the AIDS Programme of Research in South Africa, Durban, South Africa, 2University of Cape Town, Division of Medical Virology, Department of Laboratory Sciences, Cape Town, South Africa, 3University of Cape Town, Division of Medical Virology, Institute of Infectious Diseases and Molecular Medicine, Cape Town, South Africa, 4University of KwaZulu Natal, Centre for the AIDS Programme of Research in South Africa, Durban, South Africa Background: Causal relationships between cytokines in acute HIV infection and clinical symptoms or disease progression have not been investigated, nor have cytokine profiles in the genital tract. Understanding the compartmental immune response may provide clues to understanding HIV pathogenesis, the impact of concurrent STIs, and design of future microbicides and vaccines. We evaluated inflammatory cytokines in cervicovaginal lavage (CVL) and plasma in acute HIV-1 and their relationship to clinical outcomes. Methods: Matched CVL and plasma samples were obtained from nineteen women with acute HIV at 22-62 days post-infection. Participants are sex workers followed up monthly as part of CAPRISA 002, a cohort study on immunological events in acute infection. Levels of IL-113, IL-6, IL-8, IL-10, IL-12, and TNFa were measured using the BD Human Inflammation Cytometric Bead Array Kit. Clinical signs and symptoms were evaluated using the CAPRISA Clinical Checklist administered by study clinicians. Results: Of eight participants evaluated for clinical symptoms, the three symptomatic women had elevated total CVL cytokine compared to the five asymptomatic women. Four of fifteen participants followed for seven months progressed to CD4+ cell counts less than 350 cells/uL. These four rapid progressors had higher levels of TNF-a (6.0pg/mL vs. 2.0pg/mL), IL-10 (1.6vs.0.8), IL-6 (93.8vs.30.3), IL-13 (341.0vs.143.3), and IL-8 (1793vs.1212) in CVL compared to other participants, but lower levels of IL-12 (0.7vs.1.1). Participants with bacterial vaginosis (BV) (n=16) had significantly higher levels of IL-8 (3997 vs. 581, p=0.033) and lower IL-10 (0.0vs.2.9, p=0.07) in the CVL compared to BV negatives (n=3). Levels of all cytokines except IL-10 were significantly elevated in CVL compared with plasma (p<0.001 to 0.05). Conclusions: Elevated CVL cytokines in acute HIV may be associated with rapid disease progression. Women co-infected with acute HIV and BV also have higher cytokine levels. Further research will focus on defining the relationship of CVL cytokines to local genital tract pathogenesis. MOAX0103 Interferon regulatory factor 1: a novel determinant of resistance to infection by HIV-1 in highly exposed uninfected sex-workers H. Jil, T. Ball', J. Kimani2, P. McLaren', C. Marlin', A. Hill3, F. Plummer4. 'University of Manitoba, Department of Medical Microbiology & Infectious Diseases, Winnipeg, Canada, 2University of Nairobi, Department of Medical Microbiology, Nairobi, Kenya, 'Oxford University, The Wellcome Trust Centre for Huamn Genetics, Oxford, United Kingdom, 4Public Health Agency of Canada, National Microbiology Laboratory, Winnipeg, Canada Background: Natural resistance to HIV-1 infection has been well described in multiple cohort studies although the underlying mechanisms remain elusive. Genetically, polymorphisms in HIV-1 co-receptors and Human Leukocyte Antigen (HLA) have been identified as important factors for HIV-1 resistance, but none of these factors account for this phenomenon conclusively. The objective of this study was to determine potential genetic determinants responsible for HIV resistance. Methods: A cross-sectional genetic analysis of microsatellite markers within the interleukin-4 (IL-4) gene cluster was conducted in a well described female sex worker cohort from Nairobi, Kenya known to exhibit differential susceptibility to HIV infection. Polymorphisms in the Interferon regulatory factor-1 gene (IRF1) were identified and analyzed for association with resistance to infection. Functional consequences of these polymorphisms were assessed by quantitative western blot. Results: A particular MS marker and two single nucleotide polymorphisms (619A>C and 6516G>T) in the IRF-1 gene were strongly associated with HIV-1 resistance (P values 0.0054, 0.00073 and 0.030 respectively). An independent replication study found that HIV-1 infected subjects with 179 allele or 619A were less likely to seroconvert ( P values 0.0396 and 0.0016 respectively) while subjects with 6516G allele showed a clear trend to reduced seroconversion (P=0.1281). In combination, individuals with more than 1 protective alleles showed even significantly longer HIV-1 free time before seroconvertion (P=0.0001). Despite their location in introns, all three polymorphisms associate with significantly decreased basal IRF-1 protein expression and depressed IRF1 response to exogenous IFN-y stimulation. Conclusions: IRF-1 is a host immune regulator and a potential transcriptional activator of HIV-1 replication. We conclude that IRF-1 is an important determinant of host susceptibility to HIV-1 infection. Lowered IRF-1 expression or response at early stage may be crucial in disrupting the establishment of HIV-1 infection and allow for the generation of an adaptive immune response which may contribute to resistance to HIV-1 infection. MOAX0104 Clinical and immunological impact of HAART during acute HIV-1 infection H. Streeck', H. Jessen2, G. Alter', N. Teigen', M. Waring', A. Jessen2, I. Stahmer3, 3. v.Lunzen', X. Gao4, M. Lichterfeld', T. Allen', M. Carrington', B. Walker', M. AItfeld', J. Rockstroh'. 'Massachusetts General Hospital, Partners AIDS Research Center, Boston, United States, 'Private Practice Jessen/Jessen, Berlin, Germany, 'University of Eppendorf, Infectious Disease, Hamburg, Germany, 4National Cancer Institute, Laboratory of Genomic Diversity, Frederick, United States, sUniversity of Bonn, Internal Medicine, Bonn, Germany Background: Despite anecdotal reports of control of viral replication in subjects receiving short-term treatment during acute infection, the virological and immunological benefit of initiation of HAART during acute HIV-1 infection remain unclear. Methods: We assessed the impact of short-term treatment in acute HIV-1 infection in 20 acutely infected study subjects [neg./ind. ELISA or < 3 bands] XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  19 who either received treatment for 6 months during acute infection (group A n=12), or remained off therapy over the entire 12 months study period (group B n=8). CD4+ T cell count, HIV-1 plasma RNA levels and HIV-1-specific T cell responses by Elispot and ICS were assessed over the study period. Results: The two groups did not differ with respect to host genetic factors CD4+ count (p=0.91) or viral load (p=0.86) at baseline. At the 24 wks time point there was a significant difference in the median VL of the treated group (<50 cop/ml) compared to the untreated group (131,000cop/ml) (p=0.006) and CD4+ T cell numbers were significantly elevated in the treated subjects than in the untreated arm(p=0.007). Short-term treatment in acute infection resulted in significantly higher HIV-1-specific IFN-y+ and CD107a+ CD8+ T cells at week 48 compared to the untreated group (p=0.06 and p<0.05), and in a better differentiation of these virus-specific T cells from effector memory to effector cells (28% (untreated) vs. 49% (treated)). However, despite these changes in HIV-1-specific immune responses, no differences in the treated and untreated group was observed 6 months following therapy discontinuation at week 48 with respect to VL (32,300 cop/ml vs 38,300 cop/ml; p=0.41) or CD4+ (596/pl vs. 456.1/pl, p=0.15) Conclusions: Our data suggest that despite a boosting of immunological functions and T cell maturation following 6 months of therapy in acute HIV-1 infection, this intervention had no impact on immunological control of HIV-1 replication. MOAX0105 Comprehensive analysis of HIV-specific IL-2 and IFN- y immune responses in treatment-naive individuals in acute infection early disease (AIED) versus long term non progressors (LTNP) and individuals with progressive disease N. Lubaki', Y. Peretz', M.P. Boisvert2, R. Boulassel', C. Tremblay3, R. LeBlanc4, D. Rouleaus, C. Tsoukas', J.P. Routy', N. Bernard'. 'McGill University, Montreal, Canada, 2Montreal General Hospital Research Institute, Montreal, Canada, 3Centre Hospitalier de l'Universite de Montreal, Montreal, Canada, 4Clinique Medicale G.L.R, Montreal, Canada, 5Hopital Notre Dame, Universite de Montreal, Montreal, Canada Background: The initial host response to HIV is associated with viral load (VL) control during acute infection and is an important determinant in the subsequent disease course. HIV-specific IL-2 secretion is associated with VL control and better clinical outcome. Objective: To screen and compare the breadth, magnitude and hierarchy of HIV-specific IL-2 and IFN-y responses in subjects in AIED, LTNP and progressors. Methods: The study population included 18 individuals in AIED within 6 months of infection. We compared responses in these individuals to those in 10 untreated LTNPs infected >7 yrs with CD4 counts >500cells/mm3 and low VL and 6 untreated progressors infected for >1 yr with a median CD4 count of 301 (range 16-540). Peripheral blood mononuclear cells (PBMC) were tested for IL-2 and IFN-y secretion using the ELISPOT assay. PBMC were stimulated with peptide pool matrices corresponding to all expressed clade B HIV genes. The stimulatory capacity of peptides was verified individually in a second ELISPOT assay. Results: Individuals in AIED were recruited and evaluated for IL-2 and IFN-y responses 78 (range 46-160) days following date of infection. The hierarchy of the breadth and magnitude of IL-2 responses was LTNP > subjects in AIED > progressors (p<0.05 for all comparisons). The breadth and magnitude of IFN-y responses were higher in LTNP versus individuals in AIED (p<0.05). Only the magnitude (p<0.05) and not the breadth of IFN-y responses were higher in LTNP versus progressors. An inverse correlation was found between HIV VL and magnitude (p=0.032) and breadth (p=0.0018) of IL-2 responses. Nef was recognized most frequently during AIED and Gag during chronic infection. Conclusions: The specificity and hierarchy of HIV recognition in AIED differs from that of subjects with chronic infection. Both LTNP and subjects in AIED have HIV-specific IL-2 responses and these are associated with VL control. MOAX0201 Intersecting sexuality, gender, race and citizenship: mental health issues faced by immigrants and refugees living with HIV/AIDS in Toronto J.P. Wong', A. Li2, Y.B. Chen', P. Kanagaratnam', S. Yee3, K. Fung4, A. Roy Sen'. 'Toronto Public Health, Planning & Policy, Toronto, Canada, 'Regent Park Community Health Centre, Toronto, Canada, 'Committee for Accessible AIDS Treatment, Toronto, Canada, 'University Health Network, Toronto, Canada Issues: Advances in medical knowledge and access to HIV treatments have changed the nature how people living with HIV/AIDS (PHA) experience this illness in Canada and other developed countries. While a substantial number of research have been conducted to examine the impact of HIV/AIDS as a chronic illness on the mental health of PHAs, these studies mostly focus on gay white males or MSM or address PHA mental health issues in unidisciplinary silos. Research on mental health issues faced by immigrants and refugees living with HIV/AIDS (I&R-PHAs) and multiple marginalities in developed countries is almost non-existent. Description: A preliminary study that explored the mental health needs of I&R-PHAs living in the Greater Toronto Area was conducted in order to identify the research priority for this population. It included a detailed literature review, a scan of existing programs and two separate focus groups attended by 7 I&RPHAs and 10 service providers. Lessons learned: The mental health of I&R-PHAs is affected by intertwining biophysical, psychosocial, socioeconomic and sociopolitical determinants. In addition to coping with HIV/AIDS stigma, many I&R-PHAs reported experiences of racism, inadequate housing, unemployment, poverty and social isolation. Immigration procedures and citizenship status were named as key stressors for refugee and non-status PHAs. Female I&R-PHAs expressed a fear of becoming ill and having nobody to take care of their children. When I&R-PHAs seeked help to deal with these stressors, many of them were re-traumatized by uncoordinated health care services as they were asked to retell their histories repeatedly to different service providers while they navigated the system. Recommendations: Service coordination, research on the mental health needs of I&R-PHAs, and policy analysis of HIV/AIDS in the contexts of migration, employment, health care access and systemic discrimination are critical to promoting health and reducing health disparity in this PHA subpopulation. MOAX0202 The silent bullet, the unfought war: HIV/AIDS amongst young people in conflict situation W. Ochan', E. Mugumya2, R. Nambooze2. 1IPPFAR, Programmes, Nairobi, Kenya, 2FPAU, Office of Executive Director, Kampala, Uganda Background: In war situations, young girls and boys get caught between the fire of bullets and risk of HIV infection. Physical survival takes precedence despite the risks involved, while HIV continues to spread silently showing its devastating impact on host & displaced population later in the post conflict period. Methods: We conducted a descriptive cross-sectional study amongst 345 young people (10 - 24 years), randomly sampled in Awer and Palenga camps In Gulu District, Northern Uganda. We used both quantitative and qualitative research methods to determine knowledge, attitude and practices of young people relating to HIV/AIDS. Factors that make young people vulnerable in conflict settings were also explored. Results: The study respondents mean age was 17.4 years. 45% were in sexual relationships and 25% married, and age of sexual debut is 13.8 years (national 17 years). Level of awareness on HIV/AIDS & its mode of transmission were high. However, only 6.4% knew of VCT as confirmatory HIV test. First sexual intercourse was involuntary amongst 36% of the girls; perpetrators being: soldiers, rebels, neighbours and camp leaders. Condom use was 43.4%, because of lack of condoms and negative attitude and limited skills in its use. HIV/AIDS services are lacking in the camps. Factors that make girls vulnerable to HIV/AIDS infections were sex with soldiers or camp leaders for material/ monetary reward, insecurity, lack of condoms, lack of VCT & STDs services, substance use, multiple sex partners, being orphaned, etc. Spots for rapes included: water points, night clubs, and nearby bushes Conclusions: Despite high level of awareness on HIV/AIDS, young people in conflict situations are constrained in practicing safer sex methods. Material and security needs, coupled with lack of HIV/AIDS services mak MOAX0203 International migration and HIV risk among Mexican gay men H. Carrillo, J. Fontdevila, J. Brown. University of California, San Francisco, Center for AIDS Prevention Studies, San Diego, United States Background: Previous survey research has found that recent Latino gay male immigrants in the U.S. have lower levels of HIV risk than U.S.-born Latino gay men, but also that HIV risk among longer-term immigrants resembles that of U.S.-born men. The goal of this study is to describe and analyze how HIV risk is produced among recent Mexican gay immigrants in U.S. cities. Methods: We conducted in-depth, semi-structured interviews with 80 men in San Diego who self-identified as gay, bisexual, or transgender, and who were raised in Mexico. We utilized a rigorous qualitative analytical method that combines reading and summarizing of individual cases with coding of transcript material and thematic searches using QSR N6.0. Additionally, we analyzed field notes from 62 participant observation sessions in venues where Mexican gay immigrant men socialize. Results: Participants' HIV safety or risk in the U.S. is related to processes that begin in Mexico and that influence their paths of migration and incorporation into U.S. gay life. The degree or urbanization of participants' place of origin in Mexico; their personal characteristics in terms of social class, education, and ethnic features; their language skills; their degree of participation in genderbased versus object-choice Mexican homosexualities; their expressed sexual attractions towards different types of men; their imaginaries of U.S. gay life; and the mix of expressed motivations for migration (sexual, family, or economic) all influence their experiences of incorporation into U.S. gay communities and, in turn, the contexts of HIV safety or risk to which they gain access. Conclusions: To fully understand HIV risk and safety among gay immigrant populations (particularly among those individuals whose motivations for migration are primarily sexual) and design appropriate interventions, we must pay close attention to their situations and sexual histories before relocation, their paths of international migration, and their processes of incorporation into gay life in host countries. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  20 MOAXO204 MOAXO301 Participatory research into HIV/AIDS with African Impact of universal access to antiretroviral therapy communities in Australia on HIV stigma in Botswana C. Lemoh', M. Hellard2, A. Street3, B. Biggs4. 1The University of Melbourne, Department of Medicine, Melbourne, Australia, 2Somdejprayannasangworn Hospital, Melbourne, Victoria, Australia, 3Somdejprayannasangworn Hospital, Parkville, Victoria, Australia, 4Somdejprayannasangworn Hospital, Department of Medicine, Melbourne, Australia Issues: African communities in Australia need information about HIV/AIDS and other sexually transmissible infections (STI), but there has been little discussion about this topic in these communities to date. Clinicians and public health practitioners fear encountering social and cultural barriers during research or interventions concerning HIV/AIDS, but no research has identified these barriers, or possible means of overcoming them. Description: This study was intended to identify ways in which African communities could be provided with relevant, culturally appropriate information about HIV and STI. Several issues were considered in designing and carrying out this study. These included: identifying, contacting and engaging the relevant communities; overcoming suspicion of academic research; overcoming community reluctance to discuss HIV/AIDS; and maintaining the relevance of the research to the African communities. A participatory research model was developed, that included members of several African community organizations in the design, management, and conduct of the study. Lessons learned: Social and cultural inhibitions about discussing HIV/AIDS were overcome by involving the communities in the research process. Participants spoke frankly about the issues surrounding HIV/AIDS in their communities. The absence of prior discussion of this topic was largely due to the belief that HIV/AIDS was not common in Australia, particularly among immigrant communities who had been previously screened for HIV infection prior to migration. Community members expressed great willingness to become involved in public health interventions arising from research results. Recommendations: Social and epidemiological research into HIV/AIDS in immigrant or culturally diverse communities should involve members of the communities in order to improve the quality of the studies and the relevance of their findings. MOAXO205 Optimizing health outcomes in HIV+ refugees from sub-Saharan Africa presenting to urban medical settings J. Cyr', D. Thompson', N. Gilmore', C. Duchesneaul, A. Ankouad2'. 1McGill University Health Center, Immunodeficiency Service, St-Urbain, Montreal, Quebec, Canada, 'Centre de Ressources et d'Interventions en Sante et Sexualite, Montreal, Canada Issues: New patient referrals to our Immunodeficiency Service included disproportionately high numbers of refugee claimants newly arrived from central African countries known to have recent ethnopolitical struggles. Our multidisciplinary healthcare team is challenged with diagnostic and therapeutic care problems in this population. In addition to the adjustment to a new HIV diagnosis, patients have been faced with multiple and often traumatic changes before and after their arrival in Canada. Description: We identified 93 HIV+ refugees originating from Burundi, Cameroon, Democratic Republic of Congo, Republic of Congo and Rwanda. 20 subjects consented to complete a self-administered questionnaire and answer open-ended interview questions, structured to study factors that facilitate or interfere with adjustment to illness. Questionnaires were scored on a 5-point ordinal-scale, and transcripts of 10 individual interviews and two "focus groups" were analyzed using Thematic Analysis qualitative methodology. Lessons learned: Subjects were satisfied with their state of health at the time of interviews, showed confidence in their health-care team, felt well-informed, and capable of making decisions. Subjects expressed that family separation, family members with continued exposure to violence and fear, financial uncertainty, social isolation due to stigma, and poor nutrition interfered with their adhering to treatments and engaging in health-promoting behaviours. Factors facilitating their adjustment to illness included ability to confide in healthcare providers, sustain contact with family/loved ones, use spiritual faith, and maintain purposeful activities. Recommendations: A multidisciplinary team with a collaborative, skillful and culturally sensitive approach will intervene most effectively with this vulnerable population. Rapid assessment of psychosocial stressors and emotional adjustment via the involvement of medical, social work, mental health and pastoral services can help to enhance patients' coping resources and optimal health outcomes. W. Wolfe', S. Weiser2, K. Leiter3, W. Steward2, F. Percy-de Korte3, N. Phaladze4, V. Iacopino3, M. Heislers. 'University of California, San Francisco, Department of Psychiatry, San Francisco, United States, 2University of California, San Francisco, Center for AIDS Prevention Studies, San Francisco, United States, 'Physicians for Human Rights, Cambridge, United States, 4University of Botswana, Department of Nursing, Gaborone, Botswana, 'University of Michigan School of Medicine, Department of Internal Medicine, Ann Arbor, United States Background: Botswana, with the second-highest rate of HIV infection worldwide (37% of adults aged 15-49), has a program of universal access to antiretroviral therapy (ART). We assessed the impact of treatment access on HIV stigma three years after rollout of the national ART program. Methods: We studied the prevalence and correlates of HIV stigma in a crosssectional population-based study of 1,268 individuals drawn from five districts in Botswana, employing a two-stage probability design. Measures of stigmatizing attitudes were adapted from the UNAIDS General Population Survey and matched questions from a 2001 Botswana national survey which predated universal access; additional questions regarding anticipated discrimination constituted a 9-item scale of "projected stigma." Multivariate analyses included measures of respondents' socio-demographic characteristics, behaviors, and attitudes. Results: Significantly lower rates of respondents reported HIV stigmatizing attitudes compared to the earlier survey. Ninety-five percent of respondents stated that they would care for a relative with AIDS (compared to 88% previously); 97% stated that a teacher with HIV should be allowed to teach (compared to 59%); and 77% stated that they would buy vegetables from a shopkeeper with HIV (compared to 42%). Seventy percent of respondents endorsed at least one measure of "projected" HIV stigma: 53% anticipated ostracism after testing positive for HIV; 40% predicted loss of friends; and 31% anticipated mistreatment at work. In multivariable analyses, perceived access to ART was independently associated with decreased odds of holding at least one stigmatizing attitude (AOR 0.42, CI 0.24-0.74) and of projected stigma (AOR 0.09, CI 0.03-0.30). Inconsistent condom use was also associated with increased odds of stigmatizing attitudes (OR 1.51, CI 1.15-1.98). Conclusions: Our findings support the hypothesis that ART access may be a key factor in reducing HIV stigma. Nevertheless, evidence of significant projected stigma suggests that HIV discrimination remains a significant concern despite expanded access and requires ongoing programmatic attention. MOAX0302 Time to make health services safe from stigma: voices of Canadian Aboriginal people living with HIV/AIDS and health care providers R. Jackson', L. MacLean2, L. Leonard2, J. Mill3, F. Reintjes3, W. Austin3, N. Edwards2, C. Dumont-Smith4. 'Canadian Aboriginal AIDS Network, Ottawa, Canada, 2University of Ottawa, Ottawa, Canada, 'University of Alberta, Edmonton, Canada, 4Consultant in Aboriginal Health, Ottawa, Canada Background: As part of a larger study, this presentation documents stigmatizing health care practices experienced by Canadian Aboriginal persons living with HIV/AIDS (APHAs), and the reflections of service providers to eliminate such practices. Methods: A participatory action research design, using interviews, focus groups, and document reviews guided the study. Thirty-three individuals living with HIV (16 Aboriginal) recruited from hospitals, HIV/AIDS service organizations, and community health clinics in Ottawa and Edmonton were interviewed about their experiences accessing health services. In addition, 20 interviews and 2 focus groups with healthcare providers explored their experiences providing care to people living with HIV and their perspectives on ways to improve health care for this group. Community advisory committees guided the research. Results: APHAs encounter a myriad of stigmatizing practices in healthcare settings. Most experience a layering of stigma (e.g., as Aboriginal people, as people living with HIV, as sexual minorities, as poor individuals, as injection drug users, etc.). Stigmatizing health care practices include, but are not limited to, building design, service scheduling, and interactions with all types of staff from the point of diagnosis through service provision. Problems are also encountered negotiating the health care bureaucracy, including locating support to access traditional cultural health systems. Stigmatizing experiences are compounded by historical experiences leading to a generalized mistrust of a largely nonAboriginal healthcare system. Culture appears to be one way APHAs mitigate stigma and therefore positively influences coping strategies. Service providers acknowledge that "to make a place that is safe-particularly when they have a past history" it is necessary to support cultural identity. Other areas of service provider reflection are also discussed. Conclusions: HIV-related stigma continues to influence access and use of health services for APHAs. Recommendations are made for improving access/ use of health services in a safe, trusting and culturally competent manner. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  21 MOAXO303 MOAXO402 Qualitative study of the challenges to seeking health A single dose of glycosylated recombinant simian care among HIV-positive pregnant women in IL-7 induces transient T cell homing into lymph Ho Chi Minh City nodes, increases peripheral nailve and memory T cell numbers and stimulates thymic function in healthy Monday 14 August Oral Absb-act Sessions D. Bain Brickley', D.L.D. Hanh2, L.T. Nguyet3, L.T. Giang4, A. Sohns. 'University of California, San Francisco, Center for AIDS Prevention Studies/Institute for Global Health, San Francisco, United States, 2Hung Vuong Obstetrics Hospital, Ho Chi Minh City, Viet Nam, 3Anonymous HIV Testing Site, Ho Chi Minh City, Viet Nam, 4Ho Chi Minh City Provincial AIDS Committee, Ho Chi Minh City, Viet Nam, 5University of California, San Francisco, Department of Pediatrics/ Institute for Global Health, Ho Chi Minh City, Viet Nam Background: Prevention of mother-to-child HIV transmission (PMTCT) programs, including counseling training for medical staff, are expanding in Ho Chi Minh City (HCMC). Yet there is concern that women with HIV will avoid accessing services due to HIV-related stigma, potentially resulting in higher rates of infant infection, and poor infant/maternal follow-up care. We conducted a qualitative study to explore social and structural barriers to utilizing PMTCT services. Methods: In-depth, semi-structured interviews were conducted with 20 women with HIV who were pregnant or had given birth within the previous year, and 16 key informants who work closely with them. Four focus group discussions were conducted to determine the validity of the findings and to generate ideas for interventions. Data were analyzed using grounded theory methodology. Results: Women reported that HIV-related stigma is a major factor in utilization and quality of the antenatal care and delivery experience. Many women chose not to disclose their HIV status out of fear of discrimination and thus were unable to receive social support from their families and relevant social and health services. HIV-positive women are sensitive to receiving different standards of care (e.g., segregated delivery and post-delivery rooms) in comparison to HIV-negative women. Non-medical staff, such as cleaners and security guards, were frequently identified as perpetrators of discrimination. Women who were diagnosed with HIV at the time of delivery were more likely to have negative peripartum experiences. Conclusions: Pregnant women with HIV in HCMC report fear of discrimination as a primary factor influencing the peripartum experience. Identifying infections earlier in pregnancy would help address fear of disclosure and facilitate access to medical interventions. Additional research should be conducted on the role of non-medical hospital staff in stigma and discrimination; in the meantime, HIVrelated educational training should be provided to non-medical staff to promote acceptance and sensitivity. Rhesus macaques S. Beq', C. Schilte', D. Gautier', B. Assouline2, P. Lavedan3, X. Montagutelli3, M. Brahic', R. Cheynier'. 'Institut Pasteur, Virology, Paris, France, 2Cytheris SA, Issy-les-moulineaux, France, 3Institut Pasteur, Animalerie centrale, Paris, France Background: IL-7 is a crucial cytokine for thymopoiesis and T cell homeostasis. Treating SIV-infected and non-infected macaques with recombinant simian r-sIL-7 leads to a transient increase of circulating T cells, due to both enhanced thymopoiesis and increased T cell proliferation. However, the effect of non-glycosylated IL-7 is blunted by the development of anti-IL-7 antibodies. Methods: In this study, we investigated the impact of glycosylated r-sIL-7 (r-sIL-7gly) on T cell homeostasis in healthy Rhesus macaques. Using 8 parameters flow cytometry and quantitative PCR for measuring the sjTREC frequency, we followed the absolute numbers as well as the cycling and the survival capacity of the different peripheral T cell subsets: CD4, CD8, naives, memory, effector and RTEs during the first days following r-sIL-7gly injection. Results: Within the first 6 hours following r-sIL-7gly injection we observed a strong decline of all T cell subtypes, correlated with a strong expression of Ki-67 (30 to 90% in all subsets). The analysis of T cell subsets in lymph nodes suggests that this decrease was a consequence of T cell homing into secondary lymphoid organs. After this initial drop in T cell counts, the T cell subpopulations rebounded by day 3-4, reaching higher values than in pre-treatment samples. Finally, the absolute number of circulating RTEs began to increase by day 7, leading to a 5- to 10-fold increase at day 14. This was confirmed by the quantification of the sjTREC molecule in peripheral blood. Finally, contrarily to the non glycosylated molecule, r-sIL-7gly did not induce the development of IL-7 specific antibodies during the 45 days of follow-up. Conclusions: The administration of a single dose of r-sIL-7gly both stimulates thymic function leading to enhanced RTE frequency and induces an increase of peripheral naive and memory subset numbers in healthy Rhesus macaques, suggesting that r-humanlL-7gly might be used to help patient to recover from lymphopenia. MOAXO403 Treatment with recombinant human growth hormone (r-hGH) leads to increased thymic output MOAXO304 in HIV-Infected subjects with incomplete immune All because I am positive - video documentary on rReconstitution on highly active antiretroviral HIV-related stigmatization of PLWH in Nigeria therapy (HAART) O. Oladapo', E. Musa2, S. Garba3, B. Olotu4. 1Positive Life Association of Nigeria (PLAN), Programs, Ibadan, Nigeria, 'Defence Health Club (DHC), Program Office, Abuja, Nigeria, 3Positive Action for Change (PAC), Program Office, Kotangora, Nigeria, 4Hope World Wide - Nigeria, Counseling, Lagos, Nigeria Issues: HIV-related Stigmatization and discrimination are perhaps the greatest impediments to successful implementation of HIV/AIDS prevention, care and support interventions in all communities. Various leaders of organizations of people living with HIV (PLWH) have at different times witnessed HIV-related stigma and discriminatory acts since the onset of the epidemic in the country. The Positive Life Association of Nigeria (PLAN) in collaboration with Community Link Project (CLIP) produced a video documentary of stories of HIV-related stigmatization and discrimination of PLWH in Nigeria towards raising awareness on its ills and effects. Description: Four leading PLWH who are open about their status were interviewed in the documentary in which they relieved experiences of stigmatization and discrimination meted on them and others. The interviews highlighted the various forms of, the factors responsible for, the effects of, as well as strategies for coping with and addressing cases of stigma and discrimination at various levels, places and institutions. The documentary also highlighted the major changes in the lives of the interviewees after having access to skills and information for coping with stigma and discrimination. The documentary is being used in workshops on HIV/AIDS by various organizations in Nigeria. Lessons learned: The use of the documentary has helped in demystifying HIV/AIDS among participants in workshops on HIV/AIDS. The documentary helps in identifying the need to address stigma and discrimination in all HIV/ AIDS-prevention interventions. Using the documentary has made it possible for more PLWH to reach a larger number of workshops participants than could be reached by being physically present in the programmes. Recommendations: Using audio-visual AIDS helps in facilitating better understanding of HIV/AIDS-related issues and problems by workshops and seminars participants. Video documentaries also help in portraying PLWH leaders as role models for others just learning about their HIV-positive status while demand for voluntary counseling and testing. K. Smith', L. Zheng2, R. Bosch2, D. Margolis', A. Tenorio', L. Napolitano4, R. Pollard', E. Connick6, B. Gross7, I. Frances', R. Wang2, N. Muurahainen8, V. Stocker', ACTG 5174 Protocol Team. 'Rush University Medical Center, Section of Infectious Diseases, Chicago, United States, 2Harvard School of Public Health, Statistical and Data Analysis Center, Boston, United States, 3University of North Carolina, Section of Infectious Diseases, Chapel Hill, United States, 4University of California at San Francisco, San francisco, United States, sUC Davis Medical Center, Section of Infectious Diseases, Sacramento, United States, 6University of Colorado Heath Sciences Center, Denver, United States, 'University of Michigan, Ann Arbor, United States, 8Serono, Inc, Rockland, United States, 9AACTG Operations Center, Silver Spring, United States Objectives: To evaluate the immunologic effects of r-hGH on HIV+ subjects with incomplete immune reconstitution on HAART. Methods: Sixty subjects on HAART were randomized to receive r-hGH 1.5mg SC QD +HAART for 48 wks (ARM A) or continue HAART alone for 24wks followed by addition of r-hGH 3.0mg SC QD for 24wks (ARM B). Twenty subjects underwent thymus CT at baseline(BL) and after 24wks of r-hGH to evaluate thymus size. Results: All subjects were on HAART >lyr, entry CD4<350 cells/mm3 and VL<400 c/mL. BL median total CD4 for ARM A and B were 223 and 219, respectively. From BL to wk24, ARM A had stable or increased naive CD4 # and % while ARM B had decreased % naive CD4. From BL to wk48, median change in naive CD4 # and % (% increase, p-value) for ARM A and B were 26 (68%, p<.0001), 8 (42%, p<.0001) and 23 (47%, p<.0001), 4 (18%, p=.003) respectively. In ARM B, the median change in naive CD4 # from BL to wk 24 (HAART alone) was 5 (10%), the change from wk24 to 48 (HAART + rGH) was 24 (51%), (median difference in changes: 24; p<0.001). There was no significant change in T cell receptor rearrangement excision circles (TREC) by wk24; by wk48, both arms had significant increases in TREC {+1.08log (23%), +0.471og (9%) for ARM A and B respectively}. Greater increases in TREC were seen in subjects with low baseline TREC (p<0.001) Greater rises in insulinlike growth factor (IGF) were associated with greater rises in total CD4. After 24wks of r-hGH, 7 of 11 (p=0.06) in ARM A and 7 of 9 (p=0.016) in ARM B had increase in thymus size. Conclusions: Treatment with r-hGH is associated with improved thymic output as measured by increases in naive CD4 cells, thymus size and recent thymic emigrants. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  22 MOAX0404 Comparing CD4+ T cell decline during treatment interruption in HIV-1-infected patients who did or did not receive the candidate immunotherapy Vacc-4x M.A. Sommerfelt1, F.W.N.M. Wit2, J. Nyhus', A.-M.B. Kran3, I. Baksaas4, J.M.A. Lange2, B. Sorensen', D. Kvale3. 'Bionor Immuno, Skien, Norway, 2International Antiviral Therapy Evaluation Center (IATEC), Amsterdam, Netherlands, 3Ullevaal University Hospital, Oslo, Norway, 4Mericon, Skien, Norway Background: This study sought to determine whether the peptide-based immunotherapy candidate, Vacc-4x, targeting dendritic cells of the skin, had influenced CD4+ T cell during a prolonged treatment interruption at the end of the Vacc-4x open-label randomized phase II clinical trial. Since the clinical trial did not include a randomised placebo control arm, Vacc-4x patients were therefore retrospectively compared to similar patients from the Athena cohort that interrupted CART without receiving Vacc-4x. Although Vacc-4x patients are still being followed until they resume CART, this comparative analysis of CD4+ T cell decline encompasses the first 48 weeks following CART interruption. Methods: Patients were selected from each cohort for the CD4 comparison using the following inclusion criteria: (i) virologically successful CART for a minimum of 6 months prior to treatment interruption (ii) an increase of CD4+ T cells (>150 cells/mm3) experienced during CART. AIDS-defining illness was an exclusion criterion. CD4+ T cell decline was measured for Vacc-4x (n=35) and Athena (n=52) patients. Changes in CD4+ T cell counts were analysed using an ANOVA repeated measurements procedure. The level of significance was set at 0.05 throughout and all p-values obtained were 2-sided. Results: The Vacc-4x group showed a significantly slower decline in mean CD4+ T cell counts (p<0.0001) over time. Vacc-4x patients had remained CART-free for a median of 70 weeks (17 months) compared to 16 weeks (4 months) for the Athena cohort at the time of analysis. Conclusions: This study suggests a significant benefit of the Vacc-4x immunotherapy intervention in terms of CD4+ T cell decline following CART interruption. However, these findings should be verified through a randomised prospective placebo-controlled clinical trial. These results nevertheless support the potential for immune-based strategies to sustain immunological fitness during prolonged treatment interruptions - in line with CD4-guided therapy - to reduce exposure to CART and its associated adverse side effects. MOAXO405 Safety of VSSP as immunopotentiator in cuban HIV/AIDS patients treated with antiretroviral A. Trujillo', D. Abreu2, R. Diaz', A. Rittoles', M.C. Godinez', R. Molina', Y. Borrero', Y. Bebelagua3, D. Garrido', T. Rojas', A. Urbino', T. Serrano', D. Cofat', O. Calderon', F. Nufiez', M. Leal', A. Gonzalez', M. Trueba2, A. Carr3, R. Perez4, L.E. Fernandez', J. Perez'. 'Tropical Medicine Institute Pedro Kouri (IPK), Clinical, Havana, Cuba, 'Tropical Medicine Institute Pedro Kouri (IPK), Pharmacy, Havana, Cuba, 3Center of Molecular Immunology, Vaccine, Havana, Cuba, 'Center of Molecular Immunology, Research Director, Havana, Cuba, 'Tropical Medicine Institute Pedro Kouri (IPK), Clinical Director, Havana, Cuba Background: VSSP (very small sized proteoliposomes) is a new approach to enhance immune restoration and control HIV replication. Properties of VSSP as immunopotentiator have been reported. VSSP is a potent adjuvant for dendritic cells activation and Thl differentiation. VSSP was obtained trough the incorporation of NAcGM3 (a strong immunosuppressive ganglioside) into the outer membrane protein complex of Neisseria meningitides (Nm). On the other hand, certain experimental evidences support the view that NAcGM3 and CXCR4 are components of a functional multi-molecular complex critical for HIV1 entry. Methods: 39 patients treated with intramuscular injections of VSSP, emulsified with Montanide ISA 51, were enrolled in a Phase I clinical trial. Two groups were conformed; patients in the first group initiated anti-retroviral therapy (lamivudine + stavudine + nevirapine) 3-6 months before starting VSSP treatment while in patients from the second group the Retroviral therapy and VSSP were concomitantly administered. The first five doses were injected every two weeks (induction phase) and the other six doses, monthly. Primary outcome was the clinical tolerance. Results: After 12 weeks of treatment viral loads (VL) in 75 % of patients in the second group were not detectable (ND) (less than 500 copies/mL), while the same was just for 50 % of patients belonging to the first group. More than 45% of patients generated antibodies against the NAcGM3 ganglioside and main toxicities were: pain in the injection site, fever and cephalea, disappearing spontaneously or by antipyretic treatment. The frequency of events (classified according to WHO) was similar in both groups. All treated patients remained alive and/or free of new AIDS-defining events for a year. Conclusions: Our findings support the safety of VSSP + antiretroviral treatment in HIV/AIDS patients MOAXO501 GYP Egypt; youth-driven advocacy-based success story S. Shawer. Global Youth Partners, Mansoura, EgyptIssues: Youth participation is becoming a fact today but young people are used as an implementation tool for already designed plans. Advocacy plans are restricted to highly experienced adults as they think that youth are incapable of doing it. GYP Egypt proved the success of youth to initiate, design and implement a whole advocacy plan tackling youth-related issues as HIV/AIDS. Description: Global Youth Partners, a youth-driven, advocacy-based initiative with support from UNFPA, aims to rally stakeholders to increase investment and strengthen commitments for preventing HIV infections among youth. In community which is highly stigmatized towards even talking about reproductive health issues; In Egypt, GYP Egypt team found itself working against the belief that advocacy can't be done by youth and the stigma of the community and the decision makers. GYP Egypt team gathered and designed their own advocacy plan, made their 'own internal system, distributed tasks among the team members and even chose their own leadership alternatively through a democratic election annually. In simple words, GYP Egypt led the whole advocacy process from A to Z. And the outcome for their work; they gained the commitment of the Ministry of Education to initiate 5 Anti-AIDS clubs(AACs) to be run by the schools' students, raised fund for the AACs from different organizations and companies financially and technically, along with advocating for youth participation in the discussion of the National Strategic Plan infront of representatives from all organizations fighting HIV/AIDS. Lessons learned: Youth are not incapable of making an advocacy plan with their view. GYP Egypt is a success story (that proved the capability of youth to design and implement their advocacy plan) and should be followed Recommendations: Young people should be allowed to plan for advocacy projects tackling their own issues. Financial support should be invested in youth- driven and youth designed advocacy plans. Using human rights standards to assess HIV-prevention programs for children and youth: a case study of Uganda J. Cohen', T. Tate2. 'Open Society Institute, Law and Health Project Director, New York, United States, 2Human Rights Watch, Children's Rights Researcher, New York, United States Issues: In 2004, reports surfaced of an alleged shift in HIV-prevention policy in Uganda away from comprehensive sex education for young people and toward "abstinence-only" approaches. The U.S. Congress had recently earmarked onethird of its global HIV/AIDS prevention budget to "abstinence until marriage" programs, fueling suspicion that U.S. funding was driving the change. Little was known, however, about the actual nature or extent of U.S.-funded HIVprevention programs in Uganda and whether they promoted "abstinence-only" approaches, in possible contravention of young people's right to information about condoms and safer sex. Description: Researchers from Human Rights Watch interviewed children, young adults, teachers, HIV/AIDS service providers, and U.S. and Ugandan officials about HIV-prevention programs for youth in Uganda. Researchers also reviewed current and former HIV-prevention materials and U.S. and Ugandan HIV/AIDS policies. Information and testimony were analyzed according to international standards on the right to the highest attainable standard of health, including the right to health information. Lessons learned: Human rights standards can provide a useful tool in analyzing HIV-prevention policies and programs. In Uganda, both children's testimony and documentary analysis revealed a conspicuous shift toward "abstinence-only" approaches. Examples of this shift included the removal of images depicting condom use and safer sex from school materials; U.S. funding for organizations that publicly denigrate condoms as a means of HIV prevention; and a draft government policy stating that condom education can be "confusing" to youth alongside abstinence messages. Recommendations: HIV-prevention policies for young people should comply with international standards on the right to health information, which include the right to be informed of all effective methods of HIV prevention, including condoms. International human rights bodies should hold governments to account for restricting young people's access to potentially life-saving information about condoms and safer sex. How well do Kenyan youth understand ABC messages for HIV prevention? i. Pulerwitz', T. Lillie2, L. Apicella', A. McCauley', T. Nelson', S. Ochieng6, P. Mwarogo6, E. Kunyanga'. 'Horizons Program/PATH, Washington DC, United States, 'Family Health International, Washington DC, United States, 'Horizons Program/Population Council, Washington DC, United States, 'Formerly of Horizons Program, Washington DC, United States, 'Horizons Program/ICR W, Washington DC, United States, 'Family Health International, Nairobi, Kenya, 'formerly of Family Health International, Nairobi, Kenya Background: Although the "ABC" behaviors-being abstinent or delaying sex until marriage, being faithful to one sexual partner, and consistently using condoms-are widely accepted as key to reducing the sexual transmission of HIV, considerable debate surrounds how best to deliver messages about them to youth. To better understand how young people interpret and perceive ABC terms and behaviors, we conducted a study in Kenya in 2004. Methods: As part of a larger study, questionnaires that included three openended questions on defining the ABCs were administered to almost 1,400 inschool youth ages 13-19 in two communities in Kenya. Multiple focus group discussions were also held with in-school youth outside of the quantitative sample. Results: Although almost all in-school youth had heard of the ABC terms for HIV prevention, many were unable to define them correctly. Abstinence was XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  23 best understood, with almost half of respondents supplying a correct definition. Less than a fourth could correctly define being faithful, which was commonly confused with other concepts, such as loyalty or being honest. Only 13 percent correctly defined consistent condom use, and many chose to offer negative opinions instead of a definition. Overall, youth perceived of abstinence and being faithful as positive behaviors and condom use as negative. About a third indicated that condom use was a bad idea. Focus group discussions highlighted contextual barriers to the ABC behaviors, including conflicting messages about condom effectiveness, gender-based violence, and forced and transactional sex. Conclusions: HIV prevention programs incorporating ABC messages must clarify the ABC behaviors, particularly being faithful in the context of HIV prevention and consistent condom use. Terminology that is locally appropriate and clear should be used, and negative perceptions of condom use addressed. ABC messages should be combined with other interventions that address barriers to the behaviors, such as gender-based violence prevention. MOAX0504 Efficacy of an abstinence-only intervention over 24 months: a randomized controlled trial with young adolescents J.B. Jemmott III1, L.S. Jemmott2, G.T. Fong3. 'University of Pennsylvania, Annenberg School, Center for Health Behavior and Communication, Philadelphia, United States, 2University of Pennsylvania, Center for Urban Health Research, School of Nursing, Philadelphia, United States, 3University of Waterloo, Department of Psychology, Waterloo, Canada Background: Adolescents worldwide face the disquieting consequences of early sexual involvement, including not only HIV, but also other sexually transmitted infections and unintended pregnancies. Some have advocated an abstinence-only intervention strategy to reduce these risks, others have raised concern about potential adverse effects of such interventions on condom use, but few randomized controlled efficacy trials have been reported. We report such a trial. Methods: 662 young African American adolescents were randomized to one of four interventions based on social cognitive theory-an abstinenceonly intervention, a safer-sex intervention, a comprehensive safer-sex and abstinence intervention, or a health-promotion control intervention-and completed baseline, 3-, 6-, 12-, 18-, and 24-month follow-up surveys. Results: The participants were 10 to 15 years of age (mean = 12.0); 53.5% were girls. The 24-month follow-up rate was 84.4% and did not differ by condition. At baseline, 23.4% reported ever having sexual intercourse, whereas at 24-month follow-up, 57.0% reported ever having sexual intercourse. Logistic regression revealed that adolescents who received the abstinence-only intervention were less likely to report ever having sexual intercourse at 24 -month follow-up than were those in the health-control intervention (p =.02), the safer-sex intervention (p =.007), or the comprehensive intervention (p =.05), controlling for baseline behavior, gender, and age. A subgroup analysis on participants who were virgins at baseline revealed that a smaller percentage initiated intercourse during the follow-up period in the abstinence-only intervention as compared with the health-control (p =.01), the safer-sex (p =.007), and comprehensive interventions (p =.07). There was no difference between the abstinence-only intervention and the health-control intervention in condom use over the follow-up period. Conclusions: Theory-based abstinence-only interventions have the potential to reduce sexual activity or delay sexual debut among young adolescents, without having adverse effects on condom use when adolescents initiate sexual activity. MOAXOS05 Challenges in diagnosis disclosure to HIV positive teenagers N. Manescu, B.C. Bobolea. Romanian Angel Appeal, Projects, Bucharest, Romania Issues: In Romania are living more than 7.000 teenagers HIV+ and not all of them know the diagnosis. 85% of the HIV+ teenagers are at the age of starting their sexual life (16-18 years). They are confronted with the risk of HIV spread through unprotected sex and they need to find out the diagnosis and to receive sexual education. Description: The Right to Adolescence project aimed to facilitate the diagnosis disclosure to the teenagers by their parents, with counseling from the psychosocial staff, to educate the teenagers on sexual life and to involve the HIV+ teenagers in prevention programs. This paper will discuss the work for diagnosis disclosure for cases were the parents are refusing the diagnosis disclosure to their children for many years, and the solution recommended for such cases. Diagnosis disclosure to HIV+ teenagers is a process which continues after the disclosure with counseling, and sexual education. HIV+ teenagers who find out the diagnosis were trained and involved in programs regarding HIV prevention. They organized informative sessions on sexual education for their peers. Parents of the teenagers who find out the diagnosis were involved in activities for helping other parents to disclose the diagnosis to their children (support groups). 830 teenagers find out the diagnosis and 48 were trained as peer educators. Lessons learned: HIV+ teenagers are highly motivated to participate in programs for their peers and with help from the psychosocial staff they could become opinion leaders able to take a stand against the social exclusion of people living with HIV/AIDS. Recommendations: The young people living with HIV/AIDS and must be directly involved in programs regarding their peers. Their messages transmitted directly to other HIV/AIDS affected families are highly credible and have a strong impact on the parents who refuse diagnosis disclosure to their children. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  24 Monday 14 August iscus iur' Poster Discussions Track A MOPDAO1 Use of modified UlsnRNAs to inhibit HIV-1 replication R. Sajic, K. Lee, K. Asai, A. Cochrane. University of Toronto, Molecular and Medical Genetics, Toronto, Canada Background: The rapid evolutionary rate of HIV-1 has lead to the emergence of multi-drug resistant variants, emphasizing the need for novel inhibitory strategies. Inhibiting viral gene expression through disruption of HIV-1 RNA processing is one such target. A means of accomplishing this is through use of modified UlsnRNA variants that target highly conserved regions of HIV1. We have demonstrated such U1 derivatives can yield a dramatic (>95%) suppression of HIV gene expression. Methods: To identify possible HIV-1 regions susceptible to regulation by modified UlsnRNAs, multiple conserved sequences were tested. The complementary sequences were inserted into UlsnRNA and tested for effects on HIV-1 protein expression when cotransfected with HIV-1 provirus. Human cell lines were transfected with HIV-1 provirus and the modified U1 constructs. Viral protein production was assayed by Western blot and viral RNA levels measured by Northern blot. Results: Several modified UlsnRNA constructs when transfected alone or in combination displayed substantial inhibition of HIV-1 protein expression. The inhibitory effect is dependent upon the presence of U1 70K and Sm proteins in the UlsnRNP complex. Loss of viral protein expression correlated with a >90% reduction in viral RNA levels, consistent with the constructs ability to block HIV RNA polyadenylation. Stable cell lines expressing the modified U1 constructs inhibited HIV-1 infection by 70% relative to control. Current work is evaluating the effects of multiple anti-HIV U1 constructs and the ability of the virus to circumvent these agents. Conclusions: We have identified several modified UlsnRNA that are able to inhibit viral structural protein expression by as much as 95%. Maximal antiviral activity is dependent upon binding of U1 70K and Sm proteins, while loss of UlA binding to the UlsnRNAs only reduced activity. The potential activity of this new strategy suggests that it may be possible to render cells expressing these constructs unable to support HIV replication. MOPDAO2 Post-transcriptional inhibition of HIV-1 subtype C by expressed long hairpin RNAs targeted to the R and U5 regions of the LTR S. Barichievy', S. Carmona', C. Crowther', S. Saayman1, K. Morris2, P. Arbuthnot', M. Weinberg'. 'University of the Witwatersrand Medical School, Molecular Medicine and Haematology, Johannesburg, South Africa, 2The Scripps Research Institute, Molecular and Experimental Medicine, La Jolla, United States HIV-1 subtype C is the predominant subtype and accounts for over 50% of the global infection burden. Although current therapies positively affect the morbidity and mortality of HIV-related illness, concerns regarding drug toxicity and resistance have prompted the search for novel therapeutic approaches. The RNA Interference (RNAi) pathway has been widely applied to target HIV-1 viral RNAs, blocking early and late stages of viral replication by post-transcriptional gene silencing (PTGS). Traditionally short hairpin RNAs (shRNAs) or small interfering RNAs (siRNAs) have been used to induce PTGS but long hairpin RNA (IhRNA) duplexes have the potential to generate multiple siRNAs simultaneously, thus limiting the possibility for viral escape induced by base changes within the targeted sequence. We generated three U6 Pol III promoter-driven cassettes that encode IhRNAs with 60 bp stems targeted to adjacent sites within the LTR of HIV-1 subtype C. G:U pairings were incorporated in the stem sequence to prevent induction of the interferon response by dsRNA-dependent protein kinase (PKR). Transient co-transfections in cultured cells showed that two of the three IhRNAs knocked-down a subtype C LTR-driven firefly luciferase reporter by 80% in the presence of Tat. Similar knockdown was observed when targeted to a subtype B LTR-driven reporter, suggesting that minor sequence variations are tolerated by the IhRNAs. However, a IhRNA targeted to the TAR stem-loop sequence and a control IhRNA targeted to an irrelevant sequence did not significantly knockdown reporter gene expression. A Northern assay showed that a single IhRNA was processed into different siRNAs with probes spanning the duplex. As an index of the activation of interferon inducible genes, none of the IhRNAs induced expression of OAS1, MxA and IFN-3 mRNA concentrations. These data indicate that expressed IhRNAs are capable of inhibiting HIV-1 gene expression without eliciting an unwanted interferon response, and may have potential therapeutic application to counter viral escape. MOPDAO4 siRNA restriction of HIV-1 replication is primarily due to mRNA rather than genomic RNA degradation Y. Gao1, M. Lobritz', J. Roth2, M. Abrehal, I. Nankyal, D. Moore', A. Abraha', K. Nelson', S. Gerson2, E. Arts'. 'Case Western Reserve University, Infectious Diseases, Cleveland, United States, 'Case Western Reserve University, Case Comprehensive Cancer Center, Cleveland, United States Background: siRNAs have been shown to effectively inhibit HIV-1 replication in vitro. Incoming HIV-1 genomic RNA is a potential target for siRNA degradation, however the accessibility of this target remains unclear. Further, it is not clear how siRNAs interact with the RNA species present during all phases of the viral life cycle. Methods: We designed siRNAs against the envelope and gag gene of two primary HIV-1 isolates (v120-UG and v126-UG) and tested their inhibitory efficiency. To assess siRNA effects on reverse transcription, we developed a self-inactivating lentiviral vector with the siRNA target region from v120-UG or v126-UG to discriminate between degradation of genomic RNA and mRNA by virtue of a GFP reporter gene. We also investigated single siRNA effects on various HIV-1 mRNAs and proteins. Results: We found that genomic RNA was not susceptible to siRNA degradation. However, siRNAs can efficiently target and degrade not only genes containing their specified target region, but also proximal genes that lack the target sequence. Multiply-spliced HIV-1 RNA was the most susceptible to siRNA degradation, siRNAs did not affect the infectivity of progeny virus. Conclusions: HIV-1 genomic RNA is protected from siRNA degradation and the dominant effect of siRNA knockdown occurs at the level of mRNA. MOPDAO5 Phase II clinical trial demonstrates the safety and tolerability of multiple doses of autologous CD4+ T cells transduced with VRX496, a lentiviral vector delivering anti-HIV antisense in patients failing 1 or more HAART treatment T. Rebello', C. Afable', S. Callahan', L. Humeau', A. Chopra', X. Lu', V. Slepushkin', D. Stein2, C. Steinhart3, R.N. Greenberg4, A. Zolopa'. 'VIRxSYS, Gaithersburg, United States, 2Jacobi Medical Center, Bronx, United States, 3Mercy Hospital, Miami, United States, 4Lexington VA Medical Center and the University of Kentucky, Lexington, United States, 'Stanford University School of Medicine, Stanford, United States Background: Gene therapy for HIV-1 infection has been proposed as an alternative to antiretroviral drug therapy due to emerging drug resistance and toxicity that often limits HAART as a therapeutic option. We have previously reported the successful completion of our Phase I clinical trial testing the safety and tolerability of a single infusion of autologous HIV-infected CD4+ T cells transduced with a lentiviral vector delivery system expressing a 937-base antisense gene against the HIV envelope (VRX496) for use in T cell therapy for HIV/AIDS. Methods: Multi-center Phase II clinical trial to evaluate the safety, tolerability, and biological activity of repeated infusions (4 or 8) of autologous VRX496 transduced T cells. The study will enroll -30 male and female HIV-positive subjects, who have failed one or more HAART regimens, in 4 centers. Every two weeks patients will receive doses by IV of approximately 5 to 10 billion genetically modified autologous T cells. The first part of the study is evaluating the safety and tolerability of multiple dosing. Additional enrollment of patients in part two will help determine an optimal dosing regimen for future confirmatory trials. Results: To date, 18 patients have been enrolled. All three patients in the first 4-dose cohort have completed their infusions and have reached the 3-month post-infusion visit; one patient in the 8-dose cohort has received all scheduled doses. Preliminary results suggest repeated infusions are safe and well tolerated, with no SAE's related to the product, no changes in hematology or chemistry laboratory evaluations, and no detection of VSVG DNA or RCL. Virologic and immunological results will be presented. Conclusions: Multiple doses of autolougous CD4+ T cells transduced with a lentiviral vector appear to be safe and well tolerated. The clinical utility of lentiviral vector technology as an alternative for treatment of HIV infection continues to be explored. MOPDA06 Safe and sustainable anti-HIV hematopoietic progenitor cell-delivered antisense: followup through month 60 from phase I trial D. Liu1, E. Dunn2, P. Unemori2, C. Eden2, M.A. Conant2, M.J. Cowan'. 'Enzo Therapeutics, Inc, New York City, United States, 'University of California San Francisco, San Francisco, United States Background: HGTV43, a Retrovirus-based vector delivering three U1/anti HIV-1 antisense genes targeting TAR and two sites of TAT has shown promise in vitro (Liu, et al. 1997). We report data through month 60 postinfusion. Methods: Nine HIV-1+ subjects were enrolled and seven were treated in this Phase I trial. Autologous CD34+ cells were isolated, transduced, and reinfused. PBMC and CD4+ cells were isolated post infusion at six month intervals at points between 6 and 20 months. These cells were assayed for the presence of anti-HIV-1 antisense RNA by reverse transcription followed by real-time PCR using a Light Cycler (Roche Applied Science) and restriction enzyme analysis on a plus/minus basis. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  25 Results: Of seven treated subjects, five were available beyond 12 months post-infusion. Two subjects were lost to follow-up early in year one. Antisense RNA was present in PBMC and/or CD4+ cells at the time of measurement in all five. Four subjects were available for evaluation through month 60. At month 48, antisense RNA was present in both the PBMC and CD4+ fraction of one subject, and in only CD4+ cells of two subjects. The fourth subject was negative at month 48 and beyond. At month 60, antisense RNA was present in CD4+ cells of only one subject. Antisense RNA was found in CD34+ bone marrow cells in all five subjects, the earliest at 6 months and the latest at 20 months. There were no treatment-related adverse events, no evidence of clonal expansion due to insertional mutagenesis, and no significant change in CD4+ cell count or HIV-1 viral load. Conclusions: These results are an example of the survival at low levels of transduced CD34+ stem cells in nonablated subjects with sustainable transgene activity as well as the long term presence of engineered cells in the'circulating progeny, i.e., CD34+ and CD4+ cells. MOPDA07 Inhibition of HIV-1 replication in human T cells by RNA interference Y. Meshcheryakoval, N. Gashnikoval, O. Plyasunoval, N. Pokrovskayal, A. Pokrovsky', N. Petyovka2, N. Tchurikov2. 'State Research Center of Virology and Biotechnology,'VECTOR', Research Institute of Molecular Biology, Department of Retroviruses, Koltsovo, Novosibirsk region, Russian Federation, 2Enge/gardt Institute of Molecular Biology Russian Academy of Sciences, Moscow, Russian Federation Background: Silencing of gene expression by RNA interference (RNAi) offers a new tool with potential therapeutic applications for the treatment of HIV-1 infection. Methods: Two plasmid vectors specifically designed for expression of small hairpin RNAs in mammalian cells were used. These are: 1) the pEGFP-N1 (Clontech); and 2) the siSTRIKET"M U6 Hairpin Cloning Systems (Promega), which provide a cloning-based approach to allow fast, easy ligation and expression of hairpin oligonucleotides. We targeted the Gag gene as degradation in this region inhibits viral genomic RNA accumulation and production of p24 antigen, the Pol region, which codes viral enzymes, and the gene for the regulatory protein Tat. MT-4 cells were transfected with shRNA expression constructs by electroporation with a Bio-Rad gene pulser on the third day of cultivation. Transfection efficiency was determined by GFP fluorescence. The transfected cells were infected 48 hours after transfection at a multiplicity of infection of 0,1-1,0 infectious units per cell. Four days later, cell-free supernatant was collected, and viral production was quantified by measuring HIV-1 p24 antigen levels by ELISA. Results: The transfection efficiency under the most optimal conditions reached 60-65%. HIV-1 production in T-lymphocytes expressing shRNAs corresponding to sequences in the Gag gene was reduced by more than five-fold compared to untransfected cells (by 85%). The constructs containing tat and pol seguences inhibited HIV-1 replication by less than two-fold (47 and 23%). There was also correlation between the inhibition level of virus reproduction and the HIV-1 infecting dosage. Moreover, we confirmed the effectiveness of the shRNAs by their dose dependence and the transfection efficiency. Conclusions: Our experiments demonstrated significant inhibition of HIV-1 reproduction in cells containing expression vector constructions compared to relevant controls. The obtained results showed the potential ability of using these HIV-1 specific shRNA expression constructs for AIDS gene therapy. MOPDA08 Inhibiting HIV-1 by augmenting cellular antiviral pathways H. Christensen', C. Ong', S. Chung', L. Frankel2, A. Daher2, S. Laine2, S. Bannwarth2, A. Gatignol2, D. Purcell'. 'University of Melbourne, Microbiology and Immunology, Parkville, Australia, 2Lady Davis Institute for Medical Research, McGill AIDS Center / Molecular Oncology Group, Montreal, Canada Background: High level expression of the cellular protein, TAR RNA Binding Protein (TRBP), correlates with high level production of HIV-1. TRBP is a dsRNA binding protein, which inhibits PKR activation. TRBP is also a component of the RNAi system that directs siRNAs processed by RNase III family protein DICER to the Ago-2 RNA silencing machinery. We investigated whether decreasing high endogenous expression of TRBP in HIV-1 permissive cells resulted in decreased HIV-1 production. Methods: We identified siRNAs to TRBP that silenced an EGFP-TRBP reporter. Next we confirmed that decreasing endogenous TRBP expression with TRBP siRNAs reduced expression of the HIV-1 molecular clone, NL4.3, in HeLa cells. Finally we assessed effects on TRBP and HIV-1 expression of shRNA and miRNA expressing vectors that produce short stem-loop RNAs that are processed by the RNA interference (RNAi) machinery into TRBP siRNAs. Results: We validated the ability of the TRBP siRNAs to decrease HIV-1 expression. Vector delivery of functional siRNAs caused a dramatic 80% knockdown of EGFP-TRBP reporter expression, however, when co-transfected with HIV-1NL4.3 no decrease in viral replication was observed. Our results suggest that processing of vector delivered TRBP siRNAs is not impeded by the knockdown of TRBP, however at the same time the vectors appear to be ineffective at decreasing HIV-1NL4.3 expression. We assessed whether the HIV-1 Tat protein suppressed the biogenesis of RNAi from vector-derived dsRNA, an essential step for the processing of vector delivered siRNAs. Conclusions: The vector-derived TRBP dsRNA yielded insufficient RNAi and did not reduce TRBP levels sufficiently to augment the PKR response to a degree that reduced HIV-1 expression. However, jointly targeting HIV Tat and TRBP with RNAi greatly enhanced the inhibition of HIV-1NL4.3 expression. Poor silencing activity of vectors targeting TRBP in HIV-1 infected cells appears to be linked to the silencing-suppressor activity of HIV-1 Tat. Track B MOPDB01 Risk of clinical progression over long term follow-up in a wide cohort of patients by different patterns of viro-immunological response assessed at month 18. results of the Italian MASTER cohort C. Torti1, G. Paraninfo', S. Casari', E. Quiros Roldan', F. Suter2, F. Maggiolo2, T. Quirino3, G. Migliorino3, L. Minoli4, R. Maserati4, F. Ghinelli', L. Sighinolfi', F. Mazzotta6, S. Lo Caputo6, A. Antinori', F. Antonucci', G. Pastore9, N. Ladisa9, F. Castelnuovo1", C. Tinellill, A. De Silvestri", G. Carosil. 'University of Brescia, Institute for Infectious and Tropical Diseases, Brescia, Italy, 2Ospedali Riuniti di Bergamo, Department of Infectious Diseases, Bergamo, Italy, 3Ospedale di Circolo, Department of Infectious Diseases, Busto Arsizio, Italy, 4University of Pavia, Institute of Infectious Diseases, Pavia, Italy, 5S. Anna Hospital, Department of Infectious Diseases, Ferrara, Italy, 6S. M. Annunziata Hospital, Department of Infectious Diseases, Florence, Italy, 7IRCCS L. Spallanzani ', National Institute for Infectious Diseases, Rome, Italy, 8IRRCS L. Spallanzani, National Institute for Infectious Diseases, Rome, Italy, 9University of Bari, Institute of Infectious Diseases, Bari, Italy, "~Spedali Civili of Brescia, Department of Infectious Diseases, Brescia, Italy, "IRCCS Policlinico S. Matteo, Department of Biostatistics, Pavia, Italy Background: HAART increases survival of HIV +ve patients. However, improved knowledge of clinical predictors over long-term follow-up is required to optimize HIV-disease management. Methods: All HIV-positive patients in the observational longitudinal MASTER cohort who started HAART between 1996-2002, with minimum follow-up available at month 18 after HAART have been studied. New AIDS-definingevents (ADE) and/or AIDS-related-deaths have been considered as outcome measure. Cross-check with Italian National AIDS Registry has been performed. Three univariate and multivariable Cox proportional hazards regression models were performed, respectively: (i) baseline; (ii) time-updated clinical variables, including initial viro-immunological effectiveness ranked into three groups (V+/I-, i.e.: HIV-RNA<400 c/ml for 1 year after six month HAART and lack of CD4+ increase by at least 25% from baseline; V+/I+ and; V-/I+) and; (iii) both baseline & time-updated variables. Results: Amongst 1,157 patients over a mean follow-up of 58 months (IQR: 39-77), 144 ADE's and 11 AIDS-related-deaths were recorded. When baseline factors were tested, only clinical class C (CDC '93, modified) was independently correlated with outcome (HR: 4.3; 95%C.I. 2.6-7.2; P<0.0001). In the timeupdated model, the following variables appeared to protect from the risk of ADE/death: months on boosted-protease-inhibitor (PI)-based regimens (per month HR: 0.98; 95%C.I. 0.96-0.997; P=0.025) and higher last CD4+ T cell counts (>350 vs. <200/mm3 HR: 0.08; 95%C.I. 0.03-0.18; P<0.0001 and 200 -350 vs. <200/mm3 HR: 0.21; 95%C.I. 0.086-0.52; P: 0.001). In the baseline & follow-up model, either baseline clinical stage and last available CD4+ resulted independent predictors. Conclusions: Diagnosis of HIV infection, treatment before ADE and maintenance of high CD4+ T cell count induced by HAART remain important priorities protecting from AIDS morbidity and mortality over a long-term followup even in this cohort of patients who followed a first line HAART for at least 18 months. Viro-immunological trends over this initial period did not appear to influence subsequent clinical progression. MOPDBO2 Causes of severe morbidity in HIV-infected patients. Aquitaine cohort 2000-2004: the importance of bacterial infections, cardio-vascular, digestive, and psychiatric morbidity F. Bonnet, G. Chine2, S. Lawson-Ayayi2, M. Dupon', J.-L. Pellegrin4, R. Thibbaut2, P. Morlat', Groupe d'Epidemiologie Clinique du SIDA en Aquitaine. 'Hopital Saint-Andrd, CHU de Bordeaux, Service de Mddecine Interne et Maladies Infectieuses, Bordeaux, France, 'Universite Victor Segalen Bordeaux 2, INSERM U593, Bordeaux, France, 'Hopital Pe//egrin, CHU de Bordeaux, Service de Maladies infectieuses, Bordeaux, France, 'Hopital Haut-Levbque, CHU de Bordeaux, Service de Medecine Interne et Maladies Infectieuses, Pessac, France Background: The increase of life expectancy of HIV-infected patients is associated with a decreased incidence of AIDS events but little is known about the evolution of other causes of severe morbidity because, in most of the cohorts, only AIDS events are systematically recorded. Methods: Among a large cohort of HIV-infected patients where all severe events are systematically recorded and coded according to the International Classification of Diseases 10th revision (ICD10), we aimed at studying the evolution of the severe morbidities leading to hospitalisation and/or deaths between 2000 and 2004. Monday 14 August Poster Discussion XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  26 Results: 1186/3863 patients were hospitalised at least once, resulting in 1854 hospitalisations for medical concerns. The yearly rate of hospitalisation / hospitalised patients decreased over time between 2000 and 2004 from 172 to 92 and from 132 to 78 per 1000 patients, respectively. 21% of events were bacterial infections, 20% AIDS events (24% in 2000 to 11% in 2004), 10% psychiatric disorders, 9% cardiovascular events (5 to 15%), 7% hepatic/ gastro-intestinal disorders (cirrhosis 60%), 6% other viral infections, 5% nonAIDS cancers, and 4% iatrogenic events (5 to 3%). CD4 count at the time of event was below 200/mm3 in 37% of patients and above 500/mm3 in 19%. As compared to other patients, patients with events were older (41.5 vs 39.9 years; P<0.001), with lower CD4 count (250/mm3 vs 489/mm3; P<0.001). They were also more likely to be contaminated through intra venous drug use (30 vs 19%; P<0.001), positive for hepatitis C (37 vs 27%; P<0.001) and at AIDS stage (43 vs 14%). Conclusions: Severe morbidity has shifted from AIDS-related to non AIDSrelated causes. Ageing, co-morbidities (hepatitis, addictive behaviours) might explain this evolving distribution. Immunodepression, even moderate may also have a role in the development of non-AIDS morbidity. Limiting endpoints to AIDS events and death could be misleading in the interpretation of prognostic and therapeutic studies. MOPDBO3 Attributes to death of HIV/AIDS patients in the era of HAART C.F. Ho, K.L.S. Cheng, K.H. Wong, K.C.W. Chan. Special Preventive Programme, Department of Health, Hong Kong, China Background: In HAART era, there is a substantial reduction in HIV-associated mortality but notable shifted causes of death. Understanding attributes to death can help in formulating strategies and establishing priorities to improve care. Although there is no consensus on the context to be examined, it is essential to include all possible attributes, i.e. biomedical, behavioural and psychosocial factors. We set out to study attributes to death of HIV/AIDS patients in Hong Kong. Methods: The clinical records of HIV/AIDS patients who died between 1st Jan 2003 and 31st December 2004 were reviewed. Information was collected on: (a) demographics, (b) last psychosocial assessment result, (c) medical and treatment history, (d) adherence to medical follow-up and HAART, and (e) medical cause of death. Results: Of 698 patients, 24 died. All were Chinese and two were female. The median age at death was 48.5 years (range: 24 to 76 years). The median time from HIV diagnosis to death was 3 years (range: 3 months to 19 years). Sixteen deaths were causally related to HIV (including 6 AIDS); four were not; and four were unknown. No patient was known to die of antiretroviral toxicity. Six deaths (25%) occurred in those who presented with CD4 <50 cells/uL and died within 1 year of diagnosis. Unfavourable behavioural and psychosocial factors were common. Thirteen (54%) had missed medical appointment for more than 6 months, had refused HAART, or had a self-reported adherence rate <95%. Conclusions: Only one-fourth of deaths in the HAART era resulted from AIDS. Beyond biomedical factors, one-fourth of deceased patients were late presenter of HIV diagnosis and half had poor adherence to medical followup and HAART. Both groups deserve special attention as their death may be avoidable. Interventions should be formulated to encourage early diagnosis, modify unfavourable behaviour and address psychosocial needs of HIV-infected persons. MOPDBO4 Predictors of mortality in HIV-infected adult African patients receiving highly active antiretroviral therapy A.M. Siika1, K. Wools-Kaloustian2, S.N. Kimaiyo', A. Mwangi3, L.O. Diero1, P.O. Ayuo1, W.D. Owino-Ong'or', J.E. Sidle4, R.M. Einterz4, C. Yiannoutsoss, B. Musicks, W.M. Tierney4. IMoi University School of Medicine, Medicine, Eldoret, Kenya, 'Indiana University School of Medicine, Infectious Diseases, Indianapolis, United States, 3Academic Model for Prevention and Treatment of HIV (AMPATH), Biostatistics, Eldoret, Kenya, 'Indiana University School of Medicine, Medicine, Indianapolis, United States, sIndiana University School of Medicine, Biostatistics, Indianapolis, United States Background: There is little data available on mortality in African patients on Highly Active anti-retroviral Therapy (HAART). This study was undertaken to determine predictors of mortality in such patients. Methods: This was a retrospective study of prospectively collected data from consecutively enrolled adult HIV-infected patients in nine HIV clinics in western Kenya. Data from records of deceased patients started on HAART between November 2001 and December 2005 were analyzed and compared with those from records of living patients started on HAART during the same period. Analyses of time to death were undertaken using Kaplan-Meyer and Multivariate Cox proportional hazard regression models. Results: Data from 527 deceased patients were compared with 1054 patients known to be alive. At initiation of therapy, median age was 38 years (range 16-77) for deceased and 36 years (range 15-73) for alive patients. Median duration of time on HAART was 7.7 weeks (range 0-110) and 42 weeks (range 0-208) (p<0.0001) for deceased and alive patients respectively. Patients with CD4 count < 100 were more likely to die than those with CD4 count 100 - 200 (HR=1.94, CI (1.63,2.53), p<0.0001) who in turn had a higher chance of dying than those with CD4 cell counts >200 (HR=1.63, CI (1.13,2.42), p<0.0093). The hazard for death of perfectly adherent patient was 0.6 times that of non adherent patients (HR=0.61, CI (0.44, 0.86), p=0.0025) while that for patients attending urban clinic was a third of that among patients attending rural satellite clinics (HR=0.35, CI (0.24, 0.51), p <0.0001). Male gender, higher WHO Stage and hemoglobin level <10 grams % were significantly associated with death. Age, marital status, educational level, employment status and weight were not associated with mortality. Conclusions: Patients on HAART who died were in poor health based on CD4 cell count and WHO Stage and often did so soon after initiation of therapy. MOPDB05 Predictors of mortality in patients initiating antiretroviral therapy in Durban, South Africa B. Ojikutu', H. Zheng2, R. Walensky2, Z. Lu2, E. Losina2, J. Giddy3, K. Freedberg2. 1Harvard Medical School, Division of AIDS, Boston, United States, 2Massachusetts General Hospital, Boston, United States, 'McCord Hospital, Durban, South Africa Background: As an increasing number of patients start antiretroviral therapy (ART) in resource-constrained settings understanding predictors of mortality will help to maximize future clinical outcomes. Our objective was to characterize factors present prior to ART initiation that are associated with mortality in HIVinfected patients who start ART in Durban, South Africa. Methods: We conducted a retrospective cohort study of patients who initiated 3-drug ART (AZT, 3TC and efavirenz or nevirapine) at McCord Hospital's Sinikithemba HIV Clinic from January 1, 1999 to February 29, 2004. The impact of demographic, clinical and laboratory parameters on mortality were evaluated using univariate and multivariate Cox proportional hazards models. The KaplanMeier method was used to assess survival. Results: Three hundred and nine patients were included in the study. Mean age was 38 (+/-8.6). 56% of patients were female. Overall one-year survival was 0.78 [95%CI (0.71, 0.85)]. In univariate analysis, pre-ART history of oral candidiasis [HR 3.17(1.70, 5.87)], history of cryptococcal meningitis [HR 2.76 (1.80, 19.2)], CD4 cell count <50/mm3 [HR 3.70 (1.96, 7.14)], and hemoglobin < 8 g/dl [HR 1.23 (1.08, 1.40)] were the strongest predictors of mortality once ART was initiated. Age, gender, history of pulmonary or disseminated tuberculosis [HR 0.93 (0.51, 1.71)] did not predict mortality. History of oral candidiasis and CD4 cell count <50/mm3 remained significant in multivariate analysis [HR 2.58 (1.37, 4.88) and HR 3.12 (1.56, 5.88)]. No difference in mortality was noted between patients with CD4 cell count <20/mm3 and 20 -50/mm3 [HR 1.06 (0.51, 2.18)]. Conclusions: History of oral candidiasis and CD4 count <50/mm3 are independent predictors of mortality in patients initiating ART in Durban, South Africa. Further interventions to reduce mortality associated with these clinical markers should be developed and urgently implemented. MOPDB06 Very low CD4 T cell counts and low total lymphocyte counts at initiation of HAART are associated with a poor outcome in the first 6 months of antiretroviral treatment H. Mayanja-Kizzal, F. Lutwama2, M. Kamya3, C. Kikawa2, L. Spacek4, T. Quinn4. 1Makerere University, Faculty of Medicine, Academic Alliance for AIDS Care and Prevention, Kampala, Uganda, 2Makerere University Infectious Diseases Institute, Kampala, Uganda, 3Makerere University Infectious Diseases Institute/ Academic Alliance for AIDS Care and Prevention, Kampala, Uganda, 4Johns Hopkins University, Public Health, Baltimore, United States Background: Global HAART scale up efforts have increased access to AIDS treatment in developing countries, but mortality remains high despite adequate management. Methods: A cohort of 550 patients starting HAART were prospectively followed up over thirty months at an AIDS treatment center in Kampala, Uganda. Regular clinical review; and CD4 T cell and viral load counts were done every 3 and 6 months respectively. Early home visits to locate those who missed clinical appointments were done. Data was compared to patients alive after over twelve months of HAART. Results: Seventy two (13%), patients (45 females, mean age 36.7 (SD 19) and 27 men, 39.3 (SD 6) years), died while on ARVs despite over 90% adherence. Twenty nine died within 6 months of commencement of ARVs, 24 between 6-12 months and 19 died after one year. HAART was started at very low CD4s, median 24 cells/mm3 among those who died, (deaths within 6, 6-12, over 12 months of HAART, median CD4T cells 14 cells/mm3, 31 cells/ mm3, 73 cells/mm3 respectively) compared to 110 cells/mm3 among over 12 months survivors (p=0.002). Initial total lymphocyte counts were significantly lower among deaths within 6 months, mean 1200/mm3, (SD 720) compared to deaths over one year 1800 cells/mm3, (SD 1038) and survivors 1780 (SD 1120) (p=0.028). Viral load at onset of HAART was similar in all groups, mean 5.5 log among survivors, and 5.7 log among all deaths. There was better viral load suppression at 12 months 2.9 log among survivors, compared to 0.4 log among deaths over one year (p=0.005). Conclusions: High mortality on HAART may be associated with late commencement of treatment at very low CD4 counts, where despite adequate treatment immune recovery lags behind virological suppression. Commencing HAART at earlier CD4 counts should be considered, even in resource limited countries to improve outcome. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  27 Track C MOPDCOI Do economic developement programmes reduce vulnerability to HIV and intimate partner violence (IPV): qualitative perspectives from a prospective cluster-randomized trial G. Phetla', J. Busza2, P. Pronyk3, J. Kim2, R. Euripidou4, J. Hargreaves2, L. Morison2, C. Watts2, J. Porter2. '1Rural AIDS and Development Action Research Programme (RADAR), School of Public Health University of the Witwatersrand, Johanneburg, South Africa, 2London School of Hygiene and Tropical Medicine, London, United Kingdom, 3Rural AIDS & Development Action Research Programme, School of Public Health, University of the Witwatersrand, Acornhoek, South Africa, 4Rural AIDS & Development Action Research Programme, School of Public Health, Acornhoek, South Africa Background: Poverty and gender inequality drive the HIV epidemic in much of southern Africa. The Intervention with Microfinance for AIDS and Gender Equity (IMAGE) study is a cluster randomised trial of a structural intervention for the prevention of HIV and IPV that integrates gender and HIV education into an existing microfinance (MF) initiative. Qualitative methods were used to document changes in economic vulnerability, social capital, gender equity and "diffusion-of-innovation" over a 3 year period. Methods: Qualitative data comes from focus group discussions with loan groups, in-depth interviews with both participants, dropouts and young people, non-participant observation of bi-weekly loan centre meetings, and participatory learning and action (PLA) workshops among young people in the communities. Thematic content analysis outlines key changes at the individual, household, and community level in response to the intervention. Results: Among loan recipients, self-sufficiency improved both materially (ability to provide) and socially (heading the household), including an increase in self-confidence. Participants' exposure to the intervention has improved many of their life skills, particularly their ability to communicate effectively in their households and wider community. Participants and their household members showed an increased awareness of HIV/AIDS and gender issues. There was substantial evidence of diffusion through community mobilization efforts around both HIV and IPV. In some centres, problems with financial performance reduced intervention uptake. While the intervention has had positive impacts on the lives of many participants and households, some see it more ambiguously. Effects from education vs. those due to MF were inseparable in the minds of participants. Conclusions: Qualitative data suggests the intervention enhances selfsufficiency, self-confidence, and critical-thinking around issues including genderbased violence, gender roles and HIV/AIDS. There is evidence to support wider changes at the household and community level. Quantitative results will also be presented at the conference. MOPDCO2 Sexual assault, sexual risks, and gender attitudes among South African men D. Cain', L.C. Simbayi2, C. Cherry', N. Henda2, S. Kalichman1. 'University of Connecticut, Psychology, Storrs, United States, 2HSRC, Cape Town, South Africa Background: Sexual assault and HIV infection are both prevalent and related social problems in South Africa. The current study examined attitudes toward women, acceptance of gender violence, and masculine ideological beliefs in relation to sexual assault history and HIV risk behaviors among men in a Cape Town township. Also, based the results, an intervention was developed and pilot tested. Methods: Men (N = 435) completed anonymous surveys; 57% indigenous African, 35% identified as Colored, and 8% White or Indian; 46% between the ages of 18 and 26; 50% unemployed; median weekly income R420 South African Rand (US$70). Results: One in five men had either threatened to use force or used force to gain sexual access to a woman in their lifetime. Men with a history of sexual assault reported greater numbers of sex partners and higher rates of unprotected intercourse in the previous 6 months than their non-sexually assaultive counterparts. Men with a history of sexual assault were also more likely to endorse hostile attitudes toward women and were more likely to accept violence against women. Based on these findings a team of primarily South African women and men developed and pilot tested a network-level intervention model designed to both reduce violence accepting social norms and reduce high risks sexual practices among men; 55 men were enrolled using chain recruitment strategies. Results show evidence for the feasibility acceptability of intervening with men for both sexual violence and HIV risk reduction in South Africa. Conclusions: These findings extend previous research to show that men who have a history of sexual assault also exhibit elevated risks for HIV/AIDS and that both sexual violence and HIV risk can be addressed in a single integrated intervention model. MoPDCo3 Post-exposure prophylaxis following sexual assault in Cape Town: adherence and HIV risk behavior M. Roland', L. Myer2, R. Chuunga3, L. Martin2, A. Maw2, T. Coates4, L. Denny2. 'University of California San Francisco, Postive Health Program at SFGH, San Francisco, United States, 2University of Cape Town, Cape Town, South Africa, 3Jooste Hospital, Cape Town, South Africa, 4University of California Los Angeles, Los Angeles, United States Background: Post-exposure prophylaxis (PEP) use following sexual assault in low HIV prevalence areas is associated with poor adherence and followup. Adherence, side effect rates and ongoing HIV risk behavior among sexual assault survivors receiving PEP in high HIV prevalence areas are unknown. Methods: Observational cohort of adult and adolescent sexual assault survivors in Cape Town, South Africa. We describe adherence, side effects, HIV risk behaviors and 6 month HIV testing outcomes. Predictors of adherence and unprotected sex were evaluated in linear regression models. Results: 135 subjects enrolled. Median days of PEP completed was 27, however 35% missed > one dose in the prior 4 days or discontinued PEP within a week. No demographic, socioeconomic or risk predictors were associated with poor adherence. Symptom rates were similar between those who did and did not adhere. 58% reported unprotected intercourse in the 6 months prior to the assault, 93% with a single partner of unknown HIV status. At months 1, 3 & 6 following the assault 37%, 53% & 66%, respectively, reported unprotected intercourse. In unadjusted analyses, predictors of unprotected sex at 3 months included baseline unprotected sex, older age, employment and higher income. In multivariate analysis, prior unprotected sex was associated with subsequent unprotected sex (OR 8.3; 95% CI 3.3, 20.9). There were 4 seroconversions at 6 months (risk = 3.7%; 95% CI 1.0, 9.1). Two were probable PEP failures, one each with excellent and incomplete adherence. The other 2 seroconversions probably resulted from ongoing exposures. Conclusions: Although overall PEP completion rates were high, adherence was often incomplete. Ongoing HIV risk behavior was common and probably resulted in new HIV acquisition. To improve HIV prevention services for sexual assault survivors, universal adherence interventions and targeted intensified HIV risk reduction counseling should be provided. MOPDCO4 A prospective cohort study of universal offering of HIV- 1 post-exposure prophylaxis in sexual assault victims/survivors M. Loutfy', S. MacDonald2, T. Myhr3, H. Humphries3, J. Du Mont', T. Leeke3, A. Rachlis'. 'University of Toronto, Medicine, Toronto, Canada, 2Sexual Assault Treatment Centre Network, Toronto, Canada, 3Centre for Research in Women's Health, Sunnybrook and Women's College Health Sciences Centre, Toronto, Canada Issues: Although HIV is a potential consequence of sexual assault, few jurisdictions have guidelines on HIV post-exposure prophylaxis (PEP). We carried out a large prospective study on counselling and offering HIV PEP universally to sexual assault victims in Ontario, Canada. Description: Sociodemographic, assailant, and assault data were collected on serial clients from 24 hospital-based Sexual Assault Treatment Centres. Those at high or unknown risk of HIV acquisition, presenting <72 hours post-assault were offered PEP. Combivir~ 1 pill and Kaletra~ 3 capsules BID were given for 28 days. Follow-up was provided at day 2-4, week 1, 2, 3 and 4; side effects were assessed at each visit. Univariate analyses were carried out using PEP uptake and completion rates as the endpoints and risk category (high-risk versus unknown risk) as the primary predictor. Lessons learned: Of 1,103 evaluable clients, 81 (7.3%) were at no-risk, 88 (8.0%) high-risk, and 934 (84.7%) unknown-risk of HIV acquisition. After excluding clients who presented >72 hours, were HIV-positive or at no-risk, 900 (81.6%) were eligible for PEP. Rates of acceptance and completion were remarkably high: HIV PEP Offered HIV PEP Accepted 28-day Course Completed High-risk 97.2% (69/71) 66.7% (46/69) 23.9% (11/46) Unknown-risk 87.9% (729/829) 41.3% (301/729) 33.2%/ (100/301) Overall 88.7% (798/900) 43.5% (347/798) 32.0% (111/347) Although not more likely to complete PEP, high-risk clients were 2.2 times more likely to accept PEP than those at unknown-risk (p=0.01). Factors that increased both acceptance and completion included being attacked by a stranger and client anxiety. Side effects were common (77.1% experienced grade 2-4 symptoms). Recommendations: Since the universal counselling and offering of PEP to sexual assault victims/survivors in our study appears feasible and warranted, all jurisdictions should consider developing guidelines for this topic. Since we found that although high-risk clients accepted PEP at a greater rate than those at unknown-risk, equal numbers completed the course, a universal strategy for offering PEP should be considered. Since our completion rate was three times that reported in earlier studies, more rigorous follow-up should be considered by all programs. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  28 Monday 14 August Poster MOPDC05 Mothers' protective variables against daughters' HIV risk B. Dancy', K. Crittenden2, M. Bowman', Z. Huang', A. Kennedy', B. Spencer', A. Starks', HIV Risk Reduction. 'University of Illinois at Chicago, Public Health, Mental Health, and Administrative Nursing, Chicago, United States, 2University of Illinois at Chicago, School of Sociology, Chicago, United States Background: African American adolescent females continue to be at increased risk for HIV infection. Mothers may serve as protective factors in reducing adolescents' risk. The purpose is to describe whether mothers' HIV transmission knowledge, safer sex self-efficacy, self-efficacy to prepare daughter to avoid HIV risks, and intention to encourage daughters to practice abstinence were associated with daughters' HIV transmission knowledge, self-efficacy and intention to refuse sex, and sexual activity. Methods: A cross-sectional survey was conducted of 435 low-income African American mothers/daughters pairs. Daughters were between 11 andl4 years of age. Bivariate correlations were used to analyze the data. Results: Almost 90% of the daughters were sexually abstinent. Daughters' sexual activity was negatively related to their HIV transmission knowledge (r = -.275, p <.01), self-efficacy to refuse sex (r = -.178, p <.01), and intention to refuse sex (r = -.410, p <.01). Daughters' HIV transmission knowledge was positively related to their mothers' HIV transmission knowledge (r =.129, p<.01) and to mothers' intention to encourage daughters to practice sexual abstinence (r =.150, p<.01). In addition, daughters' intention to refuse sex was positively correlated with mothers' intention to encourage sexual abstinence (r =.146, p <.01). Furthermore, Mothers' intention to encourage daughters' sexual abstinence was positively correlated with mothers' HIV transmission knowledge (r =.156, p <.01) whereas mothers' self-efficacy to prepare daughters to avoid HIV risks was positively related to both mothers' safer sex self-efficacy (r =.210 p.<.01) and HIV transmission knowledge (r =.193, p.<.01). Conclusions: The results suggest that mothers can be protective factors against daughters' HIV risk. Health care providers should provide mothers with comprehensive, accurate information about HIV and help mothers to increase their own safer sex self-efficacy and intention to encourage daughters to avoid HIV risks. MOPDC06 Distributing barrier methods for women: determinants of willingness to pay for microbicides, the diaphragm and the female condom F. Terris-prestholt', L. Kumaranayake', C. Macphail2, H. Rees2, C. Watts'. 'London School of Hygiene and Tropical Medicine, Public Health and Policy, London, United Kingdom, 2Reproductive Health and HIV Research Unit, Johannesburg, South Africa be less effective but more discrete than condoms, is higher among cohabitating women, a group known to lack long-term prevention options. This is reassuring for policymakers fearing condom migration. With careful price setting, it should be feasible to recover some of the costs of these products from women of higher SES. To reach lower income women, subsidised distribution is likely to be necessary. Track D MOPDDO1 Promoting greater involvement of people living with HIV/AIDS (gipa) in myanmar Z.Z. Naing', N.S. Wah2, T.M. Lwin', D. Eh', A.M. Thidal. IGIPA, Yangon, Myanmar, 2GIPA initiative group in Myanmar, Yangon, Myanmar Issues: There are an estimated 339,000 to 832,000 PLHA in Myanmar. There are few projects addressing PLHA issues and PLHA involvement is low. A number of PLHA support groups have been formed but these are managed by international or local NGOs and networking among them is weak. Description: A group of organizations formed an Advisory Committee to initiate a project to promote GIPA in early 2005. Nine PLHA were nominated to form a PLHA Committee to develop and manage the project. Training was provided to the PLHA Committee in understanding GIPA as well as in project design and proposal writing. The process also involved team building among the committee members. The project that was developed will start by building the understanding of the GIPA concept and advocating for PLHA involvement among various stakeholders, including PLHA, NGOs and religious leaders. The project will also aim to decrease stigma and discrimination, build capacity and networking of PLHA support groups. Lessons learned: The process of developing this project was itself a key learning. Formation of the two committees and developing clear roles for each was important in establishing a structure to undertake activities. Training in understanding GIPA among the PLHA Committee was crucial prior to developing the project. Fostering a sense of community among PLHA to work jointly towards their interests and rights was also important and team building exercises contributed to this. Discussions on confidentiality and disclosure were important to establish a safe environment for participation. Recommendations: - Ensure that PLHA understand the benefits of involvement for themselves, the organization and the community to foster commitment to the principle. - While promoting disclosure is important to ensure Greater involvement, this needs to be balanced with the personal needs of the individual. - Sharing experiences of PLHA networks in other countries provides inspiration in isolated countries like Myanmar. MOPDDO2 HIV youth ambassador programme - a communityled response to HIV & AIDS L. Gurney, MADaboutART Youth Ambassadors. MADaboutART, Knysna, South Africa Background: Future distribution of barrier methods for wome informed by evidence on willingness-to-pay (WTP) for different pr( factors influencing this. This study explores key determinants of w for microbicides, the diaphragm and the female condom and ident segments for possible cost recovery. Methods: 1017 adult women were interviewed in a Johannesbur Women were asked if they would be willing to try each product, if ti they would used it regularly, and what was the most they would be able to pay to purchase each product. To reflect their likely partial ef diaphragm and microbicides were presented as being half as effectiv condom, and the female condom as equally effective. Women's soc status (SES) index was estimated using factor analysis. Regress was used to assess key determinants of women's WTP. Results: Women were most willing to try microbicides (74%) follc diaphragm 60% and the female condom (56%); 78%-95% of worn they would/could use the products regularly if available. n must be oducts, and omen's WTP ifies market g township. Reusab Willingness to pay for.., diaphra (Constant) 44.624 Age -.425* Socio-economic status 8.240* Living with a sexual partner 5.626* Ever used any contraception? -2.519 Experienced difficulty negotiating condom.794 use Used a condom during last sex-act -3.058 Individual perception of HIV risk: high 1.837 Individual perception of HIV risk: none 6.183* ***p<0.01, **p<0.05, *p<0.1 n 597 [wtp] le Single use gm microbicide *** 24.646*** -,341*** ** 4.755*** 3.154* -.620 -.120 1.561 1.228 2.977 ey lougrlt Issues: MADaboutART has developed a toolkit of innovative, child-friendly willing and art-based interventions which build self-esteem through narrative therapy and fectiveness, expressional art. Building self-esteem is balanced with HIV education and skills ve as a male learning to ensure a strong foundation at the individual level. In order to create io-economic a sustainable community-led response to HIV & AIDS it is necessary to build ion analysis capacity locally to manage and evolve the programme in the long-term. Description: Youth facilitators self-select and enrol in an 18 month voluntary )wed by the training programme in which they develop leadership, facilitation, management nen thought and life skills. Intensive HIV knowledge training is followed by skills application through implementation of community-based interventions. Children and young participants are actively involved in the evaluation and selection of Youth Female Ambassadors. At all stages HIV-positive people are involved in the programme condom to ensure accurate understanding of feeling and experiences. Fully-trained Youth Ambassadors are mentored for a further 6 months as they develop and 14.058*** implement new projects. -.138 Lessons learned: Development of a youth-driven programme designed 2.239*** by youth for youth ensures participation at a high level. Involvement in a structured programme that provides information followed by application, -1.009 skills development and implementation of community-based projects enables.055 young people to be actively involved in Making A Difference through peerled educational projects that support the development of life skills and risk-.806 reduction through empowerment and self-advocacy. Recommendations: Young people have the capacity to input and should -.042 be involved in all stages of development and delivery of youth educational 2.818** programmes. 1.547 733 508 MOPDDO3 International cooperation, social mobilization and access to treatment of HIV/AIDS in Latin-American Younger and higher SES women were willing to pay more for all products. Methods that could be used discretely (the diaphragm and microbicides) were valued higher by cohabitating women. Conclusions: Interest in the diaphragm and microbicides, which are likely to L. Kamel, I. Maksud, J.C. Raxach, C. Pimenta, V. Terto Jr., R. Molnar. Brazilian Interdisciplinary AIDS Association, Rio de Janeiro, Brazil Issues: The Brazilian Interdisciplinary AIDS Association has been acting in the fight against the HIV/AIDS epidemic in the areas of prevention, advocacy, XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  29 social mobilization, adherence to treatment and support to people living with HIV/AIDS, and monitoring of health policies. During 2004 and 2005, ABIA conducted case studies of Bolivia and Paraguay where most of the first line ARV medication is made available through donations under cooperation agreements of the Brazilian government. Accomplishments: For the case studies, interviews were conducted with leaders and activists, government officials and health professionals in countries. Documents and reports were consulted and a Latin American multisectorial meeting was conducted ( Feb.2006) with the participation of representatives from Bolivia, Paraguay and Brazil to discuss initial results of access to ARV treatment in the context of international cooperation efforts and the role of civil society. These actions contributed to the enhancement of networking between Brazilian civil society organizations and other Latin American countries. Results will be disseminated through reports, publications and seminars. The final document analyses the Brazilian donations of ARV in the mentioned countries and points out the challenges for universal access to treatment and sustainability issues involved. Recommendations: - The project offers a methodological contribution to the analysis of south to south cooperation; - Promoted the strengthening of knowledge exchange among countries in the region; - Enriched the work methodology for monitoring of public policies related to HIV/AIDS treatment access; - Involvement of civil society organizations in the international cooperation scene enriches and strengthens effectiveness collaboration and partnerships. MOPDDO4 Voluntary support groups improve the quality of live of people living with HIV/AIDS J.H. Mello. Brazilian Network of People Living With HIV/AIDS, Social Studies, Patos de Minas, Brazil Issues: To assess the impact of group support formed by PLWHIV/AIDS on quality of live measures in HIV-1 infected men and women members of the Brazilian Network of People Living With HIV/AIDS. Description: Behavioral data were gathered from HIV-1 infected males (75) and females (25) aged 19-55, using a trained interviewer and standardized questionnaires. Most of the participants (64%) were homosexuals, 6% were bisexuals and 20% were intravenous drug users. Six support groups met weekly for 3 months; discussions focused on knowledge and prevention of drug abuse and/or sexual risk behaviors, family and social interactions, nutrition topics and attitude to medical treatments. Lessons learned: Prior to group meetings, relatively 37% of participants expressed adequate knowledge of HIV/AIDS prevention or nutritional aspects of disease (5%). 7% of participants were unwilling to accept medical treatment and positive family relationships were reported by 41% of patients. Following group meetings, increased HIV/AIDS knowledge and prevention were reported by 88% of participants; 68% of patients increased their understanding of nutrition as a cofactor of HIV disease progression, and the importance of medication adherence. Better social integration and family reinsertion were reported in 84% of participants. Regarding to acceptance of medical treatment all of the resistant patients agreed to start conventional treatment and therapy monitoring during and after the meetings. Recommendations: Voluntary support groups formed and directed by PLWHIV/AIDS appear to be an extremely cost-effective method to facilitate information exchange, enhance of knowledge, and promote self-steem, as well as foster and expand better social relationships. We intend to implant these support groups in our branches in order to inhance quality of life of PLWHA. MOPDDOS Lesotho and Swaziland: a trade union (civil society) response to the workplace and AIDS V. Ndlovu', C. Mariel'. 'Solidarity Center, Swaziland/Lesotho Trade Union AIDS Program, Durban, South Africa, 'Solidarity Center, Africa Region, Washington, DC, United States Issues: The HIV prevalence rates in Swaziland and Lesotho are second and third highest in the world. For young Swazi women, 15-24, the rate is 47.3%. However, a trade union partnership - Swaziland and Lesotho's garment workers unions, the International Textile, Garment, and Leather Workers Union/Africa, and the Solidarity Center - is challenging this situation. Description: Trade unions are driving the AIDS responses in Swaziland and Lesotho's garment factories that manufacture for international buyers such as WaI-Mart, GAP, and Target. These factories, which employ 50,000 (nearly all women), provide meager pay and foster workers' fears of unwarranted job dismissal, including from perceived HIV+ status. Trust between workers and management is rare. Unions are applying their skills in educating and mobilizing workers, defending human rights, negotiating with business, securing fair policies, developing safety and health programs, and building coalitions to mount a collaborative response to AIDS that engages workers, businesses, nongovernmental organizations, government, and the community. Unions also are grooming new AIDS leaders. Most importantly, the union-driven efforts are making progress among the garment workers and businesses where other initiatives have had minimal success. Lessons learned: Why are trade unions making these strides in Swaziland and Lesotho? The nature of these civil society organizations is mass-based, democratic, ethnically and religiously diverse, membership-focused, and easily reachable. Also, unions are grassroots, easily link with communities, and have elected leadership and structures that reach government and business. Unions offer a known entity that workers trust to advocate on their behalf and a record that proves this. Recommendations: Unions must be lead actors in workplace AIDS to leverage workers'trust and participation, to protect workers' rights, and to build coalitions that stretch globally and reach across business, government, nongovernmental organizations, and communities. The lessons learned, relevant to all AIDS stakeholders, implementers, and decision-makers, are replicable in workplaces throughout the world. MOPDDO6 Mobilizing communities for the care and support of HIV/AIDS affected children and families A. Tesfaye. Save the Children UK Ethiopia programme, Policy and programme development, Addis Ababa, Ethiopia Issues: In Ethiopia, where an estimated 11% of children are orphans, increasing number of parents are becoming bed-ridden and dying leaving children behind without parental care and protection. The burden on extended families and the community at large to care for orphans and other vulnerable children has already stretched traditional community coping mechanisms. Therefore, building the capacity of the communities to respond to the situation is of paramount importance so as to ensure sustainable community based care, support, and protection of vulnerable children. Description: Save the children UK Ethiopia programme has been implementing Orphan and other vulnerable children (OVC) care and support project since January 2004. The aim of the project is to build the capacity of the community under six administrative units to care for children affected by HIV/AIDS. The project has been using the CAC (Community Action Cycle) community mobilization tool which involves helping communities to identify and prioritize problems, plan, implement, monitor and evaluate. The major achievements of the project so far include organized and trained community structures (six OVC/CRC committees and six community mobilization groups) to mobilize resources and coordinate OVC care and support activities within the community, increased access to basic services to 5000 OVC registered by the community through partnership with local government and the community, and increased awareness of the community and government bureau representatives about child rights and OVC issues. Lessons learned: Involvement of the community throughout the project cycle using the CAC tool increased the ownership of the project and volunteerism that was minimal at the inception of the project. Capacity building activities have enabled some CBOs to mobilize and manage internal and external resources. Recommendations: The CAC model of community mobilization, if replicated to other areas with some adaptation, can bring the same outcomes that would ensure sustainability of response. Track E MOPDEO1 HIV/AIDS among displaced populations in northwest Zimbabwe: awareness, knowledge and behavioural patterns I. Araujo de Carvalho', E. Stigter2, H. Voetem3, L. Haliman'. 'International Organization for Migration, Migration Health Department, Harare, Zimbabwe, 2Independent Consultant, Geneva, Switzerland, 3Erasmus MC, University Medical Center Rotterdam, Department of Public Health, Rotherdam, Netherlands Background: Available HIV and AIDS control strategies have largely excluded groups such as internally displaced people (IDP). A baseline behavioural survey was undertaken among IDPs in Mashonaland West Province, Zimbabwe. The surveyed group is food insecure, and recipient of food aid. Methods: The study used a non-random proportional purposive sampling, and interviewed a total of 344 IDPs. Primary sample units (clusters) were chosen proportionate to the size of the population of each one of the seven villages studied. The BSS Family Health International methodology and tools were adapted and used in this study. Results: 54% of the population have had an chronically ill household member over the past twelve months, with 82% having at least one orphan residing in their household. HIV and AIDS awareness is high, however knowledge is limited; attitudes of acceptance towards people with HIV were low, revealing high levels of stigmatization. Female youth and women tend to have their first sexual experience upon marriage, with men being their senior in terms of age. The median age for their first sexual experience is 17 years old. The majority of the adults have had sexual intercourse in the last twelve months, with adult men outnumbering women and young males. The percentage of respondents who reported more than one partner in the past six months was low. Condom use was very low among the sexually active group Conclusions: The study provides evidence of significant high risk sex, and the high impact of AIDS within the community. The findings indicate that food insecurity brought by displacement seems to be fuelling risky behaviours such as early marriages for women and intergenerational sex. The surveyed IDP group do not access government programmes within the context of addressing the persisting complex emergency in Zimbabwe. Monday 14 August Poste Discussion XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  30 MOPDEO2 Using a rights-based approach to promoting the access of urban refugees to national HIV/AIDS programmes in South Africa L. Bruns', F.J. Groot2. 1United Nations High Commissioner for Refugees, Pretoria, South Africa, 2United Nations High Commissioner for Refugees, Geneva, Switzerland Issues: Refugees are often excluded from host country HIV/AIDS policies and programmes. In South Africa, an inclusive Constitution and national refugee legislation that conforms to international standards provided a sound legal framework for the United Nations High Commissioner for Refugees (UNHCR) and its partners to facilitate refugee access to local HIV/AIDS programmes. Description: Through consistent advocacy efforts undertaken at national, provincial and local levels, UNHCR and partner organisations used existing tools to ensure that HIV/AIDS prevention, care and treatment programmes, including antiretroviral treatment, were available and accessible to urban refugees in South Africa. Parallel efforts were undertaken to educate refugees about HIV/AIDS and the local services to which they are entitled. Lessons learned: Access to HIV services was secured through a number of strategies including the solicitation of official policy statements and directives from government and health institutions, awareness raising on refugee rights with government and non-governmental organisations, and partnership building with bilateral donors that support HIV/AIDS programmes. In addition, international best practice, guidelines and policies on HIV-related rights proved to be effective advocacy tools. These efforts resulted in a demonstrable increase in the number of refugees seeking advice and support on HIV issues from UNHCR and its partners, as well as directly seeking services from local institutions. Challenges encountered included high staff turnover at public sector institutions and difficulty in reaching the diverse and dispersed nature of the refugee population. Recommendations: Repeat training of health care providers due to high staff turnover is necessary. Census data on urban refugee combined with a sensitisation campaigns will ensure more refugees are reached. The approach outlined above could be adapted to other countries hosting urban refugees using a combination of rights-based advocacy and education. Using this approach, UNHCR continues to lobby for refugee access to government disability grants, which are currently limited to South Africans. MOPDE03 Securitizing HIV: peacekeeping, politics and peril O. Williams, S. Rushton. University of Wales, Centre for Health and International Relations, Department of International Politics, Aberystwyth, United Kingdom Issues: Debate is emerging in International Relations, Security Studies and Public Health regarding the manner in which HIV/AIDS has become 'securitized' - whereby the pandemic has been increasingly articulated in terms of international security and state stability. Description: This paper critically assesses one of the central mechanisms by which the disease has become securitized in global policy circles. UN peacekeepers have been identified both as being especially vulnerable to the disease, and as a vector for HIV transmission in conflict-affected countries. Security Council Resolution 1308 - often viewed as one of the key events in the securitisation process - specifically targeted the apparent problems associated with HIV and peacekeeping rather than the broader global dimensions of the pandemic. Major claims regarding the security and health implications of this nexus have followed in train, with many related to peacekeepers in African countries. Lessons learned: This paper identifies a need to question the actual scale of the problem posed by HIV to the effectiveness of UN peacekeeping forces, and in turn the potential danger posed to conflict affected populations. Evidence supporting many of the claims made about the threats and risks involved appears weak. Whilst high levels of HIV infection are apparent in some militaries, the degree of risk posed by and to peacekeeping operations cannot explain the significant international attention that it has attracted. An approach which combines the disciplines of International Relations, Public Health, and epidemiological perspectives is forwarded as a way of better understanding the consequences of securitization. Recommendations: Securitization has had ramifications not only for how the disease is viewed, but for the policy initiatives of certain actors. Current international policy initiatives on these issue need rethinking, and further research on the possible distorting effects that the securitization has had on policy responses to the pandemic are indicated. MOPDEO4 Shutting the door: a comparative analysis of refugee laws from the perspective of individuals living with HIV/AIDS A. Mangalji. Student at University of Toronto Faculty of Law, Toronto, Canada Issues: Since the late 1980's there has been a marked shift in national refugee laws, as countries adopt increasingly restrictive polices. These laws are especially detrimental and discriminatory towards refugees living with HIV/ AIDS. Advocates desperately require legal mechanisms, specifically adapted to different government policies, which would allow them to effectively use the judicial system to overcome burdens specific to refugees living with HIV/AIDS. Description: This paper explores the various asylum barriers from the perspective of a hypothetical African family fleeing persecution, whose major bread earner (the father) is HIV+. Three flight options are compared: South Africa, Tanzania, and the USA. A categorical survey of the asylum laws in these three countries unearths the different legal and policy barriers enacted by governments and demonstrates how they are disproportionately discriminative to those living with HIV/AIDS. Particular attention is put on interAfrican migration, comparing South Africa's integrationist model to Tanzania's containment model. The focus of this paper is to critically assess how different anti-refugee policies increase the vulnerabilities of families dealing with HIV/ AIDS, including access to health care for sick family members, and risk of contraction by other family members. This paper then explores legal solutions, developed from international and comparative humanitarian and human rights law that can be used by advocates to deconstruct discriminatory asylum barriers through the judicial system. Lessons learned: Although pressure from international organizations have prompted countries to revoke outright discriminatory laws preventing asylum and healthcare to refugees living with HIV/AIDS, it is still the case that they are disproportionately burdened under current regimes. African refugee and human rights case law offers advocates a comprehensive set of judicial tools to protect African refugees living with HIV/AIDS. Recommendations: It is imperative to adapt legal advocacy skills to the particular burdens faced by HIV/AIDS refugees in different countries. MOPDEO5 The stigmatisation of AIDS orphans and vulnerable children in slums,ghettoes,shanties and hardto-reach-communities in Lagos get attention of Nigerian youths - a resolution of the international youth day celebration(Aug.12th,2005) G. Obi. United Nations of Youth, Lagos, Nigeria Issues: Out of over 130 million estimated population of Nigeria,over 57% are children between ages 5 and 18.AIDS Orphans increase so also is child abuse and slavery street kids and other vulnerable children in Nigeria.Despite the fact that the Convention on the rights of the child states that "no child should suffer any discrimination irrespective of origin,birth,colur,sex,language,religion,politi cal and social beliefs,status or disability",yet over one Million AIDS Orphans and other vulnerable in Nigeria and my slum communities wallow in abject poverty and penury because they are living with or affected by HIV/AIDS.In the light of the above,United Nations of Youth Network Nigeria while marking the International Youth Day,August 12th 2005 at GoldenGate Restaurant Ikoyi,Lagos rolled out intervention strategies to minimise the miseries and agonies of children orphaned by HIV/AIDS and the impact of the incresein the number of households headed by young people due to the death or ailing health of one or both parents as a result of the infection. Description: This work articulates some excruciating pains,stigma,suffering and death these children went through as they were regarded as TABOO since they lost their parents to AIDS.This work is based on personal experience as a project-co-ordinator of this on-doing UNOY sopnsored HIV/AIDS intervention programme among the poorest of the poor communities starting with Itunagan,Araromi etc in Amuwo Odofin LGA of Lagos State. Lessons learned: The various support including material,financial and technical etc helped in reducing the poverty and stigma/discrimination. Recommendations: Government,international agencies to assist these communities wallowing in abject poverty instead of spending their scarce resources in doing programmes in the toens and cities where every body finds it very easy to operate. MOPDE06 HIV/AIDS and persons with disabilities: Indian scenario A. Ghosh. Shodhana Consultancy, Pune, India Issues: HIV/AIDS and Disability are surrounded by myths, misconceptions, stigma & discrimination. In India, both HIV/AIDS & disability is also about access to information & services, rights in relation to poverty alleviation, education, public & reproductive healthcare. Description: Though HIV/AIDS has been the concern of this century, not much attention is being paid in India to explore the current situation of the already disabled population with regards to creating awareness & risk assessment regarding HIV/AIDS and / or such issues. Despite a total population over 22 million persons with disabilities, both policy and programmatic interventions do not have any focus on this group. In addition to violating the rights of persons with disabilities, this large population also remains excluded. Lessons learned: A Global survey by World Bank & Yale University has concluded that individuals with disability confront all known risk factors for HIV / AIDS at rates equal to / or up to three times higher than the rates faced by general public. In India, we neither have prevalence rate of HIV/ AIDS among disabled population nor do we know to what extent this population is affected and has knowledge about HIV/AIDS. Such information becomes critical for inclusion of disabled population in existing HIV/AIDS related interventions and can guide the way forward for future Policy Development and Decision-making Processes. Recommendations: It is important therefore, to undertake various studies regarding sexual health & rights of the disabled population encompassing various facets of HIV/AIDS. It is also important that the disability policy along with other relevant policies converge with rights based approach. The need is to XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  31 bring inter linkages amongst policies for inclusion of persons with disabilities. With reference to HIV/AIDS, the paper will discuss policies and programs of Govt. of India in relation to disabled population. MOPDEO7 Improving the access to HIV-testing and treatment among vulnerable populations from Brazil M. Malta', F. Bastos', H. Lima2, M. Monteiro3. 1Oswaldo Cruz Foundation, Health Information Department, Rio de Janeiro, Brazil, 2Brazilian National STD/AIDS Program, Treatment and Care Unit, Brasilia, Brazil, 3Pan American Health Organization, Regional Advisor on Alcohol and Substance Abuse, Washington, United States Issues: Latin America produces 95% of all available cocaine, and major trafficking routes cross Brazil. Brazilian towns close to borders, ports, and near trafficking routes have high AIDS incidence among injecting drug users (IDUs). Brazil provides free antiretroviral therapy (ART) for 150,000 people living with HIV/AIDS, but less then 10% are IDUs. Preliminary studies showed that integrated services providing prevention strategies; HIV, STIs and hepatitis screening; drug dependence treatment; access to general health care and socials services is pivotal to reach/maintain IDUs and other at-risk populations under treatment. Description: We provided a comprehensive set of health services to both injecting and non-injecting drug users, achieving good results. This successful experience fostered the development of a guideline for the management of HIV+ drug users - sponsored by OPAS and the Brazilian Ministry of Health - aiming to inform the development/implementation of best practices in other countries with similar conditions. Using this guideline, workshops have been provided for health professionals throughout Brazil, including those working in hard-to-reach areas, e.g. health facilities located in the Amazon area. Another major goal of this Brazilian effort is to foster better links between health services, Needle Exchange Programs (NEPs), and Non-Governmental Organizations (NGOs); and to provide treatment for those actors. Lessons learned: In order to improve the access of vulnerable populations to HIV-testing/treatment, it is pivotal to provide better training to actors responsible for their counseling and treatment. Recommendations: Culturally sensitive interventions and low-threshold approaches (NEPs, NGOs, CBOs, peer education) are important strategies adopted in Brazil to reach/maintain IDUs and other at-risk populations under treatment. Those groups are frequently involved in high-risk networks, therefore by improving their health status and significantly reducing their HIV viral load - through effective ART - and fostering/maintain safer behaviors over time, we can reduce HIV transmission and improve their quality of life. Key Challenges The impact of ART on HIV transmission among HIV serodiscordant couples K. Kayitenkore', B. Bekan', J. Rufagari', S. Marion-Landais', E. Karita', S. Allen', RZHRG. 'The Rwanda Zambia HIV Research Group, Projet San Francisco, Kigali, Rwanda, 2Emory Univerity, International Health, Atlanta, United States Background: Scaling-up of antiretroviral Treatment (ART) started in Kigali in the year 2003. Recent studies have shown that ART reduces sexual transmission of HIV-1. At Projet San Francisco (PSF) in Kigali, a case control study was conducted to assess the impact of that treatment on HIV-1 transmission within HIV discordant couples, and to confirm whether or not it is legitimate to forecast a meaningful reduction in HIV transmission based on provision of ART. Methods: All infected individuals who had a CD4 count < 200cells/y L or/and a clinical stage III/IV (according to the WHO classification) were eligible for ART. We reviewed the clinical charts and analyzed the data of HIV discordant couples followed in Kigali. Self-reported condom use was adjusted for and included in the analysis. Results: Of the 1034 couples followed at PSF, 24B have the HIV positive partner on ART. Only 2 (5%/) of the 42 seroconversions observed since 2003 occurred in couples in which the positive partner was on ART. HIV negative individuals whose partners are on ART are less likely to seroconvert compared to those whose partners are not on ART, OR=0.19 (g5%/ CI 0.05-0.60). After adjusting for the confounding effect of condom use, the result remains statistically significant with an OR of 0.21 (g5%/ CI 0.05-0.B9). Conclusions: Our analysis confirms that the benefit of ART goes beyond the expected effect on disease progression and life prolongation, with a protective effect on the negative partners. The ongoing up-scaling of ART could result in a considerable decrease in HIV incidence in the population when part of a comprehensive effort for treatment and prevention. However since most discordant couples have HIV+ partners who do not qualify for AR MOKC102 Phase III trial of HIV prime-boost vaccine combination in Thailand: completion of the screening phase S. Rerks-Ngarm', P. Pitisutthithum2, S. Nitayaphan3, J. Kim3, J. Kaewkungwal2, S. Gurunathan4, M. Gurwiths, A.E. Brown6, J. Khamboonrueng', P. Thongcharoen', P. Kunasoll. 'Prime-Boost HIV Vaccine Trial Phase III, Dept of Disease Control, Muang, Thailand, 2Mahidol University, Faculty of Tropical Medicine, Bangkok, Thailand, 3Armed Forces Research Institute of Medical Sciences, Bangkok, Thailand, 4Aventis Pasteur, Pennsylvania, United States, 'VaxGen Inc, CA, United States, 'Walter Reed Army Institute of Research, MD, United States Background: A Phase III prime boost HIV vaccine trial was initiated in 2003. The objectives were to determine if this prime-boost vaccine strategy 1) prevents infection, 2) alters disease course in vaccinees who become infected, and 3) is safe. Methods: Vaccines were designed specifically for the predominant circulating HIV serotypes in Thailand (subtypes E and B). The prime vaccine is a recombinant canarypox ALVAC-HIV (vCP 1521) with a subtype B gag/pro and gp41, and subtype E gp120 (R5)gene insertions (sanofi Pasteur). The boost was AIDSVAX~gpl20 B/E, monomers of gp 120B (X4) + gp120E (R5) with alum (VaxGen). The study is designed as a randomized, placebo-controlled, double-blind phase III trial. Immunization will be intramuscular over 6 months with a 3-year follow up period. Results: After two years of recruitment and screening activities, the communitybased, phase III efficacy trial of a prime-boost HIV vaccine combination in Thailand completed enrolment of 16,402 volunteers. Conclusions: The world's first efficacy trial of a prime-boost HIV vaccine combination started in September 2003. By December 2005, 16,402 Thaiadults (ages 18-30), were recruited through the health care system of the Ministry of Public Health. With the large number of volunteers and a long duration of follow-up, volunteer compliance to the scheduled trial appointments will be a real challenge. Equivalent early suppression of HIV-1 RNA levels in breast milk after randomization to perinatal combined ZDV/nevirapine vs. HAART M. Chung', D. Lehman', J. Kiarie3, B. Richardson', J. Overbaugh2, J. Kinuthia4, F. Njiri4, G. John-Stewart'. 'University of Washington, Seattle, United States, 2Fred Hutchinson Cancer Research Center, Seattle, United States, 3University of Nairobi, Obstetrics & Gynaecology, Nairobi, Kenya, 4University of Nairobi, Nairobi, Kenya Background: Perinatal regimens of zidovudine plus nevirapine or HAART are presently used to prevent mother-to-child transmission of HIV-1 in resourcelimited settings. This randomized clinical trial compared breast milk HIV-1 RNA from women assigned to each of these regimens. Methods: HIV-1 positive pregnant mothers were randomized to receive perinatal zidovudine for 6 weeks prior to delivery plus single-dose nevirapine during labor (ZDV/nevirapine) or combination ZDV/3TC /nevirapine for 6 weeks prior to and 6 months after delivery (HAART). Fifty-eight women were randomized and followed with their infants for 12 months postpartum. Intensive sampling (2-3 times/week) of breast milk samples was conducted during the first 4 weeks postpartum, followed by collection every 3 months. Results: Women randomized to ZDV/nevirapine had significantly higher log10 HIV-1 RNA in breast milk during the first 2 days postpartum compared to those randomized to HAART (2.96 vs. 2.07, p=0.03). Maternal plasma HIV-1 RNA was significantly lower in the HAART arm compared to the ZDV/nevirapine arm during the early postpartum period. However, breast milk HIV-1 RNA in the ZDV/nevirapine arm was comparable to those who received HAART between 3 and 7 days postpartum (1.70 vs. 1.70, p=0.3) and between 8 and 14 days postpartum (1.70 vs. 1.70, p=0.4). After 15 days postpartum, HAART exhibited more pronounced suppression of breast milk HIV-1 RNA compared to ZDV/ nevirapine: 15 to 21 days (1.70 vs. 2.10, p=0.001); 22 to 2B days (1.70 vs. 2.42, p=0.007). Conclusions: Perinatal administration of ZDV/nevirapine was comparable to HAART in suppression of HIV-1 RNA in breast milk between 3 and 14 days postpartum. This may be attributable to nevirapine's long half-life and high levels in breast milk despite single-dose administration. The additional benefit of 6 months of HAART for prevention of breast milk HIV-1 transmission may derive primarily from prevention of infections between 2 weeks and 6 months post pa rtu m. Targeted screening criteria for detecting acute HIV infection in Malawi K. Powers', W. Miller', C. Pilcher', C. Mapanje2, F. Martinson2, S. Fiscus', D. Chilongozi2, D. Namakhwa2, S. Gama2, M. Price1, S. Galvin', I. Hoffman', M. Cohen'. 'The University of North Carolina, Chapel Hill, United States, 2UNC Project, Lilongwe, Malawi Background: Identification of persons with acute HIV infection (AHI) holds strong potential for individual and public health benefits, but it requires detection of HIV viral proteins or nucleic acids, techniques that are not routinely available or affordable in resource-limited settings. We developed selective criteria for XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  32 Monday 14 August PosterDkktuss on targeted application of these tests in individuals with a high probability of AHI. Methods: We conducted a cross-sectional study of 1450 adults attending an STD clinic in Lilongwe, Malawi from February 2003 through October 2004. Consenting participants received a physical exam, underwent HIV VCT, and completed a questionnaire. Subjects with detectable HIV RNA who met one of the following criteria were classified as AHI: 1) negative results on two parallel rapid tests, 2) discordant rapid tests and negative/indeterminate Western Blot, or 3) discordant rapid tests and weakly positive Western Blot with subsequent evolution. We used logistic regression to identify individuals with the highest likelihood of AHI, based on demographics, risk behaviors, acute Retroviral symptoms, rapid-test results, and STI syndromes. Results: Twenty-one (1.4%) subjects had AHI. Detection of AHI was associated with discordant rapid-test results (OR: 29.46, 95% CI: 10.31, 84.19), genital ulcer disease (GUD) (OR: 8.60, 95% CI: 3.29, 22,47), diarrhea (OR: 5.57, 95% CI: 1.78, 17.45), fever (OR: 4.75, 95% CI: 1.97, 11.44), body ache (OR: 4.39, 95% CI: 1.83, 10.53), and >1 sexual partner in two months (OR: 3.65, 95% CI: 1.53, 8.73). Selective criteria based on the presence of one "major" predictor (discordant rapid tests, GUD, diarrhea) or two "minor" predictors (fever, body ache, >1 partner in two months) were 95.2% sensitive and 60.5% specific in detecting AHI. Conclusions: Using this model, we would have detected 20/21 AHI cases by screening only 40% of persons receiving VCT. Selective criteria could substantially reduce the number of tests needed for reliable identification of AHI in resource-limited settings. MOKC201 Integrating HIV primary care into MCH clinics - a conceptual framework & early experiences in Kenya J. Kayita'1, D. Mbori-Ngacha2, K. Nolan3, P. Cherutich4, I. Yonga5, S. Ojoo4, ANECCA Steering Committee. 'Family Health International Institute for HIV/ AIDS, Care and Treatment Division, Nairobi, Kenya, 2Centers for Disease Control, HIV/AIDS Division, Nairobi, Kenya, 3Family Health International Institute for HIV/AIDS, Care and Treatment Division, Arlington, United States, 4Ministry of Health, National AIDS and STI Control Programme, Nairobi, Kenya, 'Elizabeth Glaser Pediatric AIDS Foundation, HIV/AIDS Division, Nairobi, Kenya Issues: A logical link exists between PMTCT programs housed in MCH clinics regularly attending large volumes of women and young children, and pediatric HIV/AIDS care and treatment. However, despite concerted efforts to scale up HIV care and treatment programs for children, few children enrolled in care and treatment are aged < 4 years. Description: With continued up-scaling of PMTCT interventions, a significant number of women attending MCH clinics know their HIV status. Integration of HIV care in MCH clinics will reach, identify and actively recruit young infants of these mothers, who are at highest risk HIV infection, rapid disease progression and death - a multi-pronged approach is proposed. This approach must be complemented by efforts to build pediatric HIV capacity across other services (OPD, IPD) already attending large numbers of symptomatic children. The shift to more efficacious PMTCT ARV prophylactic regimens presents further imperative and opportunities to strengthen capacity for this model. Collaboration andreferrals to specialized HIV services remains vital. Kenya and Nakuru Provincial General Hospital are presented as a case study. The case study includes a framework demonstrating links between the HIV Comprehensive Care Center and: pediatric inpatient facility, pediatric outpatient specialty clinic, OPD MCH clinic, VCT (children of exposed clients), laboratory. Lessons learned: A logical but not automatic link exists between PMTCT and pediatric HIV/AIDS care services. Facility-level decentralization of pediatric HIV care capacity is necessary to optimize treatment outcomes and sustain early benefits of PMTCT services. Such a comprehensive approach has policy and operational implications for paediatric HIV care/ART service delivery. Recommendations: This experience highlights one response to reverse the unacceptably poor outcomes for HIV-infected infants and young children. Beyond increasing access to services at lower levels, decentralization of pediatric HIV services must take into account facility-level decentralization. This approach requires significant investments, which must be supported at the highest level. MOKC202 Prevention and care of orphans through scaling up family centered care continuum services S. Vijayakumar, P. Costanza2, N. Tarakeshwar3, M. Jagadeesan, A. Sathishkumar4, G. Srinivas', S. Raghavan4. 'Tamilandu State AIDS Control Society, Chennai, India, 'Children Investment Fund Foundation, Chennai, India, 'Yale School of Public Health, CIRA, New Heaven, United States, 4SAATHI, Chennai, India, sYale School of Public Health, CIRA, Chennai, India Issues: India is estimated to have 150,000-200,000 orphaned children who are infected or affected by HIV/AIDS. Prevention and care programs catering to the comprehensive needs of children and their families are lacking. Description: A family-centered continuum of care program has been established at three government hospitals in Tamil Nadu in partnership with NGOs and positive networks to prevent 2000-3000 children from being orphaned. Critical phases of the program scale-up included signing of an MoU, planning, site preparation, NGO recruitment, establishing patient and content management, service delivery, monitoring and evaluation (M&E), training and capacity-building components and procurement systems. Since inception in October 2005, 1412 HIV-positive patients have been registered. Lessons learned: Technical and implementing assistance played a significant role in program design and implementation. An MoU with the government was instrumental in building sustainable cost-sharing programs from initial stages of the project. Involvement of key medical and administration staff at the sites contributed to the successful integration of clinical services and facilitated hospital admissions in various wards. Partnership with NGOs and positive networks were critical to the delivery of counseling, nutrition services, adherence counselling, treatment preparedness, and community-based support such as home based care, support groups and linkages to income generating activities, legal services and housing. A rigorous M&E component focusing on both affected and infected family members including children will be instrumental in identifying critical program elements that can be replicated in other parts of the country. Provision of macro and micronutrient supplements for prevention and treatment of nutrition complication is another unique aspect of the project. Recommendations: For building sustainable large-scale orphan prevention programs, partnership with the government is critical. Public-private partnerships are essential for technical, implementing and monitoring assistance and in meeting the multifaceted needs of families with children. Simpler multisectoral program delivery models need to be evaluated in resource-constrained settings. MOKC203 Screening for tuberculosis (TB) in HIV voluntary counseling and testing (VCT) services in Lusaka, Zambia M. Jham', J. Levy', N. Kancheya2, D. Pankratz', S. Kaminsa-Kabanje', V. Jurkuvenas3, M. Kimerling4, S. Reid'. 'Center for Infectious Disease Research in Zambia, Lusaka, Zambia, 2University Teaching Hospital, Department of Medicine, Lusaka, Zambia, 3University of Alabama, Department of Medicine, Vilnius, Lithuania, 4University of Alabama, Department of Medicine, Birmingham, United States Background: Zambia faces concurrent TB and HIV epidemics with a high burden (62%) of co-infected patients. These patients have a high rate of mortality and respond optimally to care if identified and treated early. TB screening conducted as part of VCT can serve as an entry point for early TB diagnosis in a high-risk co-infection population Methods: In October 2005, a TB screening pilot was initiated within VCT services at a primary health clinic in Lusaka. Counselors ask all clients if they are experiencing respiratory symptoms suggestive of pulmonary TB (PTB). All clients with a positive PTB screen, regardless of HIV test result, are referred and escorted by a VCT staff member to the laboratory for sputum collection and examination. If TB diagnosis is confirmed in HIV-infected patients, TB treatment is initiated prior to enrollment in HIV care. Patients accessing VCT 1215 Patients Accepting Testing 1174 (97%) HIV Positive 732 (62%) HIV Negative 442 (38%) atientwitpositive screen Patientswithpositive screen 249 (34% 37 (8%) TB Smear Positive 4(2%) TB Smear Positive 12 (6%) [TB cases identified in VCT ] Results: HIV positive patients were 4.1 (95% CI 2.9, 5.6) times as likely to have a positive TB screen than HIV negative patients. However, of those patients identified with TB symptoms, HIV negative patients were 20.2 (95% CI 8.0, 131.2) times as likely to have a positive smear as HIV positive patients. Conclusions: In settings of high TB and HIV prevalence, routine PTB screening in VCT centers is feasible and important to identify early the high percentage of respiratory symptomatic patients who otherwise would be missed. In our setting, despite symptom screening in HIV-infected individuals with a high risk of TB, smears yielded very few confirmed TB diagnoses. This suggests a strategy that includes more sensitive TB culture should be prioritized as part of the diagnostic work up for identifying PTB smear-negative co-infected patients. MOKC204 Advantages of integrating HIV care, treatment and support services into routine district health center services: the Vietnam experience V. Ngoc Son', M. Hoang Anh2, H. Van Tam', N. Phuoc Hail, V. Ngoc Phinh'. 'Family Health International, Treatment and Care, Hanoi, Viet Nam, 'Prevention Medicine Center, Long Xuyen, Viet Nam, 3District Health Center, Tan Chau, Viet Nam Issues: Approximately 6,000 people are estimated to be living with HIV/AIDS in An Giang province. Tan Chau district, which borders Cambodia, is one of XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  33 the hardest hit districts in the province. As of December 2004, the provincial government reported 840 PLWHA in Tan Chau; 70% of whom are male. There are more than 200 orphans infected and affected by HIV/AIDS. Description: In 2005 FHI and the An Giang Preventive Medicine Center developed and implemented a HIV care, treatment and support program in Tan Chau District, An Giang Province. Under this program HIV treatment, care and support services were integrated within routine services of the District Health Center (DHC). This included Home Based Care (HBC); clinical outpatient services; PLWHA group support and a program to support orphans and vulnerable children (OVC). These services were linked to existing programs in VCT, PMTCT and HIV prevention among IDUs. Home care teams (HCT) have been established in all 11 communes supporting 145 clients and 128 pregnant women. To date the OPC has provided clinical services to 100 patients. Approximately 80 PLWHA have participated in peer support group activities. A total of 263 OVC have participated in play groups and outings organized by the Women's Union. VCT services have been improved by training staff in VCT, counseling and linkage with care and support services. Ten IDU peer educators have participated in HIV prevention training in a district adjacent to Tan Chau organized through a separate FHI program. Lessons learned: In Vietnam Tan Chau district was among one of the first HIV care treatment and support programs to be fully integrated into a district Health Center. Its success has been largely due to high levels of commitment from the leaders of An Giang Province and Tan Chau district. High level of collaboration between government sectors and NGOs has also contributed to the success of this program. Recommendations: HIV care, treatment and support should be integrated in DHC services wherever possible to maximize health care facility support, reduce costs and to reduce stigma and discrimination. MOKC301 Injecting risk behavior and HCV prevalence among injecting drug users including women sex workers in Barnaul, Russian Federation S. Maximova, N. Goncharova, N. Sterlyadeva. Altai State University, Faculty of Sociology, Barnaul, Russian Federation Background: To establish the prevalence of HIV and hepatitis C (HCV), and associated risk behavior among injecting drug users (IDUs) including women sex workers in Barnaul, Russia. At present, IDUs and commercial sex workers (CSWs) are the main groups of risk in transmitting HIV and HCV and sexually transmitted infections. Often it was associated with an absence of research knowledge on patterns of risk behaviour. Methods: An unlinked anonymous cross sectional survey of IDUs (n=501) including commercial sex workers (n=100) recruited from non treatment settings with oral fluid sample collection. Participants completed a structured questionnaire administered by field workers and oral fluid samples were tested for antibodies to HIV and HCV. Results: HCV prevalence was 53,9% in Barnaul (95% CI 49,0%-58,3%, 263/488). Almost all HIV positive IDUs were also HCV positive. In adjusted model, the odds of HCV were higher in IDUs reporting injection of home produced drugs. There was some indication of increased odds associated with paraphernalia sharing in general or front-loading in particular. In Barnaul higher odds of HCV positivity were associated with duration of injecting. We found high rates of unreported HCV positivity, with 74,9% (173/231) unaware that they were HCV positive. Conclusions: The research carried out is significant not just at a scientific level, but also from a practical point of view since it increases awareness of IDUs' behaviour as being one of the most important indices of risk, as it reflects the potential danger of a large-scale spread of HIV and HCV and sexually transmitted infections in society. The information obtained is significant for developing policies and carrying out effective preventative treatment intervention, and also for the programme for harm reduction. MOKC302 Discrimination and the impact of seropositivity status on adults living with HIV/AIDS F. Lazar1, A.G. Blaglosov', C. Constantin', S.M. Erscoiu2. 'Romanian Children's Appeal Foundation, Bucharest, Romania, 2Clinical Infectious and Tropical Diseases Hospital,Dr. Victor Babes', Casa Andreia Pavilion, Bucharest, Romania Background: For over a decade after the fall of the Iron Curtain, Romania had more than half of the total HIV pediatric cases of Europe, but in the last 5 years the newly diagnosed HIV cases are mainly of adults. The social research in the field of HIV/AIDS in Romania is scarce, even more so in the case of adults. The main objective of this study is to assess the impact of the HIV+ status on adults at personal, relational and social level and their perception of discrimination. Methods: A self-applied anonymous questionnaire has been used, comprising items regarding discrimination at the workplace, in accessing health services, the level of confidentiality, the level of social entitlements and changes after the diagnosis disclosure at personal level, relationships with the others and perception of the future. The study included 68 outpatients and patients of "Dr. Victor Babes" Hospital from Bucharest. Results: The perception of high risk of discrimination leads to high unemployment (50%), avoiding accessing other/non-infectious hospitals (44% never accessed other hospitals after the diagnosis) and availing of social entitlements ensuring maximum confidentiality (89.7% are benefiting of a food allowance paid through bank transfer). The nuclear family (82.4%), the doctors (57.4%) and the NGO's (33.8%) are most trusted. 14.7% did not tell the family their diagnosis. The HIV diagnosis results in a low self confidence and withdrawal from social participation. 19.1% have broken up with their partners, while 26.5% do not have a partner. The uncertainty over the future is the most difficult task to handle for 57.4%, followed by the financial problems (19.1%), keeping the secret (16%) and the reactions of the family and friends (13.2%). Conclusions: The HIV status and the perception of potential discrimination is leading to reduced social interactions, low take up rates of non-confidential social entitlements and uncertainty over the future. MOKC303 NGO recommendations to improve EU's responses to HIV/AIDS in Europe A.W. Simon', E. Trenado2. 'AIDES, European Partnerships and Advocacy, Pantin, France, 2AIDES, International Programmes, Pantin, France Issues: The European Commission (EC) recently renewed it commitment to "combating HIV/AIDS within the European Union and in the neighbouring countries" (EC Communication, 15/12/05). EC promises notably "to strengthen the involvement of civil society in all aspects of the response to the epidemic". Specific reforms with regards to the capacity of EC to effectively fund NGO initiatives are needed to ensure these new promises will be kept. Description: The French NGO AIDES has coordinated since 2001 the Integration Projects to support fellow HIV/AIDS NGOs in Central and Eastern Europe - www.integration-projects.org. AIDES participates to the Civil Society Forum on HIV/AIDS in Europe, and has received a total of nine EC grants since 1997. Lessons learned: On one hand, EC is pertinent when it (1) promotes evidence-based strategies for prevention, harm-reduction and treatment (2) funds research (3) consults more systematically with civil society. On the other hand, EC needs to vastly improve the ways it supports NGOs. Due to its limited legal mandate, notoriously tortuous bureaucratic regulations, as well as lack of resources and leadership, EC funding is hardly accessible for most NGOs. For the few that succeed, EC supports comes along with a growing set of conflicting and unclear rules, which hinder the capacity of the NGO to accomplish optimal work. The obligation in terms of co-funding that must be secured (up to 50% of costs) is notoriously detrimental for NGOs. Recommendations: (1) EC grant-making processes need to be streamlined on the basis of best practices which suit NGOs as developed by private foundations and other institutions. While ensuring proper use of the funds, these process need to focus primarily on results and on the specific added value brought by NGOs in terms of community-based mobilisation. (2) The nomination of an HIV/AIDS ambassador would further foster coherence, visibility and efficiency in EU HIV/AIDS Policies. MOKC304 Is social movement of people with HIV even possible in Russia? N. Nedzelskiy. INFO Plus Center, Moscow, Russian Federation Issues: During last years PLWHA movement become the necessary part of agenda for Russian AIDS-service community, extensively due to influence of international agencies and financial flow from foreign funds, supporting PLWHA community development. Still on the regional level there is almost total absence of grass roots PLWHA groups, and community development is realized in top-down approach. Description: This paper is based on the analysis of the history of PLWHA movement in Russia and the experience of INFO Plus Center in support of HIV-activists. The data was also gathered during halfstructured interviews with representatives of both AIDS-service organizations (ASOs) and members of PLWHA communities in 5 Russian regions. Lessons learned: PLWHA show high levels of internalized stigma and "victim mentality", with lack of primary psychosocial support PLWHA have no resources for self-empowerment, which leads to lack of or inadequate motivation in activism. One of the main obstacles for PLHWA movement is also lack of examples of successful social movements, there are almost no HIV-activists with experience in another social fields. Also the movements of most vulnerable groups (LGBT, drug users, women) is even in worst shape than PLWHA movement. So HIV-activists usually have very clouded perception of what can be done, they obviously lack of skills. Specialists from ASOs show high levels of latent HIV stigma (no declared prejudice, but yet distinction from PLWHA and paternalism). This leads to misunderstanding of PLWHA needs, formality of involvement and fear of strong PLWHA activism. Recommendations: There is urgent need for rapid development of complex direct services for PLWHA with accent on consultations and information provision. Funds should support more primary psychosocial support, than "advanced" community projects. ASOs need extensive education on stigma issues and PLWHA involvement, as long as support in development of GIPA policies. HIV-activists need education programs on project planning and management, fundraising and advocacy. Monday 14 August Poster Discussion XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  34 MOKC401 UNGASS monitoring: a joint construction between the Brazilian Government and the civil society P. Chequer', M. Simao', J. Cortes', C. Civil Society Organizations in Brazil2. 'Ministry of Health of Brazil, National STD/AIDS Program, Brasilia, Brazil, 2Health Institute, GESTOS and GAPA/SP., SCO, Brasilia, Brazil Issues: Since the establishment of the UNGASS Declaration on HIV/AIDS in 2001 the Brazilian Government has started a process of monitoring and evaluation of the targets and commitments stated in the Declaration. For the UNGASS Review Meeting to be held in 2006 the Brazilian civil society was included in the process bringing its valuable inputs and views. Description: The elaboration of the reports was originated from the Brazilian response to HIV/AIDS which includes the governmental response itself, a critical analyses from a great part of the academy and NGO and a Case Study on treatment access in Brazil conducted by NGO activists and PLWA. Researches, Seminars, Meetings and Analyses were tools used along the process in order to obtain a wide view of the Brazilian response. Lessons learned: Strengthening of the partnership between the Brazilian Government and the Civil Society through a transparent and democratic process which brought a better understanding of our achievements, challenges and innovative proposals on how to face the epidemic within the country. Recommendations: The necessity of deepening the knowledge of the commitments stated within the UNGASS Declaration for the Civil society; the possibility of working together aiming at a wider mobilization among sectors for an even better national response and the certification that the Brazilian Government has endeavored to respond to HIV/AIDS as fast as possible taking into account the national diversity and the social, cultural and political aspects of the country. Inclusiveness, democracy and solidarity are fundamental ingredients for a reasonable HIV/AIDS Response. MOKC402 Peru in-country monitoring and evaluation report on the implementation of the United Nations general assembly special session declaration of commitment: a shadow report from the civil society R. Cabello, R. Valverde. Association Via Libre, Lima, Peru Issues: This experience features a participative model in the elaboration of a monitoring and evaluation shadow report on the implementation of the UNGASS declaration of commitment. Description: This project is an ICASO initiative put into action by Association Via Libre between October and December of 2005. The purpose was to develop a report based on the contribution of civil society leaders and the available multisector academic and programmatic data. Likewise, an analysis and reflection process was developed on the incorporation and participation of the civil society in such response. The first step was the formation of a consulting committee that was composed of the different civil society groups and that defined the working methodology. Next, there was the creation of discussion workshops for the following groups: people living with HIV/AIDS, vulnerable populations, non-governmental organizations, and scholars from universities and research centers from around the nation. Third, indirect sources of information from different sectors were collected, and lastly, there were plenary sessions organized for discussing and approving the development of the report. This report was widely distributed and forms part of the country report submitted to the United Nations. Lessons learned: The elaboration of a shadow report is essential since it allows for a wide, participative, self-critical, and independent analysis of the national response and is a space for discussion and reflection prior to the development of the country report, which is a government-led project. Access to information in Peru is a challenge to improvement, and in that sense, the report becomes a reference paper since it gathers together current information, citing sources and references. Recommendations: This experience needs to be repeated annually. Furthermore, the results will have to be made public on different web sites, and additionally, it is important that experiences of other regions be discussed and exchanged. MOKC403 Human rights and HIV/AIDS programming In Vietnam T.N. Nguyen, T.T. Huynh. CARE International in Vietnam, Health & HIV/AIDS, Hanoi, Viet Nam Issues: The human rights of HIV positive people in Vietnam are often not fully respected and protected by duty bearers. Contributing factors include: authorities unfamiliarity with human rights instruments and how they apply within the Vietnamese legal context; policy makers are inexperienced and cautious about participatory processes around HIV/AIDS; social and cultural norms influence misconceptions about "rights". Many advocates are associated with activities deemed to be "socially evil" and criminal by authorities. Description: CARE International in Vietnam works to address human rights and HIV/AIDS through increasing the knowledge,,awareness and practices of decision makers and community based organisations. This approach is expected to influence leaders to transform laws and policies and to strengthen HIV positive people's advocacy capacity for the fulfilment of their rights. Lessons learned: CARE has demonstrated effective facilitation of dialogue between policy makers and HIV positive people. Government authorities are eager to learn more about human rights and to apply international best practice models when developing related policies and laws. Curricula on human rights and HIV/AIDS developed using a participatory process involving all stakeholders may serve as a useful model for participatory approaches to other policy development. Community based organisations play an increasingly influential role in contributing to policy development and protecting the rights of HIV positive people. Recommendations: Targeting support to government institutions to facilitate participatory approaches to "policy feedback" is a useful strategy for advancing democracy in Vietnam. INGOs (International Non-Government Organisations) and donors have a catalytic role to play in stimulating understanding of human rights through work on HIV/AIDS. Strengthening the capacity of emerging civil society organisations gives a voice to HIV positive people. Greater exposure of Vietnamese policy makers and community based organisations to international best practices around HIV/AIDS policy and programming will strengthen commitment to institutional change and help to lead efforts to change perceptions and norms. MOKC404 Beyond implementation: strengthening civil society dialogue in the World Bank's Multi-Sectoral AIDS Project in east Africa S. Harman. University of Manchester, Government, International Politics and Philosophy, Manchester, United Kingdom Issues: This paper explores the successes, limits and opportunities of civil society engagement within the World Bank's Multi-Sectoral AIDS Project (MAP) as a model for multi-sectoral policy development in East Africa. The paper argues that the MAP presents a breakthrough in donor funding of HIV/AIDS projects in East Africa in terms of finance and scope of those involved. However the project is failing upon implementation because of a narrow conception of civil society and an inability to build civil society capacity, feedback, dialogue and policy input. Description: The paper is based upon fieldwork findings on the MAP project in Kenya, Tanzania and Uganda comprising 200 semi-structured interviews with: people involved in government and donor responses to AIDS, International non-governmental organizations (INGOs), non-governmental organizations (NGOs), and community projects working on care, prevention, treatment, advocacy and the mitigation of the socio-economic impact of the epidemic in East Africa; International Organisations; and participant observation of dialogue forums. The paper has four main sections. First, it outlines the roles and relationships between: the World Bank; National AIDS Councils; District AIDS Councils or Regional Facilitating Agencies; National NGOs; INGOs; International Organisations; Ministries of Health; and the community. Second, it highlights the successes of such engagement. Third it focuses upon the limits and problems to civil society relations. Fourth, it presents concluding comments and recommendations. Lessons learned: Despite the involvement of a wide range of actors within the MAP, such involvement is often unstructured and limited in capacity for dialogue, feedback and policy input. Multisectorality is therefore limited to project implementation for national NGOs and the community, with policy dialogue only occurring between international organizations, INGOs and select National NGOs. Recommendations: Open dialogue forums at regional and national level; greater donor transparency; strengthening government agency capacity; increased access to information; co-ordination; structured feedback mechanisms; and a broader conception of civil society. MOKC405 Concasida Coordinating Committee: a Central American experience of multi-sectoral integration and networking to streamline the response to HIV/ AIDS C.A. Nufiez. Futures Group, HIV/AIDS Center, Guatemala City, Guatemala Issues: Coordination among stakeholders from different sectors requires trust and a willingness to sit and discuss a logical and fair course of action for the collective response to the HIV/AIDS epidemic. Description: The CONCASIDA Coordinating Committee is comprised of 21 members from seven Central American countries representing stakeholders across all sectors: one representative from the PLWHA, one from civil society and one from government. The Committee's original goal, when created in 2004, was to assure consistency and oversight to the Central American AIDS Conference. Success of this coordinating body is based on the ownership of process and outcomes. The formulation of by-laws that guide their operations and systems for assuring smooth transitions of the Secretariat every two years from one country to another have proven to be a successful combination. The Committee now has sub-regional recognition by both their peers and the international community, making them a desirable partner to spearhead initiatives advocating to improve the national and sub-regional response to HIV/AIDS. At the moment the Committee works on a joint initiative with UNAIDS in Central America. Lessons learned: 1. Having first developed national committees facilitated the appointment of a representative sub-regional body with a mirror structure. 2. Having agreed on a set of by-laws and operating systems clearly defined the group's operational context. 3. Their familiarity with the sub-regional agenda has opened opportunities to advocate before their governments and XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  35 the international community. 4. Despite ongoing coordination, dialogue may become fragile if objectives fail to coincide. Recommendations: This initiative is still young and will require nurturing from both members and sponsor technical and financial partners. The foreseen results will make it worth the effort. MOK C 0 1 Decentralization, scaling-out antiretroviral treatment to health centres in a rural district in Malawi process, progress and lessons learnt after two years M. Massaquoi', M. Fitzgerald2, F. Samura', R. Nalikunkgwi', R. Teck', R. zachariah@internet.lu3, A. Harries4. Medecins Sans Frontieres, Thyolo District, Malawi, Medical Department, Brussels, Blantyre, Malawi, 2Medecins Sans Frontieres District, Malawi, Medical Department, Brussels, Blantyre, Malawi, 3Medecins Sans Frontieres - Operational Centre Brussels (OCB), Medical Department, Brussels, Brussels, Belgium, 4Ministry of Health and Population, Malawi, HIV Unit, MoH, Malawi, Lilongwe, Malawi Issues: Since April 2003, people living with HIV/AIDS in Thyolo, in rural Malawi were offered antiretroviral treatment (ART) through "centralized" clinics located in hospitals. High patient load and "congestion" became a reality with potential detrimental implications on the quality of care. Besides, hospital-based care implies high transport costs and "time lost" from livelihood activities for both patients and their families. Decentralizing ART initiation, and follow-up to health centres is thus desired. Description: In July 2004, seven of eleven public health centres were selected on the basis of set criteria. Lower cadres of health staff (medical assistants/ nurses) were trained on follow-up of patients on first-line ART. Health surveillance assistants, (the Malawian brand of community health workers) were included to manage patient registration, adherence counselling and patient flows. A referral-system was established between hospital clinics and health centres. A mobile team moves around health centres on a scheduled basis to provide "on the job" support to health centre staff. Lessons learned: After a period of two years, 650 ART patients are managed at health centres comprising 25% of all people currently on ART in the district. Health centre staff developed confidence in ART management. In the first year, patients expressed concerns over the quality of care they might receive at health centres and decentralisation was achieved in only 10% of all placed on ART. Greater emphasis on patient counselling, on establishing good links between hospital and health centre teams, and continued supervision of health centres reassured patients who then gladly accepted being seen at health centres. Recommendations: Progressive ART decentralization to health centres in rural settings is an inevitable reality to promote access, ensure long term adherence and the quality of care. Embarking on decentralisation strategies is pivotal in the efforts towards trying to achieve "Universal ART Access". Providing continuum of care for patients with dual TB/HIV infections A. Kulsharova', D. Hausner', L. Khodakevich', A. Deryabina', V. Seledtsov'. 'The CAPACITY Project, JSI/Central Asia, Almaty, Kazakhstan, 'Almaty Institute of Advanced Medical Training, Almaty, Kazakhstan Issues: Cooperation of Tuberculosis (TB) and AIDS services to provide a continuum of care for dual-infected patients. Description: Health care systems in the countries of Central Asia have weak linkages between vertical service providers. Integrating AIDS and TB services is a challenge. In Central Asia, there are more than 50,000 new TB cases annually. HIV is spreading quickly in the region, especially among injection drug users. TB is the leading cause of death among people with AIDS. The USAID funded CAPACITY Project facilitated form Technical Working Groups (TWG) in Uzbekistan, Tajikistan, and Kyrgyzstan. For the first time, the Ministries of Health and Justice, National AIDS and TB Centers, UN agencies, and NGOs discussed methods of linking TB and AIDS services. TWGs developed national protocols for diagnosis, registration, treatment, and reporting dual infections, and joint work plans including patient flow and budgets. CAPACITY assisted in developing training curricula and trained more than 70 national trainers in the three countries. The later in turn trained about 500 specialists on dual infection management. TWGs selected model sites in each country for testing and refining the integration approaches. Lessons learned: Recognition by the officials of the urgency for integration of TB and AIDS services was raised. Joint planning through multi-sectoral TWGs played a key role in the development of one training program, one team of trainers, and one monitoring team for integrating the two services. Models of service delivery are currently being tested in countries where integration of these services was previously not possible. Recommendations: CAPACITY continues involvement in the implementation, monitoring, and supervision of the models of TB and HIV service integration in Central Asian countries. Following rigorous model evaluation, successful models will be promoted for national scale-up. MOKCS03 Implementation of PMTCT policies and programs in east, central & southern Africa S. Onyango1, T. Mwikali2, K. Chebet3. 'Ministry of Health, STD/AIDS Control Program, Kampala, Uganda, 2Ministry of Health, NASCOP, Nairobi, Kenya, 3ECSA Health Community Secreteriat, HIV/AIDS, Arusha, Tanzania, United Republic of Issues: MTCT is a growing problem in sub-Saharan Africa due to high HIV prevalence among women of reproductive age, high fertility rates and ineffective nationwide interventions to prevent transmission. Effective interventions can virtually eliminate HIV among children as evidenced by experience from developed countries. The East, Central and Southern Africa Health Community Secretariat commissioned a review to assess the implementation of PMTCT within 6 member countries namely: Lesotho, Zimbabwe, Zambia, Tanzania, Kenya and Uganda. Description: Literature review was conducted followed by visits to selected countries and interviews with representatives from relevant Government Departments e.g. National AIDS Commissions, Reproductive and Child Health Departments; National AIDS Control Programmes and Nutrition Departments. Information was also obtained from Development Partners supporting HIV/ AIDS interventions and PMTCT; civil society organisations; organisations for people living with HIV/AIDS; faith-based organisations and medical professional organisations. Lessons learned: The PMTCT issues had been included in related HIV/AIDS or Reproductive Health policy documents except in one country that had a specific PMTCT policy document. The guidelines had been finalized and disseminated in two countries while the rest had draft copies guidelines. There was variation in content and scope of the PMTCT guidelines among the member countries, including failure to address the first and fourth strategic prongs of comprehensive PMTCT. In addition, the guidelines had not taken into account recommendations for use of more efficacious regimens that include HAART for the eligible mothers. Training curricula and manuals for in-service use varied among the member states in terms of content and duration of training while there was a clear gap in the pre-service training. Recommendations: PMTCT is a priority intervention as evidenced by the policies and guidelines being in place. However, they need to reviewed to address the four strategic prongs of comprehensive PMTCT and operationalised in order to have a greater impact on the programs. Diagnostic HIV counseling and testing of TB patients in Kinshasa, Democratic Republic of Congo: from pilot project to evidence-based policy development and roll-out A. Van Rie', M. Sabue2, K. Vanden Driessche2, F. Behets', J. Kokolomani3, E. Bahati4. 'The University of North Carolina at Chapel Hill, Epidemiology, Chapel Hill, United States, 2UNC-DRC, Kinshasa, Congo, the Democratic Republic of the, 3Programme National de Lutte contre le SIDA, Kinshasa, Congo, the Democratic Republic of the, 'Programme National de Lutte contre la Tuberculose, Kinshasa, Congo, the Democratic Republic of the Issues: In July 2004, WHO published the Interim Policy for Collaborative TB/HIV activities. Key to reducing the burden of HIV among TB patients is implementing HIV counseling and testing (CT) for all TB patients. Few TB patients are currently tested, in part because little evidence is available on how, where and when HIV CT should be offered to TB patients. Description: Evaluation of a pilot study (2004-2005) including 1289 TB patients demonstrated that provider (TB nurse) initiated diagnostic HIV CT was acceptable, feasible and the preferred method by both patients and nurses. The preferred time for CT was at commencement of TB treatment. Confidentiality was identified as an important issue. Discussion of results with stakeholders resulted in: a policy of diagnostic HIV CT; clearly-defined roles of health care workers and National TB and HIV Programs, and identification of potential barriers to large scale implementation of activities. A training manual for collaborative TB/HIV activities was developed and field tested by health care workers, National HIV and TB Control Program officers, educational specialists, and international TB experts. The 4-day training targets all health care workers involved, i.e. primary health care nurses, clinic directors, laboratory technicians and physicians. Lessons learned: Pilot projects provide evidence for translation of international guidelines into local policy. Involving key decision makers in operational research accelerates the process of translating research into practice. Integrating new collaborative TB/HIV activities into clinical practice demands the development of training materials to equip health care workers with the knowledge and skills required to provide quality HIV CT and care for HIV co-infected patients. Recommendations: Assa next step, monitoring, and evaluation of the program in Kinshasa, aimed at counseling and testing 5000 TB patients in 2006, will identify barriers to diagnostic CT as a routine program activity at primary healthcare level and further refine the training manual. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  36 Uoda Poster Exhibition Track A MOPEO001 The road to finding potent HIV-1 entry inhibitors: lessons learned from requirements for BMS-806 binding to HIV-1 envelope glycoprotein N. Madani', A. Hubicki2, D. Ng3, A. Smith', J. Sodroski'. 'Dana-Farber Cancer Institute, Harvard Medical School, Cancer Immunology and AIDS, Department of Pathology, Boston, United States, 2Dana-Farber Cancer Institute, Cancer Immunology and AIDS, Boston, United States, 3University of Pennsylvania, Department of Chemistry, Philadelphia, United States Background: BMS-806 is a novel compound that binds HIV-1 envelope glycoprotein gp120 and broadly inhibits both X4 and R5 viral isolates. Previously we identified a series of mutations in gpl20 resulting in resistance to the antiviral effects of BMS-806. Methods: BMS-806 was synthesized and its inhibitory effects were examined using a single-round infection of recombinant HIV-1 encoding firefly luciferase. In parallel, direct binding assays were performed using [3H]BMS-806. Results: Based on the CD4-bound conformation of gpl20, the amino acid residues implicated in the resistance to BMS-806 were located in the "phenylalanine 43 cavity" and a water-filled channel that extends from the cavity to the inner domain of the protein. We further extended our panel and demonstrated that critical residues within the stem of the V3 loop of gpl20 are necessary for BMS-806's antiviral effects. Specifically, mutation of residues at positions 305, 307, 309, and 317 from Lysine, Isoleucine, Isoleucine, and Phenylalanine, respectively, to Alanine result in escape from antiviral effects of BMS-806, without any reduction in overall replication compared to wild-type viruses. Moreover, these same mutations resulted in a significant decrease of BMS-806 binding compared to the wild-type as determined by [3H]BMS806 direct binding assays. These data suggest a preferred site for BMS-806 binding within V3 loop of gp120. In addition, the results indicate a high degree of correlation between the amino acid changes in gpl20 that affect BMS-806 binding and those that allow virus escape from inhibition, suggesting drug binding site on the gp120 monomer and on the functional trimer must coincide. Conclusions: Identification of new residues important for BMS-806 binding provides significant new insights into BMS-806 envelope interaction. Together with our previous studies, these results point to a conformation within gp120 that is critical for BMS-806 binding, providing useful information for rational drug design. MOPEO002 Envelope determinants of highly efficient macrophage-tropism and neutralization sensitivity conferred by a brain derived HIV-1 envelope M.J. Duenas-Decamp, P.J. Peters, P.R. Clapham. University of Massachusetts Medical School, Worcester, United States Background: HIV-1 binds CD4 and CCR5/CXCR4 to infect cells. We previously described R5 envelopes amplified from uncultured patient tissues that conferred distinct tropisms. R5 envelopes from brain were highly macrophagetropic, while lymph node (LN) envelopes infected macrophages inefficiently. Macrophage-tropism correlated use of low CD4 levels for infection. Envelope determinants and in vivo selective pressures that confer macrophage-tropism are poorly understood. Highly macrophage-tropic brain envelopes may have adapted for replication in resident macrophages and microglia. However, low concentrations of neutralizing antibodies (nabs) in brain tissue protected by the blood brain barrier may also play a role. Moreover, brain envelopes from two individuals were sensitive to neutralization by the CD4 binding site (CD4bs) mab, b12 while LN envelopes were resistant. Here, we map envelope determinants conferring macrophage-tropism and b12 sensitivity. Methods: NA420 envelope B33 (brain) is highly macrophage-tropic and b12 sensitive, while LN40 (LN) is non-macrophage-tropic and b12 resistant. B33 N283T was constructed. N283 is associated with enhanced macrophagetropism, is predominant in brain but rare in LN. Chimeric B33 envelopes were constructed containing non-overlapping LN40 envelope regions, C2-C3 and C3-C5. Mutant envelopes were expressed on reporter viruses to analyze phenotypes. Results: N283T reduced macrophage infection and infection via low levels of CD4, but did not affect b12 sensitivity. LN40 C2-C3 abrogated macrophage and low CD4 infection. LN40 C3-C5 conferred a minor reduction in macrophage infection but entirely modulated b12 sensitivity. Conclusions: Macrophage-tropism of B33 brain envelope was mainly determined by C2-C3 env region. N283 and C3-C5 env region contributed to lesser extents. B12 sensitivity mapped to C3-C5. Thus, envelope determinants of macrophage-tropism are mainly distinct from those conferring neutralization sensitivity. Our results do not support a role for CD4bs nabs as a selective force for evolution of macrophage-tropic variants in brain. MOPEO003 Identification of new antiviral compounds targeting HIV-1 entry S. Janvierl, F. Hamdan2, M. Bouvier2, N. Heveker'. 'University of Montreal, Sainte-Justine Hospital Research Center, Biochemistry, Montreal, Canada, 2University of Montreal, Biochemistry, Montreal, Canada Background: HIV-1 entry into target cells is currently the most promising validated new antiviral target. Several molecules have been developed in order to block viral entry by targeting the HIV-1 co-receptors CCR5 or CXCR4 some of which are currently in clinical phase III testing. Until now, only one molecule targeting HIV-1 fusion, enfuvirtide (T20), has been approved for treatment. Methods: We identified 4 new compounds, by High Throughput Screening, that can inhibit the activation of CCR5. We named them A, Aa (a derivative of A), B and C. The BRET screening assay technique detects the effect of those compounds on the CCR5-13-arrestin2 interaction following activation of the receptor by RANTES thereby identifying receptor antagonists. We also demonstrated that a molecule from green tea extract, EGCG, and two of its derivatives, TD and TM, possess similar activity. Our objective was to test the antiviral activity of those 7 molecules on HIV-1 entry via the co-receptor CCR5. To test the selectivity of the compounds for CCR5, we used stable cell lines expressing either CCR5 (R5.3) or CXCR4 (X4.15) as well as p-galactosidase under the HIV-1 LTR promoter. Dual tropic HIV-1 (89.6) viral particles were used to test the inhibitory effect of the 7 molecules on the two reporter cell lines. Results: We demonstrate that EGCG, TD, TM and compounds Aa, B and C, in contrast to compound A, show little or no co-receptor specificity in inhibiting HIV-1. That means that those compounds could either non-selectively inhibit HIV-1 entry, or other steps of viral replication. In contrast, compound A demonstrates a specific inhibitory potential against CCR5 mediated HIV-1 entry with an IC50 of 4,95 M ~ 1,55. Conclusions: This compound could serve as a new lead structure for the development of new molecules with higher CCR5 affinity. MOPEOOO4 Sialoglycoprotein (Sgp) pattern and sialyltransferase (ST) activity of HIV-1 in acutely infected cells under inhibition of glycosylation R. Gavazova', S. Ivanovl, D. Ivanovl, S. Raleva2, L. Froloshka2, P. Genova3, D. Dundarova3, R. Argirova2. 'Institute of Experimental Pathology and Parasitology - Bulgarian Academy of Sciences, Dept. of Biochemistry, Sofia, Bulgaria, 2National Centre of Infectious and Parasitic Diseases, Dept. of Virology, Lab. of Retroviruses, Sofia, Bulgaria, 3National Centre of Infectious and Parasitic Diseases, Dept. of Virology, Lab. of Cell cultures, Sofia, Bulgaria Background: Sialoglycoproteins (Sgps) are directly involved as epitopes in the recognition process permitting access to receptors. Formation of Sgps is type specific and catalyzed by specific sialyltransferases (ST). Earlier we created a laboratory model to study HIV-1 epitope structures. High and virus-specific rate of sialylation of HIV-1LAI in acutely and chronically infected cells was shown. To further understand changes of epitope structures conferring viral escape in HIV-infected individuals we studied first the Sgp profile of HIV-1LAI in MT-2 infected cells treated with tunicamycin (Tu) - a well known inhibitor of glycosylation as well as corresponding ST activies. Methods: A study of N-acetyl-[C14]-mannosamine (14C-NAcMan) incorporation in cytosols of HIV-1LAI acutely infected and uninfected MT2 cells treated with Tu (0,5pg/ml) was carried out. Fractions derived after isoelectrofocusing (IEF) were measured for 14C-incorporation, protein content and reverse transcriptase (RT) activity (Cavidi, Sweden). ST-activity was detected by Serafini-Cessi F. method. Results: Higher incorporation of 14C-NAcMan for MT-2/HIV + Tu compared to MT-2 + Tu was observed. MT-2 IEF profile compared to that of MT-2 + Tu showed a shift of the latter to the basic zone and only two common pI peaks. On the contrary, a number of common pI peaks in MT-2/HIV and those treated by Tu were seen. ST activity was reduced by 330/ for MT-2 + Tu compared to MT-2 v. 20,6 %/ for MT-2/HIV + Tu compared to MT-2/HIV (inhibition of glycosylation 27,8 and 14,20/ resp.). Conclusions: Higher inhibition of glycosylation by Tu in MT-2 cells compared to MT-2/HIV probably confers the higher inhibition of sialylation and the changes in Sgp profiles of Tu treated cells. The differing effect of equal concentrations of Tu on glycosylation in MT-2 and MT-2/HIV under experimental conditions might at least partially explain already described viral escape in HIV-infected persons by changes in glycosylation. MvOPEOOO5 Polymorphism of CCR5 and CCR2 genes associated with HIV-1 resistance in Mongolia Y. Amarjargal', N. Munkhtuvshin', T. Lkhagvasuren', C. Baigalmaa', K.-W. Kim', A. Tumanov6, E. Kazennova6, M. Bobkova6. 'Institute of Public Health, Ulan Bator, Mongolia, 'National Institute of Medicine, Ulan Bator, Mongolia, 'Health Science University of Mongolia, Ulan Bator, Mongolia, 4National Center for Communicable Diseases, Ulan Bator, Mongolia, sHealth Research Institute of Korea, Seoul, Korea, Republic of, 6DI Ivanovsky Institute of Virology, Moscow, Russian Federation Background: The CCR5 and CCR2 chemokine receptor gene polymorphism has been shown to influence susceptibility to HIV-1 infection and disease XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  37 progression. The aim of this study was to determine the distribution of CCR5delta32 and CCR2-64I alleles among basic ethnic groups of Mongolian population and their possible influence on the prevalence of HIV-1 infection in the country. Methods: The distribution of the CCR5delta32 and CCR2-64I alleles was estimated by PCR-restriction fragment length polymorphism assay. The study included 253 samples of indigenous healthy subjects representing three ethnic groups: Khalka (n = 59), Bayad (n = 90); Kazakhs (n = 80), and a group of healthy blood donors (n=25) Results:: We found no significant (p <0.05) difference between frequencies of these alleles among Khalka, Bayad, Kazakhs: CCR5delta32 (0.009, 0.011, 0.018), CCR2-64I (0.263, 0.309, 0.181). No subjects homozygous for CCR5delta32 genotype were found. The percentage of the heterozygous CCR5delta32 genotype in samples analyzed was 2.4% (6/253). However the percentage of the homozygous CCR2-64I genotype among Bayad (11/90, 12.4%) was higher (p=0.007) than among Khalka (3/59, 5.1 %) but not among Kazakhs (4/80, 5%; p=0.389). Moreover, haplotype frequencies in 253 subjects representing three ethnic groups and healthy blood donors were: 0.57 for CCR2/CCR5 and 0.33 for CCR5/CCR2-64I. Only two cases with CCR5delta32/ CCR2-64I (0.004) haplotype were found among indigenous healthy subjects from Mongolia. The CCR5delta32 and CCR2-64I allele frequencies all over the country were 0.012 and 0.246 respectively, corresponding the data on the East -Asian region. Conclusions: This data are the first findings on the frequencies of CCR5delta32 and CCR2-64I alleles in Mongolian population. The absence of HIV-1 in Mongolia is scarcely not caused by genetic polymorphisms of CCR5 in the population of the country. Results also suggest that the CCR2-64I mutation is sufficiently common in Mongolians and may cause slower HIV infection progression in Mongolia. MOPEO006 HIV-1 co-receptor tropism changes over time in drug naive patients in the absence of antiretroviral therapy K. Kitrinos', D. Irlbeck', T. Bonny', K. Frusciantel, D. Thorpe2, R. Mickalites', J. Demarest'. 'GlaxoSmithKline, Research Triangle Park, NC, United States, 2GlaxoSmithKline, Greenford, United Kingdom Background: Several studies have assessed tropism in drug-nalve and drugexperienced HIV-1 infected patients, though most assessed tropism at a single timepoint. Limited data are available on how tropism readouts change in patients over time. We assessed tropism readouts over one to three months in drug-naive HIV-1 infected patients in the absence of antiretroviral therapy (ART). Methods: Plasma samples were collected approximately one month apart from 348 drug-naive HIV-1 infected patients and tested for tropism using the Monogram Biosciences PhenoSense HIV Entry Assay. Two plasma samples were collected for 339 patients, and three plasma samples were collected for 9 patients. Results: Of the 339 patients with two plasma samples collected, 91% were R5-tropic, 6% were R5/X4-tropic, and 3% were non-phenotypeable at the time of the first collection. When the tropism results from the second collection were compared to the first, 92% were unchanged. Thus, in the absence of HIV therapy, population tropism changed for 8% of patients. Four of the nine patients with tropism assayed three times remained R5-tropic at all timepoints, while five patients had tropism changes. No consistent changes in tropism readouts were observed; changes from R5 to R5/X4, R5 to non-phenotypeable, and R5/X4 to R5 were similar in frequency. Conclusions: The majority of drug-naive HIV-1 infected patients in this study harbored R5-tropic virus at the population level and had a stable virus tropism over one to three months. A subset of patients demonstrated a change in tropism readout over time without a consistent pattern. Changes in the tropism readouts observed in the absence of therapy may be explained by limitations in the sensitivity of current tropism testing, as well as by the dynamics of the HIV quasispecies over time. As such, the clinical utility of the tropism assay remains to be determined. MOPEO007 Analysis of the CCR5 gene T303A polymorphism in Mayan and Mestizo populations of Yucatan, Mexico I. Quintal-Ortiz, N. Valadez-Gonzalez, N. Pavia-Ruz, R.A. Gongora-Biachi, D. Lara-Perera, L.G. Alonzo-Salom6n. Centro de Investigaciones Regionales "Dr. Hideyo Noguchi', Universidad Autonoma de Yucatan., Merida, Yucatan, Mexico Background: Among the CCR5 gene polymorphisms, the CCR5 A32, T303A and 893delC cause premature termination of translation. These polymorphisms have functional significance on the susceptibility for HIV infection and disease progression. The T303A Polymorphism has been reported to occur in variable allele frequencies, for example, it was determined to be 0.014 in AfroAmerican, and 0.07 in French populations, and has resulted absent in three Brazilian ethnic groups.The aim of this study was to determine the frequency of T303A polymorphism of CCR5 gene in Mayan and Mestizo populations from Yucatan, Mexico. Methods: We analyzed 100 samples, 50 from Mayan and 50 from Mestizo population. DNA was extracted from whole blood, and fragments of 1100pb of CCR5 gene were amplified by PCR with primers F2 and R2 (Carrington, 1997). The T303A polymorphism was identified by RFLP with Hinc II enzyme. Results: The wildtype genotype of the T303A polymorphism was present among all Mayan individuals (100% of samples); contrastingly, it was found in Mestizo population that 10% (5/50) corresponded to the heterozygous genotype and the remaining 90% (45/50) corresponded to the wildtype genotype. Conclusions: We identified the T303A polymorphism of CCR5 gene for the first time in Mestizo population of Yucatan. MOPE0008 The absence of Inil/hSNF5 during integration affects the epigenetic regulation of HIV-1 A. Boese', U. Nehrbass2, P. Sommer. 'Institut Pasteur Korea, Department of Biology, Seoul, Korea, Republic of, 'Institut Pasteur Korea, Seoul, Korea, Republic of The tumour suppressor integrase interactor 1 (Inil/hSNF5/BAF47/SMARCB1), a core subunit of mammalian ATP-dependent SWI/SNF chromatin-remodelling complexes, was initially discovered as an interaction partner of the HIV1 integrase. Shortly after Retroviral challenge, the nuclear Inil/hSNF5 and promyelocytic leukemia (PML) protein translocate to the cytoplasm and colocalizes with HIV-1 pre-integration complexes before nuclear migration. While PML was shown to counteract proviral establishment, it was proposed that Inil/hSNF5 might participate in the target site selection of HIV-1, but a functional requirement of Inil/hSNF5 for early steps of viral replication was not established. Employing RNAi-mediated knock-down of Inil/hSNF5, we show that the simultaneous accumulation of Inil/hSNF5 and PML in the cytoplasm reflects two non-interdependent phenomena. Inil/hSNF5 does not interfere quantitatively with integration, but the depletion of Inil/hSNF5 during integration has immediate and long-term effects on the transcriptional potential of the viral promoter. Inil/hSNF5 is directly involved in transcriptional repression of the integrated HIV-1 LTR, which partially accounts for an early boost of HIV-1 replication when integration occurs in the absence of the protein. After reappearance of Inil/hSNF5 viral expression levels decrease and changes in the pattern of histone modifications linked to epigenetic gene silencing can be observed at the viral promoter, including increased levels of H3-K9 di-methylation. The qualitative differences in the transcriptional potential and epigenetic regulation of HIV-1 proviruses established in the presence or absence of Inil/hSNF5 indicate that integration occurred near distinct chromosomal features. We propose that Inil/hSNF5 may be recruited to the HIV-1 preintegration complex to influence integration targeting in chromatin. MOPE0009 The K65R/L74V and K65R/M184V mutations in HIV1 RT decrease viral replication capacity and impair synthesis of early reverse transcribed DNA products F. Frankel, C. Invernizzi, M. Oliveira, M. Wainberg. McGill University AIDS Centre, Lady Davis Institute, Jewish General Hospital, Montreal, Canada Background: HIV-1 viruses harboring the K65R, L74V or M184V mutations in RT have been shown to possess diminished viral replication capacity (RC) as well as similar resistance mechanisms in regard to relevant NRTIs. We assessed whether combinations of the aforementioned mutations might compromise synthesis of viral DNA in both real-time PCR and cell-free assays. Methods: Viral replication capacity was determined in H9 cells and CBMCs by measuring concentrations of (-)ssDNA and intermediate DNA products by realtime PCR in a single round of infection. Viral growth kinetics were determined in multiple rounds of infection by RT activity in culture supernatants. Recombinant wt, L74V-, M184V-, K65R-, K65R/L74V- and K65R/M184V-containing RTs were purified and efficiency of (-)ssDNA synthesis was performed in the presence of tRNA3Lys, HIV-1 RNA, nucleocapsid (NC), dNTPs and wt or mutated RT and resolved in gel-based assays. Results: Monday 14 August Poster Exhibition - - - -------------------- -- H9 cells CMBCs HIV-1 virus wt L74V Intermediate DNA Intermediate DNA (-)ssDNA products -)ssDNA products 100 100 100 100 72 M184V 89 K65R K65R/ L74V K65R/ M 184V 88 15 40 58 56 35 13 29 49 60 32 22 33 49 47 35 5 28 Viral growth kinetics in multiple rounds of infection correlated with results obtained in a single round of infection, with K65R/L74V- and K65R/M184Vcontaining viruses being especially impaired in this regard. Cell-free RT assays pointed to a significant decrease in synthesis of (-)ssDNA associated with K65R/L74V RT and K65R/M184V RT compared to wt. Conclusions: Diminished viral RC of K65R/L74V- and K65R/M184V-containing viruses correlates with reduced synthesis of early reverse transcribed DNA products. Synthesis of (-)ssDNA plays a rate-limiting step in the virus life cycle. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  38 MOPEO010 HIV-1 TAR element is processed by dicer to yield a viral miRNA that contributes to viral latency Z. Klasel, P. Kale2, L. Mied2, F. Kashanchi2. 'The George Washington University, Department of Immunology, Microbiology and Tropical Medicine, Washington, DC, United States, 2The George Washington University, Department of Biochemistry, Washington, DC, United States Background: This study examines the possibility that the HIV-1 TAR element, found in viral RNA, is processed by the cellular enzyme Dicer to yield a viral miRNA and evaluates the possibility that this HIV-1 derived miRNA downregulates viral replication. Methods: Western blots were used to examine the presence of Dicer in cells relevant to HIV-1 infection. The ability of Dicer to bind the TAR RNA element was tested by pulldown of Dicer from whole cell extracts with a biotin labeled TAR. In vitro cleavage of TAR by a recombinant Dicer was performed to evaluate the ability of TAR RNA to be processed by Dicer. A Northern blot assay was used to detect TAR miRNA in vivo. The ability of a TAR miRNA to downregulate viral and cellular gene expression was analyzed by Luciferase reporter system and Affymetrix microarray. Results: In vitro analysis indicates that TAR RNA is bound by Dicer and that Dicer cleaves the TAR RNA into a 21 nucleotide miRNA that can be detected in HIV-1 infected CD4+ T cells. Finally, we show that TAR derived miRNA is capable of suppressing viral gene expression and discuss the effect of HIV-1 TAR derived miRNA on cellular gene expression. Conclusions: HIV-1 TAR element is processed to yield a viral miRNA. This miRNA is capable of suppressing viral gene expression through interaction with the LTR. That Dicer is not present in monocytes and that expression of the viral miRNA is lost upon activation of high levels of transcription suggest that the TAR derived miRNA may play a role in latent infection of CD4+ T cells. MOPEO011 Impacts of Nucleocapsid protein mutations on HIV-1 genomic RNA dimerization: a 10-fold increase in available data J. Kafaie, R. Song, M. Laughrea. McGill AIDS Centre, Lady Davis Institute for Medical Research, Jewish General Hospital, and Divison of Experimental Medicine, McGill University, Montreal, Canada Background: The distal Zn++ finger (F2) of the nucleocapsid protein (NC) plays a role in genomic RNA (gRNA) dimerization. Methods: We designed site-directed mutations to characterize the role of other regions of NC in HIV-1 gRNA dimerization. Results: The role of the proximal Zn++ finger (Fl) of NC in gRNA dimerization was demonstrated for the first time, and in 4 ways. 1) Replacing F1 by a CNBP-5 Zn++ finger inhibited gRNA dimerization in NL4-3 viruses isolated from HeLa, but not 293T, cells. 2) Replacing the Cys-Cys-His-Cys (CCHC) motif by CCHH (which remain Zn++ coordinating), inhibited gRNA dimerization in BH10 viruses, but not in NL4-3 viruses. 3) Replacing the central Phe16 of its presumed hydrophobic pocket by Ala inhibited BH10 gRNA dimerization more than deleting the distal Zn++ finger F2. Replacing F2 by an additional Fl, or switching the positions fo F1 and F2, didn't inhibit gRNA dimerization, but replacing the CCHC motif of F2 by CCCC inhibited gRNA dimerization more than the corresponding mutation in Fl. Replacing the distal CCHC by CCHH inhibited gRNA dimerization in BH10 viruses produced by HeLa cells. Replacing the central ArgLysLys34 of the linker by hydrophobic, but not hydrophilic, residues inhibited gRNA dimerization in BH10 viruses. (The linker sequence joins F1 to F2.) This is the first demonstration of a role of linker mutations in Retroviral gRNA dimerization. However, replacing RKK34 by bydrophobic or hydrophilic residues didn't inhibit gRNA dimerization in NL4-3 viruses. Wild-type yields of the gRNA dimers requires removal of p6 from NCp15. Processing NCp9 into NCp7 and pl was not necessary for gRNA dimerization, but was essential for viral infectivity. Conclusions: We have obtained the first demonstration of a role of the linker mutations and of F1 mutations in HIV-1 gRNA dimerization, and the first demonstration of the inadequacy of NCp15 in fully maturing the gRNA dimer. MOPEO012 Polymorphism in MDR-1 alleles associated with virological efficacy in naive HIV-infected patients treated with non-boosted PI-containing HAART regimens but not in those treated with boosted PIcontaining regimens X. De la Tribonniere', F. Broly2, S. Burban Deuffic', L. Bocket4, A. Cheret', F. Ajana', N. Houdret2, Y. Mouton', Y. Yazdanpanahs. 'Centre Hospitalier de Tourcoing, Infectious Diseases Department, Tourcoing, France, 'Lille University, Pharmacogenetics and Toxicological Unit, Lille, France, 3CNRS URA, Laboratoire de Recherches economiques et sociales, Lille, France, 4Lille University, Virological Department, Lille, France, sCentre Hospitalier de Tourcoing et CNRS URA, Infectious Diseases Department, Tourcoing, France Background: P-glycoprotein (P-gp), codified by the MDR-1, pumps out protease inhibitors (PI). MDR-1 genetic single nucleotide polymorphism (SNP) in exon 26 (C3435T) has been shown to regulate P-gp expression. The aim of this study was to assess the influence of MDR-1 SNP in exon 26 on the virological responses to first-line PI-containing HAART regimens. Methods: We conducted our study on 182 HIV-infected patients from a French clinical cohort who received this HAART regimen from January, 1997 to July, 2002 and followed through December, 2004. Time to the first indetectable viral load (VL) (< 400 copies/ml) was determined for MDR-1 exon 26 genotypes CC, CT and TT, considering non-boosted or boosted PI-containing regimens. Results: The proportion of patients with MDR-1 exon 26 genotypes CC, CT and TT were 37%, 44% and 19%, respectively. Females and patients from sub-Saharan Africa had more frequently exon 26 genotype CC (p<0.05). Other baseline demographic, clinical, immunological and virological characteristics were comparable in the three subgroups. Using a multivariate Cox model, in the non-boosted PI group (n=124), time to the first VL undetectability was shorter in CT (ajusted Hazard Ratio [HR]=0.56; 95%CI, 0.36-0.88; p=0.01) and TT subgroups (HR =0.69; 95%CI, 0.41-1.17; p=0.17) when compared to CC subgroup. In contrast, in the boosted group (n=58), time to first VL undetectability was not different in the CT (HR=0.70; 95%CI, 0.370-1.334; p=0.28) and TT subgroups (HR=1.07; 95%CI, 0.50-2.28; p=0.86) when compared to CC subgroup. Conclusions: Our results emphasize on the fact that MDR-1 SNP in exon 26 may be associated with virological efficacy in HIV-infected patients treated with non-boosted PI-containing regimens but not with boosted PI-containing regimens. This may be related to higher concentrations achieved with boosted PIs. MOPEO013 Dynamic interaction of HIV-1 Nef with the clathrinmediated endocytic pathway at the plasma membrane S. Benichou', A. Burtey', J. Rappoport2, J. Bouchet3, S. Basmaciogullari3, J. Guatelli4, S. Simon2, A. Benmerah3. 'Cochin Institute, Infectious Diseases, Paris, France, 2Rockefeller University, New York, United States, 3Cochin Institute, Paris, France, 4UCSD, La Jolla, United States Background: The HIV-1 Nef protein perturbs the trafficking of membrane proteins such as CD4 by interacting with the clathrin adaptor protein complexes (AP). We previously reported that Nef alters the early/recycling endosomal compartment, but the specific role of the viral protein at the plasma membrane is poorly documented. Methods: Here, we used total internal reflection fluorescence microscopy, which restricts the analysis to a -100 nm region of the adherent surface of the cells, to focus on the dynamic behavior of Nef at the plasma membrane relative to that of clathrin. The distribution of GFP-tagged Nef was explored in living cells expressing DsRed-tagged clathrin light chain. Results: Nef co-localized both with clathrin that remained static at the cell surface, corresponding to clathrin-coated pits (CCP) and with clathrin that disappeared from the cell surface, corresponding to forming clathrin-coated vesicles (CCV). The co-localization of Nef with clathrin required the di-leucine motif essential for its binding to AP complexes. Furthermore, analysis of Nefmutants showed that the capacity of Nef to induce internalization and downmodulation of CD4 from the surface of T lymphocytes correlated with its localization into CCPs. Conclusions: This dynamic analysis shows that Nef is recruited into CCPs and forming CCVs at the plasma membrane, and that this localization is required for the Nef-induced internalization of CD4. These results are in agreement with a model in which Nef uses the clathrin-mediated endocytic pathway to induce internalization of CD4 molecules from the plasma membrane. MOPEO014 Acetylated tat regulates HIV-1 splicing through its interaction with the splicing regulator, p32 R. Berro', K. Kehn2, C. de la Fuente2, A.M. Colberg-Poley3, F. Kashanchi2. 'The George Washington University, Genetics Program, Washington, DC, United States, 2The George Washington University, Department of Biochemistry and Molecular Biology, Washington, DC, United States, 'Children s National Medical Center, Center for Cancer and Immunology Research, Children's Research Institute, Washington, DC, United States Background: Post-translational modification of Tat affects its activity during viral transcription. Tat binds to TAR and subsequently becomes acetylated on lysine residues by histone acetyltransferases (HATs). Novel protein-protein interaction domains on acetylated Tat are then established, which are necessary for both sustained transcriptional activation of the HIV-1 promoter and viral transcription elongation. In this study, we investigated the identity of proteins that preferentially bound acetylated Tat. Methods: We used a proteomic approach based on MALDI-TOF to identify the protein partners of AcTat. Results were then confirmed with western blot. Chromatin immunoprecipitation was used to confirm the presence of AcTat and the splicing regulator p32 on the HIV-1 promoter. To assess the effect of AcTat and p32 on HIV-1 splicing, RNase protection assay was used to identify spliced and unspliced transcripts of HIV-1. Finally co-immunostaining was performed to study the co-localization of AcTat and p32 in vivo Results: We identified a number of proteins that preferentially bound AcTat, among which p32, a co-factor of splicing factor ASF/SF-2 was identified. We found that p32 was recruited to the HIV-1 genome, and inhibited HIV-1 splicing needed for the production of full-length transcripts. Using Tat from different clades, harbouring a different number of acetylation sites, as well as Tat mutated at lysine residues, we demonstrated that Tat acetylation affected splicing in vivo. Finally, using confocal microscopy, we found that p32 and Tat co-localize in vivo in HIV-1 infected cells. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  39 Conclusions: In this study, we demonstrated a model in which AcTat interacts with p32 and inhibits HIV-1 splicing by affecting phosphorylation of the splicing factor ASF/SF-2. MOPEO015 Substitution of RGD sequence present in second exon of HIV-1 TAT of subtype B with QGD sequence present in the Indian subtype-C isolate results in lower HIV-1 LTR mediated transctivation potential A. Banerjea, V. Sood, N. Gupta, Virology Group. National Institute of Immunology, Virology, New Delhi, India Background: It is not quite clear why genetic subtype C is responsible for driving the epidemic in India and other regions of Asia. Since HIV-1 TAT seems to play a major role in increasing the viral gene expression, we wished to find out the effect of substituting RGD with QGD in the second exon on HIV-1 LTR mediated transactivation. Methods: The wild-type subtype B possesses RGD cell adhesion motif but Indian subtype C (AF067158) has QGD. We transplanted this sequence on to the subtype B by genetic engineering to make Sub-B-QGD. We also made subtype C- second exon with RGD (Sub-C-RGD). They were transfected with various Tat constructs into HIV-1 TLR-b-gal expressing cells and blue cells were counted under inverted microscope. Results: Substitution of RGD with QGD results in lowering the transctivation potential of subtype B when compared with wild-type (WT) subtype B. Transplantation of RGD sequence onto subtype C background did not alter the transactivation potential of subtype C and was same as the WT-subtype C. Conclusions: RGD sequence present in the second exon of subtype B contributes to enhanced transactivation probably by exploiting this cell adhesion motif. MOPEO016 Nitric oxide and neural damage in acquired immunodeficiency syndrome patients K. Shevchenko, Y. Zadorin, O. Zadorina. Clinical Research Institute, Zadorin department, Kiev, Ukraine Background: Nitric oxide (NO) plays an important role in normal neural cell function. Dysregulated or overexpression of NO contributes to neurologic damage associated with various pathologies, including human immunodeficiency virus (HIV)-associated neurological disease. Previous studies suggest that HIVinfected monocyte-derived macrophages (MDM) produce low levels of NO in vitro and that inducible nitric oxide synthase (iNOS) is expressed in the brain of patients with neurologic disease. Methods: NO production was assessed via measurement of nitrite in culture supernatants by the Griess reaction. We used RNA isolation and RT-polymerase chain reaction (PCR),reverse transcriptase (RT) assay,preparation and HIV-1 infection of primary cells. Results: Supernatants from cocultures of infected MDM and astrocytes also stimulated iNOS/NO expression in astrocytes, but cytokines known to induce iNOS expression (interferon-, interleukin-1, and tumor necrosis factor-) were not detected. In addition, the recombinant HIV-1 envelope protein gp41, but not rgpl20, induced iNOS in cocultures of uninfected MDM and astrocytes. Conclusions: This suggests that astrocytes may be an important source of NO production due to dysregulated iNOS expression and may constitute one arm of the host response resulting in suppression of HIV-1 replication in the brain. It also leads us to speculate that neurologic damage observed in HIV disease may ensue from prolonged, high level production of NO. MOPEO017 Associations of HLA-DRB alleles with resistance/ susceptibility to HIV-1 infection in the Pumwani sex worker cohort P. Lacap, 3. Huntington (co-presentor)', M. Luo, J. Ndinya-Achola, S. Nenga, J.B. Bwayo, S. Ramdahin, T. Bielawny', J. Rutherford4, L. Slaney4, 3. Kimani', C. Wachihi', E.N. Ngugi', F.A. Plummer'. 'National Microbiology Laboratory, HIV and Human Genetics, inig,C, Canada, 'National Microbiology Laboratory and University of Manitoba, HI V/Human Genetics and Medical Microbiology, Winnipeg, Canada, 3University of Nairobi, Medical Microbiology, Nairobi, Kenya, 'University of Manitoba, Medical Microbiology, Winnipeg, Canada, 5University of Nairobi, Community Health, Nairobi, Kenya, 'National Microbiology Laboratory and University of Manitoba, Medical Microbiology, Winnipeg, Canada Background: A group of sex workers in the Pumwani Sex Worker Cohort remain HIV-1 PCR negative and IgG antibody negative despite heavy exposure to HIV-1 through sex work. Previous studies showed that this resistance to HIV-1 infection is associated with several HLA alleles, HIV-specific CD8+ and CD4+ T cell responses as well as mucosal neutralizing antibody to HIV-1. The strong CD4+ T cell responses of HIV resistant women to p24 antigen indicate that HLA class II antigens are important. To comprehensively study the effect of DRB alleles and haplotypes on the resistance/susceptibility to HIV-1 infection in the Pumwani Sex Worker Cohort we conducted a high-resolution sequencebased DRB typing of 1083 women. Methods: DNA was isolated from whole blood or PBLs. HLA DRB genes were amplified and sequenced. A two-step sequence-based method was used for DRB typing. Allele and haplotype frequencies were determined using PyPop 32 -0.6.0. Data analysis was conducted with SPSS 13.0 for Windows. Results: Three DRB1 alleles were significantly associated with resistance to HIV-1 infection: DRB1*010201 (OR, 2.13; 95% CI, 1.31-3.47; P = 0.002), DRB1*1102 (OR, 1.91; CI95%, 1.21-3.01; P = 0.005) and DRB1*130201 (OR, 1.51; CI95%, 1.00-2.28; P = 0.047). Two corresponding DRB1 -DRB3 haplotypes were also significantly associated with HIV-1 resistance: DRB1*1102-DRB3*020201 (OR, 1.85; CI95%, 1.15-2.97; P = 0.010) and DRB1*130201-DRB3*030101 (OR, 1.55; CI95%, 1.03-2.35; P = 0.037). DRB1*1503 (OR, 0.603; CI95%, 0.37-1.00; P = 0.046) and its corresponding haplotype, DRB1*1503-DRB5*010101(OR, 0.571; CI95%, 0.35-0.94; P = 0.027), were significantly associated with susceptibility to HIV-1 infection. Conclusions: We identified two DRB alleles, DRB1*1102 and DRB1*130201, as well as two DRB1-DRB3 haplotypes, DRB1*1102-DRB3*020201 and DRB1*130201-DRB3*030101 that are associated with resistance to HIV-1 infection. Our findings provide additional support that HLA class II-specific CD4+ responses are important in resistance to HIV-1 infection. MOPE0018 Populational HIV-1 adaptation to human leukocyte antigen (HLA) class I-mediated selective pressures: evidence for gene-specific effects Z. Brumme, C. Brumme, C. Chui, T. Mo, W. Dong, C. Woods, B. Wynhoven, R. Hogg, J. Montaner, P.R. Harrigan. B.C. Centre for Excellence in HIV/AIDS, Vancouver, Canada Background: Variation in the polymorphic HLA class I genes influences the strength and diversity of the immune response, and acts as a selective pressure mediating viral sequence evolution. We investigated populational associations between HLA and HIV sequence diversity in a cross-sectional analysis of 765 chronically-infected, antiretroviral naive individuals with subtype-B infection initiating HAART. Methods: Sequence-based typing (SBT) for HLA-A, B and C was performed on extracted DNA (N=765) using a validated protocol. Alleles were summarized to two-digit resolution. Inferred amino acid consensus sequences over HIV Nef, RT, PR and the envelope V3 region were generated from cross-sectional pretreatment data. A codon-by-codon chi-squared analysis was performed to identify HLA alleles positively/negatively associated with divergence/ preservation from consensus at all 'variable' codons (<98.5% conservation). Results: 198 significant associations (p<0.001) between specific HLA alleles and HIV consensus sequence were observed across HIV genes investigated. 206, 400, 99 and 35 codons were examined within Nef, RT, PR, and V3, respectively, of which 62%, 29%, 35% and 74% were variable. 87, 67, 21 and 2 positive HLA/HIV associations were observed in Nef, RT, PR and V3, respectively. Fewer negative associations were observed (Nef =20 and RT =1). 76 (38%) of all associations map within or near known HLA-restricted CTL epitopes. HLA-B/HIV associations accounted for half (N=99) of observed associations, consistent with a dominant role of the HLA-B locus in mediating HIV sequence evolution. Conclusions: Differential contributions of HLA selective pressures on population HIV sequence diversity were observed across genetic regions (Nef>PR/RT>V3), consistent with the level of HLA-restricted, CTL-mediated selective pressure on these genes over the course of infection. The patterns of HIV genetic evolution are relatively consistent among individuals sharing HLA alleles, and may thus be predictable in nature. Results have implications for the future design of CTLbased therapeutic and/or preventative vaccines. MOPE0019 TNF microsatellite alleles may confer protection against the development of lipodystrophy in Brazilian AIDS patients A.P. Fernandes', M. Silva', R. Simbes2, E. Casteli', M. Tesin', A. Machado', E. Donadi'. 'University of 5o Paulo, College of Nursing of Ribeiro Preto, Ribeiro Preto, Brazil, 2University of SCo Paulo, School of Medicine of Ribeir o Preto, Ribeirbo Preto, Brazil Background: Despite the enormous impact of antiretroviral therapy on life quality and expectancy, the appearance of lipodystrophy has caused several clinical and psychosocial problems. Mechanisms associated with the development of lipodystrophy following antiretroviral therapy have not been elucidated. Evidence supports a possible role for TNF in the development of this complication. Methods: To evaluate the TNFa, TNFc and TNFe microsatellite polymorphism in HIV patients presenting the lipodystrophy syndrome or not, we studied 40 HIV patients treated with antiretroviral therapy (30 with and 10 without lipodystrophy) and 120 blood samples from healthy controls. The TNF microsatellites were typed using genomic DNA hybridized with sequence specific primers. Statistical analysis was performed using Fisher's exact test. Results: The TNFa5 allele was associated with protection against lipodystrophy development, since the allele was underrepresented when patients with lipodystrophy were compared to those without it (p=0.02, OR=0.1579), and was over represented when patients without lipodystrophy were compared to controls (p=0.0072, OR=5.82). In addition, a protective effect was conferred to the TNFa2 and TNFa8 alleles, since these were over represented in controls when compared to patients with lipodystrophy (p=0.012, OR=0.34 and OR=12.57, p=0.026; respectively). Conclusions: Taken together, these results indicate that the TNF region may participate in lipodystrophy development and the TNFa2, a5 and a8 may be considered as a protection factor for lipodystrophy. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  40 Monday 14 August Poster xi:ior MOPE0020 MOPE0022 HLA-G alleles and their association with resistance The influence of HLA class II antigens on motherand susceptibility to HIV-1 in Kenyan sex-trade child HIV transmission at birth workers W. Turk', M. Luo2, T. Bielawny', J. Kimani3, J. Ndinya-Achola3, F. Plummer4. 1National Microbiology Laboratory, HIV and Human Genetics, Winnipeg, Canada, 2National Microbiology Laboratory, and University of Manitoba, HIV and Human Genetics and Medical Microbiology, Winnipeg, Canada, 3University of Nariobi, Medical Microbiology, Winnipeg, Canada, 4National Microbiology Laboratory, and University of Manitoba, Medical Microbiology, Winnipeg, Canada Background: A group of sex trade workers in Pumwani, Kenya have been shown to be resistant to HIV-1 infection despite frequent exposure. Previous studies have shown associations between some HLA class I and class II alleles and resistance or susceptibility to HIV-1 infection. HLA-G is a non-classical class I allele that is primarily involved in mucosal and inflammatory defence. In this study, we examined the influence of HLA-G genotypes on the resistance to HIV-1 infection using a sequenced based method. Methods: DNA was isolated from whole blood and/or PBLs of 607 women from the Pumwani Sex Worker Cohort. The HLA-G gene was amplified with PCR and subsequently sequenced using a BigDye Cycle Sequencing Kit (Applied Biosystems). Alleles were determined using an HLA typing program based on Taxonomy-based sequence analysis. HLA-G typing results were analyzed with SPSS 11.0.1 for Windows. Results: Survival analysis showed that G*010102 (including G*01010201, G*01010202, and G*0106) was associated with increased susceptibility to seroconversion (Log rank:7.66, p=0.022). This increased susceptibility is attributed to homozygous for this allele (Log rank:7.41, p=0.006). G*010101 genotype (including G*01010101, G*01010102, G*01010103, G*01010104, G*01010105, and G*010106) was associated with resistance to HIV-1 infection (p = 0.03, odds ratio: 1.6, CI95%: 1.04-2.47). G*010108 was associated with resistance to HIV-1 infection (p = 0.031, odds ratio: 2.41, CI95%: 1.06 -5.47). Conclusions: Our study showed that HLA-G plays an important role in resistance/susceptibility to HIV-1 infection. Since HLA-G is important in mucosal and inflammatory responses, further studies will be conducted to better understand HLA-G and mucosal defence. M. Luo', J. Embree2, S. Ramdahin2, T. Bielawny3, T. Laycock2, J. Tuff3, D. Haber2, J. Ndinya-Achola4, S. Njenga4, J.B. Bwayo4, M. Plummer2, J. Ottenson2, C. Piech2, F.A. Plummer'. 'University of Manitoba and National Microbilogy Laboratory, Medical Microbiology and HIV and Human genetics, Winnipeg, Canada, 2University of Manitoba, Medical Microbiology, Winnipeg, Canada, 'National Microbiology Laboratory, HIV and Human Genetics, Winnipeg, Canada, 4University of Nairobi, Medical Microbiology, Nairobi, Kenya, sUniversity of Manitoba and National Microbilogy Laboratory, Medical Microbiology, Winnipeg, Canada Background: HIV-1 can be transmitted from infected mothers to their children during gestation and during birth. About 16% of HIV positive children were infected at birth in the Mother-child HIV transmission cohort (MCH) established in 1986 in Nairobi, Kenya. Previous studies shown that HLA class I concordance between mother and child increases the risk of HIV transmission. However, the effect of HLA class II antigens on mother-child HIV transmission has not been well studied due to the small sample size and other confounding factors, such as antiretroviral treatment. We conducted a study to investigate the effect of HLA class II genes on mother-child HIV transmission at birth in the MCH cohort. Methods: HLA class II genes were typed for 274 mother-child pairs using a sequence-based method. Among 274 children born to HIV positive mothers, 166 were HIV negative and 108 were HIV positive. The effect of HLA class II genes on mother-child HIV transmission was assessed by statistical analysis with SPSS 13.0. Results: DRB concordance between mother-child increased risk of HIV transmission at birth (p=0.001, Odds ratio: 2.7, CI95%, 1.5-4.7). Mothers with DRB1*1503 alleles and concordant at DRB have a significantly higher risk to transmit virus to their children at birth (p=0.004). DRB1*1503 genotype also abolishes the protective effect of DRB discordance. The effect of other HLA class II antigens, such as DQB1, DPA1 and DPB1 on perinatal transmission of HIV-1 are under investigation. Conclusions: DRB concordance increases the risk of perinatal HIV transmission. Mothers with DRB1*1503 genotype were more likely to transmit the virus to their children. Alloimmunity by DRB discordance plays an important role in mother-child HIV transmission at birth. MOPE0021 Homozigosity for the promoter variant XAXA in the MOPE0023 mannose-binding lectin (mbl2) gene is a genetic Upregulation of apobec 3G and apobec 3F in determinant of susceptibility to pediatric HIV-1 HIV-exposed but uninfected individuals infection A. Mangano'1, C.A. Rocco', F. Genre', D. Mecikovsky2, S. Marino', P. Aulicino1, R. Bologna2, L. Sen'. 'Hospital de Pediatria J.P. Garrahan, LAb. Biologia Celular y Retrovirus, Buenos Aires, Argentina, 2Hospital de Pediatria J.P. Garrahan, Servicio de Infectologia, Buenos Aires, Argentina Background: MBL is a pattern recognition molecule that plays an important role in innate immune defense. Several mutations in the coding region including the B, C, and D alleles, and the promoter X variant were identified and account for some of the variation in plasma MBL levels. We analyzed whether the MBL alleles are associated with HIV-1 susceptibility. Methods: The study included 147 blood donors and 345 perinatally HIV-1 exposed children, 161 infected and 184 exposed uninfected. Among infected infants, the median follow-up was 96.5 months (range: 2-221 mo), and 42% developed AIDS. MBL genotyping was assessed by PCR-RFLP assays. Plasma MBL levels were tested by a commercial assay. Hardy-Weinberg equilibrium and frequency differences were tested with Pearson X2. Effect on HIV vertical transmission was fitted to logistic models. Time curves for progression to AIDS were estimated with Kaplan-Meier methods. Hazard ratio were estimated with Cox proportional hazards models. Results: In the Argentinean population B, D and X alleles were identified with frequencies of 0.1815, 0.0333, and 0,1463 respectively. The B and D alleles were pooled as 0. The 0 genotypes significantly deviate from the HardyWeinberg equilibrium (P=0.036), with a higher number of homozygous 0/0 than expected (14 vs. 9). The combined XAXA genotype was associated with a higher risk of HIV-1 vertical transmission (p=0.004, OR 39.88 CI 95%=/o3.24 -490.8) and a rapid progression to AIDS (p=0.022, RH=3.55 CI 95%=/o1.20 -10.45). MBL levels were tested in 76 infected patients with median levels (ng/ul) of: YAYA=3800 YA/XA=3916, XAXA=1814, YAYO=906, XAYO=272, YOYO=50. The X variant reduced MBL levels and lower concentrations were associated with the 0 allele. Conclusions: Our results showed that homozygosity for XAXA genotype is highly associated with an increased risk of acquiring HIV-1 and rapid rate of disease progression to pediatric AIDS, which could be related to an impaired activity of the protein. L. Piacentini', M. Biasin', S. Lo Caputo2, Y. Kanari', G. Magri', D. Trabattoni', V. Naddeo1, F. Fasano', C. Bergamaschi', L. Lopalco4, A. Clivios, E. Cesanas, F. Mazzotta2, M. Miyazawa3, M. Clerici'. 'University of Milan, Department of Immunology, Milan, Italy, 2SS Annunziata Hospital, Infectious Diseases Clinic, Florence, Italy, 3Kinki University School of Medicine, Department of Immunology, Osaka, Japan, 4Duke University Medical Center, Department of Surgery, Laboratory for AIDS Vaccine Research & Development,, Durham, United States, sUniversity of Milan, Department of Biology, Milan, Italy Background: The human cytidine deaminases APOBEC3G and APOBEC3F are potent inhibitors of Retrovirus infection. HIV-1 Vif protein counteracts APOBEC3s by triggering their degradation via a proteasome-dependent pathway. Among existing human clusters with different susceptibility to HIV infection there are HIV-exposed seronegatives (ESN) who have evidence of multiple and repeated exposure to HIV but nevertheless possess no serum anti-HIV IgG antibodies. Interferon-alpha (IFNa) was recently shown to upregulate APOBEC3 proteins. Methods: We analyzed mRNA expression and protein levels of APOBEC3G and APOBEC3F in ESN, HIV-infected patients (HIV+) and healthy controls (HC) by Real Time PCR and ELISA assays. Surface expression of IFNa receptor 1 (IFNAR1) on the different cell subsets of PBMC from these individuals was also evaluated. Results: 1) IFNa but not IL-2 stimulation resulted in the upregulation of APOBEC3G and APOBEC3F independently of IL-15; 2) IFNa-induced expression of APOBEC3G and APOBEC3F was significantly increased in PBMC of ESN compared to HIV+ and HC; 3) IFNa increased APOBEC3G and APOBEC3F mRNA mostly in CD14+ cells, which also showed significantly higher levels of IFNAR1; 4) APOBEC3s mRNA expression was higher in cervical biopsies of ESN compared to HIV+ and HC; and 5) APOBEC3G protein levels were significantly higher in PBMC from ESN compared to HIV+, and HC. Conclusions: These data suggest that the higher quantities of APOBEC3G and APOBEC3F found in ESN could play a role in amplifying and strengthening resistance to HIV-1 infection in vivo. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  41 MOPE0O24 HLA class II DP and DQ alleles associated with resistance and susceptibility to HIV-1 Infection in Kenyan sex trade workers R.-A. Hardie1, B. Bruneau2, E. Knight2, C. Semeniuk2, K. Gill', T. Bielawny2, K. Joshua3, C. Wachihi4, E. Ngugi4, M. Luo', F. Plummer'. 'University of Manitoba, Medical Microbiology, Winnipeg, Canada, 2National Microbiology Laboratory, Winnipeg, Canada, 3University of Nairobi, Medical Microbiology, Nairobi, Kenya, 'University of Nairobi, Community Health, Nairobi, Kenya, 5Public Health Agency of Canada, Winnipeg, Canada Background: Despite being highly exposed to HIV-1 through active sex work, a group of women in the Pumwani Cohort in Nairobi, Kenya have remained HIV-1 seronegative and PCR negative. These differential susceptibilities to HIV1 infection have been attributed to genetic differences in the highly variable Human Leukocyte Antigen (HLA). HLA Class II antigens are key in the immune response to HIV-1 in their presentation of viral peptides to CD4+ cells. This study attempts to identify associations of HLA DP and DQ alleles and resistance/ susceptibility to HIV-1 infection by a sequence-based method. Methods: DNA samples from over 1100 cohort members were amplified and sequenced using primers specific to each HLA class II gene. Genotyping was performed with a Taxonomy-based Sequence Analysis method (TBSA). Correlation analyses were performed using SPSS 11.0. Haplotype analyses are currently being performed using PyPop. Results: We identified several DPA, DPB, DQB alleles that were associated with either resistance or susceptibility to HIV-1 infection. The alleles associated with resistance to HIV-1 infections are: DPA1*010301 (p=0.001, odds ratio:1.85, CI95%, 1.30-2.64), DPA1*0105 (p=0.018, odds ratio:3.02, CI95%, 1.15 -7.91), DPB1*2301 (p=0.044, odds ratio:2.37, CI95%, 1.00-5.64), DPB1*3001 (p=0.0004, odds ratio:3.53, CI95%, 1.69-7.36), DQB1*0603 (p=0.009, odds ratio:2.52, CI95%, 1.23-5.12). DQB1*0602 genotype is significantly associated with HIV positive women (p=0.047, odds ratio:0.65, CI95%, 0.43 -1.00). Women with DPA1*010301 are less likely to seroconvert (log rank:4.82, p=0.028), while DPB1*0402 genotype are more likely to seroconvert (log rank:7.13, p=0.008). Haplotype analyses results are pending. Conclusions: The significant associations of several DP and DQ alleles with resistance /susceptibility to HIV-1 infection in Pumwani Sex Worker Cohort further confirm the importance of CD4+ T cells in anti-HIV-1 immunity. MOPEO025 M 1 and M 2 activation of macrophages results in differential susceptibility to R5 and X4 HIV-1 infection E. Cassol, M. Alfano, G. Poli. DIBIT San Raffaele Scientific Institute, AIDS Immunopathogenesis Unit, Milano, Italy Background: Altered gene expression in macrophages may contribute to the shift from a Thl response during early HIV-1 infection to a predominantly Th2 response in late-stage disease. A similar switch in macrophage activation, from M1 to M2, may bear relevance for viral replication and accelerated disease progression. Objectives: The aim of this study was to determine whether M1 and M2 activation differentially supports productive infection of R5 and X4 HIV-1. Methods: After 7 days in serum-containing medium, MDMs were stimulated with IFN-yand TNF-a (M1) or IL-4 (M2) for 18 hrs, washed and infected either with BaL (R5) or IIIB (X4) HIV-1. Receptor/co-receptor expression were assessed by FACS; virus production was measured by RT activity in culture supernatant. Results: M1 and M2 activation led to a decreased ability to support productive R5 infection. M1-activated MDMs exposed to low viral inoculums (MoI;0.1) were unable to support R5 infection. Increasing the viral inoculum (MoI;1.0) resulted in productive infection, with delayed replication kinetics, similar to untreated controls. Surprisingly, M1 activated MDMs were able to support X4 infection in some donors. RT levels in supernatant were ten times lower with X4 relative to R5 viruses. M2 activation led to inhibition of virus production in all donors, with complete inhibition occurring in 50% of donors. Both M1 and M2 activation resulted in the down-regulation CD4 expression, with levels falling to undetectable in M1 cells. The inability of VSV-pseudotyped viruses to cause productive infection in either M1 or M2 MDMs, however, suggests that part of the inhibition in viral replication is due to a post-entry mechanism. Conclusions: Uncommitted macrophages are more prone to support productive R5 infection, whereas Mi-activated MDMs showed a limited capacity to support X4 virus replication. The decrease in virus production following activation was due to both CD4 down regulation and alternative post-entry mechanisms. MOPEOO26 Specific HLA-B alleles which influence untreated HIV-1 disease progression do not appear to affect response to highly active antiretroviral therapy C. Brumme, C. Chui, C. Woods, B. Wynhoven, R. Hogg, J. Montaner, P.R. Harrigan, Z. Brumme. BC Centre for Excellence in HIV/AIDS, Vancouver, Canada Background: Host genetic variation within the HLA-B locus influences untreated HIV disease progression. Specifically, HLA-B*5701 and B*27 are associated with protective effects, whereas HLA-B*35P(x) (comprising B*3502,*3503,*3504 and *5301) and B22 serogroup (comprising B*54, *55 and *56) are associated with disease progression. We investigated associations between these HLA-B alleles and therapeutic outcomes in a cohort of 765 antiretroviral-naive individuals initiating HAART. Methods: HLA-B sequence-based typing of subjects (N=765) was performed with a validated protocol. Alleles were resolved to intermediate-level resolution. Associations between HLA-B alleles and baseline (pre-therapy) parameters were investigated in a cross-sectional analysis. Cox proportional hazards regression was used to investigate the effect of HLA-B alleles on time to pVL suppression <500 copies/ml, subsequent time to pVL rebound 500 copies/ml, time to CD4 decline below baseline, and time to non-accidental death. Results: HLA-B*5701, B*27, B*35P(x) and B22 alleles were observed in N=47, 52, 37 and 39 individuals, respectively. At baseline, HLA-B*5701 was associated with significantly lower pVL (p=0.001) whereas B22 was associated with higher pVL (p=0.02). No significant differences in baseline CD4 counts were observed. In multivariate analyses controlling for baseline parameters, initial therapy type, adherence estimates, and other host and viral genetic markers of HIV disease progression, we observed no significant association between these HLA-B alleles and virologic or immunologic treatment outcomes, or with survival following HAART initiation (p>0.05). In a secondary analysis exploring associations between other HLA-B alleles and survival after initiating HAART, B*18 (N=55) and B*35P(y) (comprising B*3501 and B*3508; N=91) were associated with decreased survival (multivariate HR=1.9 and 2.1, respectively, p<0.05), while B*44 (N=149) was associated improved post-HAART survival (multivariate HR= 0.5, p=0.03). Conclusions: HLA-B*5701, B*27, B22 and B*35P(x) appear to have no influence on therapeutic outcomes in individuals initiating HAART. HAART outcomes may be influenced by a different set of HLA-B alleles than untreated outcomes. MOPEOO27 Functional and phenotypic characteristics of CD8+ T cells to dominant and sub-dominant epitopes in subtype C HIV-1-infected individuals V. Morafo1, P. Mohubel, P. Mokgotho1, H. Maila', N. Martinson2, G. Gray2, J. McIntyre2, G. de Bruyn2, C. Williamson3, C. Gray'. 'National Institute for Communicable Diseases, HIV Research Unit- Immunology, Johannesburg, South Africa, 2Perinatal HIV Research Unit, Johannesburg, South Africa, 3University of Cape Town, Cape Town, South Africa Background: A robust cytotoxic T lymphocyte CTL response has been shown to play a critical role in the control of viral replication and slower disease progression in HIV-1 infection. Studies have focused on HIV-1 specific-CD8+ T cells secreting IFN-y as an indicator of CTL response using the ELISpot assay, however, the ability and the capacity of responding CTL to function effectively and efficiently in destroying infected cells requires further examination. Our aim was to determine functional and phenotypic profiles of HIV-1 specific CD8+ T cells from chronically HIV-1 subtype C infected individuals using intracellular cytokine staining (ICS) and flow cytometry. Methods: Single reactive peptides across the subtype C proteome were identified in 33 chronically HIV-infected individuals using the IFN-y ELISpot assay. Using multi-parameter ICS flow cytometry, antigen-specific CD8+ T cells were assessed for functional ability to express IL-2, IFN-y and CD107a/ b (degranulation). Responses were correlated with CD4 counts, range: 305 -1367.4 cells/mm3. Results: There was preferential targeting of epitopes in Nef 75.8%, Gag 67%, Pol 48.5%, Env 33% and Tat, Rev, Vif, Vpr, Vpu (TRVVV) 30% by ELISpot assay. We identified, using ICS, CD8+ T cells that were IFN-y+IL-2- expressing confirming epitope recognition in Vif, Env, Nef and Gag (range: 0.144% - 1.274%). Recognition of the less frequently targeted epitopes in Vif and Env resulted in IFNy+CD107a/b+ degranulating cells. Conclusions: We identified a phenotype of antigen-specific CD8+ T cells that expressed IFN-y and functionally possessed cytolytic potential to less dominantly recognized epitopes. Our data suggest that CD8+ T cells that recognize subdominant epitopes in subtype C HIV-1 infection may have greater functional capacity than those recognizing immunodominant epitopes. MOPEOO28 NK and NKT cells immunophenotype in HIV infection E. Konsta', K. Psarra2, V. Kapsimali2, 0. Georgiou3, V. Papastamopoulos', A. Skoutelis', C. Papasteriades2. 'Natonal and Kapodistrian University of Athens, Department of Chemistry, Athens, Greece, 'Laboratory of Immunology and Histocompatibility, Evangelismos Hospital, Athens, Greece, 'Evangelismos Hospital, AIDS Unit, Athens, Greece Background: Innate immune response plays an important role in HIV infection. In the present study, the contribution of NK and NKT cells in this response is investigated by extensive four-color immunophenotyping of these cells subsets. Methods: Peripheral blood leukocytes of 20 HIV(+) patients and 20 healthy individuals were labeled with monoclonal antibodies CD3, CD56, CD16, CD2, CD7, CD11a, CD57, CD11c, CD45RA, CD45RO, HLADR, TCRy, perforin, granzyme A by direct whole blood staining and were analyzed by four-color flow cytometry. Results: HIV(+) patients in comparison to healthy individuals showed statistically significant differences as follows: 1) regarding NK cells and their subsets, higher expression of CD11c, granzyme A and decreased incidence of CD45RO, CD57 and HLADR was found, 2) regarding NKT cells and their subsets, higher expression of CD11a, CD11c, Monday 14 August Poster Exhibitio n XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  42 TCRy6 and decreased incidence of CD45RO and HLADR was observed. The CD4 cell absolute number was positively correlated with CD7 expression (p=0,011, R=0,553) and granzyme production (p=0,045, R=0,464), as well as negatively correlated with CD45RO (p=0,026, R=-0,495) in NK and NKT cells. In addition, it should be noted that granzyme A was found to be expressed mainly in the CD56+CD3- and not in the CD16+CD3- subset of NK cells in HIV(+) patients, a finding not observed in healthy individuals. Conclusions: Increased expression of adhesion molecules, decreased expression of activation markers on HIV(+) patients' NK and NKT cells, as well as their correlation with CD4 cell number found to this study, seem to indicate the importance of NK and NKT cells immunophenotyping for the assessment of the patients' immune status. MOPEO029 Prevalence of Lactoferrin (Lf) and secretory leukocyte protease inhibitor (SLPI) in the genital tract and the influence of concurrent vaginosis in women at both low and high risk for HIV infection R.M. Novak', R. Hershow2, H.Y. Chen2, P. Graham', L. Boksal, C.B. Mulder, A. Landay3. 'University of Illinois at Chicago, Infectious Diseases, Chicago, United States, 2University of Illinois at Chicago, School of Public Health, Chicago, United States, 3Rush University, Clinical Immunology, Chicago, United States Background: Recent studies suggest that innate factors in mucosal secretions including Lf and SLPI can inhibit HIV-1 infection in vitro. This study examines both Lf and SLPI levels in cervicovaginal lavages (CVLs) from women at low and high risk for acquiring HIV infection, and the effect of coexisting vaginoses on these factors. Methods: Women at high (n=64) and low risk (n=32) for heterosexual HIV acquisition were recruited in Chicago. High-risk participants had at least one HIV-seropositive sex partner or >1 of the following: crack cocaine use during the last 6 months; exchange of sex for money, drugs,r or shelter during or at least 5 sex partners during the last 6 months; a history of sexually transmitted diseases (STDs) during the last year. CVLs were collected using standardized procedures. Trichomonas and bacterial vaginosis (BV) were diagnosed by wet mount and Amsel criteria, respectively. Lf and SLPI were measured by ELISA. Results: The Lf concentration in the high risk group (mean 204 ng/ml, range 19-371ng/ml) was significantly higher than in the low risk cohort (mean 163 ng/ml, range 13-252ng/ml; P=0.01). SLPI concentrations in high risk women (mean 9987.0 pg/ml, range 4418-17254 pg/ml) did not differ significantly from low risk women (mean 9088.0 pg/m, range 2250-11727 pg/ml). After adjusting for risk group, LF was positively associated with the presence of leukocytes in the CVL (P<0.002) and with the coexistence of BV in the sample (P=0.033). SLPI levels were significantly lower in women with BV than those without BV (P=0.04). Trichomonas was weakly associated with LF (P=0.056) but not with SLPI. Conclusions: Higher Lf concentrations observed in high risk women and positive correlations with leukocytes and vaginoses is consistent with a leukocyte byproduct, and greater genital tract inflammation observed in this cohort. Reduced SLPI levels during BV infection is consistent with increased HIV risk seen with BV. MOPEOO3O Do neutralizing antibodies against HIV-1 arise from autoantibody precursors? X. Wang', S. Sze Tsun Wu', M. Montero', D.R. Richman', S. Little', K. Scott'. 'Simon Fraser University, Department of Molecular Biology and Biochemistry, Burnaby,B.C, Canada, 2University of California, San Diego, La Jolla, CA, United States Background: A major goal in developing an AIDS vaccine is to elicit broadly neutralizing antibodies. It has been suggested that the two broadly-neutralizing human monoclonal Abs (MAbs), 2F5 and 4E10, which target the membrane proximal region (MPR) of the envelope protein, gp41, are polyspecific autoantibodies because they crossreact with the phospholipid autoantigen, cardiolipin (CL). A concern has also been raised that current HIV-1 vaccines do not routinely induce neutralizing antibodies against the MPR because such antibodies are derived from autoreactive B cell clones that are normally deleted or made anergic. In this study, we compared the relative binding strength of MAbs 2F5 and 4E10 for different antigens, and investigated the cardiolipin reactivity of serum samples from HIV-1 positive people having different clinical outcomes. Methods: ELISAs were used to detect the binding reactivity of MAbs 2F5 and 4E10 and of 125 HIV-1 positive serum samples against different targets, including their gp41 epitopes, CL and nonspecific binding proteins, such as non-fat dried milk and ovalbumin. Results: MAbs 2F5 and 4E10 produced higher binding reactivity for their gp41 epitopes compared to cardiolipin by over one order of magnitude, and binding strength to nonspecific antigens was similar to that for CL. No increase of CL reactivity over time was observed for serum samples taken over time. Conclusions: MAbs 2F5 and 4E10 bind to the autoantigen CL with much lower affinity compared to their cognate gp41 epitopes. This is different from autoantibodies, which bind most strongly to their cognate autoantigens. Our serum data, showing no increase in CL reactivity in serum samples taken from the same individual over time, argues against the hypothesis that HIV-1 infection causes emergence of autoimmune antibodies. However, this hypothesis, which suggests that an autoimmune state is required before neutralizing antibody responses against HIV-1 can be mounted, requires much further investigation. MOPE0031 Gpl20-derived CD4 chimeras useful molecules to expose and strongly increase the CD4-induced epitope recognition J. Gajardo', D. Misse', A. Martinez', F. Roquette2, M. Pugniere2, D. Bray3, F. Veas'. 'Research Institute for Development, Health, Montpellier, France, 2CNRS, CBPS, Montpellier, France, 3Immunoclin, London, United Kingdom HIV-1 entry into cells involves target cells binding of the gp120 exterior envelope glycoprotein to CD4. This interaction induces conformational changes in gp120 that expose the gp120 co-receptor binding site so called CD4-induced (CD4i) epitopes. The coreceptor binding is one of the most important steps for subsequent virus-cell fusion and therefore are a promising target for anti-HIV vaccine and therapies. In order to produce a small CD4i transconformed gp120, we constructed two single-chain polypeptide analogue of the HIV-1 gp120 -CD4 complex. These chimeric envelope glycoproteins, termed gpl20chx and gpl20chy, contain a derived CD4 protein within different sites of gpl20 region to avoid linkers and cross-linking agents. This CD4-derived reproduce the CDR2-like loop of CD4, which interact with the gp120. Structural integrity of the chimeric proteins was determined by its ability to bind a panel of monoclonal antibodies against known epitope specificities. Both chimeric proteins exhibiting an increase exposure of CD4i epitopes and a decrease exposure of CD4 binding site epitopes. Biacore studies revealed that both chimeras bound to 4.8D CD4i MAb with a dissociation constant 100-fold lower than the gp120-sCD4 complex. The ability to bind the HIV receptors was also evaluated. Both proteins bound to CCR5 as well as the gp120-sCD4 complex, but did not bind to CD4 receptor. Further, pseudovirus expressing chimeric proteins were able to bind CD4i MAb, demonstrating that CD4i epitopes are properly exposed at the surface. Thus, these chimeric proteins have the ability to mimic most of the properties of the gp120-CD4 complex, representing a good candidate for the development of a safe and effective vaccine. We are currently testing their capacity to elicit an effective immune response. This work was supported by ANRS, SIDACTION, IRD, CNRS, France MOPEOO32 Identification of peptides specific of the IgA of long term non progressors S. Deroo', M. Vausort', J.-M. Plessbria', S. Delhalle', N. Beaupain', M. Counson', J.-C. Schmit. 'Centre de Recherche Public Sant, Laboratoire de Rdtrovirologie, Luxembourg, Luxembourg, 2Centre de Recherche Public Santd/Centre Hospitalier Luxembourg, Laboratoire de Rdtrovirologie/Service National des Maladies Infectieuses, Luxembourg, Luxembourg Background: To obtain an efficient HIV-1 vaccine both humoral and cell mediated immunity are required. However, the induction of a broadly neutralising antibody response remains difficult. The identification of epitopes/ mimotopes that recognise human neutralising antibodies is crucial to develop new approaches to build effective immunogens. The objective of the present study was to identify mimotopes of HIV-specific IgA present in the plasma of long term non progressors (LTNP). Methods: IgA was purified from plasma from two LTNP, one HIV-infected individual with normal progression and three healthy donors by affinity chromatography. The purified IgA of the LTNP#1 was used to screen a random 6 mer phage displayed peptide library. The sequence of the positive phage clones was determined and their HIV specificity was analysed by ELISA. Results: After three rounds of selections on the purified IgA of LTNP #1, we isolated eight specific phage clones. Sequence analysis of the positive clones revealed eight different peptides. Seven of the eight peptides contained an arginine at the second position. Three other motifs were identified among the sequences i.e. DRAXXX, RRXXXX and XRVGXS. The HIV specificity of the purified phage clones was analysed by ELISA. The phage clones did not react with control proteins (milk and BSA) and the IgA of two healthy donors and a HIV-infected individual with normal progression. At the highest phage concentration tested, a weak reactivity with the IgA of a third healthy control was observed. Seven of the eight phage clones reacted with the IgA of LTNP#1 used for screening but also with the IgA of another LTNP. Conclusions: Seven different peptides specific for the IgA of at least two LTNP were identified. Further analysis of these peptides is required to determine their immunogenic value. MOPEOO33 HIV impairs phagocytic clearance of placental malaria variants: implications for pregnancyassociated malaria in co-infected women J. Keen', K. Ayi2, S. Patel', L. Serghides3, K.C. Kain3. 'Institute of Medical Science, University of Toronto, Toronto, Canada, 2Faculty of Medicine, University of Toronto, Toronto, Canada, 3McLaughlin-Rotman Center, UHN and University of Toronto, Toronto, Canada Background: Millions of women are co-infected with HIV and malaria. Even a small interaction between these two diseases could have profound public health implications. Pregnant women, especially primigravidae, are at high risk XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  43 for pregnancy-associated malaria (PAM). Multigravidae acquire protective immunity against PAM via the generation of IgG specific for novel variant surface antigens (VSA-PAM) expressed by parasitized erythrocytes (PEs) that bind to chondroitin sulfate A (CSA) in the placenta. This protection is lost in the presence of HIV infection, but the underlying mechanisms remain incompletely understood. The objective of this study was to examine the mechanisms of IgG-mediated protection against PAM and the impact of HIV infection on this protective response. We hypothesized that 1) VSA-PAM specific IgG protects against PAM by promoting the opsonic clearance of placental CSA-binding PEs and 2) HIV infection results in the inability to generate or sustain a cytophilic (IgG1 & IgG3) antibody response to placental parasites, rendering the HIV positive (HIV+) multigravid woman susceptible to PAM. Methods: In vitro opsonic phagocytosis assays were performed using the CSAbinding Plasmodium falciparum parasite line CS2 and macrophages, CS2 PEs were opsonized with plasma from HIV negative (HIV-) or HIV+ primigravid and multigravid Kenyan women or sympatric men. Purified IgG subclasses from plasma were also used to opsonize CS2 PEs. Results: Plasma from HIV- multigravid women, but not plasma from primigravid women or men promoted the opsonic phagocytosis of CS2 PEs (p<0.001). Phagocytosis was dependant on the presence of VSA-PAM specific IgG1 and IgG3 cytophilic antibodies. In contrast, plasma from HIV+ multigravid women was unable to promote opsonic phagocytosis of CS2 PEs (HIV- vs. HIV+, p=0.017). Conclusions: HIV infection impairs opsonic phagocytic clearance of placental CSA-binding parasites in multigravid women, representing a novel mechanism by which HIV may increase the susceptibility of multigravid women to pregnancy-associated malaria. MOPEO034 HIV-specific T cell responses in chronic paediatric infection during antiretroviral therapy (continuous and structured treatment interruption) S. Reddy. HIV Pathogenesis Programe - University of Kwa-Zulu Natal, Paediatrics, Pinetown, South Africa Introduction: CD8+ cytotoxic T-lymphocytes (CTL) are important in HIV-1 viral control. Sub-Saharan Africa has the highest number of individuals infected with HIV-1, with limited treatment programmes available. Structured Treatment Interruption (STI) has been successful in acutely infected subjects. Aim: The longitudinal assessment of HIV-1 specific CTL responses in Chronic paediatric infection during continuous HAART and STI. Methods: 28 chronically HIV-1 infected children were enrolled. All received HAART before being randomized into either the continuous or STI arm. The criteria for restarting therapy was a rebound in viral load of 1000 RNA copies/ml. Viral load was estimated using the Roche Amplicor Kit. Screening of HIV-specific CTL responses was undertaken using 410 overlapping peptides spanning the entire C clade consensus genome. Recognition of the peptide within IFN-y ELISpot pool was confirmed using individual overlapping peptides. Results: 20 of 28 HIV-1 infected children reached undetectable viral load levels within 12 weeks on HAART while 8 had decrease in viral load < 60 000 copies/ml. 8 children had the M184V mutation to 3TC. CD8+ Gag specific CTL responses were present in 22/28 children and 14/22 also had Gag specific CD4+ responses. 6/28 had neither Gag specific CD8+ nor CD4+ responses. 7/9 children who harbored resistant virus had detectable Gag specific CD8+ responses. All children including those with resistant virus are clinically well. During continuous HAART, HIV-1 specific responses waned over time but 1-3 immunodominant HLA epitopes were detectable up to 96 weeks. During the first STI, there was broadening of immune responses which did not occur in the subsequent interruptions although certain HLA restricted responses were monitored for up to 96 weeks. Conclusions: HIV-1 specific CD8+ and/or CD4+ T cell responses is not associated with improved clinical outcome or with viral containment irrespective of treatment structure. MOPEO035 Memory HIV-specific CD8+ T cell responses and correlations with clinical status in a Kenyan cohort L. McKinnon', B. Ball', C. Wachihi2, E. Irungu2, M. Luo1, R. Kaul', K. Fowke', F. Plummer'. 'University of Manitoba, Medical Microbiology, Winnipeg, Canada, 'University of Nairobi, Medical Microbiology, Nairobi, Kenya, 'University of Toronto, Clinical Infectious Disease, Toronto, Canada Background: Rationale vaccine design requires a clear understanding of the correlates of protective immunity, and methods through which these correlates can be induced. While HIV-specific CD8+ T cell responses are capable of containing viral replication in some contexts, several studies find functionally defective cells in chronic infection and no correlations between these responses and either viral load or CD4 counts. A better understanding of other phenotypes of CD8+ T cells and disease progression is needed. Methods: An epitope mapping study using an HIV Env overlapping peptide library identified a number of commonly recognized epitopes in a cohort of Kenyan commercial sex workers (N=95). We compared overnight IFN-g responses and longer term cfse-based proliferative responses to a panel of commonly recognized, conserved, HLA-diverse, optimal length CD8 epitppes, and correlated these responses to clinical and HLA genotypic data. Results: Approximately one-third of Env 15mers were found to be immunogenic by Elispot, but substantial responses (>5% of responders) were seen to 12 of these peptides. Frequently recognized peptides tended to be in relatively conserved regions of HIV Env, and restricted by multiple HLA class I alleles. A panel of optimal length, frequently recognized epitopes was then tested in parallel proliferation and Elispot assays. Preliminary analysis indicates a trend for correlation between CD4 count and optimal proliferative response (r2 = 0.422, P = 0.09), while no correlation between optimal IFN-g response and CD4 count was observed (r2 = 0.103, P = 0.69). Conclusions: Several conserved, HLA-diverse Env epitopes were found to be immunogenic in this cohort. Epitope mapping by proliferation versus IFN-g as an immunological readout suggests there are differences between these assays, and that proliferation may be a better predictor of clinical status. Future analyses of CD8+ T cell responses to HIV need to consider the immunological complexity of this response. MOPEO036 Characterizing CTL success and failure in HLA B*57 HIV-1-infected individuals F.J. Ibarrondo', R. Kilpatrick', R. Shih', R. Detels2, C.R. Rinaldo, Jr.3, O.O. Yang', B.D. Jamieson1. 'David Geffen School of Medicine at UCLA, Medicine, Los Angeles, United States, 2UCLA School of Public Health, Los Angeles, United States, 3University of Pittsburgh Graduate School of Public Health, Department of Infectious Diseases and Microbiology, Pittsburgh, United States Background: HIV-1-infected, long-term non-progressors (LTNP) control viral replication, maintain CD4+ T cells >450/mi of blood, and show no clinical symptoms for more than 10 years in the absence of treatment. Specific HLAclass I genes correlate with the rate of disease progression. In some cohorts up to 85% of LTNP are HLA-B*57+ (< 4% in the general population). We hypothesize that the mechanisms that differentiate LTNP from progressors are mediated by CD8+ cytotoxic T-lymphocytes (CTL) early in infection. Methods: We compared the CTL responses of 14 HLA-B57+ men - 7 who progressed to AIDS within 10 years (Progressors) and 7 LTNP. Cryopreserved PBMC obtained soon (<12 months) after infection were assessed for specific HIV-1 CTL responses by IFN-y ELISpot. Results: LTNP and progressors had similar viral load, CD4+ T cell count, and breadth and frequency of CTL responses. CTL responses against HIV-1 peptides containing known HLA-B*57 epitopes predominated in all of the participants. LTNP targeted a significantly higher number of peptides (47 vs. 26), and showed more immunodominant responses (71% vs. 43%) within structural proteins than progressors. Responses to Env were found exclusively within LTNP. 100% of LTNP targeted at least one epitope within integrase, while only 57% of progressors responded to this protein. 86% of the LTNP targeted the peptide containing the p24 IW9 epitope; only 14% of the progressors recognized this peptide. Comparing peptides' Shannon Entropy (index of the sequence variability), we found that LTNP targeted high entropy peptides with significantly higher frequency (68%) than progressors (33%). High entropy peptides were immunodominant in 57% of LTNP and in 14% of Progressors. Conclusions: Our results show that in early infection, HLA-B*57-restricted CTL from LTNP preferentially target high entropy epitopes within structural proteins, integrase and conserved epitopes (e.g., IW9). Our results suggest that differential CTL targeting early in infection confer a protective advantage to LTNP. MOPE0037 Circulating IL-2 and IFN-y producing specific CD4 T cells in HIV(+) individuals with different level of viral control K. Tsalimalma', S. Solakidi', A. Dimitrakopoulou', T. Kordossis2, H. ChoremiPapadopoulou'. "LAIKO' General Hospital, Department of Immunology, Athens, Greece, 2University of Athens, School of Medicine, AIDS Unit, Department of Pathophysiology, Athens, Greece Background: Studies investigating antiviral memory CD4+T cell responses have shown that the combined assessment of IL-2 and IFN-y may distinguish functionally distinct populations of memory CD4+T cells in association with different viral persistence and control conditions. To determine whether control of HIV replication is associated with the frequency of IFN-y, IL-2 or with particular pattern of cytokine secreting CD4+T cells, we evaluated the CD4+T cells producing IFN-y, IL-2 or both in response to HIV-env, HIV-p55gag and CMV-p65 peptide-pools. Methods: Blood samples of 54 HIV-1 and CMV co-infected individuals were assessed including: 5 antiretroviral untreated "controllers" with low level viremia (<10.000 RNA copies /ml), 28 antiretroviral treated "responders", 10 "partial responders" with antiretroviral therapy but low-level viremia, 11 "non controllers" with high level viremia and 6 HIV-1 negative persons with controlled CMV infection. The fraction of cytokine-secreting CD4+Tcells was determined by four colour flow cytometry (FACSCalibur). Results: HIV and CMV specific CD4+T cells were present in most of the HIVinfected patients (81% and 86%). The CMV and HIV-env specific CD4+T cellresponses were not significantly different between the patient groups. Sig nificant differences were observed in HIV-p55gag-specific CD4+T cells. The controllers exhibited higher frequencies of IL-2+IFN-y+CD4T+cells compared to responders (p=0,029), partial responders (p=0,039) and non controllers (p=0,008); higher frequency of total IL-2+CD4+T cells compared to non-controllers (p=0,038) and higher total IFN-y+CD4+T cells compared to responders (p=0,034). The magnitude of HIV specific IL-2+CD4+T cells was negatively correlated to the level of viremia when controllers, partial responders and non controllers were combined (r=0,44; p=0,02). Conclusions: Control of HIV replication in absence of therapy was associated XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  44 Monday 14 August t) tic osterr i with higher percentage of circulating HIV-specific IL-2+IFN-y+CD4+T cells, while full viral suppression under antiretroviral therapy was accompanied with decline of circulating HIV-p55gag specific IFN-y+ and IL-2+IFN-y+ CD4+T cells. High-level viremia was combined with suppression of iIL-2+CD4+T cell response. MOPE0038 Breadth and magnitude of HIV-specific T cell recognition at the acute stage of subtype C infection does not correlate with viraemia M. Mlotshwal, G. Khoury', F. van Loggerenberg2, K. Mlisana2, C. Williamson2, S. Abdool Karim2, C.M. Gray', on behalf of the CAPRISA Acute Infection Study Team. 'National Institute for Communicable Disease, HIV AIDS Immunology Laboratory, Johannesburg, South Africa, 'Centre for AIDS Programme of Research in South Africa, Ne/son R Mandela School of Medicine, Durban, South Africa Background: To date, most studies on HIV-1 infection focus on HIV-1 specific T cell responses in chronic infection and HIV vaccines; there being very limited data examining responses induced in acute infection. We hypothesize that the breadth and magnitude of HIV-specific T cell responses within the first few weeks of primary infection correlates with viral control. Methods: We followed a cohort of 24 acutely subtype C HIV-1 infected subjects for the breadth and magnitude of T cell responses with interferon gamma ELISpot assay using a set of 396 overlapping subtype C peptides. Subjects were followed for the first 0.5-6 months of infection. Results: The median time from infection in this cohort was 6 weeks. Of the detected HIV-specific T cell responses across the genome, 74% of responses recognized epitopes in Nef, 37% in Pol, 36% in Env, 34% in Gag, 29% in Vif, 25% in Vpr, 17% in Rev, 16% in Vpu and 6% in Tat. Overall the highest cumulative magnitude of HIV-specific T cell responses was directed toward the central region of Nef, between amino acids 52 and 171, where the most frequently recognized immunodominant epitopes were RQDILDLWV and RYPLTFGWC. Neither the breadth (1-12 peptides, r=-0.03010, ns) nor the cumulative magnitude (145-21170 spu/106 PBMC, r=0.1618; p=0.0883) of the total HIV-specific T cell responses correlated with plasma viral load or CD4 T cell counts up to week 1-12 of infection. There was also no correlation between preferential targeting of specific regions across the proteome with viraemia. Conclusions: Our data suggest that high magnitude and recognition of multiple epitopic regions is unrelated to early viral control. These data also reflect that Nef immunodominance is established during the acute stage of subtype C infection. MOPE0039 Poor recognition of HIV-1 Nef protein by CD8+ T cells from HIV-1-infected children: impact of age F. Buseyne', D. Scott-Algara2, B. Corre', F. Porrot', E. Monchatre', M. Burgard3, C. Rouzioux3, S. Blanche4, Y. Rivibre'. 'Institut Pasteur, Unite Postulante d'Immunopathologie virale, Paris, France, 2Institut Pasteur, Unite de Biologie des Retrovirus, Paris, France, 3CHU-Necker, Universite Paris V, Laboratoire de virologie, Paris, France, 4H6pital Necker, Federation de Pediatrie, Paris, France Background: The specificity of HIV-specific CD8+ cells may be important for the efficiency of this immune response. Methods: The present work is based on two independent sets of data. First, we used the highly sensitive IFN-g based Elispot assay to define the viral targets of ex vivo activated HIV-specific CD8+ T cells from 51 HIV-infected children during the 1999-2001 period. Secondly, we performed a retrospective analysis of a second set of data, those obtained by 51Cr release assays performed after in vitro expansion of PBMC from 63 HAART naive children. Results: Using the Elispot assay, we report that 80% of patients recognized Gag, 77% recognized Pol, 61% recognized Env, 44% recognized Nef and 29% recognized Vif. No child recognized either Tat or Rev. Frequencies of Gag-, Pol-, and Env- specific IFN-g producing CD8+ T responses were higher than frequencies of Nef and Vif-specific CD8+ T cells. The retrospective analysis of data from HAART naive children using the 51Cr release assay confirmed the low rate of positive CD8 response against Nef protein (25% of positive response versus 44, 63 and 62% for Env, Gag, and Pol, respectively). Memory Gag-specific cytotoxic T lymphocytes were positively correlated with age, whereas Nef-specific CTL were negatively correlated with age. Conclusions: We report a relatively poor Nef-specific CD8+ T cell response in HIV-infected children that contrasts with dominance of Nef-specific responses in infected adults. Our data suggest an early loss of Nef-specific CTL in pediatric HIV infection. MOPE0040 Identification of HIV-1 specific T lymphocyte responses in Highly Exposed Persistently Seronegative (HEPS) Chinese H. Liu', K. Hong', J. Ma2, L. Yuan', Y. Zhang2, Q. Zhao', H. Peng', Y. Ruan', J. Xu', Y. Shao'. 'National Center for AIDS/STD Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing, China, 2Xinjiang Center for Disease Control and Prevention, Urumqi city, China Background: Studies of Highly Exposed Persistently Seronegative (HEPS) individuals may provide valuable information on mechanisms of protection and on vaccine design. Cellular immune responses play a critical role in containing human immunodeficiency virus. However, the cellular immune responses in HEPS individuals have not been thoroughly assessed at the entire viral genome level. Methods: 12 HEPS Chinese with a history of frequent penetrative vaginal intercourse (mean frequency, at least once a week), with some unprotected sexual contact occurring in the weeks or days immediately before enrollment, 25 HIV-1 seropositive individuals, 10 HIV-1-seronegative healthy individuals with low-risk sexual behavior and no history suggestive of exposure to HIV-1 infection were enrolled. HIV-1-specific T cell responses were comprehensively analyzed by an IFN-yElispot assay against 770 overlapping peptides spanning all HIV-1 proteins in the present study. Results: HIV-1-specific T cell responses of interferon-gamma secretion were identified in 7 (58%) out of 12 HEPS individuals, the specific cytotoxic T lymphocytes are targeted at gag (1/5, 20%), pol (4/5, 80%), env (2/5, 40%), nef (1/5, 20%), vif (1/5, 20%) and tat (1/5, 20%). HIV-1-specific T cell responses of interferon-gamma secretion were identified in 20 (80%) out of 25 seropositive intravenous drug users (IDUs), the results revealed that all HIV-1 proteins and protein subunits could serve as targets for HIV-1-specific CD8+ T cell responses with 85% recognizing Gag, 80% recognizing Nef, 75% recognizing Pol, 60% recognizing Env, 55% recognizing Vpu, 45% recognizing Vpr, 20% recognizing Vif, 20% recognizing Tat and 15% recognizing Rev in these seropositive individuals. None of the seronegative healthy individuals gave the positive responses. Conclusions: About half of HEPS Chinese mounted HIV-1 specific T cell immune responses and cell-mediated immunity against HIV-1 may be developed through non-productive infections. MOPE0041 Identification of CD8+ T cell subsets with noncytotoxic anti-HIV activity M.S. Killian, S. Ng, J.A. Levy. University of California San Francisco, Department of Medicine, San Francisco, United States Background: The ability of CD8+ T cells to inhibit HIV replication through noncytotoxic mechanisms has been well described. However, many features of this CD8+ cell response remain unclear. Subset differences and regulatory effects could explain the observed variation in the quality of CD8+ T cell responses between individuals. Our previous investigations of the phenotype of mitogen stimulated CD8+ cells revealed that differential noncytotoxic activity was associated with CD28, HLA-DR, CD11b, and VCAM expression [1;2]. We have also observed that IL-2 is required for optimal noncytotoxic activity. These observations have encouraged further studies of CD8+ cells with particular attention to IL-2 responsive subsets and those with potential regulatory activity. Methods: CD8+ cells, isolated from the PBMC of HIV-1 infected subjects, were separated into phenotypically distinct populations by FACS. Antiviral activity was assessed upon coculturing the CD8+ cell subsets with acutely infected heterologous CD4+ cells. HIV replication levels were determined by the extent of reverse transcriptase (RT) activity present in the cell culture supernatants. Results: Our studies demonstrate that the phenotypes of stimulated and unstimulated CD8+ cells with noncytotoxic activity are very similar. In addition, we have identified novel phenotypes associated with the noncytotoxic antiviral response (Figure 1). Our observations also indicate that other subsets of CD8+ cells (e.g. CD25- cells) may have the ability to negate or regulate this anti-HIV activity. Conclusion: These studies better characterize the relationship between phenotype and the CD8+ T cell noncytotoxic antiviral response, and could offer an understanding of why infected subjects can differ in this important anti-HIV activity. Figure 1. Identification of CD8+ T cell subsets with noncytotoxic anti-HIV activity. Shown are the abilities of various CD8+ cell subsets, separated by FACS, to supress HIV-1 replication in vitro. CD8+ cells from HIV-infected subjects were separated into subsets based on the surface expression patterns of A) CD45RA and CD62L, B) C1.7, C) HLA-DR and CD38, and D) CD122 XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  45 MOPE0042 MOPEOO44 Novel CTL epitopes identified in the EBNA-3A region Tat-specific CD8+ T lymphocytes more effectively from Epstein Barr virus infected individuals living in suppress SIVmac239 replication than those directed Boston and Johannesburg: relevance to global HIV against Nef, Gag, and Env in a functional in vitro vaccine immunogenicity measurements assay Moda NO. Malatsi', G. Alter2, G. Khoury', S. Nyoka', D. Barkhan', A. Masemola', M. Altfeld2, C. Gray'. 'National Institute for Communicable Diseases, HIV Immunology, AIDS Research Unit, Johannesburg, South Africa, 2Massachusetts General Hospital, Harvard Medical School, Partners for AIDS Research, Boston, United States Background: Many immunological studies rely on the use of Cytomegalovirus, Epstein Barr virus and Influenza (CEF) control peptide pool as a quality control for immunogenicity assays, such as the ELISPOT assay and the intracellular cytokine staining (ICS) assay. This study was undertaken to identify CTL epitopes to the EBNA-3A region of the Ag876 EBV isolate that are highly targeted across populations of different HLA backgrounds particularly those who are likely to participate in HIV vaccine clinical trials conducted in Africa, for inclusion as positive control peptides in the current CEF pool. Methods: PBMCs of HIV negative and positive donors from Boston and Johannesburg were screened for responses to pools of EBNA-3A peptides and the CEF pool. Positive responses were confirmed on a subsequent IFN-g ELISPOT assay using single peptides. MHC Class I restrictions of epitopes were identified in the Johannesburg donors from fresh and cultured cell lines using the IFN-g ELISPOT assay and ICS. Results: The frequency of donors responding to EBNA-3A and CEF was relatively high in the Boston donors compared to the Johannesburg donors. The EBNA-3A responses were dispersed across the complete gene region for the Boston donors and targeted the N-terminus for the Johannesburg donors. Collectively, 35 novel epitopes were identified and five novel epitopes namely SRRSQVKWRM, WRMTTLAAGW, LLQSPGRAFA, NPRAPLGDQLand YQAYSSWMYSY identified in the Johannesburg donors were shown to be restricted by B*2705, B*0801, B*1501, B*8101, and A*3002, respectively. Conclusions: No obvious immunodominant regions were recognized and two novel common epitopic regions targeted in both Boston and Johannesburg populations were identified. Newly identified epitopes, restricted by common HLA alleles in the South African population, may account for up to 10% increased CEF pool coverage. Inclusion of these new peptides to the existing CEF pool would contribute to a more relevant positive control in ELISPOT and ICS assays to measure vaccine immunogenicity. MOPE0043 Functional profile and expansion ability of HIV-specific CD8+ T cells in a cohort of long term nonprogressors M. Lopez, V. Soriano, A. Cascarejo, S. Lozano, J. Gonzalez-laHoz, J.M. Benito. Hospital Carlos III, Laboratorio de Biologia Molecular, Madrid, Spain Background: A small proportion of HIV - subjects is able to control virus replication and halt disease progression. A higher and/or better HIV-specific immune response in this subset of patients is believed to contribute to their favourable outcome. However, it is not well understood what characteristics of HIV-specific immune response better correlate with protection. Methods: 50 HIV+ subjects were examined in a case-control study. 25 belonged to a cohort of well-characterized long-term-nonprogressors (LTNP). The remaining 25 were HIV-progressors naive for HAART. Three functions of CD8+ T cells (production of MIP1I3, IL2 and TNFa) were simultaneously examined in response to PMA, HIV-Gag and Nef peptide-pools using multiparameter-flowcytometry. The ability of HIV-specific CD8+ T cells to expand was measured after a 10-day culture in the presence of HIV-peptides. Differences between both groups for the different variables were evaluated using non-parametric tests. Results: In response to PMA, CD8+ T cells from LTNP produced higher levels of IL2 (9.5% vs. 6.3%, p=0.01) and had higher contribution to the total response of cells producing two or more cytokines than progressors (46% vs. 37%, p=0.02). The level and contribution of the seven functional subsets in response to HIV-Gag and Nef peptide-pools were similar in both groups. The subset of CD8+ T cells producing only MIP1p was the most frequently recognized in response to Gag and Nef in both groups (0.97% vs. 0.83% for Gag and 0.37% vs. 0.28% for Nef, respectively). The proportion of patients showing a positiveexpansion of CD8+ T cells producing only MIPIb tended to be higher in LTNP than progressors (82% vs. 50%, p=0.07). Conclusions: The functional profile of HIV-Gag and Nef-specific CD8+ T cells is similar in LTNP and HIV-progressors. However, a greater ability of HIV-specific CD8+ T cells to expand in culture in LTNP could explain the more favourable outcome of this group. J. Loffredo, B. Burwitz, E. Rakasz, S. Spencer, J. Stephany, A. Bean, J.P. Giraldo-Vela, S. Martin, S. Piaskowski, J. Furlott, K. Weisgrau, G. Napoe, N. Wilson, D. Watkins. University of Wisconsin-Madison, Wisconsin National Primate Research Center and Department of Pathology and Laboratory Medicine, Madison, United States Background: CD8+ T lymphocytes play an influential role in controlling HIV replication. However, it remains unclear as to which of the many epitopespecific CD8+ T lymphocyte populations contribute to this control. Standard immunological assays do not directly measure the antiviral efficacy of CD8+ T lymphocytes. Therefore, we developed a functional in vitro assay to assess the ability of epitope-specific CD8+ T lymphocytes to control SIV replication. Using this assay, we compared the antiviral efficacy of six SIV-specific CD8+ T lymphocyte populations directed against epitopes in Tat, Nef, Gag, and Env. Methods: To measure viral suppression, we infected peripheral blood mononuclear cells depleted of CD8+ cells with SIVmac239. These target cells were co-cultured with in vitro stimulated, epitope-specific CD8+ T cell lines for eight days at effector:target (E:T) ratios of 1:10 and 1:20. Viral infection was monitored using quantitative PCR and Gag p27 intracellular staining. Results: Suppression of SIV replication varied depending on the specificity of the CD8+ T lymphocytes. Tat28-35SL8-specific CD8+ T-lymphocytes were superior at suppressing viral replication. Adding Tat-specific CD8+ T lymphocytes at an E:T of 1:10 markedly reduced viral replication at least 10 -fold as measured by both quantitative PCR and Gag p27 staining. Epitopespecific CD8+ T lymphocytes against proteins expressed late in the viral life cycle, Gag and Env, suppressed SIV replication to a lesser extent, typically 2- to 5-fold. However, SIV-specific CD8+ T lymphocytes recognizing a region of another early protein, Nefl59-167YY9, suppressed viral replication minimally. Conclusions: Our findings suggest that certain epitope-specific CD8+ T lymphocytes are better than others at suppressing viral replication. Interestingly, not all CD8+ T lymphocytes directed against early proteins effectively suppressed SIV replication, contrasting with previous findings. Differences in CD8+ T lymphocyte antiviral efficacy, in conjunction with viral variation, are crucial when considering epitopes to include in HIV vaccines. Track B MOPE0045 Predictive value of plasma HIV RNA levels measured at 6 weeks among in-utero and intrapartum infected Zimbabwean infants on mortality at 6 and 12 months K. Mutasal, R. Ntozini', S. Rukobol, R. Simbi', L. Moulton2, P. Iliff', J. Humphrey2, ZVITAMBO Study Group. 1ZVITAMBO Project, Harare, Zimbabwe, 2Johns Hopkins Bloomberg School of Public Health, International Health, Baltimore, Maryland, United States Background: Data regarding the prognostic value of plasma HIV RNA levels in African infants are scarce. Methods: As part of the ZVITAMBO trial, we measured plasma HIV RNA levels at 6 weeks of age in 141 in-utero infected infants (IU, defined as HIV-1 DNA PCR positive <96 hours of birth) and 269 intrapartum infected infants (IP, defined as HIV-1 DNA PCR negative at birth and positive at 6 weeks). Infants were followed up to 12 months for vital status. Univariate and multivariate Cox models were used to investigate the predictive value of 6-week HIV RNA levels on mortality by 6 months, by 12 months, and between 6 and 12 months. Results: The risk of death between 6 weeks and 6 months increased 1.81 (95%CI: 1.43-2.28) times with each additional 1-log10 of plasma HIV RNA measured at 6 weeks. In the fully adjusted model, infant sex, timing of infection, and birth weight, and maternal CD4 at delivery were also independent predictors of mortality by 6 months, and the HR associated with HIV RNA level remained unchanged [HR=1.82 (95%CI: 1.43-2.31)]. The risk of death between 6 weeks and 12 months increased 1.79 (95%CI: 1.45-2.22) times with each additional 1-log10 of plasma HIV RNA measured at 6 weeks. After adjusting for the same covariates, the associated risk remained unchanged [HR=1.83 (95%CI: 1.49 -2.26)]. Among infants who survived to 6 months, plasma HIV RNA measured at 6 weeks was the only factor assessed that significantly predicted mortality by 12 months (HR=1.71 95%CI: 1.13-2.58) Conclusions: HIV-positive infants who have high plasma HIV RNA levels at 6 weeks are at risk of early death and should be targeted for intervention. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  46 MOPEO046 Proteinuria, hematuria and creatinine clearance in Rwandan women with and without HIV infection J.S. Mugabol, J. Lu2, A. Binagwaho3, M. Cohen4, L. Munyakazis, F. Ndamage', A.-C. d'Adesky6, A.-C. d"Adesky6, L. Szczech'. 'Treatment and research in AIDS Center, Ministry of Health, Kigali, Rwanda, 2Data Solutions, Bronx, United States, 3Executive Secretary of the Commission to combat AIDS, Kigali, Rwanda, 4Cook County Hospital, Chicago, United States, 5National Bureau of Statistics, Kigali, Rwanda, 6WE-ACTx, San Francisco, United States, 7Duke University School of Medicine, Durham, United States Background: The prevalence of proteinuria among HIV-infected US women varies between 10 and 30% is highly dependent on racial demographics. There are currently no estimates of prevalence of proteinuria or kidney dysfunction in other countries. Because of the high rate of HIV-infection in Rwanda and the correlation of kidney disease with poorer outcomes, this study was undertaken to assess the prevalence of renal disease among Rwandan women with HIVinfection. Methods: The Rwandan Women's Interassociation Study and Assessment (RWISA) is an observational cohort of HIV-infected and uninfected women. Among the HIV-infected women, 515 were enrolled just prior to initiating ARVs as recommended by their physicians, and 250 had CD4 >200 and no indication for treatment. The 983 women were enrolled using a structured interview, physical exam, and collection of specimens. Serum creatinine was measured, and urine protein and blood assessed by dipstick. Comparisons of means were performed by ANOVA or Wilcoxon rank test. Results: 740 women were HIV-infected and 227 uninfected. No women were taking ARVs. While the prevalence of both proteinuria and hematuria increased with decreasing CD4 count, the prevalence of both parameters in the group without infection was also elevated. The odds of having hematuria were higher among women with proteinuria (OR=2.53, p=0.006). All groups demonstrated mild kidney disease, with HIV-infected women, particularly with lower CD4 counts, having the lowest mean. HIV-negative CD4 >=350 CD4 200-349 CD4< 200 p-value Proteinuria 6.87% 6.12% 8.27% 12.55% 0.09 Hematuria 4.58% 7.65% 8.65% 9.96% 0.33 Creatinine clearance 83.1 78.1 80.5 72.2 0.03 Conclusions: A significant proportion of women in Rwanda have proteinuria and hematuria particularly among those with HIV-infection. Similarly, while kidney function appears to be decreased among all, it is accentuated among those with HIV-infection and lower CD4 counts. These findings suggest significant subclinical renal disease in HIV positive Rwandan women. MOPEO047 Prevalence, etiology and stage of liver cirrhosis assessed by elastography in HIV-infected patients C. Castellares, P. Barreiro, L. Martin-Carbonero, A. Ruiz-Sancho, R. Galindo, L. Casado, M. Nufiez, J. Gonzalez-Lahoz, V. Soriano. Hospital Carlos III, Service of Infectious Diseases, Madrid, Spain Introduction: Non-invasive tools for the assessment of liver fibrosis, either using biochemical serum markers (Fibrotest) or transient elastography (FibroScan) have attracted much attention in recent years. They are replacing liver biopsy to assess hepatic fibrosis in most situations, particularly for the management of chronic viral hepatitis B and C. Methods: Clinical and laboratory data were analyzed in 986 HIV+ patients examined so far at our institution with FibroScan. Those with liver stiffness above 12.5 KPa (Metavir score F4) were identified. Previous studies have shown that values above this threshold correlate well with Metavir score F4 in a paired liver biopsy (sensitivity 0.87, specificity 0.97). Results: A total of 130 HIV+ patients had F4 estimates using FibroScan (prevalence of 13%). Mean age was 43 years, 76% were male; 88% were HCV+, 4% HBV+; and 38% alcohol abuse. The mean liver stiffness using elastography was 25.7 KPa. Overall, 83% of patients had F3-F4 estimates using the Forns index. Mean laboratory parameters were: ALT 81 IU/I, bilirubin 1.4 mg/dl, albumin 3.55 g/dl, prothrombin 81%, platelets 143,126/pI, CD4 516 cells/l, HIV-RNA 0.88 log copies/ml. The distribution of patients according to Child-Pugh score was: A 84%, B 14% and C 2%. Signs of ESLD were present in 24% of patients: ascites 9%, encephalopathy 6%, esophageal varices 16%, variceal bleeding 5%, portal hypertension 14%, splenomegaly 60%. In the remaining 76% of patients with F4 clinical manifestations of decompensated cirrhosis were absent. The mean liver stiffness was significantly different according to the Child-Pugh score (A: 21.5 KPa, B: 41.2 KPa, and C: 44.7 KPa). Conclusions: Transient elastography is an useful non-invasive tool of liver fibrosis assessment. It may allow to recognise easily subclinical cirrhosis and to design appropriate therapeutic strategies in this population, such as treatment interventions, variceal bleeding prophylaxis and screening of hepatocellular carcinoma. MOPEso48 Expression of CD95 high increase in CD4+ T cells and decrease in CD8+ T cells in HIV-1-infected patients E.E. Escobar Guevara', A. Monzon de Orozco2. 'Laboratorio Bio Cell 220 C.A., Flow Cytometry, Caracas, Venezuela, 2Instituto de Oncologia y Hematologia, Universidad Central de Venezuela, Inmunologia, Caracas, Venezuela Background: To study changes in expression of CD95 High in T cells in HIV-1 infection, in naive and HAART patients. Methods: Flow cytometry determinations of expression of CD95 high (Dim considered as negative) in peripheral blood T cells from 22 naive and 48 HAART (Lamivudin, Stavudin and a combination of lopinavir and ritonavir) HIV-1 infected patients and 15 non HIV-1 infected controls. Results: Expression of CD95 high in CD4+ T lymphocytes was greater in naive patients than in controls (U-Mann- Whitney, p=0.0139), it was greater in AIDS (C1, C2, C3; CDC, Atlanta) than in asymptomatic (Al, A2) patients (p=0.0008), it had a negative statistically significant correlation with percentage and absolute counts of CD4+ T cells (Spearman, r=-0.7119 and r=-0.6266) and a positive statistically significant correlation with viral load (r=0.4992). In CD8+ T lymphocytes, expression of CD95 high was lower in HAART patients than in naive and control (p<0.0001, p=0.0194). It's worthy to mention that in HAART patients absolute counts of CD8+ T Cells was greater than in control and naive (p<0.0001, p=0.0002). Conclusions: Expression of CD95 had been related with progression to disease in HIV infection, expression of CD95 high reflect a higher density of CD95 molecules in cell membrane and a greater susceptibility to suffer apoptosis. Considering as positive only high expression of CD95, we founded, as expected, in CD4+ T cells, relationship with decrease of this population, high viral load and AIDS. In CD8+ T cells, it was peculiar our founding of decrease of expression CD95 high in HAART patients with the increase of this CD8+ population. Other studies, that considered as positive total CD95 expression (Dim and High), don't detect this decrease. We recommend the use of CD95 high and no total expression in studies staging disease. MOPEO049 Estimated prevalence of liver fibrosis in HCV monoinfected and HCV/HIV co-infected patients according to APRI and other clinical indexes A. Sanvisens, K. Langohr, I. Serra, J. Tor, C. Tural, G. Sirera, D. Fuster, C. Rey-Joly, R. Muga. Hospital Universitari Germans Trias i Pujol, Internal Medicine, Badalona, Spain Background: Liver fibrosis is the main predictor of the progression of chronic hepatitis C. The aim of study was to estimate the prevalence of fibrosis using known clinical indexes (APRI/POHL/FORNS/FIB-4) in assymptomatic HCVmonoinfected, HCV/HIV co-infected and HCV/HBsAg/HIV tri-infected injecting drug users (IDUs) seeking substance abuse treatment. Methods: Patients were recruited between Jan. 1994-Jun 2005 in a detoxification unit. Blood samples for liver function tests and serologies were collected at admission; sociodemographic and drug use characteristics were obtained through clinical records and questionnaires. Results: 486 (83% M, 17%) out of 552 HCV + individuals were elegible. Age at admission was 30 yrs (median) (IQR 27-34); median duration of IDU was 10yrs (IQR5.6-15); alcohol intake >40gr in 33.6% of cases; prevalence of HIV and HBsSAg was 54.6% (263/482) and 6.4% (29/451) respectively; current ART use among HIV+ patients in 35% of them. Median AST: 36 U/I, ALT: 46.5 U/I, GGT: 38 U/I, platelets 180.000, total cholesterol 155 mg/dl. The majority of patients (62%) were HCV-genotype I; prevalence of HCV-RNA > 850.000 UI/I was 35,4 %. Prevalence of liver fibrosis according to 4 clinical indexes is shown in the table: APRI POHL Score Forns FIB-4 HCV (n=202) HCV/HIV (n=218) HCV/HIV/HBV (n=19) 14.5 22.6 2.0 1.0 1.0 18.0 14.4 12.0 26.3 21.1 47.4 52.6 Conclusions: in settings other than HIV/Aids units prevalence of liver fibrosis by APRI is relatively high and suggest that clinical care, assessment of liver fibrosis and treatment of chronic hepatitis C and/or B should be emphasized in UDIs seeking substance abuse treatment. Sponsorship: This work was partially supported by grants Fundacio La Marat6 de TV3 02/1330, FIS G03/005, FIS PI05/1550 and FIS PI05/1364 MOPEO050 Studies on HIV+ discordant couples in Nairobi, Kenya M. Patel', B. Dunbar2, M. Otsyula3, S. Patel4. 'African Biomedical Centre, Nairobi, Kenya, 2African Biomedical Centre & Adjunct Professor, Baylor College of Medicine, Nairobi, Kenya, 3Institute of Primate Research & African Biomedical Centre, Head of Virology, Nairobi, Kenya, 4M. P. Shah Hospital & African Biomedical Centre, HIV/AIDS Clincial Research Program, Nairobi, Kenya Issues: There are approximately 1.1 million HIV+ adults in Kenya (Ministry Of Health, 2005). The greater availability and use of antiretroviral drugs and other lifestyle changes is increasing the lifespan of infected individuals. In order to evaluate these factors, we have identified a cohort of HIV+ Discordant Couples (DCs) whose HIV- partners have not been infected despite sexual activity. Description: Fourteen DCs composed of 7 HIV+ Asian male partners and 7 HIV+ African partners (4 males and 3 females) were identified. From patient interviews, it was found that none of the couples used protection during intercourse on a regular basis. Ten (71%) of the DC had been HIV+ for more than 5 years (overall median infection time of 6.9 years). Among the HIV+ partners, 8 had elevated CD8 cell levels at one point during the study. Eleven XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  47 persistently had below normal CD4+ counts (median African male = 280 cells/ pL, median African female = 95.5 cells/pL). Three HIV+ individuals progressed from Clinical stage 1 to stage 2 (WHO HIV/AIDS Staging System). All others are Clinical stage 1. To date, none of the HIV- partners have seroconverted. Two of the couples elected to have a child and, through counseling both children were born HIV-. Lessons learned: These studies show there are cohorts of HIV+ individuals who survive for many years with minimal clinical symptoms. The survivors are also in relationships with partners who do not become infected despite having unprotected sex. The ethnic or genetic background, social and financial status of the couples may influence disease progression and infectivity. Recommendations: It will be important to continue following these patients who have been HIV+ for many years and to evaluate the clinical and immunological factors to determine which might be associated with lack of viral transmission to their non-infected partners. MOPEOO51 Correlation of autonomic variables with CD4 counts in HIV positive patients A. Sakhuja', A. Goyal', A.K. Jaryal2, N. Wig', M. Vajpayee3, K.K. Deepak2. IAIIMS, Medicine, New Delhi, India, 2AIIMS, Physiology, New Delhi, India, 3AIIMS, Microbiology, New Delhi, India Background: In our earlier report, HIV patients were found to have reduction in both components of Heart rate variability (HRV) with relative sympathetic predominance. We evaluated two specific questions in present study in HIV patients who acquired HIV through heterosexual contact -1) Does autonomic activity and reactivity correlate with CD4 counts? 2) Do autonomic symptoms have any correlation with lab tested autonomic parameters and CD4 counts? Methods: A case control study was designed in a tertiary care hospital. We used a battery of 5 autonomic function tests (AFTs) - LST (Lying to Standing Test), DBT (Deep Breathing Test), HGT (Hand Grip Test), CPT (Cold Pressor test) and CFT (Cold Facial Test). We performed Time Domain, Frequency Domain and Poincare Analysis of variables of HRV in both patients and controls. History of autonomic symptoms was taken. Results: 30 patients (age- 36.20+6.85 yr, 16.7% females, CD4- 346.57+238.43 /pL) and controls participated in the study. The diastolic BP responses in HGT and CPT were significantly lower in HIV positive patients when compared with controls (p < 0.001 in both the tests). SD2 and variance were also significantly lower (p < 0.048, p < 0.048) in patients as compared to controls. Autonomic dysfunction was found in HIV positive patients and the severity of dysfunction directly correlated with CD4 counts (p < 0.050 with most variables). We found that in patients with higher CD4 counts only sympathetic reactivity was deranged in contrast with those with lower CD4 counts in whom global reduction in both autonomic tone and reactivity was seen. The autonomic symptoms did not show any significant correlation with any of the autonomic variables or CD4 counts. Conclusions: The severity of autonomic dysfunction is correlated with CD4 counts. It appears that laboratory evidence of autonomic dysfunctions manifests before clinical symptoms. MOPEOO52 HIV in African Americans diagnosed over 50 years of age at an inner city teaching hospital J. Gajjala, F. Farhat, V. Mody. Howard University Hospital, Internal Medicine, Washington DC, United States Background: The prevalence of HIV infection in people over the age of 50 years is growing because of increased longevity due to HAART. Data regarding the impact of age on HIV progression have been conflicting. Trials involving older patients are needed to evaluate the efficacy of treatment in this population, as measured by virologic suppression, CD4 cell count response and HIV disease progression. The aim of our study is to compare risk factors, HIV progression and compliance to the treatment between patients diagnosed with HIV after 50 years of age and before 50 years of age. Methods: A retrospective chart review was done in HIV clinic from 1999 to 2004. Twenty seven patients with HIV diagnosed after 50 years of age (older group) were identified. Twenty seven patients with HIV diagnosed below 50 years of age (younger group) were randomly selected. Risk factors, CD4 counts and compliance to the treatment were compared between the two groups over a 2-year period. Results: In older group, mean age was 55.74 years (range: 50-77) and 34.37 years (range: 18-49) in younger group. There were 4 intravenous drug users in each group and 4 were homosexual in younger versus 1 in elder. 18 patients were compliant to treatment in older group versus 13 patients in younger group (p=0.16). Mean CD4 counts at initial visit, 1st and 2nd follow up years were 465, 597 and 571 respectively in older versus 260, 330 and 299 respectively in younger (p=0.13, 0.07 and 0.03 respectively). Conclusions: African Americans with HIV diagnosed after 50 years of age tend to be more compliant with treatment and maintain higher CD4 counts at follow up visits compared to the younger patients. Risk factors are comparable in both groups except homosexuality. Younger patients need aggressive counseling regarding risk factors and compliance. MOPEO053 M. tuberculosis disease in HIV-infected patients in HAART era J. Guardiola, L. Matas, A. Mauri, S. Herrera, M. Mateo, J. Cadafalch, M.A. Sambeat, M. Fuster, P. Domingo. Sant Pau Hospital, Internal Medicine, Barcelona, Spain Background: The incidence and prevalence of M. tuberculosis in HIV-infected patients remains variable. The aim of this study was to evaluate the presence of M. tuberculosis diseases during the HAART era in our HIV populaion. Methods: We retrospectively studied all HIV-AIDS records from 1997-2004 at a teaching-urban hospital in Barcelona (Spain). All positive microbiologic cultures of M. tuberculosis from our data-base and medical records from 1997 to 2004 were reviewed. Results: We analyzed 1502 HIV-infected patients. During this period, a total of 623 (41 %) patients showed one or more microbiologically documented infections. A total of 71 /1502 (4.7%) patients showed one or more positive cultures of M. tuberculosis, with 132 positive microbiological samples (30 patients had more than one site infection), representing 11% of total prevalence of documented infections during this period (71/623). 68.8% were men. Mean age was 40 + 9 (range: 18-79). 89 % of patients were on highlyactive antiretroviral therapy. The most frequent samples isolates were: sputum 63 samples, bronchial lavage 18 samples, urine 12 samples, adenopathy 12 samples, and hemoculture 11 samples. 31/71 (43%) patients showed disseminated infection. Conclusions: 1. Almost 5% of patients had a M. Tuberculosis infection. 2. M. Tuberculosis constituted 11% of all infections. 3. Respiratory tract infections were the most prevalent site of infection 4. 43% patients showed disseminated infection. MOPEOO54 HIV-associated renal impairment in children: clinical and virologic features T.M. Nishimotol, J. Filgueiras Medeiros', L.A. Silva2, F. Merlos', P.C. Koch-Nogueiral. 'Curso de Cidncias Medicas do Centro Universitario Luisiada - UNILUS, Pediatrics, Santos, Brazil, 2Secretaria de Saude do Estado de Sao Paulo - Hospital Guilherme Alvaro, Laboratory Analysis, Santos, Brazil Background: Renal injury in HIV-positive patients encompasses a clinical spectrum with varying degrees of severity. The aim of the present study was to describe the frequency and clinical picture of renal impairment in HIV-positive children. Methods: We performed a transversal study on a case series of 65 children and adolescents (mean age=9.2+3.9 years, 33 girls/32 boys) diagnosed with HIV and/or AIDS infection. Results: There were no urinary complaints or changes at physical examination, except an increase in blood pressure in some children. We classified 20/65 patients (31%) as having renal impairment, where 12 of these had clinical microalbuminuria, 6 had increased blood pressure, 4 proteinuria, 2 hematuria, and 1 with reduced glomerular filtration rate. Three patients presented two concomitant alterations (2 had proteinuria + microalbuminuria, and 1 presented hypertension + microalbuminuria) and 1 presented three concomitant alterations (hypertension + hematuria + proteinuria). Out of the patients with renal impairment, 11/20 (55%) were on antiretroviral treatment whilst 09/20 (45%) were not. When we grouped the patients according to the occurrence of renal abnormalities, microalbuminuria (168+56 versus 688+1196 mg/mmol) and log of viral load (2.4+1.9 versus 3.8+1.6) were both significantly greater in the group of renal patients. We propose the hypothesis that greater viral load translates to greater risk of renal injury. Conclusions: Our data suggests the possibility of renal impairment with symptomatic paucity in a large number of patients. The impact of this change on renal function in such patients over the long term has yet to be ascertained and warrants further investigative study. MOPEOOS5 Predictors of anemia type and relationship to mortality S.L. Fultz', K.A. McGinnis2, N. Berliner', T.P. Duffy', A.A. Butt2, D. Rimland', M.C. Rodriguez-Barradass, R. Peck6, R.S. Braithwaite', S. Brown', M. Goetz', L. Mole9, K. Bryant"o, A.C. Justice'. 'Yale University and VA Connecticut Healthcare System, Internal Medicine, West Haven CT, United States, 'University of Pittsburgh and VA Pittsburgh Healthcare System, Pittsburgh PA, United States, 'Yale University, Internal Medicine, New Haven CT, United States, 4VA Medical Center and Emory University, Atlanta GA, United States, sMichael E. DeBakey VAMC and Baylor College of Medicine, Houston TX, United States, 'Washington VA Medical Center and George Washington University School of Medicine, Washington DC, United States, 'James J. Peters VAMC and Mt. Sinai School of Medicine, New York NY, United States, 8VA Greater Los Angeles Healthcare System and UCLA School of Medicine, Los Angeles CA, United States, 9VA Palo Alto Healthcare System, Center for Quality Management in Public Health, Palo Alto CA, United States, "oNational Institutes of Health, National Institute of Alcohol Abuse and Alcoholism, Bethesda MD, United States Background: Anemia is a predictor of mortality, but the impact by type of anemia has not been fully studied. We determine the relationship of anemia XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  48 Monday 14 August Poster Exhibition type to mortality and examine associated factors in subjects presenting for HIV care at VA clinics from 10/97 to 12/02. Methods: Using centralized VA records, the blood count closest to first HIV care episode was identified for 6825 HIV-infected men. Anemia was defined as hemoglobin <13g/dl with anemia type based on mean corpuscular volume. Cox proportional hazards models were used to examine relationship of anemia type with mortality, adjusting for demographics and clinical factors. Multinomial logistic regression was used to determine the factors associated with anemia type. Results: Anemia was present in 2375 (35%), with 11% microcytic, 74% normocytic, and 15% macrocytic. At baseline, median CD4 and viral load were 265 cells/mm3 and 22,600 copies/ml, and 14% had received HAART in the prior 90 days. Median follow-up was 3.5 years. While microcytic anemia (Hazard Ratio [HR] 1.5, 95%CI 1.2-2.0), and normocytic anemia (HR 1.6, 95%CI 1.4 -1.8) were significantly associated with mortality, macrocytic anemia (HR 2.5, 95%CI 2.0-3.1) had a larger impact. In decreasing order of magnitude, age, CD4, hepatitis C, viral load, alcohol abuse and hepatitis B were associated with mortality. In a separate model also including zidovudine, the impact of anemia was unchanged. Baseline presence of macrocytic anemia was significantly associated with (by decreasing strength of association) CD4, age, viral load, zidovudine, black race, and hepatitis C. Only 40 (11%) of the 357 subjects with macrocytic anemia received zidovudine. In subjects with anemia, 58% had basic anemia work-up labs performed. Conclusions: Macrocytic anemia was independently predictive of a 2.5-fold risk of death, while microcytic and normocytic anemia were associated with 1.5-fold increase. Clinical and demographic factors predicted macrocytic anemia. MOPEOO56 Evaluating the prognostic value of the new WHO pediatric clinical staging system in a cohort of untreated HIV-infected children in Belo Horizonte, Brazil C.A.A. Cardoso, A.G. Dantas, A.C.M. Dias, Q.C. Lisboa, R.M. Linhares, I.R. Carvalho, T.M.S. Candiani, J.A. Pinto. Federal University of Minas Gerais, Maternal and Pediatric AIDS Group, Belo Horizonte, Brazil Background: In November 2005, WHO published a provisional pediatric clinical staging system intended to assist clinical care providers in determining when to start, stop or substitute ARV therapy in HIV-infected children as well as to serve as a HIV/AIDS surveillance tool in resource limited settings. This study aimed to evaluate the prognostic value of WHO clinical staging system in a cohort of untreated HIV-infected children in Belo Horizonte, Brazil. Methods: Historic observational cohort of untreated children admitted at a referral center from 1989 to 2003. WHO stages 1 to 4 were evaluated for the risk to disease progression, defined as: HAART initiation or CDC/1994 category C condition or death. Results: 262 subjects were evaluable for this analysis, 51.1% males, median age at admission 24.4 months. The median follow up period was 11.9 months. At the end of observational period (December/2003), 220 (84%) subjects remained in follow up, 13 (5%) died, 26 (9.9%) were lost to follow up and 3 (1.1%) were transferred to another clinic. In Kaplan Meier univariate analysis, subjects presenting with stage 1 conditions were significantly less likely to present disease progression (log rank: 12.01, p=0.0005) and subjects in stages 3 and 4 were at significantly higher risk for progression (p=0.007 and <0.00001, respectively). In multivariate analysis by Cox proportional hazards, relative risks for disease progression were 0.52 (95% CI: 0.38-0.72), 1.46 (95% CI: 1.07-2.00) and 1.94 (95% CI: 1.20-3.16) for stages 1, 3 and 4, respectively. Stage 2 was neutral in predicting the risk for progression (log rank 2.45, p=0.12). Conclusions: Stage 1 was protective for risk of disease progression and stages 3 and 4 were good predictors of risk of progression in this cohort of untreated Brazilian children. These findings support WHO proposition to start ARV treatment for children in stages 3 and 4. MOPEOO57 Long-term follow-up of HIV-1+ treatment naive patients undergoing HAART S. Magaev', M. Nikolova', A. Michova', D. Beshkov2, K. Kostov', H. Taskov'. 'National Center of Infectious and Parasitic Diseases, Central Laboratory of Immunology, Sofia, Bulgaria, 'National Center of Infectious and Parasitic Diseases, National Reference Laboratory of HIV Virology, Sofia, Bulgaria, 'Hospital of Infectious Diseases, Sofia, Bulgaria Background: In a previous study we examined the recovery dynamics of COB T cell subsets in HIV-I+ patients subjected to HAART for 24 months. Three types of therapy response (immunological and virological) were established, based on CD8 differentiation markers, CD4AC, VL and immune activation. Now we extended our observations up to 48 months of HAART in order to check the consistency of therapy response type in each patient group. Methods: Fifty-two treatment-naive HIV-I+ patients receiving HAART (2 NRTI, 1 PI) were followed for 48 months (at baseline and every 3 months thereafter). At 24 months the study subjects were retrospectively divided in three groups: A (good immunological and virological response: n=28, log VL_2.7, ACD4AC_150 cells/ii); B (transient response, n=9, log VL>2.7, ACD4AC<_150 cells/pi) and C (discordant response, n=15, VL>2.7 log RNA copies/ml, ACD4AC_150 cells/ l). CD4AC and percentage, and the quantitative expression of CD38 on CD8 T cells were determined by multicolor flow cytometry, HIV-1 RNA plasma levels - by RT-PCR. Significant differences between groups were determined by KruskalWallis ANOVA. Results: In the majority of patients the therapy response pattern, defined at the end of the second year, was preserved during the 24 months of follow-up. Good responders marked a significant increase of CD4AC (p<0.01), while the levels of CD38 and VL were similar to those at 24th month. In the transient responders group all parameters of the immunological response remained steady, while VL significantly increased (p<0.01). Importantly, in the end of follow-up the discordant responders were characterized by a significantly lower CD4AC as compared to good responders (p<0.05), in contrast to the 24th month when both groups had similar CD4AC. Conclusions: A discordant immunological and virological response may not be beneficial in the long-term, underlining the importance of the early and precise definition of the therapy response in HIV+ patients subjected to HAART. MOPEO058 Declining CD4+ cell counts during suppressed or low level viremia A.M.L. Anderson', AS. Kosinski2, J.A. Bartlett'. 'Duke University, Department of Medicine, Durham, United States, 2Duke University, Department of Biostatistics and Bioinformatics, Durham, United States Background: Observations on declining CD4+ cell counts in HIV-infected patients with suppressed or low level viremia have been described previously. Our aim was to identify the prevalence and predictors of this phenomenon in a clinic cohort. Methods: We queried the Duke University Adult Infectious Diseases Clinic database (N= 3949). Criteria for declining CD4+ cell counts ("case") included: 1)Decline in absolute CD4+ count of _10% relative to the previous value on >_2 consecutive timepoints OR 2)Absolute decline in CD4+ percent of _3% relative to the previous value on _2 consecutive timepoints. Two controls were matched for each case by age, sex, year, and absolute CD4+ cell count. All subjects had plasma HIV RNA levels of <1000 copies/ml. Results: 41 cases were identified, representing a prevalence of 1.04% in our population. Few cases (7/41 or 17.1%) or controls (9/82 or 11%) had plasma HIV RNA levels >500 copies/ml at any timepoint during the decline. Univariable regression showed that hepatitis C antibody status, race (Caucasian compared with African-American), and plasma HIV RNA >500 copies/ml on _1 timepoint were not independently associated with decline. By univariable regression, we were not able to detect an association between decline and these medications: didanosine, (odds ratio [OR] 0.667, 95%CI 0.135-3.303); zidovudine, (OR 1.5, 95%CI 0.701-3.209); or stavudine, (OR 1.842, 95%CI 0.832-4.078). None of our cases and three controls were taking the didanosine/tenofovir combination, which has been associated with decline. Conclusions: Declining CD4+ cell count in the setting of low plasma HIV RNA levels is relatively rare in our population. The vast majority of cases had plasma HIV RNA levels consistently <500 copies/ml and none were taking the didanosine/tenofovir combination, suggesting the involvement of other factors. We examined several independent variables, including hepatitis C antibody status and antiretroviral medications, but none were detected to be associated with decline. MOPEOO59 Absence of sustained benefit of HAART followed by structured treatment interruptions (STI) in primary HIV-1 infection (PHI): prolonged follow-up of patients enrolled in the PRIMSTOP (ANRS 100) trial B. Hoen', C. Deveau2, I. Fournier', C. Lacabaratz4, M. Burgard', S. Izard3, L. Meyer2, F. Raffi6, Primstop study group & Primo Cohort. 'CHU de Besangon - Universite de Franche-Comte, Maladies Infectieuses et Tropicales & EA 3186, Besangon, France, 2INSERM, Unite 569, Le Kremlin Bicetre, France, 3INSERM, SC 10, Villejuif, France, 4INSERM, E 109, Le Kremlin Bicetre, France, sCHU Necker-Enfants Malades, Laboratoire de Virologie & EA-MRT 3620, Paris, France, 6CHU de Nantes, Maladies Infectieuses et Tropicales, Nantes, France Background: The Primstop trial enrolled 29 patients with early symptomatic PHI who were given HAART continuously for 34 weeks (W) and then entered the STI phase that consisted of 3 consecutive periods of 2, 4, and 8 W off HAART, each separated by 12 W on HAART. HAART was stopped at W84. Of the 26 patients who completed the trial, no patient had restarted HAART 6 months after HAART discontinuation. Only one patient (3.8%) had plasma viral load (PVL) < 50 copies/ml, while 6 (23.1%) had PVL < 1000 copies/ml (JAIDS 2005; 40:307-16). Methods: The post-trial long-term follow-up (F-U) of the 22 patients who accepted such F-U assessed the changes in CD4 count and plasma viral load and the time to HAART re-initiation. Analysis was performed in December 2005, after a median duration of F-U of 36 months (range 20-43) after HAART discontinuation. Results: Six patients (27%/) restarted HAART after a median of 12 months (range 7-25), at a median CD4 count of 245/mm3 (range 197-266) and a median PVL of 4.75 log10 copies/mi (range 3.86-5.44). One of these was the single patient whose PVL was < 50 copies/ml throughout the 6 months after HAART discontinuation. Among the 16 patients who did not restart HAART, 30 months after HAART discontinuation, the median absolute CD4 count was 456/mm3 (range 333-639); the median loss of CD4 cells was 240 cells/mm3; the median PVL increase was 3.1 log10 copies/ml; and 11 (68%) patients had a PVL > 4 log10 copies/ml. One patient experienced clinical progression (oral candidiasis) and one developed non-Hodgkin lymphoma. Conclusions: These data show that virtually no PHI patient can maintain XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  49 suppression of viremia after a sequence of HAART/STIs followed by HAART discontinuation. In addition a significant proportion of them need to restart HAART, due to CD4 decrease < 300/mm3. MOPEO060 Does early treatment of primary HIV-infection delay treatment indication? C. Koegl', E. WolF, H. Jessen3, K. Schewe4, M. Rausch5, J. Goelz6, A. Goetzenich', H. Knechten', H. Jaeger8, and the Prime-DAG and Ac-DAG Study Group. 1MUC Research, Science, Munich, Germany, 2MUC Research, Munich, Germany, 3Private Practice, Berlin, Germany, 4Practice St. Georg, Hamburg, Germany, 5Private HIV Practice, Berlin, Germany, 6Practice Centre Kaiserdamm, Berlin, Germany, 7DAGNAE e. V., Aachen, Germany, 8HJV Research and Clinical Care Centre Munich, Munich, Germany Background: Scientific data on optimal management of primary HIV-infection are inconclusive. There is only poor evidence that treatment of primary HIV infection can reduce the viral load set point and thereby delay disease progression. Our primary endpoint was the time to CD4-decline to <350/pl and/ or VL-increase to >100,000 cop/ml in treated and untreated seroconverters. Methods: Analysis of two prospective national cohorts of seroconverters: 1) Prime-DAG started in July 2001 with a focus on early treatment and 2) Ac-DAG started in January 2003 with a focus on non-treatment of primary HIV-infection. Criteria for primary HIV-infection were either a negative ELISA, coupled with a positive viral load (VL), or a documented western blot with less than 5 bands. Results: 200 (191 male) cases of primary HIV-infection have been reported. In 144 patients (pts), treatment was started immediately, 56 pts remained untreated. In pts without treatment, the median first measured viral load was 240,000 cop/ml versus 500,000 cop/ml in pts initiating treatment (p<0.001). The median CD4 counts were 629/pl and 453/pl respectively (p=0.001). 98/144 treated pts stopped treatment after a median time of 9.0 months. At this point, VL was below detection in 81% of these pts (range: <49 - 7.300 cop/ml). The median CD4 count was 803/pl. 37 of those discontinuing treatment (38%) reached the primary endpoint after a median treatment interruption of 14.3 months. In 20/56 untreated pts (36%), the primary endpoint was reached after a median observation time of 8.3 months after seroconversion (p=0.02). Using Kaplan-Meier analysis (treatment (re-)start was censored in case of CD4>350 or VL<100.000), the primary endpoint was only significant for pts with a first measured VL of >50,000 cop/ml (Breslow-Gehan, p=0.02). Conclusions: Our cohort shows a trend, where early treatment of primary HIV-infection delays the time until treatment indication in pts presenting with a viral load VL >50,000 cop/ml during seroconversion. MOPE061 Inverse relationship between viral load and genotypic resistance mutations in Korean primary HIV-1-infected patients B.S. Chin, J. Choi, J.-G. Nam, M.K. Kee, S.D. Suh, J.Y. Choi, C. Chu, S.S. Kim. Korean Center for Disease Control and Prevention, Division of AIDS, Seoul, Korea, Republic of Background: The transmission of antiretroviral resistant HIV-1 strain is associated with suboptimal virologic response to initial antiretroviral therapy. Furthermore, primary HIV-1 infection (PHI) may play an important role in HIV-1 transmission due to high titers of circulating viruses and patients' unawareness of being infected while maintaining high-risk behaviors. Recently, certain types of resistance mutations are known to be associated with decreased viral fitness, which confers lower replication capacity than wild type virus in the absence of antiretroviral drugs. So we evaluated the relationship between antiretroviral resistance mutations and viral replication in PHI period. Methods: From January 2002 to March 2005, 52 patients were identified as PHI by definition of 1) positive HIV-1 RNA and negative HIV-1 EIA and 2) positive HIV-1 RNA and HIV-1 EIA with indeterminate HIV-1 Western Blot assay. HIV-1 RNA genotyping was performed and the Resistance Mutation Score for each available antiretroviral drug was obtained from the HIV DRUG RESISTANCE DATABASE by STANFORD UNIVERSITY. We regarded the sum of the average Resistance Mutation Scores (SARMS) of each antiretroviral drug class as the resistance degree of specific strain. Results: Overall mean SARMS was 2.00 + 2.74 and the annual mean SARMS did not show significant change during the study period. No critical resistance mutation gene was identified in the study group, but the SARMS showed weak negative correlation with Bogl0viral load during PHI without statistical significance (r=-0.274, p=0.051). But the mean SARMS of patients with viral load exceeding 100,000 copies/ml was lower than the patients with viral load less than 100,000 copies/ml with statistical significance (p=0.03). Conclusions: The evaluation of potency for antiretroviral resistance revealed weak negative correlation with viral replication in PHI period, and we suppose it could be one of the reasons why the transmission of resistant strains in PHI patients is not increasing significantly despite of generalization in HAART. MOPEO062 Predictors of clinical outcome among HIV-infected patients who maintain virologic suppression with HAART: long-term follow-up of an observational cohort F. Gutierrez, S. Padilla, M. Masia, J.A. Iribarren, S. Moreno, P. Viciana, L. Mufioz, J.L. G6mez sirvent, F. Vidal, J. L6pez-Aldeguer, J.R. Blanco, M. Leal, M.A. Rodriguez-Arenas, S. Perez Hoyos, CoRIS-MD. Spanish AIDS Research Network, Elche, Spain Background: Limited information is available on the long-term outcome of patients with sustained virologic response to highy active antiretroviral therapy (HAART). We aimed to assess predictors of unfavourable clinical outcome in patients who maintained viral supression with HAART. Methods: Using data collected from 10 clinic-based cohorts in Spain between January 1997 and December 2003, we selected all antiretroviral-naive HIVinfected adults who initiated HAART and maintained plasma HIV-1 RNA levels <500 copies/mL throughout follow-up. Factors associated with disease progression, defined by death or the occurrence of a new AIDS-defining event (ADE) after the first 3 months of HAART, were determined by Cox proportionalhazards models. Results: Of 2613 patients who started HAART, 757 fulfilled the inclusion criteria. Sixty one percent of them initiated a protease inhibitor-based HAART regimen, 29.7% a nonnucleoside reverse-transcriptase inhibitor-based regimen, and 7.8% a triple-nucleoside regimen. During 2556 person-years of follow-up, 22 (2.9%) patients died (mortality rate 0.86 per 100 person-years), 21 (2.8%) experienced a new ADE, and 40 (5.3%) died or developed an ADE. In adjusted Cox regression models, mortality was independently associated with a CD4-T cell response <50 cells/L after 12 months of HAART (adjusted hazard ratio [AHR], 4.26 [95% confidence interval {CI}, 1.68-10.83]; P = 0.002), and age 50 years at initiation of HAART (AHR, 3.19; 95% CI, 1.13-9.01; P = 0.029). Conclusions: Patients with sustained virologic response on HAART have a low mortality rate over time. Low CD4-T cell responses at 12 months and older age at initiation of therapy are the main determinans of unfavourable long-term outcome. MOPE0063 Factors predictive of 30-day post-operative mortality from 3213 surgical procedures carried out in 1840 HIV/AIDS patients being treated with antiretroviral therapy J. Chan', R. Hogg2, B. Yip2, A. Levy2, J. Montaner2, S. Wiseman1. 'St Pauls Hospital, Vancouver, Canada, 2BC Centre for Excellence in HIV/AIDS, Vancouver, Canada Background: Despite an increasing population of individuals undergoing surgical procedures with a pre-operative diagnosis of HIV and AIDS, factors which predict post-operative mortality remain poorly defined. Methods: All patients who received antiretroviral (ARV) therapy and who underwent any surgical procedure (excluding dental and endoscopic procedures) between June 1995 and March 2002 were included in this study. The primary outcome evaluated was the 30-day post-operative mortality. Demographic, clinical, and hospitalization-related variables were examined with logistic regression analyses to assess possible associations with this outcome. A sub-analysis was carried out for a subset of procedures for which additional laboratory data was available within 6 months prior to surgical admission. Results: A total of 3213 procedures in 1840 patients (1480 [80.4%] males) were carried out over the 7-year study period. All patients had started ARV before admission, and 508 (15.8%) procedures were performed in the pre-HAART era and 2705 (84.2%) in the post-HAART era. A total of 1026 patients (31.9%) had an AIDS diagnosis prior to surgery. Admissions were identified as urgent/ emergent in 1840 (57.3%) of all procedures. Overall, 30-day post-operative mortality was 7.4%/ (238 deaths). In a stepwise multivariate analysis, older age (10yr increment) (OR=1.32; p<0.001), previous AIDS diagnosis (OR=1.50; p<0.001), injection-drug naivety (OR=1.58; p=0.007), surgery at a teaching hospital (OR=1.63; p=0.009), and urgent/emergent admission (OR=7.32; p <0.001) were significantl associated with 30-day post-operative mortality. For the sub-analysis of 1825 procedures, injection-drug naivety (OR=1.62; p=0.036), older age (10yr increment) (OR=1.64; p=0.001), urgent/emergent admission (OR=4.60; p<0.001), CD4<200 cell/mm3 (OR=1.67; p=0.032), pVL >100,000 c/mL (OR=2.06; p<0.001), Hb<=120 g/L (OR=2.38; p<0.001), and WBC >11 g/L (OR=2.55; p=0.003) were significantly associated with 30-day post-operative mortality. Conclusions: In HIV/AIDS patients undergoing surgery, a thorough preoperative evaluation, which includes specific demographic and laboratory investigations, is useful for prediction of post-operative mortality and thus preoperative surgical risk assessment and patient counselling Monday 14 August Poster Exhibition XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  50 MOPEO064 Autopsies in HIV: still identifying missed diagnoses D. Cohen', M. Beadsworth2, N. Jenkins', L. Ratcliffe', B. Taylor3, N. Beeching'. 'Royal Liverpool University Hospital, Tropical and Infectious Diseases Unit, Liverpool, United Kingdom, 2Royal Liverpool University Hospital, Tropical and Infectious Diseases Unit, Manchester, United Kingdom, sUniversity Hospital Aintree, Department of Histopathology, Liverpool, United Kingdom Background: Mortality due to HIV has greatly reduced due to the introduction of chemoprophylaxis for opportunistic infection (OI), improved anti-microbial therapy, better diagnostics and highly active antiretroviral therapy. Despite these interventions, deaths still occur in developed world cohorts. Post mortem examination remains a sensitive issue but can provide important information to confirm cause of death, or change the presumed cause and eventually change practice. Methods: A retrospective study of all HIV positive patients known to have died while under the care of our Unit between 1983-2005. Information was obtained from case notes and autopsy reports. We assessed pre-mortem diagnoses, proportion of autopsies performed, and changes in diagnoses after autopsy. Results: Data were available on 107/115 patients who died between 1983 -2005. 81% were male and median age was 37.7 years (25-55). Ethnic origin was 82% caucasian, 12% Black African, 1% Asian and 6% South American. HIV risk factors included MSM 52%, heterosexual contact in Europe 11%, sexual contact in sub-Saharan Africa 17%, 9% injecting drug user and 3% from blood products. Autopsy was requested in 54 (50.4%) and carried out in 41 (38%), A substantive change in primary cause of death was found in 21 (51.2%) patients. 70.7% of all diagnoses were changed post-mortem. The commonest cause pre and post-mortem was respiratory tract infection, pre 26.2% and post 36.6%. Overall, 42% of total OI diagnoses were missed. There was little change in premortem diagnostic inaccuracy in the decade 1996-2005 compared to previous years. Conclusions: The cause of death changed in the majority of patients who underwent autopsy. Autopsy provides useful information for future management of patients with HIV and should be considered in every HIV related death. Opportunistic infections continue to be a significant cause of death in the HAART era Despite excellent resources, investigative tools remain inadequate for diagnosis. MOPEO065 Effectiveness of HAART on the quality-adjusted life year among HIV-1-infected women C. Liu', H. Chu2, E. Robison3, K. Weber', S. Gange2. 1Georgetown University, Department of Medicine, Washington D.C., United States, 2Johns Hopkins University, Department of Epidemiology, Baltimore. Maryland, United States, 3Montefiore Medical Center, New York, United States, 'Chicago Cook County Hospital, Chicago, Illinois, United States Background: The impact of highly active antiretroviral therapy (HAART) on the combined quantity and quality of life has not been well studied. Methods: To evaluate the effectiveness of HAART on quality-adjusted life years (QALYs), a one-to-one matching with equivalent (<0.1%) propensity scores for predicting HAART initiation was carried out between the HAART using and HAART naive HIV-infected women in the Women Interagency HIV Study (WIHS) and 458 pairs of participants were obtained. Quality of life (QOL) was repeatedly measured using a shortened version of MOS-HIV form. QALYs were calculated as integrated survival-quality products, i.e., weighting the follow-up periods by utility coefficients derived from a QOL summary score. The effectiveness of HAART on QALYs was assessed using Kaplan-Meier survival analysis and parametric life regression models accounting for right censoring. Results: After propensity score matching, the distributions of the baseline covariates between the two groups were the same. The subjects had a mean age of 39 years at the matching visits and had been followed up till October 2004. The survival benefit of HAART usage was obvious ( 2 = 118.3; P < 0.0001). QOL summary scores were nearly the same except for the first year after matching (P = 0.0051) between the two groups. The effectiveness of HAART on QALY was similar to that on overall survival time (log rank x2=111.4; P < 0.0001). After controlling for baseline age, number of CD4+ cell counts, calendar time, education level at study entry and race/ethnicity, the HAART using group took 4.8 or 5.6 times as long as the HAART naive group to reach 50% of survival or QALY events. Conclusions: Our study showed that HAART not only improved HIV-infected women's survival time, but also enhanced their overall quality of life. Using HAART did not cause severe tradeoff between quantity and quality of life among the HIV-infected women.. MOPE O066 Effectiveness analysis of antiretroviral therapy over the last decade at a population level G. Paraninfo', M.C. Uccelli2, S. Casari', C. Torti2, E. Quiros-Roldan2, F. Castelnuovo', G. Cristini', G. Lapadula2, V. Tirelli2, G. Cologni2, S. Costarelli2, A. Matti2, P. Nasta2, F. Gatti2, A. Patroni2, G. Carosi2. 'Spedali Civili di Brescia, Infectious Disease Dpt, Brescia, Italy, 2University of Brescia, Infectious Disease Dpt, Brescia, Italy Objectives: To assess drug exposure, viro-immunological status, occurrence and predictors of AIDS events and deaths in a single Italian teaching Centre. Methods: Descriptive analysis was conducted. Logistic regression analysis was used to explore factors related with risk of death in patients with a first AIDS event recorded since 1997 to September 2005. Results: 5,677 patients are imputed in our electronic database (Health & NotesTM) since starting of the HIV epidemics. Among these patients, 1413 (24.9%) were lost to follow up, 1389 (24.5%) died, and 2875 (50.6%) are on a regular follow-up. Among patients on follow-up, only 352 (12%) are naive to antiretroviral drugs. Among experienced patients, 1341 (53%) experienced the 3 classes (NRTI, NNRTI and PI). Percentage of undetectable viral load increased from 49.4% in 2001 to 76.4% in 2005. More than 60% of patients with at least 8 experienced treatment lines, still have an undetectable viral load. Last CD4+ T cell count is <50/mm3 in only 1% of patients. The following variables appeared independent predictors of death: achieving undetectable viral load at least once (OR: 0.28; 95% C.I. 0.11-0.73; p=0.009), last CD4+ T cell count >200/mm3 (OR: 0.17; 95% C.I. 0.06-0.5; p=0.002 for 201-350 versus <50 cells/mm3; OR: 0.07; 95% C.I. 0.02-0.28; p<0.0001 for 351-500 versus <50 cells/mm3; OR: 0.02; 95% C.I. 0.001-0.17; p:0.001 for >500 versus <50 cells/mm3) and number of experienced treatment lines (OR: 0.73; 95%IC: 0.59-0.9; p=0.005). By contrast, non Hodgkin lymphoma as first AIDS event, among others, seemed to confer the highest risk of death. Conclusions: The actual regimens are able to control viral replication in a substantial proportion of patients. Non Hodgkin lymphoma at AIDS occurrence seemed associated with the worst prognosis. Maintenance of CD4+ T cell count as higher as possible and achievement of undetectable viral load at least once appeared to be important priorities. MOPEO067 Mortality and frequency of hospital admissions in a cohort of HIV positive Ugandan adults with CD4 counts less than 200, prior to and after starting ART R. Parkes', J. Todd2, H. Grosskurth2, A. Kamali2, D. Lalloo'. 'Liverpool University, Liverpool School of Tropical Medicine, Liverpool, United Kingdom, 2Medical Research Council (MRC)/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda Background: In the context of a trial evaluating the reduction of cryptococcal disease by use of prophylactic fluconazole, patients were referred to and accessed antiretroviral therapy (ART) from local service providers in Masaka district, Uganda. We used this opportunity to compare mortality and morbidity in the cohort, before and after initation of ART. Methods: At trial enrolment participants were randomised to oral fluconazole or placebo. After enrolment they were referred for ART. Mortality and frequency of hospital admissions were analysed for the first 500 patients prior to and after initiation of anti-retroviral therapy (ART). The Kaplan Meier method was used for survival analysis. Results: 66% of patients were female. At enrolment, mean age was 35.8 years (range 16-67) and median CD4 count 97 cells/UI. Total patient years observed (PYO) were 333. 389/500 (77.8%) patients started ART at a median time of 61 days from enrolment (range 1-398), with a median duration of follow-up on ART of 158 days (range 4-398). Mortality: 49 patients died. The overall mortality rate per 100 PYO (95%CI) was 14.7 (11.1-19.4). Mortality rate prior to ART was 18.6 (12.5-27.7), in first 3 months of ART was 19.4 (12.0-31.2) and after 3 months was 6.9 (3.4-13.8). The mortality rate prior to ART was 38.9 (22.6-67.1) in those with CD4 <50 and 11.4 (6.30-20.5) for CD4 counts between 50-199. Corresponding rates after starting ART were 20.9 (12.4-35.2) and 8.1 (4.5-14.6) respectively. Hospital Admissions: The rate of hospital admissions prior to ART was 48.4/100 PYO (95%CI) (35.9-65.3), 61.0 (45.7-81.4) in the first 3 months of ART and 24.5 (16.2-36.8) after 3 months of ART. Conclusions: The overall mortality and need for hospitalisation before ART, and in the first 3 months of ART appear to be similar. However, mortality was considerably reduced thereafter, even in patients with highly advanced immunosuppression. MOPE0068 Improved anti-viral cellular immunity in HAARTtreated, HIV clade C infected individuals presenting with active Kaposi's sarcoma A. Mosam', F. BihI', L.M. Henry', J.V. Chrisholm', L. Butler', S. Dollards, J.N. Martin', P. Kiepiela6, S. Cassol', D.T. Scadden', H.M. Coovadia', C. Brander'. 'Nelson R Mandela School of Medicine, University of KwaZulu Natal, Dermatology, Durban, South Africa, 'PARTNERS AIDS Research Centre, Boston, United States, 'Massachusetts General Hospital, PARTNERS AIDS Research Centre, Boston, United States, 'University of California, Department of Epidemiology and Biostatistics, San Francisco, United States, sCenters for Disease Control and Prevention, Atlanta, United States, 6University of KwaZulu-Natal, HIV Pathogenesis Program, Doris Duke Medical Research Institute,, Durban, South Africa, 'HIV Pathogenesis and Therapeutics Unit, University of Pretoria, Pretoria, South Africa, 'Massachusetts General Hospital, Center for Regenerative Medicine, Boston, United States, 9UKZN, HIVAN, Durban, South Africa Infection with Kaposi's Sarcoma Herpesvirus (KSHV/HHV8) is endemic in South Africa and clinical manifestation of Kaposi's Sarcoma (KS) in wake of the HIV epidemic has become a significant clinical problem. Treatment with antiretroviral drugs (HAART) is known to improve KS, presumably by restoring general immune function. Here, we study 65 HIV clade C infected subjects presenting with active KS XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  51 lesions for up to 12 months after initiating HAART. In PBMC samples from a total of 122 time points, the KSHV, EBV and HIV specific cellular immune responses were determined and compared to plasma HIV and cellular KSHV viral loads. Cellular immunity to KSHV, HIV and EBV was assessed by direct exvivo IFN-g Elispot assay using peptide sets covering 6 different, latent (K10.5, K12, ORF 73) and lytic (K8.1, ORF57, ORF 65) KSHV antigens. Treatment effectively suppressed HIV viral loads and reduced KSHV viral burden over time and most patients had complete or partial response of the KS lesions within the study period. In 33 subjects followed for at least 6 months, KSHV viral loads declined from a median of 709 viral genome copies per 106 PBMC at baseline to 97 and 29 copies at 6 and 12 months, respectively. CD4 counts increased over the same period of time from a median 175 to 421 CD4 T cells/ml. This immune reconstitution was reflected in significantly increased cellular immune responses to KSHV and EBV derived antigens (p = 0.02) but not to HIV (p=0.1). These data document a gradual recovery of anti-viral cellular immunity and effective suppression of KSHV viral antigen upon initiation of HAART in this HIV clade C cohort with endemic KSHV infection MOPEO069 Did HIV-infected children benefit from antiretroviral therapy improvements as much as adults? L. Meyer', A. Faye2, C. Goujard3, F. Boufassa4, J. Le Chenadec4, C. Deveau4, C. Dollfuss, C. Rouzioux6, S. Blanche', 3.-F. Delfraissy3, J. Warszawski', the ANRS EPF PRIMO and SEROCO groups. 'University Paris Sud - Faculty of Medicine, Epidemiology, Le Kremlin-Bicetre cedex, France, 'Robert Debre Hospital, Pediatrics, Paris, France, 3Bicetre Hospital, Internal Medicine, Le Kremlin Bicetre cedex, France, 4INSERM, U569, Le Kremlin Bicetre cedex, France, 'Trousseau Hospital, Pediatrics, Paris, France, 'Necker Hospital, Virology, Paris, France, 'Necker Hospital, Pediatrics, Paris, France Background: HIV-infected children could have less benefit than adults in terms of survival improvements due to HAART (peculiar pharmacokinetics, poor observance due to underinformation or inadequate galenic forms, high viral loads during the first weeks of life, or comorbidities due to prematurity). However they are less exposed than adults to severe comorbidities such as HCV infection or drug and alcohol-related illnesses. Here we examined among 1598 HIV-1 seroconverters enrolled over a 20-year period (1985 to 2005) whether overall survival and Aids-free survival differed between adults and children, stratified on different calendar periods of birth/seroconversion and follow-up. Methods: 512 HIV-1 infected children followed since birth (N=403 born in 1985-1995 and N=109 in 1996-2004) in the EPF cohort and 1086 HIV-1 infected adult seroconverters enrolled in the SEROCO cohort between 1988 and 2001 (N=487) or in the PRIMO cohort between 1996 and 2005 (N=599). Progression to clinical AIDS and death was compared by using Kaplan-Meier curves and Cox models. Results: When infected before 1996, both boys and girls had until 1996 a significantly worse survival and Aids-free survival than male and female adults, respectively, which, at least in boys, was explained by the occurrence of earlyonset severe form of childhood HIV disease. When only considering follow-up since 1996 of those subjects infected before 1996 and having survived until then, Aids-free survival was similar in infants and adults, and, as expected, overall survival tended to be better in infants (p=0.06). Finally, among subjects infected since 1996, survival did not differ in boys and men, while survival in girls was shorter than in their adult female counterparts (RR=5.0 [95% CI: 1.04-25.0]). Conclusions: Children did not have a worse prognosis compared to adults when they had survived until the HAART era. Factors contributing to the higher mortality of HIV-infected girls born since 1996 are currently under investigation. MOPE0070 Creating and validating a verbal autopsy algorithm to measure AIDS mortality P. Mare', B. Lopman', R. Barnabas', T. Boerma4, G. Chawira', C. Donnely2, G. Garnett', C. Nyamukapas, P. Mason', S. Gregson6. 'Biomedical Research and Tranining Institute, Harare, Zimbabwe, 'Imperial College London, Department of Infectious Disease Epidemiology, London, United Kingdom, 3University of Oxford, Oxford, United Kingdom, 4World Health Organisation, Geneva, Switzerland, sBiomedical Research and Tranining Institute\Imperial College London, Department of Infectious Disease Epidemiology, Harare, Zimbabwe, 6Biomedical Research and Tranining Institute\Imperial College London, London, United Kingdom Background: Vital registration and cause of death reporting is incomplete in the countries where the HIV epidemic is most severe. Because HIV serostatus is often unknown, a reliable tool independent of HIV status is needed for measuring the frequency of AIDS deaths and ultimately the impact of antiretroviral therapy on mortality. Methods: A verbal autopsy questionnaire was administered to caregivers of 381 adults of known HIV status who died between 1998 and 2003 in Manicaland, eastern Zimbabwe. Individuals who were HIV positive and did not die in an accident or during childbirth were considered to have died of AIDS in the reference standard. Verbal autopsies were randomly allocated to a training dataset (n = 279) to generate classification criteria or a test dataset (n = 102) to verify criteria. Results: A rule-based algorithm created to minimise false positives had a specificity of 66% and a sensitivity of 76%. Eight predictors (weightloss, wasting, jaundice, herpes zoster, presence of abscesses or sores, oral candidiasis, acute respiratory tract infections and vaginal tumours) were included in the algorithm. 73% of deaths were correctly classified as AIDS/non-AIDS, without the need to invoke a differential diagnosis of tuberculosis. Presence of any one of these criteria gave a post-test probability of AIDS death of 0.84. Conclusions: Analysis of verbal autopsy data in this rural Zimbabwean population revealed a distinct pattern of signs and symptoms associated with AIDS mortality. Using these signs and symptoms, demographic surveillance data on AIDS deaths may allow for the estimation of AIDS mortality and even HIV prevalence. MOPEOO71 Temporal trends in hospitalizations and hospitalization-associated diagnoses in the HIV Outpatient Study (HOPS) during 1994-2002 A. Moorman', K. Buchacz', J.T. Richardson2, R.K. Baker2, K.C. Wood', S.D. Holmberg3, J.T. Brooks', the HOPS Investigators. 'CDC, NCHSTP/ DHAP/Epidemiology Branch, Atlanta, United States, 'Cerner Corporation, Washington, United States, 3Research Triangle Institute, Atlanta, United States Background: Highly active antiretroviral therapy (HAART) has extended survival and reduced rates of AIDS opportunistic infections (Ols). These gains have been countered by the emergence of complications related to HAART and to chronic HIV disease. We sought to assess changes in hospitalizations in light of these opposing trends. Methods: We analyzed data from 6,223 participants enrolled in HOPS at 10 HIV specialty outpatient clinics in the United States from 1994-2002. We examined rates of hospitalization per 100 person-years (PY), the spectrum of hospital-associated diagnoses, and trends in CD4+ cell counts at the time of hospitalization. Results: Rates of hospitalization fell from 28.3 hospitalizations per 100 PY in 1994 to 16.0 hospitalizations per 100 PY in 2002 (P < 0.01). The rates of AIDSassociated Ols at hospitalization decreased from 8.3 per 100 PY during 1994 -1996 (pre-HAART era) to 2.4 per 100 PY during 2001-2002 (HAART era [P < 0.01]). Conversely, rates of chronic end-organ diseases in aggregate (including cardiovascular, pulmonary, renal and hepatic and pancreatic conditions) increased from 1.8 per 100 PY during 1994-1996 to 2.5 per 100 PY during 2001-2002, and these conditions represented a larger proportion of diagnoses associated with hospitalizations in the HAART era compared with pre-HAART era (5.1 % in 1994-1996 vs 10.2 % in 2001-2002, [P < 0.01]). Median CD4+ cell count at hospitalization increased from 87 cells/mm3 in 1994 to 288 cells/ mm3 in 2002 ( P < 0.01). Conclusions: Overall rates of hospitalizations for HIV-infected patients declined substantially during 1994-2002. In the HAART era, HIV-infected patients are increasingly hospitalized for chronic illnesses and at higher CD4+ cell counts. MOPEO072 Differences and similarities in lipoprotein levels in HIV-infected and uninfected Rwandan and United States women F. Ndamage', J. Lu2, A. Binagwaho3, M. Cohen4, P. Tiens, L. Munyakazi6, R. Kaplan', J. Justman', J. Semahore Mugabo', D. Lu2, Q. Shi2, S. Cole", K. Anastos". 'Treatment and Research in AIDS Care, Clinic, Kigali, Rwanda, 2Data 2 Solution, New York, United States, 3National Commission to Combat AIDS, Kigali, Rwanda, 4Cook County Hospital, Chicago, United States, sUniversity of California at San Francisco, Medicine, San Francisco, United States, 6National Bureau of Statistics, Kigali, Rwanda, 'Albert Einstein College of Medicine, Epidemiology and Population Health, New York, United States, 8Columbia University School of Public Health, New York, United States, 9Treatment and Research in AIDS Care, Kigali, Rwanda, "Johns Hopkins Bloomberg School of Public Health, Epidemiology and Statistics, Baltimore, United States, 1Montefiore Medical Center, Epidemiology and Population Health, and Medicine, New York, United States Background: HIV lowers total, low and high-density lipoprotein cholesterol levels (Total-C, LDL-C, HDL-C), and increases triglycerides (TG). We compared lipoproteins in untreated HIV-infected and uninfected African and US women. Methods: Rwandan Women's Interassociation Study and Assessment (RWISA), an observational cohort enrolled May-November 2005, assesses effectiveness and toxicity of antiretroviral therapy (ART) and influence of comorbidities. The US-based Women's Interagency HIV Study (WIHS), with similar design, is in its 11th year of data collection. Lipid levels were determined on fasting blood specimens. No women were taking ART. Results: Full data was available for 967 RWISA (740 HIV+ and 227 HIV-, mean age 36.7) and 1259 WIHS participants (623 HIV+, 636 HIV-, 66.3% AfricanAmerican, 38.6 years). In Rwandan and US women, adjusted for BMI and age, with lower CD4 cell counts the Total-C (p<0.01 and <0.0001 for Rwandan and US women respectively) and HDL-C (p<0.0001 for both) were progressively lower. LDL-C did not vary by CD4 cell count/HIV serostatus in Rwandans, but in US women ranged from 104 in the HIV negative to 88 mg/dL in HIV+ CD4<200 cells/pL (p<0.0001). In Rwandan compared to US HIV-negative women, totalC (144 vs. 178 mg/dL) and LDL-C (73 vs. 104 mg/dL) were significantly lower (p<0.0001 for both), but TG was similar (94 vs 107, p=0.252), and in AfricanAmericans was nearly identical to that in Rwandans (94 and 91 mg/dL). HDLC was lower in Rwandan than in white US HIV- women (50 vs. 53 mg/dL, p=0.002), but similar to African-Americans and Latinas (58 and 53 mg/dL, p=0.12 and 0.83 respectively). XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  52 Uoda Conclusions: In untreated African and US women, immunosuppression was associated with higher TG, and lower total and HDL-C; but with lower LDL-C only in US women. HDL and total-C were lower in Rwandan than in US HIVwomen, but TG and HDL-C were similar, especially in African-Americans. MOPEO073 Prediction of clinical benefits of TMC125 from treatment effects on CD4 counts and HIV RNA H. Grossman', C. Cohen2, J. Nadler', A. White4, B. Woodfall4, A. Hills. 'American Academy of HIV Medicine, HIV, Washington, United States, 2Clinical Research New England, HIV, Boston, United States, 3Tampa General Hospital, HIV, Tampa, United States, 4Tibotec, HIV, Mechelen, Belgium, sLiverpool University and Tibotec, Pharmacology, Liverpool, United Kingdom Objective: To predict the decrease in clinical progression from the treatment benefit of TMC125 over Active Control on CD4 counts and HIV RNA. Methods: In the TMC125-C223 trial, multi-drug resistant patients (N= 199, baseline median CD4 99, HIV RNA 4.7 log) were randomised to optimised background treatment plus either TMC125 400mg bid, TMC125 800mg bid or best available treatment (Control). 24 wk CD4 and HIV RNA data from TMC125 800mg group (N= 79), the selected dose, was used to predict clinical benefits (lower progression to AIDS or death) using a standard regression method and a new categorisation Methods: (1) Regression Method - data from 14 randomised clinical endpoint trials (N>9000) was used to correlate previous CD4 and HIV RNA treatment benefits with the relative hazard of clinical progression. (2) CD4 Categorisation method - Data on clinical progression in the EuroSida cohort within CD4 count ranges was combined with the C223 CD4 data and used to predict clinical progression rates. Results: At week 24, CD4 counts rose by mean 48 cells/ul for TMC125 800 mg BID versus +10 for Control; HIV RNA fell by mean -1.2 and -0.2 log10 at week 24 in the two groups. The regression method predicted a 39% comparative reduction from the difference in HIV RNA levels, and a 33% comparative reduction in progression from the difference in CD4 counts.The CD4 categorisation method predicted 1 year rates of progression to AIDS and death of 12% for TMC125 versus 17% for Control, a comparative reduction of 31%. Conclusions: Based on the 24 week results from the TMC125-C223 trial 800mg bid group, the benefits of TMC125 versus Control in raising CD4 counts and suppressing HIV RNA are predicted to lower progression rates to AIDS/death by 31-39% for TMC125 treatment, using independent prediction methods. MOPEO074 The impact of HIV on maternal morbidity in Ugandan women H. Nuwagaba-Biribonwoha', R.T. Mayon-White2, P. Okong3, P. Brocklehurst4, L.M. Carpenter2. 'Columbia University, International Center for AIDS Care and Treatment Programs, Dar es salaam, Tanzania, United Republic of, 2Oxford University, Department of Public Health, Oxford, United Kingdom, 3St. Francis Hospital, Nsambya, Kampala, Uganda, 4National Perinatal Epidemiology Unit (NPEU), Oxford, United Kingdom Background: There were limited data about the effect of HIV on maternal morbidity around childbirth in Uganda. We aimed to describe, estimate and compare maternal morbidity occurring between pregnancy term and end of puerperium in HIV positive and HIV negative women. Methods: Maternal morbidity was measured prospectively in a cohort of 132 HIV positive women and 399 HIV negative women attending St. Francis Hospital, Nsambya, Kampala, Uganda. Nulliparous and uniparous women were followed from 36 weeks of pregnancy to 6 weeks after delivery. Major morbidity included any of the following: illness requiring hospital admission, severe febrile illness, revision of surgical incisions made at delivery or conditions resulting in death. Non-major morbidity included depression, delayed wound healing and breast inflammation. The risk of major morbidity was calculated at 6 weeks after delivery by determining crude odds ratios, COR (95% confidence interval, 95% CI). Factors associated with major maternal morbidity were examined using logistic regression to generate adjusted odds ratios, AOR (95% CI). Results: Of the 129 HIV positive women and 390 HIV negative women followed until 6 weeks after delivery, 46(36%) and 104(27%) had major morbidity respectively, COR=1.5 (1.0-2.4). In the regression analysis, the risk of major morbidity was independently associated with HIV infection: AOR=1.7 (1.1-2.7), nulliparity AOR=2.0 (1.3-3.0) and a lower level of formal education, AOR=2.1 (1.1-3.8). Maternal age, having own income and being a private patient lacked a statistically significant impact on major maternal morbidity. Depression was twice as common among HIV positive women COR 2.0 (1.1-3.5), but differences in wound healing and breast inflammation were not statistically significant. Conclusions: In this Ugandan cohort, HIV increased the risk of any major maternal morbidity by 70%. Maternal morbidity remains a significant health issue in such resource-limited settings. There is need for more interventions to address the effects of HIV on maternal morbidity. MOPEOO75 Elimination kinetics of single 200 mg dose of oral nevirapine in HIV-1-infected pregnant Indian women R.B. Mhatrel, P.A. Thakur', S. Dalvi', J. Sastry2, A. Kshirsagar', F. Hamzeh3, M.A. Phadke4, S. Nair2, R.C. Bollinger', N.A. Kshirsagar'. 'Seth GS Medical College & KEM Hospital, Mumbai, India, 2EDSEARCH, Pune, India, 3Johns Hopkins University, Baltimore, Maryland, United States, 4Maharashtra Medical University, Mumbai, India, 'Seth GS Medical College & KEM Hospital, Department of Clinical Pharmacology, Parel, Mumbai, India Objective: To study Elimination Kinetics of Single 200 mg dose of nevirapine in HIV-1-infected Pregnant Indian Women. Methods: Protocol was approved by institutional Ethics Committee and written informed consent was taken from all participating mothers who were screened during antenatal visits and selected as per the inclusion and exclusion criteria. At the onset of the labor, 200 mg single dose of oral nevirapine suspension was given to the mother and blood samples were collected at specific time intervals at day-3, 5 and day-8 post drug to study Elimination Kinetics of nevirapine. Blood samples were analyzed by high performance liquid chromatography for nevirapine levels. The nevirapine elimination half life (T1/2) was calculated by using Win-Nonlin software (version 1.1). Results: The nevirapine half life (T1/2) was calculated for 14 mothers who fulfilled all the requirements. The mean nevirapine elimination half life (T1/2) was 58.25 hours (SD=22.74) and the median T1/2 was 50.23 hours (Range 30.93- 115.50 hours). Conclusion: This study is the first one in Indian pregnant mothers. The study showed reasonable concurrence with the published Ugandan study in which nevirapine T1/2 in pregnant Ugandan women after a single 200 mg nevirapine dose was reported 61.3 hours, with a range of 27.4-90.4 hours. However, the study in US volunteers, showed the T1/2 of 70 hours while studies in US mothers, demonstrated median T1/2 of 36.8 hours. Further studies are necessary to evaluate the efficacy and pharmacokinetics of intrapartum nevirapine and it's impact on response to subsequent treatment. MOPE0076 Predictors of mortality in a cohort of HIV-infected patients in South Africa awaiting ART G. De Bruyn', P. Pronyk2, M. Willie', F. Van der Linde', M. Lurie', A. Heyer2, T. Kotzee2, N. Tshabangu1, H. Struthers', G. Gray', J. McIntyre', N. Martinson'. 'Perinatal HIV Research Unit, University of the Witwatersrand, Johannesburg, South Africa, 2Rural AIDS and Development Action Research Programme, University of the Witwatersrand, Acornhoek, South Africa, 3International Health Institute, Brown University, Providence, RI, United States Background: Understanding prognosis for patients who are HIV-1 infected is an important basis for clinical management and program implementation. Although well documented for patients from industrialized nations, data are limited for patients from developing settings, such as South Africa. This study examined predictors of mortality among a prospective cohort study of ARV naive individuals, the Wellness Project, conducted at two sites (Perinatal HIV Research Unit, Soweto and Tintswalo Hospital, Limpopo province) since June 2003. From 2004, people eligible for ARV's were referred to treatment programs. Methods: We used standard methods for survival outcomes to investigate the mortality among enrolled participants, and the impact of demographics, income, health behavior, disclosure, and urban or rural residence on these outcomes. The dataset includes visits to October 2005. Kapla-Meier survival estimates, by site 0 13 0 1. 3 Person Years 95% CI - Survivorfunction GCrepS.by.sibs [Figure 1. Survival curves by site] Results: 1724 HIV-infected individuals [median age 33 yrs, 78% female, median follow up 0.8 years] had two or more visits recorded. There were 147 deaths over 1595 person years of follow up (mortality rate 9.2/100py; 95% CI 7.8 - 10.8). In univariate analysis, baseline body mass index (BMI), baseline WHO stage, requirement for assistance with activities of daily living, and rural residence were significantly associated with the risk of death. However, mean BMI's differed by site (Tintswalo 20.3 vs. PHRU 24.5, t = -14.1, p <0.0001). XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  53 Age, income, gender, and disclosure of HIV status were not associated with the risk of death. Conclusions: Nutrition in rural areas may play a role in mortality, although access to care (other than through the wellness program), local municipal services, water, and sanitation may also contribute in the observed difference in mortality between rural and urban sites. Ascertainment of deaths may also be different between sites. MOPEO077 Infant morbidity and mortality by HIV exposure and infection status A. Ruffs, B. Gudetta2, T. Awano-Lemtuche3, A. Abdosh3, D. Hailu3, R. Adamu4, S. Omer', A. Abashawli', Y. Mengistus, U. Nayak', A. Bedri2. 1'Johns Hopkins University, International Health, Baltimore, United States, 2Addis Ababa University, Pediatrics, Addis Ababa, Ethiopia, 3Addis Ababa University, Nigat Project, Addis Ababa, Ethiopia, 4Johns Hopkins University, International Health, Addis Ababa, Ethiopia, sAddis Ababa University, Microbiology, Addis Ababa, Ethiopia Background: Some studies have reported increased mortality among HIV exposed, but un-infected infants while other studies have failed to confirm those findings. Methods: We evaluated morbidity due to > Grade 3 diarrhea, pneumonia, and failure to thrive, and mortality among the following 3 groups of infants being followed in a prospective study in Addis Ababa, Ethiopia: Infants born to HIV negative women (Neg), Uninfected infants born to HIV-infected women (Exp) and Infected infants (Inf). Infants were followed through the 1st year of life and infected infants were further categorized according to their PCR status at birth. Results: Infant Group (n) Neg (93) Exp (728) Inf - Neg @ birth (54) Inf - Pos @ birth (33) Diarrhea Proportion % (n) 6 (6) 12 (89) 26 (14) 27 (9) RR (95% CI) Reference 1.9 (0.8-4.2) 4.0 (1.6-9.8) 4.2 (1.6-11) Pneumonia Proportion % (n) 8 (7) 5 (34) 17 (9) 18 (6) RR (95% CI) Reference 0.6 (0.3-1.4) 2.2 (0.9-5.6) 2.4 (0.9-6.6) The hazard ratios (95% CI) for death in the 1st year of life compared to the Negative cohort were as follows: Exp: 1.7 (0.7-4.3), Inf - Neg @ birth: 4.9 (1.77-13.9) and Inf-Pos @ birth: 10.9 (3.9-30.6) Conclusions: HIV-exposed, uninfected infants had a somewhat greater risk of diarrhea and death compared to infants born to negative women. HIV-infected infants who acquired the infection in utero had the greatest risk of morbidity and mortality. Such infants must be identified as soon as possible after birth in order to increase their changes of survival. MOPE0078 Bacteraemia in severely malnourished children infected and uninfected with the human immunodeficiency virus-1 in Kampala, Uganda H. Bachou', T. Tylleskar2, D. Kaddu-Mulindwa3, J.K. Tumwine'. 'Makerere University, Paediatrics and Child Health, Kampala, Uganda, 2University of Bergen, Centre for International Health, Bergen, Norway, 3Makerere University, Microbiology, Kampala, Uganda Background: The objective was to establish the magnitude of bacteraemia in severely malnourished children, and describe the types of bacteria and antimicrobial sensitivity by HIV status. Methods: A total of 450 severely malnourished children (weight- for- height< -3 z-score or presence of oedema) studied between 2003 and 2004. CD4+ were measured (FACScan) and HIV serology was confirmed (by ELISA) for those > 18 months, and RNA PCR for those < 18 months. Complete blood count, including differential counts was done using a Beckman Coulter counter. Isolates were recovered from 76 blood specimens. Antibiotic susceptibility tests were performed using commercial antibiotic panels. Results: Of the 450 children 63% were male; median age 17.0 months (IQR 12-24) and 57% had oedema. 151 (37 %) of 411 tested HIV+ve. 76 (17 %) 445 blood specimens grew bacterial isolates; 58% were gram negative - S. typhimurium (28 %) and S.enteriditis (12%). Staph. aureus (26 %) and Strep. pneumoniae (13.2%) were the main gram positive organisms. There was no difference in the risk of bacteraemia by HIV status, age < 24 months, male sex, or oedema. However, oral thrush (OR 2.3 CI 1.0-5.1) and hypoalbuminaemia (OR 3.5 CI 1.0-12.1) increased the risk of bacteraemia. Isolates from severely immuno-suppressed children (CD4% <15%) were more likely to grow Salmonella enteriditis (OR 5.4; CI 1.6 - 17.4). The isolates were susceptible (> 80%) to ciprofloxacin, ceftriaxone and gentamicin; with low susceptibility to chlorampenicol, ampicillin (< 50%) and co-trimoxazole (<25%). Mortality was higher among the HIV positive children with bacteraemia (43.5% vs 20.5%), OR 3.0 (95%CI 1.0, 8.6). Conclusions: Bacteraemia affects 1 in every 6 severely malnourished children and carries high mortality especially among the HIV-positve. The high level of resistance to common antibiotics, raise the need for revision of the recommended combinations of antibiotics for management of bacteraemia in severely malnourished children. MOPEOO79 Cryptoccocal meningitis a common cause of mortality among AIDS patients initiated on HAART H. Mayanja-Kizzal, F. Lutwama2, C. Kikawa2, C. Kalule2, D. Kizza2, M. Kamyal. 'Makerere University, Academic Alliance for AIDS Care and Prevention, Kampala, Uganda, 2Makerere University, Infectious Diseases Institute, Kampala, Uganda Background: Opportunistic infections (OIs), often fatal, are commonly seen among patients on HAART. Frequently, patients die at home and cause is not ascertained. Methods: Patients commenced on HAART were prospectively followed up over two years at an AIDS treatment center in Kampala, Uganda. Regular clinical review, and home visits to for missed clinical appointments were done, as well as verbal autopsy at death. Cause of death was determined from the diagnosis at the last clinic visit, combined with verbal autopsy. Results: Of 550 patients commenced on HAART and followed up for up to thirty months, with over 90% adherence, 72 died; 29 (40.3%) within 6 months of HAART, 24 % (33.3%) between 6-12 months and 19 (26.4%) after 12 months treatment. The commonest cause of death was cryptococcal meningitis (CM), 15 (20.1%), (9 within 6 months of HAART initiation), followed by Kaposi sarcoma 6 (8.3%), PCP 6 (8.3%), and chronic diarrhoea 5 (7%). Tuberculosis was surprisingly uncommon at the time of death, a cause of death in 3 patients, and a possible cause in 2 patients. Prurigo was a common associated feature at the time of death, 10 (13.8%) patients. Death was attributed to severe anemia in 3 patients, and lactic acidosis in two (both died after 12 months HAART). Three patients died after two years of HAART, (lactic acidosis, hypertension and sigmoid volvulus). Viral load at onset of HAART was high, mean 5.2 (SD 0.7) log among all deaths. Six month viral loads were available for only 20 patients, of whom 14 (70%) had adequate suppression. Conclusions: CM is a common cause of death among patients commenced on HAART, probably due to immune reconstitution syndrome. Efforts should be made to actively and regularly look for Ols even after start of HAART, especially within the first year of treatment. MOPE0080 Depression, insomnia, peripheral neuropathy, and fatigue: a cluster of HIV-related symptoms K.D. Phillips', L. Moneyham', A. Tavakoli', C. Murdaugh2, K. Jackson3. 'University of South Carolina, College of Nursing, Columbia, South Carolina, United States, 2University of Arizona, College of Nursing, Tuscon, Arizona, United States, 3University of South Carolina, Arnold School of Public Health, Columbia, South Carolina, United States Background: Depression (DEP), insomnia (INS), peripheral neuropathy (PN), and fatigue (FAT) are among the most frequent and bothersome symptoms of HIV disease. Their relationships to quality of life (QOL) have been studied individually, but not as a cluster of symptoms. The purposes of this analysis were to test whether these four symptoms form a symptom cluster in HIV disease and to test the relationship of this cluster of symptoms with QOL. Methods: A descriptive, correlational design was used. The sample consisted of 134 HIV-infected women living in the rural southeastern United States. Most of the women were poor African Americans who were single heads of household and living with their children. The Center for Epidemiological Studies Depression Scale was used to measure DEP. The Pittsburgh Sleep Quality Index was used to measure INS. Single items from the HIV Symptom Distress Scale were used to measure PN and FAT. QOL was measured using the Chronic Illness Quality of Life Ladder. Trained interviewers collected data using a structured interview. Results: Bivariate correlations were calculated using Pearson's r. Exploratory factor analysis was performed and Cronbach's alpha was calculated for the factor. Multiple regression was used to test the relationship of the four variables individually and collectively with QOL. Moderate correlations were observed among the independent variables and with QOL. DEP, INS, PN, and FAT loaded (>0.40) on a single factor (o = 0.72). The symptom cluster was significantly associated with all four temporal dimensions of QOL (p<0.0001) and explained more variance in QOL than the four variables individually. Conclusions: Our data suggest that these four symptoms form a cluster of HIVrelated symptoms. Interventions that address these symptoms simultaneously may be beneficial. MOPE0082 Implementing a HIV and STD testing program in the emergency department (ED) N. Glick', A. Silva2. 'Mt. Sinai Hospital, Internal Medicine/Infectious Diseases, Chicago, United States, 2Sinai Urban Health Institute, Chicago, United States Background: Emergency departments (EDs) have been shown to be effective venues for screening people for HIV and STDs. Furthermore, EDs are the only source of health care for many patients. We implemented a screening program to assess the feasibility, effectiveness, and cost of routinely recommended HIV/ STD screening in our urban emergency department (ED). Methods: From April 2003 to August 2004, patients 15-54 years were offered Monday 14 August Poster Exhibition XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  54 rapid HIV testing regardless of symptoms or risks and those 15-25 years were also offered gonorrhea and chlamydia (testing (nucleic acid amplification). Screening was offered Monday-Friday, 11AM-8PM. Infected patients were referred for treatment and care. Results: Among 3,030 patients offered HIV testing, 1447 (47.8%) accepted, 8 (0.6%) tested positive, and 3 (37.5%) were linked to care. Among 791 patients offered gonorrhea and chlamydia testing, 386 (48.8%) accepted, 320 provided urine (82.9%), 48 (15.0%) tested positive, and 42 (87.5%) were treated. The program cost was $71,402. Costs per HIV-infected patient identified and linked to care were, respectively, $8,925 and $23,801; costs per STD-infected patient identified and treated were, respectively, $1464 and $1,700. Screening for both HIV and STDs cost $13,192 more than screening for HIV only. Conclusions: Through ED-based HIV/STD screening, we identified and treated many STD-infected patients, but identified few HIV-infected patients. Identifying and linking to care more infected pathents would increase the effectiveness of HIV screening. STD screening can be added to HIV screening at a reasonable cost MOPEO083 Visual dipstick detection of HIV-1 genome in resource-limited settings M. Dineval, D. Candotti2, F. Fletcher-Brown', J.-P. Allain', H. Lee1. 'University of Cambridge, Cambridge, United Kingdom, 2National Blood Service, Cambridge, Cambridge, United Kingdom Background: The effective management of HIV infection and monitoring of antiretroviral therapy in resource-limited settings require access to simple nucleic acid-based tests (NAT) for HIV RNA detection. We did a survey at 32 district and local hospitals and clinics involved in the care of 18,000 HIV/AIDS patients in developing countries, showing that 70% of these sites lack basic resources and infrastructure to perform NAT with currently available assays. A semi-quantitative or a qualitative test would give the necessary information for infant diagnosis and HAART monitoring. Methods: We have developed the technology of rapid and visual detection of nucleic acid hybridization by dipstick. Dipstick assays have not been used for the nucleic acids detection, because of the inherent insensitivity of this format. To overcome this limitation, a signal amplification system was developed which enabled the rapid and sensitive visual detection. Results: Dipstick HIV RNA detection has been validated both, by testing a panel of HIV-1 subtypes (NIBSC, UK) and by blind testing 237 plasma HIV positive or negative samples from West Africa. The performance of the dipstick detection was compared with fluorescent TaqMan probe detection in Q-PCR System and showed 97.2% sensitivity and 100% specificity, as opposed to 97.2% and 98.5% for TaqMan PCR in African samples (36 HIV+ samples, viral load range 200 - 2000000 copies/ml and 201 negative samples). The dipstick assay detected all members of the subtype panel (subtypes A through H) and CRFO2 recombinant forms of HIV-1 with sensitivity equal to TaqMan PCR. Conclusions: These results demonstrate feasibility of an instrumentindependent and sensitive method for the detection of HIV-RNA. A new HIV NAT system is under development integrating this visual detection technology into a closed disposable, complemented by simple instrumentation that can be battery driven. MOPEO084 Influence of cytotoxic cells functional activity on the mother-to-child HIV-1 transmission A.B. Shemshura', L.V. Sveshnikova', S.Y. Poddubskaya', T.E. Kalinina2, S.R. Saukhat1. 'Rostov Research Institute of Microbiology and Parasitology, Rostov-on-Don, Russian Federation, 2Rostov regional AIDS-Center, Rostovon-Don, Russian Federation Background: Cellular immune responses play a important role in mother-tochild HIV-1 transmission. The influence of both altering functional activity of cytotoxic cells and viral replication on frequency of the mother-to-child HIV-1 transmission was assessed. Methods: CD4, CD8 T cell counts, CD56CD16 NK count, CD95, HLA DR, FasL expression on various lymphocytes subpopulations and HIV-1 plasma viral loads were measured in 55 HIV-infected women patients before delivery without ARV prophylaxis. Results: Patients who had transmitted HIV-1 to children exhibited lower level of CD8+FasL+ (95% CI, 2-4%), CD56+CD16+FasL+ cells (95% CI, 2-11%), and higher level of CD8+CD95+ cells (95% CI, 13-19%), in comparison with the group who didn't transmit HIV-1 to their children (95% CI, 6-10%; 13-18% and 6-12%, respectively). In the last group there were registered higher viral load, than in the first group. The correlation ratio between CD56+CD16+FasL+ count and viral load made 0.81. Conclusions: Our results suggest the possible role of cytotoxic cells functional activity in supression of viral replication and in probability of mother-to-child HIV-1 transmission. The evaluation of cell activation and apoptotic markers can provide diagnostic and prognostic benefits. MOPEOO85 Point of care lactate testing is an effective measure in supporting the WHO first-line regimen in settings with a high incidence of stavudine-related toxicity S. Mathee, M. Abrahams, N. Jackson', G. Van Cutsem2, Z. Szylagyil, T. Krombein', K. Hilderbrand2, A. Boulle3. 'Provincial Government of the Western Cape, Metro District Health Services, Cape Town, South Africa, 2Medecins Sans Frontieres, Cape Town, South Africa, 3University of Cape Town, School of Public Health and Family Medicine, Cape Town, South Africa Background: The Khayelitsha ART programme began in 2001 and since late 2003 has started all new adults on stavudine in line with national protocols. As patients have been on stavudine for longer, the number presenting with suspected sympomatic hyperlactataemia or lactic acidosis (SH/LA) has increased markedly, with many patients being referred to hospital for this to be confirmed or excluded. Traditional lactate measurement - sample storage on ice and tests run within 15 mintes - is impractical in resource-limited settings. In early 2005, point of care venous lactate testing of symptomatic patients with a hand held device was introduced. This study describes the experience with this technology. Methods: Prospective cohort study of of all regimen substitutions since 2001, combined with a register started in 2006 of point-of-care lactate testing (Roche, AccutrendTM), documenting values and subsequent management. Patients with lacatate values above 4 mmol/l were referred to hospital, and those between 2.5 and 4.0 substituted within the primary care system if clinically stable. Results: Of 34 patients who had stavudine substituted due to SH/LA, 19 were substituted within the primary care system (changed to zidovudine) based on point-of-care testing, with one of these patients subsequently referred to hospital after the lactate levels failed to resolve. 39/63 patients tested on symptomatic grounds had levels above 2.5, 18 of whom had levels above 4.0 and were referred to hospital. Symptoms most closely correlated with markedly elevated values were, in order of importance, acute weight loss, peripheral neuropathy and abdominal pain. Conclusions: Point-of-care lactate testing, if based on appropriate clinical indications, is a rational and effective tool for early detection of hyperlactataemia. The ability to rapidly rule out or confirm hyperlactataemia in symptomatic patients has contributed enormously to clinician confidence, and saves patients referral resources. Costs of current tests are however too high, and more producers are needed. MOPEOO86 Saving the cost of CD4 determination by diluting the monoclonal antibodies S. Sadoh', T. Pankam', C. Suphatchara2, S. Sirivichayakul3, S. Tantipaibulvut2, P. Phanuphak2. 'The Thai Red Cross AIDS Research Centre, Laboratory, Bangkok, Thailand, 2The Thai Red Cross AIDS Research Centre, Bangkok, Thailand, 3Chulalongkorn University, Bangkok, Thailand Background: Immunologic (CD4) monitoring is essential for initiating antiretrovirals and for monitoring treatment outcome. Cost is a limiting factor in most resource-limited coumtries. Here, we reported the results of diluting CD4 monoclonal antibody as a means for cost saving. Methods: One hundred HIV-infected individuals with different ranges of CD4 counts{CD4<200(N=48), 201-400(N=36)and > 400(N=16)cells/cumm} from the Thai Red Cross Anonymous Clinic were enrolled for the study. Three dilutions (undiluted, 1:2, 1:4) of Cytostst 45/4/3 monoclonal antibodies (Beckman Coulter, USA) were used for CD4 staining. The CD4 counts were accomplished by EpicXL (Beckman Coulter, USA). The paired t-test was used to evaluate the correlation. Results: We found that a more diluted reagents for CD4 staining could be reliably used. As a groups, the means of %CD4 among different dilutions of Cytostst 45/4/3 are 12.81+8.81,12.68+8.88 and 12.62+8.85 for undiluted, diluted 1:2 and 1:4, respectively. The means of absolute CD4 were 237.03+189.05, 235.26+191.06 and 234.75+189.84 for undiluted, diluted 1:2 and 1:4, respectively. The correlation ( r ) among these comparisons were 0.997 between for undiluted and diluted 1:2 and 1:4 both % CD4 and absolute CD4 counts. The correlation did not differ whether absolute CD4 was above or below 200 cell/cumm. Conclusions: By using less amount of Cytostst 45/4/3, the costs of staining reagents for CD4 evaluation can be reduced from US$ 9.8 if undiluted to US$ 4.9 and US$ 2.4 if diluted 1:2 and 1:4, respectively. Such cost-saving approach is extremely important for resource-limited counters. MOPEOO87 State-of-the-art HIV testing - combined rapid and HIV RNA testing in a public STD clinic, San Francisco, 2004-2005 S. Philip, K. Ahrens, G. Nieri, R. Kohn, B. Louie, S. Liska, C. Kent, J. Klausner. San Francisco Department of Public Health, San Francisco, United States Background: STD clinic patients are at increased risk for HIV infection, but may not return to receive conventional testing results. Persons with acute HIV infection (HIV antibody negative but detectable HIV ribonucleic acid (RNA)) are at increased risk of transmitting HIV because of high viral loads and unknown infection status. Advances in HIV testing technology allow for highly sensitive testing for HIV RNA, ensuring identification and counseling of patients with acute infection. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  55 Methods: Patients at risk of HIV infection are offered confidential HIV testing at the San Francisco municipal STD clinic. Select high-risk patients (criteria: unprotected anal sex, unprotected vaginal sex with HIV+ or unknown partner with risk factors, concurrent STD, or high likelihood of loss to follow up) are tested onsite with rapid antibody tests (Oraquick Advance HIV-1/2 Antibody Test, Orasure Technologies Inc.). Persons who are rapid test negative are tested for HIV RNA (Versant 3.0, Bayer Laboratories) at the Public Health Laboratory using a one-stage pooling of 10 serum specimens, with results available within 10 days. Positive HIV RNA tests are confirmed by follow-up antibody testing. Results: Beginning in December 2003, 510 persons had rapid HIV antibody tests: 34 (6.7%) were HIV positive. Among the 476 persons with rapid antibody negative tests, 6 (1.3%) were RNA positive and all 6 later had detectable HIV antibodies. Rapid antibody tests identified 85% (34/40) of HIV infections. HIV RNA screening increased HIV case detection by 17.6% (6/34). Conclusions: Acute HIV infection screening can be incorporated successfully with rapid antibody testing. The combination of rapid HIV antibody testing and HIV RNA screening assured that most infected patients learned their test results immediately and helped identify an additional 18% of those with HIV infection. Furthermore, patients with acute infection were identified and counseled when highly infectious, thereby potentially averting transmission to their partners. MOPEO0088 A quantification of HIV-1 group M proviral DNA using a TaqMan MGB real-time PCR M. Kondo', K. Sudo', R. Tanaka2, T. Shima', H. Sagara3, S. Iwamuro4, Y. Takebes, S. Kato2, M. Imai6. 1Kanagawa Prefectural Institute of Public Health, Division of Microbiology, Chigasaki, Japan, 2Keio University School of Medicine, Departent of Microbiology and Immunology, Tokyo, Japan, 3yokohama Municipal Citizen's Hospital, Yokohama, Japan, 4Atsugi City Hospital, Atsugi, Japan, sNational Instituteof Infectious Diseases, AIDS Research Center, Tokyo, Japan, 6Kanagawa Prefectural Institute of Public Health, Chigasaki, Japan Background: It is becoming a wider agreement that proviral HIV-1 DNA levels in peripheral blood mononuclear cells could be a useful marker for exploring viral reservoirs and monitoring antiretroviral treatment, particularly when HIV-1 RNA is undetectable in plasma. We have developed a new protocol of a TaqMan real-time PCR assay to quantify proviral DNA of HIV-1 group M subtypes. Methods: The PCR primers and TaqMan MGB probe were designed in a gag p24 region that is the least variable among HIV-1 group M isolate sequences obtained from the Los Alamos HIV databases. The real-time PCR assay was evaluated using cultured cell DNA 19 HIV-1 clinical isolates belonging to subtypes A, B, C, AE, F and G. This was conducted by comparing with quantification of the same samples by the Poisson distribution analysis of nested PCR results. The standard curve was generated from dilutions of HIV-1 DNA clone NL432 with a known copy number. Results: The real-time PCR was able to detect as few as 4 copies of HIV-1 DNA, and the quantification provided a good linearity in a range from 4 to 5000 copies of HIV-1 DNA (r2=0.984). HIV-1 DNA was undetected in all 40 HIV negative samples. In 19 HIV-1 clinical isolates of subtypes A, B, C, AE, F and G, the real-time PCR assay agreed closely with the Poisson analysis limited dilution PCR (r2=0.988, regression coefficient =0.983). The intra- and interassay coefficients of variability for these samples were 1.0% to 35.9%. Conclusions: Our real-time PCR assay has high sensitivity, linearity, reproducibility and accuracy. This assay will be useful for quantification of HIV1 group M provirus and for long-term evaluation of antiretroviral treatment efficacy. MOPE0089 Prevalence of HIV-1 antiretroviral resistance among Brazilian patients R. Diaz', C. Barreto2, E. Sabino3, R. Rodrigues4, J.E. Ferreiras, R. Corria6, S. Oliveira', P. Chequer6. 'UNIFESP, Infectious Diseases Division, Sao Paulo, Brazil, 'Universidade de S~o Paulo, Laboratorio de InvestigagAo Medica em Dermatologia e Imunodefici~ncia, Sao Paulo, Brazil, 3Fundago Prd-Sangue, HEMOCENTRO de S~o Paulo, Sao Paulo, Brazil, 'Instituto Adolfo Lutz de S~o Paulo, Sao Paulo, Brazil, sUniversidade de So Paulo, Instituto de Matematica e Estatistica, Sao Paulo, Brazil, 6Programa Nacional de DST/AIDS, Sao Paulo, Brazil Background: Since 2001, the Brazilian AIDS program has implemented a laboratory network (RENAGENO) to perform HIV-1 genotypic resistance testing for patients falling antiviral therapy, including 18 laboratories distributed throughout different regions of the country. A committee of Brazilian experts developed an algorithm for online interpretation of mutation patterns, and guidelines and recommendations for the use of resistance testing. Workshops were organized to train 265 reference physicians to serve as expert and to provide interpretation of resistance testing to other attending physician. The objective of this study was to evaluate the prevalence of drug resistance according to the Brazilian algorithm interpretation. Methods: A total of approximately 12,000 pol sequences were generated from 2002 to 2005. In this analysis, 2433 sequences from 4 different reference labs were included, and resistance profile was determined according to the Nov 2005 version of the Brazilian interpretation algorithm (www.aids.gov.br/ genotipagem). Results: The table below shows the percentage of antiretroviral resistant for each available drug in Brazil. Antiretroviral AZT DDI 3TC D4T TDF EFV NVP % of Resistance 46 40 68 54 27 53 55 Antiretroviral APV/r SQV/r IDV/r LPV/r NFV %/ of Resistance 24 39 39 16 60 ATV 33 A total of 126 samples (5%) were sensitive to all drugs, and 76 (2%) presented full resistance to all antiretrovirals. Conclusions: Besides the clinical utility of the testing for salvage therapy, the surveillance of drug resistance pattern will enable the AIDS program to build guidelines and optimize the use of new available antiretrovirals. MOPEO090 Comparison of local versus central laboratory viral load testing: implications for clinical trial outcomes S. Walmsley', R. Harrigan2, A. Thorne3, CTN 164 Study Group. 'University Health Network, Medicine, Toronto, Canada, 2BC Center for Excellence, Virology, Vancouver, Canada, 3Canadian HIV Trials Network, Data Collection and Statistical Analysis, Vancouver, Canada Background: To examine differences between local and central laboratory determinations of HIV RNA. Methods: CTN 164 was a randomized trial comparing responses to salvage ARV with an immediate switch compared to a pre-switch 12 week treatment interuption. The primary outcome was a 90 day sustained viral load < 50 copies/ml while on original salvage therapy. Viral loads were determined at a local laboratory, with duplicate samples stored and frozen and forwarded to a central lab for standardization by Roche ultrasensitive PCR test if < 1000 copies/ml. Results: For 930 study viral loads, the local laboratory assays used were RNA PCR 44%, bDNA 51%, and NASBA 5%. Of the 500 (54%) sent to the central lab, 497 are available for analysis. The central lab confirmed local values in 62%, with all but one < 50 copies/ml. Of the remainder, 14% were within 50 copies/ml, 8% within 50-100 copies/ml, and 3% > 500 copies/ml, with the largest difference 2023 copies/ml. In the 314 cases where the local lab reported < 50 copies/ml, 94% were confirmed by the central lab, and 5% were within 100 copies/ml. There were 37 cases (7% of the 497) where the local value was > 50 copies/ml and the central value < 50 copies/ml, with some differences >600 copies/ml. Overall, agreement on the endpoint between labs, using a 50 copies/ml cutoff, was 89%. Using a cutoff of 400 copies/ml, agreement would be 98%. Conclusions: These data highlight the need for standardization of viral load determination when used as a clinical trial primary endpoint. Although the majority < 50 copies/ml in a local laboratory were confirmed centrally, 6% were not, and a significant number of local determinations were discrepant with the central lab in the opposite direction. Using < 400 copies/ml as an endpoint was more reliable, as agreement between labs was 98%. MOPE0091 The HIVRMI: a new affordable quantitative HIV monitoring tool L.E. Scott', W. Stevens2, D. Lawrie', D. Glencross2. 'University of the Witwatersrand, Molecular Medicine and Haematology, Johannesburg, South Africa, 'University of the Witwatersrand and National Health Laboratory Services, Molecular Medicine and Haematology, Johannesburg, South Africa Background: Quantitation of virus reservoirs in monocyte/macrophages endosomes is an alternative approach to quantitating plasma viral load for HIV monitoring. A new assay, the HIVRMI (reservoir monitoring index) is introduced with the hypothesis of measuring these cellular reservoirs or increased cell response to HIV production. HIVRMI measures increasing mean thiazole orange fluorescence in monocytes of HIV-infected individuals by flow cytometry as a ratio of the background granulocyte fluorescence. Methods: A cohort of 18 patients pre-ARV-12 weeks were measured for changes in CD4 count, HIVRMI and log viral load to determine the application of HIVRMI for patient management. Results: The mean viral load for the five visits was 3.2(1.7-5.8)c/ml, the HIVRMI 1.5(1.04-5.27) and the CD4 count 217(13-573)cells/ppl. No direct correlation was found between plasma viral load and HIVRMI for random samples n=90 (r=0.107, p=0.314). This is due to the HIVRMI increasing where no change in plasma viral load was detected. The CD4 count increased, viral load decreased and the HIVRMI decreased over visits as expected in response to therapy in 22.3% of patients. In 27.7% the HIVRMI showed increases before any changes occurred in the CD4 count or viral load. In 50% the HIVRMI increased where a decrease in the CD4 count was detected with no change in the viral load. Conclusions: The HIVRMI appears useful for longitudinal monitoring as an early and sensitive indicator of virus production/cell activity. A single HIVRMI result is not useful for direct conversion to a plasma viral load value, but changes detected by the HIVRMI not yet reflected in the plasma viral load may explain the non-response in the CD4 count. In addition this assay is rapid (<1hour result) and affordable (<$10) with the added option of combining additional cell markers such as a CD4 count measured in a different fluorescent channel. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  56 MOPEOO92 suPAR baseline levels in children at time of ART initiation is predictive of treatment efficacy J. Eugen-Olsen', J. Nuttall2, R. Ryt Hansen', H. Westh', G.D. Hussey2, B. Eley2'. 'Copenhagen University Hospital Hvidovre, Clinical Research Unit, Hvidovre, Denmark, 'Red Cross Childrens Hospital, Dept. of Paediatrics and Child Health, Cape Town, South Africa, 3Copenhagen University Hospital Hvidovre, Dept. of Clinical Microbiology, Hvidovre, Denmark Background: Response to ART differs among children initiating treatment with advanced disease. Here we investigate whether soluble urokinase receptor (suPAR) levels are predictive of treatment response. Methods: 29 South African children (16 boys) were enrolled into study. Mean age at inclusion were (SD): 45.2 + 34.8 months. 19 children had CDC stage B disease and 10 stage C disease. Children were treated with d4T, 3TC plus ritonavir or efavirenz. Two blood samples were drawn before treatment (-7 days and day 0). Thereafter, samples were drawn on 1 day, 1 week, 1, 3, 6, 9, and 12 months. SuPAR was measured using ELISA (ViroGates SA, Cape Town, South Africa). HIV viral load (pVL) was measured using the Amplicor assay (Roche). Resistance was determined using the ViroSeq assay (Applied Biosystems) at inclusion and after 12 months. Comparison between groups was carried out using 2-tailed Mann-Whitney tests. Results: During the study, 3 of the 29 children died (2 after 1 month and 1 after 6 months) and four were lost to follow-up after one month (3) or 9 months (1) of treatment. Median suPAR at inclusion was 5.3 ng/ml (range 1.9-42.0), median log10pVL was 5.9 (4.8-7.1) and median CD4 was 578 (0 -2060). One year of treatment lead to lower suPAR levels in 21/22 children. Children were divided into two groups according to median suPAR at inclusion. The 3 children that died were from the high-suPAR group. After 6 months of ART, 13/24 children had undetectable pVL, 11/14 in the low-suPAR group and 2/10 in the high-suPAR group (p=0.002). After 12 months, 13/13 children in low-suPAR group and 5/9 children in high-suPAR group had undetectable pVL. Children with detectable pVL developed drug associated resistance mutations. Conclusions: This first study of suPAR and treatment efficacy in HIV-infected children indicate that suPAR may be a predictor of treatment outcome. MOPEO093 New challenge for countries with limited resources: early diagnosis of HIV infection for children under 18 months - first evaluation of WHO clinical diagnosis proposed in December 2004 (revised in November 2005) on 106 children in Kigali, Rwanda C.A. Peltier', M.P. Cyaga2, J. Mukherjee3, G. Tuyishime4, C. Omes', N. Muganga6, V. Arendt'. 'Lux Development, Department of pediatrics- CHU of Kigali-Rwanda, Kigali, Rwanda, 2Lux Development, ESTHER Project in Rwanda, Kigali, Rwanda, 3Partner in Health, Harvard University, Harvard, United States, 4CHU of Kigali-Rwanda, Department of pediatrics- CHU of Kigali-Rwanda, Kigali, Rwanda, 5Lux Development, ESTHER project, Kigali, Rwanda, 6CHU of Kigali-Rwanda, Department of pediatrics-Rwanda, Kigali, Rwanda, 'CHU Luxembourg, Infectious Deseases, Luxembourg, Luxembourg Background: All infants born to HIV-positive mothers have maternal HIV antibodies. Definitive diagnosis is only possible using advanced technical approaches such as PCR (DNA, RNA). Recent WHO recommendations suggest that clinical criteria could be used to make a presumptive diagnosis of clinical Stage 4 disease (AIDS) and initiate HIV treatment in young children when PCR is not available. These criteria suggests that ARV should be initiated if children have two or more of clinical or immunological signs:-sepsis-severe -pneumonia-severe malnutrition-thrush or CD4< 25%. Methods: From January to July 2005, we conducted a prospective study on 106 hospitalized children less than 18 months old with positive HIV serological test at CHU de Kigali. The following data was collected: DNA -PCR (Amplicor Roche), clinical and immunological WHO criteria and absolute CD4 count. Absolute CD4 count was measured with a Cyflow counter and CD4 percent was estimated by the following algorithm: CD4 < 1500=CD4 < 25 % (1994 CDC Atlanta). Results: Forty-eight (45,3 %) of the 106 children (aged from 1 to 17 months) were confirmed to be infected with HIV using DNA-PCR.Clinical criteria proposed by the new WHO recommendations were present in 33 children of the 48 HIVinfected children given a 68,8 0/0 o v a, 0f specificity for HIV infection in comparison to the gold standard DNA-PCR. The clinical signs have a positive predictive value of 68,8 % and a negative predictive value of 74,1 %. Using a cut-off of absolute CD4 under 1500 for children under 18 months demonstrated a sensitivity of 70,8 % and a specificity of 63,8 % with a positive predictive value of 61,8 % and a negative predictive value of 72,5 %. Conclusions: As PCR is not yet widely available, clinical diagnosis is necessary. However current criteria have a very poor sensitivity and specificity. MOPEO094 Viral load monitoring is critical to assess early paediatric response to highly active antiretroviral therapy in a resource limited setting: the Ugandan experience R.A. Kekitiinwal, M. Sekadde2, S. Bakeera Kitaaka3, I. Kalyesubula3, C. Pitter', D. Thomas4, S. Kelly', M. Kamya', M. Kline6, A. Magandal. 'Baylor College of Medicine International Pediatric AIDS Initiative, Retrovirology, Kampala, Uganda, 'Infectious Diseases Institute, Paediatrics, Kampala, Uganda, 3Pediatric Infectious Diseases Clinic, Makerere Medical School/Mulago Hospital, Paediatrics, Kampala, Uganda, 4Infectious Diseases InstituteMakerere University, Research, Kampala, Uganda, 'Infectious Diseases Institute- Makerere University, Medicine, Kampala, Uganda, 'Baylor College of Medicine International Pediatric AIDS Initiative, Retrovirology, Houston, United States Background: CD4+ T cell responses are brisk in HIV -positive children receiving highly active antiretroviral therapy (HAART). We hypothesized that CD4+ T cell responses are sensitive markers of HAART-related viral suppression in children. Methods: 240 HAART-naive, HIV-infected children were initiated on HAART between January and June 2005. Virologic and immunologic success was defined as < 400 copies/ml and _10% (>_ median) CD4 rise after 6 months of therapy, respectively. The kappa statistic was used to measure the agreement between immunologic and virologic responses. Logistic regression was used to determine factors associated with discordance after adjusting for gender and baseline CD4%. Results: Discordance between Immunologic and Virologic Response to HAART Viral Load (Copies/ml) after 6 months CD4% Increase after 6 months < 400 > 400 Total >10% <10% Total 93 (38.8%) 24(10.0%) 117 (48.8%) 84 (35.0%) 39 (16.3%) 123 (51.2%) 177 (73.7%) 63 (26.3%) 240 (100%) Contrary to our hypothesis, there was low agreement between tests: kappa (N=240) =0.1106; (standard error 0.056; Confidence Interval (CI), 0.02-0.20; p=0.049). For prediction of virologic response, immunologic response was not sensitive (52. %) nor specific (61.9%) and the negative predictive value was 31.7%. Discordant responses were five fold more likely in children <5 years of age (OR, 5.04; CI, 2.11-12.06; p=0.000) compared to those who are greater than 5. In fact, in children <5, the sensitivity of immunologic monitoring for viral suppression is only 67.6% and the negative predictive value is 38.9%. Conclusions: These data underscore the importance of virologic monitoring of HAART in children since immunologic monitoring was an insensitive marker of viral suppression. Key definitions: All confidence intervals (CI) were calculated at 95%. MOPEO095 A concurrent real-time quantitation/subtyping protocol for HIV-1 S. Wong, C. Tolzmann, J. Bremer, D. Huang. Rush University Medical College, Department of Immunology/Microbiology, Chicago, United States Background: Our real-time non-nested multiplex RT-PCR protocol concurrently quantifies and identifies the subtype of HIV-1 group M strains. Full-length cDNA copies of HIV-1 viral genome are used directly for quantitation and the WRAIR multiregion hybridization assay (MHAacd). Methods: cDNA made from virion RNA using a LTR primer is template for both quantitation and MHAacd assays in the same wells. A set of PCR primers and VIC probe designed from consensus subtype sequences for quantitation to detect the protease gene was added to the MHAacd real-time PCR primers and FAM probes. MHA PCR assay conditions allowed parallel detection. Quantitation standards are plasmids carrying a subtype B insert containing protease diluted serially to 50 - 5x106 input copies. The composite protocol was tested using lysates and cDNA made from NED panel-infected cells and cultured virus or clinical plasma samples. Results: The quantitation primer and probe set, separately from the MHA, detects all subtypes and recombinant strains in the 44 member NED panel and clinical B isolates, but not group O strains. Combined, the real-time portion of the MHAacd performs as expected using subtype strains in the NED panel originating from or near the geographic regions for which the assay was designed. MHAacd also identifies subtype A, C and D panel strains from more diverse geographic areas. cDNA of subtypes A,B,C,D, CRF_02AG and CRF_06 are detected consistently in both the quantitation and MHAacd assays. Replicates of cDNA diluted to -1,000 input copies/well yield MHAacd data and consistent quantitation, including those wells negative for MHA probe detection. Conclusions: Subtype identification and quantitation of plasma virions is accomplished together in this non-nested multiplex protocol. Adding quantitation to the MHA AIDS the interpretation of data where no MHA probe binding is detected. The protocol will provide flexibility needed to assess dualsubtype and recombinant infections and potential for clinical diagnosis. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  57 MOPEOO96 Affordable CD4 enumeration A. Ymetil, X. Li', B. Lunter', C. Breukers', S. Brinkers', A.G.J. Tibbe2, L.W.M.M. Terstappen3, J. Greve'. 'University of Twente, Faculty of Science and Technology, Biophysical Engineering, Enschede, Netherlands, 2Immunicon Europe Inc., Enschede, Netherlands, 3lmmunicon Corporation, Huntington Valley, United States Background: CD4+ T-lymphocyte counts are generally used for monitoring HIV patients. Flow cytometry is the golden standard for this purpose, however it is rather expensive and complicated for use in resource-poor countries. Therefore, development of easy-to-use, affordable point-of-care methods is an immediate need. Methods: We developed an affordable method for point-of-care CD4 enumeration. In this method, whole blood is diluted with buffer and incubated with CD4-paramagnetic particles together with CD3-PE. The sample is then introduced in a magnetic field whereupon the immuno-magnetically labeled CD4+ cells are collected at a test surface. A CD3+CD4+ T-lymphocyte count is achieved by counting the immuno-fluorescent lymphocytes at the test surface. 470 nm high-power LEDs illuminate the sample directly and excite the PE fluorescence. The PE signal is filtered by a 595 emission filter and a 6.8x enlarged image is projected onto a high performance low cost CCD camera. The captured image is downloaded to a single board computer, which is operated via a touchscreen monitor, and analyzed with a dedicated algorithm. For blood with a CD4+ T-lymphocyte count of 50 pl', this system yields an accuracy of <15%. The prototype instrument (25cm x 25cm x 20cm) runs on a 12 V rechargeable battery and (single unit commercial) component costs were C 2,500. Results: The performance of the method was evaluated by comparison with flow cytometry (FCM). A good correlation between our image cytometer and FCM was obtained for 63 HIV positive patients (R=0.97, slope 0.98). BlandAltman comparison showed a bias of -1.4%. Cell counts can be obtained within 40 min after blood draw and one operator can analyze about 40 specimens in 8 hrs with one instrument. Conclusions: Our image cytometer is an absolute, compact, stand-alone, easy-to-use and affordable instrument that can be applied for point-of-care HIV monitoring in resource-poor countries. Field-testing in resource-poor countries is now relevant. MOPEO097 The advantages of using the MagNA PC automated nucleic acid extraction followed by real-time reverse transcriptase-PCR for determination of HIV-1 viral RNA load in Malawi T.-C. Hsieh', K.-L. Yu', J.-Y. Yang2, C.-C. Chen3, K. Liu3, W.-S. Chang4, R. Mwendas, H. Juma6. 'Taiwan Medical Mission in Malawi, Mzuzu, Malawi, 2Center of Diease Control, Department of Health, Taipei, Taiwan, Republic of China, 3Ping-Tung Christian Hospital, Pingtung, Taiwan, Republic of China, 4Bureau of International Health, Department of Health, Taipei, Taiwan, Republic of China, 5Technical Support, Ministry of Health, Lilongwe, Malawi, 6Mzuzu Central Hospital, Ministry of Health, Mzuzu, Malawi Issues: HIV viral RNA load is an important index for ARV (antiRetrovirus) treatment. However, the HIV viral load tests are usually expensive and technique-intensive. We have developed a convenient, sensitive real-time reverse transcription-PCR assay for HIV-1 RNA based on resource-limited setting. Description: There are three major commercial methods that are approved by the U.S FDA for the measurement of HIV-1 viral RNA load in plasma. But it is difficult if we want to introduce them in developing countries. Especially the step of nucleic acid extraction needs well-trained laboratory technicians to make sure the quality. The Roche MagNA PC automated nucleic acid extraction system provides more reproducibility and ease of performance than manual extraction. The product of automated nucleic acid extraction is quantified by Roche LightCycler 1.5 real-time PCR system. The detection limit is 500 RNA copies/mL and the range is linear up to at least 10^8 copies/mL. The automated system can process 8 specimens in 30 minutes with only one technician. The technician who does the test doesn't need to be good in experimental skills but to know how to push the buttons only. In order to lower the cost, we have developed in-house HybProbe assay for Roche LightCycler system. The cost of our assay is USD20/test. Comparing to the commercial methods, which are about USD40/test, it is a more economical choice. Lessons learned: To set up a new test in resource-limited countries needs more consideration on cost, human resource, and supply. We successfully developed a lower-cost, manpower-saving, and sensitive HIV viral RNA load assay for ARV patients in Malawi. Recommendations: The real-time PCR system is not for single purpose. Changing primer/probe sets can fit in most of the microorganisms. It will be a very powerful tool for virology and bacteriology diagnosis in developing countries. MOPE0098 The HIV-1 RNA real time PCR: a low cost strategy to diagnose HIV infection in infants born from HIVinfected mothers in Cambodia and Viet Nam S. Ngin', L. Truong thi Xuan2, L.S. Kruy3, A.H. Do Lien2, T. Tran Chi2, V. Ung4, J. Nouhin', S. Tun', F. Barre-Sinoussis, M. Burgard6, C. Rouzioux6, E. Nerrienet1. 'Institut Pasteur du Cambodge, Phnom Penh, Cambodia, 2Institut Pasteur d'Ho Chi Minh City, Ho Chi Minh, Viet Nam, 3Hopital Calmette, Phnom Penh, Cambodia, 4National Pediatric Hospital, Phnom Penh, Cambodia, 5lnstitut Pasteur, Unite de Rdgulation des Infections Rdtrovirales, Paris, France, 6CHU Necker- Univ Paris 5, Paris, France Background: Programs for the prevention of mother to child (PMTCT) transmission of HIV have been implemented in Cambodia and Viet Nam. However, the early diagnosis of HIV infection in infants born from HIV-infected mothers remains one of major concern. The conventional approaches are not adapted in routine mainly because they remain too expensive. There is an urgent need for low-cost HIV-1 early diagnosis and viral load (VL) monitoring technologies to improve the biological and medical follow up of the HIV-infected children. Methods: To implement and evaluate a low-cost alternative strategy, the HIV1 LTR RNA real time RT PCR, to early diagnose HIV infection in infants in Cambodia and Viet Nam. 339 blood samples collected from 99 HIV-1 DNA positive and 240 HIV-1 DNA negative children were tested by the HIV-1 RNA LTR real-time RT-PCR assay, as standardized by the ANRS, against the detection of HIV-1 DNA in peripheral blood mononuclear cells by nested PCR Results: All the 240 HIV-1 DNA negative samples had undetectable HIV-1 RNA by real time. The specificity of the real time was 100% (95% CI, 90 to 100%). All the 99 HIV-1 DNA positive samples presented a detectable viral load by real time, yielding a sensitivity of 100% (IC 95%: 97.3 to 100%). Conclusions: The HIV-1 RNA real time PCR test provided a significant virologic contribution to the early diagnosis of HIV infection. This technique (actually 25 USD per test) is now routinely used to diagnose HIV infection among babies, and for the virological follow up in adults, in our laboratories. MOPEO099 Evaluation of immunologic monitoring to identify patients with virologic failure after initiation of antiretroviral therapy in rural Uganda D. Moore', A. Awor2, R. Downing2, W. Were2, P. Behumbiize2, J. Mermin2. 'British Columbia Centre for Excellence in HIV/AIDS, Entebbe, Uganda, 2US Centers for Disease Control and Prevention, Global AIDS Program, Entebbe, Uganda Background: WHO guidelines for resource-limited settings state that CD4 cell counts may be used to monitor response to antiretroviral therapy (ART). However, their performance in terms of predicting viral load (VL) changes has not been evaluated. Methods: Participants from the Home-Based AIDS Care program in Tororo, Uganda aged >_18 years, who had CD4 cell counts _250 cells/pL or WHO stage III or IV disease were offered lamivudine, stavudine and nevirapine, as the primary ART regimen. CD4 counts, CD4 percentages and VL were measured at 3- monthly intervals. Logistic regression was used to generate receiver operator characteristics curves to determine which immunologic measures were best able to identify subjects with VLs >500 copies/mL at 6 and 12 months after treatment initiation. Results: 1111 subjects initiated ART. The median baseline CD4 cell count was 128 cells/ pL. The median CD4 cell count increases at 6 months and 12 months were 161 and 185 cells/ pL, respectively. VLs <500 copies/mL occurred in 96.2% and 94.8%, at six and 12 months, respectively. Of the 46 subjects who had VLs > 500 copies/ mL at 12 months, 40 (87%) had CD4 cell count increases. Of the 16 subjects who had no CD4 cell count increases at 12 months, 10 (62.5%) had VLs < 500 copies/ mL. Using no CD4 count increase at 6 months to predict VL >500 copies/ mL at 6 months resulted in a sensitivity of 0.08 and a PPV of 0.08. Using no CD4 increases at 12 months to predict VL>500 copies/ mL at 12 months had a sensitivity of 0.13 and a PPV of 0.38. Using other CD4 increase-, CD4 percentage- or absolute CD4 count-thresholds to define treatment failure did not improve predictive value. Conclusions: Failing to achieve immunologic thresholds does not accurately identify those with viral loads > 500 copies/mL. MOPEOIO0 Absolute lymphocyte count and WHO pediatric clinical stage as markers to assess need to initiate antiretroviral therapy among HIV-infected children in northern Tanzania O.O. Johnson', D.K. Benjamin Jr.', W. Schimana2, D.K. Benjamin', K. Landman4, L.G. Tillekeratne4, J.A. Crump4, G.D. Kinabo2, M. Swai2, J.F. Shao2, B.T. Mmbaga2, L.J. Msuya2, C.K. Cunningham'. 'Duke University Medical Center, Department of Pediatrics, Durham, United States, 2Kilimanjaro Christian Medical Centre, Department of Pediatrics, Moshi, Tanzania, United Republic of, 3Clemson Univeristy, Department of Economics, Clemson, United States, 4Duke University Medical Center, Department of Medicine, Durham, United States Background: The World Health Organization (WHO) recommended that clinical staging with absolute lymphocyte count (ALC) be used to help identify Monday 14 August Poster Exhibition XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  58 HIV-infected children in need of antiretroviral therapy (ART) in resource-limited settings. Studies in developed countries have assessed the accuracy of lowcost laboratory and clinical markers, but data from developing countries are limited. This prospective cohort study was conducted to determine if clinical staging with ALC allows improved identification of children with severe immunosuppression (defined as CD4%<15, 12-59 mo; CD4<200/mm3, >60mo of age) compared to clinical staging alone. Methods: Children obtaining care for HIV infection at an outpatient clinic at Kilimanjaro Christian Medical Centre in Moshi, Tanzania between March 2004 and Feb 2006 were enrolled. Questionnaires were administered; medical records reviewed for demographic data, medical history, growth parameters and preART WHO clinical stage; and laboratory results including ALC, hemoglobin and CD4 cell count. Results: Of 127 subjects currently enrolled; median age was 7.1 (range 0.2 -15.8) years and 67(53%) were female. Eighty-five (67%) met criteria for WHO pediatric HIV clinical stage 3 or 4. Prior to ART initiation, 59 (46.5%) were severely immunosuppressed of whom 49 (38.5%) had ALC <2500cells/mm3 and 38 (30%) had ALC <2000cells/mm3. Weight-for-age z-score identified 39 (30.7%) as severely wasted, and height-for-age z-score identified 36 (28.3%) as severely stunted. Values predicted severe immunosuppression to the following accuracy: ALC<2000cells/mm3 sensitivity=0.47 (95% CI 0.35, 0.59), specificity=0.85 (0.74, 0.91); ALC <2500cells/mm3: sensitivity=0.83, (0.71, 0.90), specificity=0.71 (0.58, 0.80) and WHO pediatric stage 3 or 4: sensitivity=0.72, (0.62, 0.81), specificity=0.46 (0.32, 0.61). Growth failure was not associated with severe immunosuppression. Conclusion: The use of ALC<2500 cells/mm3 and WHO stage 3 or 4 as markers to initiate ART may serve as a useful tool in managing HIV among children in developing nations with limited access to CD4 testing techniques. This observation requires confirmation in a larger cohort. MOPE0101 Investigating MTB-specific immune responses related to mycobacterial infection in HIV-infected patients A. Hammond', A. Jaye2, S. McConkey3, P. Hill', M. Gomez', H. Whittle2, S. Crozier2, M. Klein4, R. Adegbola', R. Brookes', S. Rowland-Jones2. 'Medical Research Council, Bacterial Diseases Program, Banjul, Gambia, 2Medical Research Council, Viral Diseases Program, Banjul, Gambia, 'Royal College of Surgeons in Ireland, Dept. of International Health & Tropical Medicine, Dublin, Ireland, 4Leiden University Medical Center, Dept. Immunohaematology and Blood Transfusion, Leiden, Netherlands, s'Sanofi Pasteur, Immunology Research, Toronto, Canada Background: Although patients with advanced HIV have poor reactivity to many antigens, they are more susceptible to mycobacterial infections and progress to TB disease faster. Regardless of HIV status, the mechanisms underlying reactivation of Mycobacterium tuberculosis (MTB) are poorly understood. Recent studies both in human and animal models have shown ESAT-6 and CFP-10 (two closely related antigens) to have the ability to induce IFN-gamma responses with improved specificity over PPD-tuberculin and can distinguish recent and active infection. Methods: We investigated T cell reactivity and the phenotype of the cells mostly involved by monitoring immune responses to mycobacterial antigens (including ESAT-6, CFP-10, PPD-tuberculin and PPD-avium) in ex-vivo ELISPOT and ICS using cells obtained from HIV-infected patients with differing CD4 counts. Results: Our results show that (i) even at low CD4 count high levels of IFNgamma responses were detected, (ii) as the CD4 count reduces, there is a decreasing trend in the proportion of HIV-infected individuals that responded to PPD-tuberculin by ELISPOT, (iii) several fold increase in mycobacterial-specific IFN-gamma responses in the more immunosuppressed category compared to the less immunosuppressed, when the median SFUs were normalised by median percent CD4 count, (iv) majority of the responses were biased towards CD4 upon depletion of CD8 cells by RosetteSep technique, (v) only a small minority of the total MTB-specific T cell response are mediated by CD8 T cells. Conclusions: Taken together our findings suggest that (i) there is reactivation of mycobacterial infection in severely immunosuppressed individuals, (ii) in the absence of CD8 T cells the frequency of IFN-gamma secreting CD4 T cells specific to MTB may increase their function and perhaps promote specific proliferation when exposed to antigen. MOPE0102 New fourth-generation assay with unique differential detection between antibodies to HIV-1 & 2 and p24 antigen B. Rivetz, E. Zemer-Tov, I. Russo, A. Ben-Zvi, O. Faktor Orgenics Ltd, Yavne, Israel Background: Most of the HIV Ag/Ab combined 4th-generation EIA kits present their results as a single answer for the presence of HIV infection. In spite of the increased sensitivity, there is no differentiation between the antigen and antibody results and thus such tests do not permit precise interpretation at early infection stages. In light of this limitation we developed a new 4thgeneration assay - the ImmunoComblI HIV1&2 Ag/Ab TriSpot assay (TriSpot) that enables the differential detection of antibodies to HIV types 1 and 2 and the simultaneous detection of p24 antigen. Methods: The TriSpot test is a direct solid-phase EIA, in the form of Orgenics' ImmunoComb platform. Assay time is about one hour and the results are visible as spots on the Comb's teeth. The study was carried out with over 2000 serum/plasma samples. It included 377 HIV-1 positives (51 from non-B subtypes and CRFs; 32 type O; 27 sero-conversion panels) and 129 HIV-2 positive samples. 1373 negative samples were used (953 healthy donors; 170 from high risk populations; 250 from patients with different diseases). Results: All positive samples were detected by the TriSpot test, yielding 100% sensitivity. The average specificity on the different HIV negative sample groups was 99.7%. The calculated detection level of p24 was about 5 pg/ml. By using the sero-conversion panels, a reduction of the "window" period by 6.7 days was shown in comparison to 3rd-generation assays. Conclusions: The TriSpot kit showed to be a highly sensitive and specific fourth-generation assay. It provides, in addition to the sensitivity advantage over the 3rd-generation antibody tests, an advantage of presenting separate signals for p24 antigen and for HIV antibodies. Having the kinetics of each of the parameters during the sero-conversion may be crucial at the early stages of HIV infection, particularly in cases such as mother-to child transmission. MOPEO103 Monitoring HIV viral load in resource-limited settings: evaluation of the Cavidi ExaVir Load R. Pilon', L. Ares', B. Munjeri2, B. Ndawana2, S. Mabiza2, P. Thistle2, J. Kim3, Z. Chen3, P. Sandstrom'. 'Public Health Agency of Canada, National HIV & Retrovirology Laboratories, Ottawa, Canada, 2Howard Hospital, Glendale, Zimbabwe, 'Public Health Agency of Canada, National Lab for HIV Reference Services, Ottawa, Canada Background: Current molecular methodologies for monitoring HIV virus levels are costly, technically demanding and highly sensitive to contamination and template degradation, making them difficult to implement in resource-limited settings. The ExaVir assay (Cavidi) determines viral load by measuring reverse transcriptase activity. This study evaluates the performance characteristics of the function-based ExaVir Load assay compared to standard viral loads obtained using molecular methods. Methods: Viral loads of 110 archived clinical plasma specimens were obtained with ExaVir Load (v2) and Bayer Versant assays. Two quality assurance panels were also tested with ExaVir, and the values compared to those obtained by participating labs using Roche Monitor, Bayer Versant (bDNA) and Nuclisens (NASBA) assays. Performance of ExaVir in the field was also evaluated by testing study specimens at a rural Zimbabwean hospital and matching dried plasma spots in Canada (Nuclisens). Results: Clinical viral load values ranged from below detection (Cavidi <400 copies/mL and Versant <50 copies/mL) to >500,000 copies per ml. Linear regression of log transformed viral load values yielded a linear correlation with slope of 0.86, with an R2 value of 0.89. Panel ExaVir Load values compared favorably to those of Monitor and Versant but were slightly higher than Nuclisens. Zimbabwe assay results yielded a slope of 0.92 and R2 of 0.80. Viral loads of patients on ART were very low or below detection limit. Conclusions: The results obtained with ExaVir Load were biologically equivalent to those from molecular assays in the untreated cohort. In treated individuals, it remains to be seen whether the assay is sufficiently sensitive to make that claim. The assay is easy to use, costs less and is less susceptible to contamination than molecular-based assays, and can be performed with rudimentary lab equipment. This affordable viral load assay could represent a reasonable patient management tool for resource-limited settings. MOPEO104 Routine early infant HIV testing as national program: preliminary results and lessons learned, Rwanda, 2005 - 2006 T. Finkbeiner', A. Ayaba2, J. van't Pad Bosch3, P. Rugimbanya4, A. Tanuris, L.F. Gonzalez', E. Kayirangwa2, N. Shaffer5, J. Hanson2. 'Centers for Disease Control and Prevention, Global AIDS Program, Atlanta, United States, 2CDC Rwanda, Global AIDS Program, Kigali, Rwanda, 'Elisabeth Glaser Pediatric AIDS Foundation, PMTCT, Kigali, Rwanda, 4National Reference Laboratory, Molecular Diagnostics, Kigali, Rwanda, sCDC Atlanta, Global AIDS Program, Atlanta, United States, 'Columbia University, Laboratory support, Kigali, Rwanda Background: In most resource-limited settings, children born to HIV-positive mothers cannot be tested for HIV before 15-18 months by serology due to persisting maternal antibodies. Studies show a mortality rate of 40-50% in perinatally-infected children in the first two years. Earlier identification and treatment of these children could significantly reduce this high mortality rate. With polymerase-chain-reaction (PCR) HIV-infection can be diagnosed as early as 6 weeks. We present early results of an infant PCR testing program in Rwanda. Methods: The first phase of a national early infant testing program was implemented at three sites in the Rwandan capital Kigali in October 2005. Children were identified as HIV-exposed during routine visits by the information on the mother's antenatal card. The program aims for HIV-testing during the vaccination visit at age 6 weeks. HIV DNA PCR testing (Roche Amplicor 1.5) on dried blood spot (DBS) specimens was performed at the national reference laboratory. Results: Among 3549 children seen at follow-up visits between October and December 2005, maternal HIV-status was known for 2423 (68%) and 177 (7.3%) children were identified as HIV-exposed (median age: 5.4 months; range: 6 weeks - 18 months). All known HIV-exposed children were tested; XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  59 20 (12%) tested PCR-positive and were referred for treatment. Data on PMTCT prophylaxis was known for 164 mother-child pairs. Of 106 mother-child pairs who received PMTCT prophylaxis (mainly single-dose nevirapine), 8.5% (9) children tested HIV positive, compared to 19% (11/58) who did not receive prophylaxis (OR 2.5%; 95% CI = 0.9-7.2). Conclusions: Routine early PCR testing is feasible. HIV-exposed children can be identified during routine follow-up if mothers are counseled appropriately and maternal HIV status is documented on the antenatal card. In addition to identifying HIV-infected children and linking them to early care and treatment, routine early infant testing provides valuable information on the effectiveness of PMTCT programs. MOPEO105 Improved between-laboratory performance of South African NHLS laboratories using PLG CD4 methodology for the national antiretroviral (ARV) treatment programme D. Glencross', H. Aggett', W. Stevens2, G. Vercauteren2, M. Bergeron3, G. Houle3, F Mandy3. 'University of the Witwatersrand and the National Health Laboratory Services of South Africa, Johannesburg, South Africa, 2Essential Health Technologies, World Health Organization, Geneva, Switzerland, 3Public Health Agency of Canada, Ottawa, Canada Background: The introduction of ART in South Africa offers an opportunity to establish essential laboratory infrastructure for monitoring of HIV/AIDS. An alternative more cost-effective CD4 methodology was introduced in a number of laboratories in Africa. The feasibility of the PanLeucoGating (PLG) methodology was monitored through the external quality assessment (EQA) scheme jointly organized by the WHO, the University of the Witwatersrand, the National Health Laboratory Services (NHLS) of South Africa and the Public Health Agency of Canada. The objective is to assess the performance of the laboratories using the alternative PLG CD4 methodology in the African context. Methods: QASI specimens were shipped from Canada to Johannesburg for redistribution. Stabilized whole blood preparations, QC18 and QC19 (CD4 REQAS Trial XIV), were then redistributed to 111 sites, including 35 standardized NHLS PLG CD4 sites and 76 other (not standardized) sites. All standardized sites used BC Epics-XL, FIowCARE PLG CD4 and microfluorospheres (FIowCOUNT) for absolute CD4 T cell determination. Results: The overall performance of the 35 South African NHLS/ARV laboratories using PLG methodology was 7.0 % and 8.5 % CV's for QC18 and QC19 respectively. The African WHO/REQAS laboratories had 10.8% and 14.6% compared to QASI global CV's of 10.7 % and 15.4% for QC18 and QC19 respectively. Conclusions: Laboratories using PLG methodology have significantly outperformed both their African and global participants from resource-limited countries. NHLS/ARV laboratories exceeded the performance of the others by over 35%. This is a remarkable achievement considering that a vast majority of site personnel had limited flow cytometry skills and that the PLG is a manual gating method. MOPEO0106 Chronic diarrhea as presenting feature of abdominal tuberculosis in HIV/AIDS patients in a tertiary care center in India A. Pazare, A. Mathew Davis, D. Atre Singh. Seth G. S. Medical College & KEM Hospital, Parel, Department of Medicine, Mumbai, India Introduction: Chronic diarrhea and colitis common in immunocompromised host. Mycobacterium tuberculosis in HI/AIDS patients has non- specific manifestations. Prior studies from Indian subcontinent reported a prevalence rate of 13% of Abdominal tuberculosis as common cause of chronic diarrhea. Objectives: Prevalence of abdominal tuberculosis in HIV/AIDS patients presenting to tertiary care centre and rate of co-infections in these subsets of patients. Methods: Open label, cross sectional study in 50 consecutive patients with HIV/AIDS and chronic diarrhea seen in Virology OPD. Diagnosis of abdominal TB was done by a set of investigations, which included abdominal ultrasound, CAT scan, barium meal follow through roentgenogram and microscopic examination of ascitic fluid cells. Descriptive statistics was used for data analysis. For Post hoc analysis the study population was divided into patients diagnosed with abdominal tuberculosis (group 1) and those without (group 2). Results: The study population had 13 patients (260/) who had abdominal tuberculosis. More than 850/ of the patients in both groups belonged to the 20 -40 years age with a male female ratio of 7:3.Abdominal pain (950/), anorexia (92%/) weight loss (77%/) and anemia (77%/) were more common in group 1 and this was statistically significant. The mean CD4 count in group 1 (89.77) versus group 2(167) was statistically significant (p<0.05). Isospora sp was the most common co-existing parasitic infection in both the groups and prevalence was more when CD4 count was <50 cells! mm'. Conclusions: Abdominal tuberculosis is an emergent infection in patients with CD4 counts < 200 cells/mm3 in the Indian subcontinent. Isospora sp is the most common co-existing parasitic infection in patients with abdominal TB and HIVAIDS in our setting unlike in the western population where Cryptosporidium spp is the commonest.This is of public health importance as in developing countries,co-existing parasitic infections are overlooked in these patients. MOPEO107 Assessment of the performance characteristics of a low-cost HIV viral load technology G. Vercauteren', E. Dax2, R. Gribben2, A. Sands', D. Jardine2'. 'World Health Organisation, Essential Health Technologies, Geneva, Switzerland, 2National Serology Reference Laboratory, Fitzroy, Australia Background: Quantification of human immunodeficiency virus type 1 (HIV-1) RNA has been shown to be most efficacious for monitoring disease activity in patients receiving highly active antiretroviral therapy. However costs including assays and equipment as well as complex technical requirements render the customary monitoring technologies unsuitable for most resource-limited settings. The ExaVir~ Load is an EIA-based method that determines viral load by measuring activity of the HIV Reverse Transcriptase (RT) enzyme. The assay is simple, robust and requires only standard EIA equipment and the ExaVir~ Load start up equipment. WHO/EHT and the NRL, have assessed the performance of the Cavidi Tech ExaVir~ HIV viral load assay, which offers a potential solution to providing viral load estimates in resource limited settings. Methods: Several performance characteristics of the Cavidi ExaVir~ Load assay were determined, including reproducibility, linearity, sensitivity and specificity. Results: Sensitivity was estimated in 65 HIV positive. Thirty-five samples were plasma drawn from HIV-infected individuals; thirty were cultured HIV-1 isolates spiked into normal human plasma. Detectable RT activity was present in 91% and 99% of samples with HIV RNA >1,000 copies/mL and >10,000 copies/mL respectively. All but one cultured isolate of HIV subtype D gave results above the assay's limit of detection. Assay specificity was estimated in 115 anti-HIV negative specimens. Twentyone of the sero-negative samples gave low viral loads (<1,000 copies/mL). Conclusions: The ease of use and the performance characteristics as well as the relatively low cost of the Cavidi ExaVir~ Load assay make it an appropriate assay for resource-limited settings. The occurrence of false positive results may preclude its use for any purpose other than HIV therapeutic monitoring. Others have demonstrated correlation between viral loads estimated by ExaVir and more conventional techniques (Greengrass et al., 2005). * Greengrass et al., Current HIV Research. 2005 Apr;3(2):183-90. MOPEO1O8 The dual importance of immunologic and virologic monitoring of antiretroviral therapy in resourcelimited settings M.R. Kamya', A.D. Kambugu2, F.C. Semitala', P.S. Mwebaze2, B. Castelnuovo2, P. Schaefer', J. Martin', D. Guwatudde3, E.T. Katabira', R. Colebunders4, A. Ronald', D. Thomas6, H. Mayanja-Kizza'. 'Makerere University, Internal Medicine, Infectious Diseases Institute/Academic Alliance for AIDS Care and Prevention in Africa, Kampala, Uganda, 'Infectious Diseases Institute/ Academic Alliance for AIDS Care and Prevention in Africa, Kampala, Uganda, 3Makerere University, Institute of Public Health, Kampala, Uganda, 4Institute of Tropical Medicine Antwerp/Infectious Diseases Institute/Academic Alliance for AIDS Care and Prevention in Africa, Antwerp, Belgium, 'University of Manitoba/Infectious Diseases Institute/ Academic Alliance for AIDS Care and Prevention in Africa, Winnipeg, Canada, 6Johns Hopkins University,Infectious Diseases Institute /Academic Alliance for AIDS Care And Prevention in Africa, Baltimore, United States Background: Virological monitoring is considered the ideal method for assessing the efficacy of an ARV regimen since virologic failure can occur in the setting of good immunologic response and clinical well-being. We evaluated predictors of viral suppression and documented discordant immunologic and virologic responses to ART. Methods: Between January 2004 and June 2005, 534 HIV-infected ART naive adults starting on ART, were enrolled into a cohort at the Infectious Diseases Institute of Makerere University, Kampala, Uganda. At enrollment and every 3 months, all individuals were evaluated by questionnaire and physical examination. CD4 count and HIV RNA were performed every 6 months. Patients eligible for this analysis had a CD4 and HIV RNA measurement at 12 months. Complete responders had both a CD4 increase of 50 cells/mm3 and a HIV RNA <400 copies/mI at 12 months. Logistic regression was used to evaluate the effect of age, sex, Hb, Karnofsky score, WHO stage, HIV RNA, CD4 and antiretroviral drug regimen on virologic outcome. Results: Of 534 patients 690/ were female, mean age, weight, CD4 and viral load were 37.7 years; 55 kg, 101 cells/mm3, 345,492 copies/mI respectively. 66 patients died. Complete data including viral load at baseline and 12 months were available for 372 patients. The mean increase in weight and CD4 count from baseline to 12 months was 5.8kg and 167 cells/mm' respectively. 327 of 372 (880/) had undetectable viral load. CD4 count was the sole independent predictor of viral load suppression (mean=Ill in suppressed vs. 77 in unsuppressed; p=0.04). 29 out of 45 (64%/) patients with virologic failure at 12 months had immunologic response. Conclusions: These data demonstrate good virological and, immunological effectiveness of antiretroviral therapy provided in this sub-Saharan African HIV clinic. The majority of patients with virologic failure could not be identified by measuring CD4 cells alone. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  60 Monday Post 14 August r Exhibition MOPE0109 Reliability of testing and potential impact on HIV prevention in Nigeria G.N. Odaibo', E. Donbraye', M. Adewumi2, A. Bakarey2, M. Ibeh2, J.-L. Sankale3, D.O. Olaleye', P. Kanki4. 'University of Ibadan, Department of Virology, College of Medicine, Ibadan, Nigeria, 2University of Ibadan, Department of Virology, Ibadan, Nigeria, 3Harvard School of Public Health, Department of Virology, College of Medicine, Boston, United States, 4Harvard School of Public Health, Department of Immunology and Infectious Disease, Boston, United States Background: Several factors including variability of human immunodeficiency virus, laboratory facilities, cost and competence of personnel handling are some of the important factors that affect accuracy and reliability of HIV testing in most parts of Africa. Recently investigators in Africa have observed that antibody detection assays based on antigens derived from HIV-1 subtype B show moderate to significantly lower sensitivity for detection of infection by various non-B subtypes. In this study, we evaluated the reliability of two EIA and 10 rapid HIV-1/2 test kits that are commercially available in Nigeria using the Western immunoblotting technique as reference. Methods: A panel of 76 sera from Western blot confirmed symptomatic or asymptomatic HIV-1 infected persons and 88 seronegative patients from those referred for testing in our laboratory were used for this study. Each sample was tested with two HIV-1/2 EIA, and 12 HIV-1/2 rapid test kits commercially available at one time or the other for HIV-1/2 testing in Nigeria. Results: Overall, the sensitivity of the two EIA kits were 100% and 89.5% with specificity of 97.5% and 96.5% respectively. The sensitivity of the rapid test kits ranged from 42.1% to 94.7% with specificity of 90.9% to 100%. Further analysis showed significant variation in the sensitivity and specificity of the same kit based on whether an individual had asymptomatic or symptomatic infection Conclusions: The results of this study highlight the problem of diagnosis of HIV infections in Africa. It shows that the sensitivity of most of the rapid assays is lower for detection of early infection. The implications of possible misdiagnosis on the various intervention strategies that rely predominantly on correct HIV status of an individual are enormous. Thus, there is an urgent need for review of the current HIV testing assays or algorithms in Nigeria and other parts of Africa. MOPEO110 CD38 expression on CD8 T cells with or without other markers (HLA DR and CD45RA) is not adequate to predict the virological response to antiretroviral therapy (ART) in Ugandans M.A. Eller', F. Lutwama2, L. John2, H. Shihab2, J. Serwanga3, B. Ouma', N. Modi', L. Spacek4, M. Robbs, T. Quinn4, K. McAdam2, B. Gazzard6, P. Kelleher6, M. Kamya2, H. Mayanja2. 'Makerere University Walter Reed Project, Kampala, Uganda, 2Infectious Disease Institute, Makerere University, Kampala, Uganda, 3MRC/UVRI Uganda Research Unit on AIDS, Entebbe, Uganda, 4Johns Hopkins University, Baltimore, United States, 5U.S. Military HIV Research Program, Henry M. Jackson Foundation, Rockville, United States, 6Chelsea and Westminster NHS Trust, London, United Kingdom Background: Less expensive methods for monitoring virological response to ART in resource limited settings (RLS) continue to be evaluated. Previously, CD8 T cell activation, measured using percentage with CD38 expression (CD38+), was shown to fall with the virologic response in Africans, but was poorly predictive of virological failure (VF) or success. We investigated whether very bright CD38 expression (CD38+++) with/without the markers HLADR (CD38+++/HLA DR+) or CD45RA (CD38+++/CD45RA-) could improve the performance of this test. Methods: Cross sectional study of 301 HIV-infected Ugandans on ART for between 6-18 months. Whole blood processed using Lyse/No Wash procedure. CD38, HLA DR, and CD45RA expression on CD8 T cells determined using a FACSCalibur (BD) flow cytometer. CD38+++ (>5000 molecules/cell) defined using monocyte gate. Phenotypic subsets were compared to HIV RNA viral load (Roche Amplicor vl.5). Results: 48 patients (16%) had VF (>400 copies/mI). Mean CD38+++ was significantly different between detectable and undetectables (7.5% (6.7-8.3) vs. 16.2% (12.4-19.9); P< 0.0001). CD38+++ correlated with viral load (e.g. CD38+++/HLA DR+ r =0.517, p<0.0001). Receiver operator characteristics gave area under of curves of: 0.77 (CD38+++), 0.71 (CD38++), 0.79 (CD38+++/HLA DR+), 0.78 (CD38+++/CD45RA-) and 0.71 (CD38 MFI). Using the best cut off, CD38+++ alone gave a sensitivity of 75% (60-86%), specificity of 69% (63- 75%), positive predictive value of 32% (23-41%) and negative predictive value of 94% (89-96%) for VF. Therefore if CD38+++ was available for a similar population of patients, 187 viral loads could be avoided but 124 would need to be done and 12 cases of VF would be missed. Conclusions: Although CD38 could be added to CD4 testing at minimal extra cost (assuming 4 color flow cytometry available), this study shows that CD38 expression with/without other markers should not be considered an adequate solution to finding an affordable surrogate viral load test for RLS. MOPE0111 Use of total lymphocyte counts in primary care settings as a monitoring tool for HIV disease progression R. Mankeshwar', S. Sawleshwarkar2, V. Phad3, D. Saple3. 'Grant Medical College & Sir JJ Group of Hospitals, Preventive and Social Medicine, Mumbai, India, 2Grant Medical College & Sir JJ Group of Hospitals, Skin and STD, Mumbai, India, 3Human Healthcare and Research Foundation, Clinical Research Division, Mumbai, India Background: Access to antiretroviral therapy is increasing in resource restricted settings with reduction in the cost of drugs and WHO's 3 by 5 initiative. The cost of monitoring patients on ART is often more than the therapy. This study assesses the utility of the total lymphocyte count (TLC) in place of the CD4 counts to assist clinicians in decision-making about diagnosis, prognosis of OI, initiation of OI prophylaxis and ART. Methods: Pearson's correlation coefficient was used to test for association between TLC & CD4. Correlation between CD4 cell count groups and TLC categories was calculated by Spearman's correlation coefficient. ROC analysis was performed. At TLC cut-off's: 1000, 1200, 1500 and 2000; specificity, sensitivity, positive predictive value, negative predictive value, false positive and negative rates were calculated. Results: Amongst 331 observations, significant linear correlation was seen between log10 CD4 count and log10 TLC (Pearson's r =0.67, p <0.001). A significant correlation between CD4 cell count groups and TLC categories was seen (Spearman's rho = 0.51, p<0.0001). Area under ROC curve was 0.78. The specificity, sensitivity, positive predictive value, negative predictive value for different cut offs of TLC against a dichotomized CD4 of <=200 and >200 are presented in table 1. TLC Cut off values Sensitivity Specificity PPV NPV 1000 1200 1500 2000 0.25 1 1 0.73 0.38 0.99 0.93 0.76 0.56 0.76 0.92 0.78 0.81 0.66 0.52 0.84 Conclusions: TLC could be used as a low cost tool for clinical decision-making in the management of HIV AIDS in primary care settings. A TLC cut off value of 1500 is a close analogue for a CD4 count of 200 cells/mm3. Regular TLC monitoring could help to chart HIV disease progression. MOPEOII2 Evaluation of p24-based antiretroviral treatment monitoring in pediatric HIV-1 infection: prediction of the CD4+ T cell changes between consecutive visits M.W.G. Brinkhof', 3. Boni2, F. Steiner3, Z. Tomasik2, D. Nadal3, J. Schupbach2, Swiss HIV Cohort Study (SHCS) and Swiss HIV Mother + Child Cohort Study (MoCHiV). 'University of Berne, Institute for Social and Preventive Medicine, Berne, Switzerland, 2University of Zurich, Swiss National Center for Retroviruses, Zurich, Switzerland, 3University of Zurich, University Children's Hospital, Zurich, Switzerland Background: Worldwide 700,000 infants are infected annually by HIV-1, most in resource-limited settings. Care for these children requires simple, inexpensive tests. Methods: We have evaluated HIV-1 p24 antigen for antiretroviral treatment (ART) monitoring in children. P24 by boosted ELISA of heated plasma and HIV1 RNA were measured prospectively in 24 HIV-1 infected children receiving ART. P24 and HIV-1 RNA concentrations and their changes between consecutive visits were related to the respective CD4+ T lymphocyte changes by means of repeated measurement statistics. Results: Age at study entry was 7.6 years, follow-up 47.2 months, yielding 18 visits at an interval of 2.8 months (medians). There were 399 complete visit datasets and 375 interval datasets. Controlling for variation between individuals, there was a positive relationship between concentrations of HIV1 RNA and p24 (P<0.0001). While controlling for initial CD4+ count, age, sex, days since start of ART, and days between visits, the relative change in CD4+ count between two successive visits was negatively related to the corresponding relative change in HIV-1 RNA (P = 0.009), but not to the initial HIV-1 RNA concentration (P = 0.94). Similarly we found a negative relationship with the relative change in p24 over the interval (P < 0.0001), while the initial p24 concentration showed a trend (P = 0.08). Overall, p24 measurement "explained" the relative CD4+ cell change slightly better than did HIV-1 RNA. Statistical support for the p24 model and the HIV-1 RNA model was similar. Conclusions: P24 may be an accurate low-cost alternative to monitor ART in pediatric HIV-1 infection. This applies particularly to epidemics caused by subtype C to which the assay, besides to subtype B, is very sensitive, as has now been shown in several different studies. Thus, the entire South of Africa, India and other subtype C dominated areas could greatly benefit. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  61 MOPE0113 Utility of QuantiFERON TB gold testing for latent TB infection in HIV-infected individuals S. Jones', D. de Gijsel2, F. Wallach', A. Gurtman4, F. Mensal, H. Sacks6. 'New York Presbyterian Hospital, Center for Special Studies, Medicine, New York, United States, 2Mount Sinai School of Medicine, AIDS Center, New York, United States, 3Mount Sinai School of Medicine, Medicine, New York, United States, 4Wyeth, Vaccine Research, Pearl River, United States, sHospital Fernandez, Infectious Diseases, Buenos Aires, Argentina, 6Mount Sinai School of Medicine, Community and Preventive Medicine, New York, United States Background: The tuberculin skin test (TST) is the test most widely used for the diagnosis of latent tuberculosis infection (LTBI). However, TST lacks both sensitivity and specificity and may be particularly prone to inaccLracies in patients with underlying immune disorders such as HIV infection. QuantiFERON TB Gold (QTF-Gold), (Cellestis, CA) is a whole blood test for the diagnosis of LTBI based upon production of inferferon y in response to exposure to TB specific antigens by previously sensitized T cells. Since there is no "gold standard" for LTBI we examined the association of known risk factors for TB infection with positivity of TST and QTF-Gold. Methods: After informed consent was obtained, TST and anergy panels were placed on subjects and blood obtained for QTF-Gold testing. Information on demographics, prior TB exposure and previous treatment/prophylaxis was obtained. History regarding antiretroviral use, CD4 count and viral load was abstracted from the medical record. QTF-TB Gold tubes were incubated overnight at 37C and supernatants obtained after centrifugation were stored at -70F. QTF assays were performed in duplicate on batched specimens after enrollment was completed. Results: Of 207 subjects tested, 3 were excluded due to missing data. 52% of analysed subjects were male; 48% black, 41.2% hispanic and 8.8% white. 13 (6.4%) had a positive TST and 10 (4.9%) had a history of active TB. 31 subjects had a CD4 <200 cells/mm3. 11 subjects had an indeterminant result by QTF and were excluded from further analysis. 11 subjects had positive results by QTF-Gold. The odds ratio (OR) for positive QTF-Gold correlated with number of TB risk factors was 1.616; p value=.0575, whereas for positive TST the OR was 0.888; p=0.6368. Conclusions: In HIV-infected subjects, there is a trend towards a statistically significant association between known risk factors for LTBI and a positive QuantiFERON TB Gold test but not positive TST. MOPEO114 The implementation of screening for syphilis in Brazilian maternity hospitals and its implications for assistance and epidemiological surveillance of congenital syphilis V. Pinto', E. Oliveira', M. Barbosa', D. Ribeiro', P. Chequer2, M. Simao3. 'Ministry of Health, National STD and Aids Programme/STD Unit, Brasilia, Brazil, 2Ministry of Health, National STD and Aids Programme/ Director, Brasilia, Brazil, 3Ministry of Health, National STD and Aids Programme/Deputy Director, Brasilia, Brazil Issues: The implementation of a screening strategy for syphilis in public maternity hospitals and wards has promoted an increase in the notification of cases of congenital syphilis and seeks to reduce the occurrence of retarded sequels of the disease. Description: In 1993 Brazil was a signatory to the Pan-American Health Organization resolution on the control of congenital syphilis in the Americas. In this context the Brazilian government initiated a series of actions to promote the widening of access to diagnosis in antenatal checkups and during labor. Over the last ten years there has been an increase in congenital syphilis notification with the introduction of the recommendation for carrying out VDRL for all women going into labor, going from little more than 200 in 1998 to 4,713 cases in 2003, but it is estimated that 12 thousand new cases occur every year. In December of 2004, by means of a Ministerial edict, testing was finally made mandatory in these services. On average, in the last five years VDRL has only been done in 30% of births and post-abortion curettages taking place in the public health network. Lessons learned: The control of congenital syphilis requires multiple actions involving childbirth services in the identification of failures in the antenatal checkups being offered to users of the health system, and treatment for those cases identified. Recommendations: Constant vigilance in the application of the established norms, on the part of health staff and managers will avoid great losses of opportunities for diagnosing maternal and congenital infection. MOPEO115 Real time PCR as routine platform in HIV RNA quantification J. Suni', M. Ristola2, A. Jarvinen2, K. Liitsola3, M. Salminen3, M. Lappalainen'. 'HUSLAB / Helsinki University Hospital, Department of Virology, Helsinki, Finland, 2Helsinki University Hospital, Department of Infectious Diseases, Helsinki, Finland, 3National Public Health Laboratory, HIV-Laboratory, Helsinki, Finland Background: Real time PCR is an expanding method in viral diagnostics. Commercially available real time PCR has become only recently available for large scale routine quantification of HIV-1 RNA. One year study using real time and end point PCR for HIV-1 quantification was conducted to collect data for clinical decision making. Methods: Altogether 2400 plasma specimen was sent for routine HIV-1 RNA quantification. All specimens were HIV-1 antibody positive. COBAS TaqMan HIV-1 (CTM) HPS and HIV-1 Amplicor Monitor vs. 1.5 Test (CAM) were used according to manufacturer's (ROCHE Molecular Diagnostics, USA) instructions. Both tests were done within one week after collecting the specimen. Samples, kept as frozen at -200C, having seemingly discrepant results were retested by one or both methods. A set of 107 samples were tested also by COBAS Ampliprep HIV-1 Taqman (CAP) method. Results: All three methods showed good correlation (R=0.996) and CV%s were similar. CTM gave 2.2 and CAP 1.5 times higher number of copies than CAM. In preliminary study higher copy values were seen in all genotypes. CTM often detected low level of copies (40-150) while CAM copies were <50. In 3.5 % of patients CAM gave > 3 times higher copy numbers and in 1.1 % of patients CTM did not detect any copies while CAM detected copies, usually 1000 - 10000 copies/ml. These deviating samples without association to any specific genotype gave similar results when using CAP. In preliminary sequencing study a selection of these samples showed one nucleotide changes at critical point in 3'end. Conclusions: CTM has been used routinely in our laboratory for two years. All new HIV-1 antibody positives are tested both by CTM and CAM to find deviating samples. Similarly researcher initiated therapy study patients are tested by both methods. There is a need to reformulate the guidelines of clinical interpretation of HIV-1 RNA quantification MOPE0116 Difference between Asian and Caucasian HIV-infected patients in absolute CD4 count and CD4 percentage 3. Zhou', F. Dabis2, S. Pujari3, R. Thiebault2, M. Law', F. Bonnet2, for the TREAT Asia HIV Observational Database and Aquitaine Cohort. 'National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, Australia, 'University Victor Segalen, Bordeaux, France, 3Ruby Hall Clinics, Pune, India Background: Total lymphocytosis is variable according to ethnicity and has an impact on the CD4 lymphocyte absolute count. This study aimed to examine the relationships between absolute CD4 and CD8 count, CD4% and total lymphocyte count (TLC) in two cohorts of Asian and Caucasian HIV-1 infected patients. Methods: Absolute CD4, CD8 counts and TLC, before initiation of HAART, were compared cross-sectionally between the TREAT Asia HIV Observational Database (TAHOD, a prospective multicentre observational cohort in sites across Asia and Pacific region) and ANRS CO3 Aquitaine (French prospective open cohort) stratified by CD4%. The relationships between square root of absolute CD4 count and CD4% were modelled using linear regression. Results: The study included 674 Caucasian patients from Aquitaine and 442 Asian patients from TAHOD. Compared to Aquitaine patients, TAHOD patients were in a more advanced stage of immune deficiency in terms of AIDS disease stage (40% vs. 18% in CDC category C, p<0.001), median CD4 count (112 vs. 260 cells/pl, p<0.001), and median CD4% (8.1% vs. 16.3%, p<0.001). For a given CD4% strata, TAHOD patients had a lower CD4 count (p=0.001), CD8 count (p<0.001) and TLC (p=0.03). The difference in CD4 count between TAHOD and Aquitaine patients increased with higher CD4%, with an estimated difference of 2 cells at a CD4% of 5% to 146 cells at 45%. The difference remained significant after adjusting for age, prior AIDS and haemoglobin level, which were independently associated with CD4 count. Conclusions: For a given CD4% strata, TAHOD patients have a lower CD4 count than Aquitaine patients. The impact of the difference in absolute CD4 count by CD4% strata on prognosis is uncertain, but it may be that the prognostic thresholds for CD4 count defined based on European and North American populations are inappropriate in Asian populations. MOPEO117 Does asymptomatic mean without symptoms? W. Holzemer', D. Wantland', S. Willard2, K. Nokes', N. Reynolds', M. Rivero', K. Kirksey6, J. Kemppainen', C. Coleman', P. Dole', L. Eller", E. Bunch", Y.-F. Tsai"2, I. Corless", P. Nicholas", M.J. Hamilton4, E. Sefcik4, G. Canavals. 'University of California, San Francisco, School of Nursing, Community Health Systems, San Francisco, United States, 'Drexel University, Division of HIV/AIDS Medicine, Philadelphia, United States, 'Hunter College, CUNY, Hunter-Bellevue School of Nursing, New York, United States, 4Ohio State University, Columbus, United States, sUniversity of Puerto Rico, School of Nursing, San Juan, Puerto Rico, 'University of Texas, Houston, Nursing Administration, Hoston, United States, 'University of North Carolina Wilmington, Wilmington, United States, 'University of Pennsylvania, School of Nursing, Philadelphia, United States, 'St. Vincents Hospital and Health Center, New York, United States, "oRutgers University, Newark, United States, "University of Oslo, Institute of Nursing Science, Oslo, Norway, 1"Chang Gung University, Tao-Yuan, Taiwan, Republic of China, "3MGH Institute of Health Professions, Boston, United States, 1"Texas A&M University - Corpus Christi, Corpus Christi, United States, "Universidad del Valle, Cali, Colombia Background: Treatment guidelines have long utilized the terms symptomatic and asymptomatic in recommending initiation of antiretroviral therapy. Treatment guidelines in the US and many other countries state that therapy should be initiated based upon CD4 count and symptoms. However, there is little guidance on what differentiates symptomatic and asymptomatic. Monday 14 August Post Exhibition XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  62 Methods: An international sample (N=1,217) was assessed for the presence of symptoms using the standardized 64 item HIV/AIDS Sign and Symptom Checklist (rev). The 823 individual who self- reported CD4 values were stratified based on DHHS guidelines (0 - 200 n = 220, 201 - 350 n=160, >350 = 443) and analysis of variance (ANOVA) compared the mean number of symptoms reported by the three groups, controlling for taking ARV medications. Results: The mean self-reported CD4 count in the sample was 422 (SD 294) and the average symptom frequency for the total sample was 18.39 (SD16.82). The mean number of symptoms by CD4 category was: 0-200 = 19.93 (SD 17.50); 201-350 = 17.46 (SD 15.64); and >350 = 17.96 (SD 16.88). 21.3% (n=175) were not taking ARV medications. A two (ARV/no-ARV) by three (level of CD4 count) ANOVA was not significant (F= 1.595, p = 0.15). There were no differences in the presence of symptom among the three levels of CD4 counts, controlling for taking ARV medications. Conclusions: The data reveal that self-reported symptoms are present in individuals regardless of the official treatment guidelines' CD4 classification or the taking of ARV medications. These data demonstrate that clinicians should carefully assess their patients throughout the illness trajectory for the presence and severity of symptoms that are associated with HIV/AIDS. These findings question the use of the term asymptomatic as a useful diagnostic tool. MOPE0118 PCR-based HIV diagnosis for infants using dried blood spots (DBS): field implementation in Maputo City, Mozambique D. Bila Ramalhol, P. Vaz2, L. Rungo2, A. Momed2, I.V. Janis. 'Instituto Nacional de Saude, Department of Immunology, Maputo, Mozambique, 2Hospital Central de Maputo, Pediatric Day Hospital, Maputo, Mozambique Background: In Mozambique women account for 57% of the HIV positive population, being the gender disparity more pronounced in women at reproductive age. With the scaling-up of antiretroviral treatment in children early diagnosis of HIV in exposed infants is becoming an urgent need. In this context, we investigated the feasibility of introducing molecular testing for early HIV diagnosis using DBS. Methods: Ninety three samples from exposed children were included in this study (48 female), whose age ranged from six weeks to 16 months. Nurses at the Paediatric Day Hospital were trained to collect, dry and ship DBS samples. These were collected onto two different filter papers (S&S 903, Schleicher&Schuell, USA and MN 615, Macherey&Nagel, Germany) and the quality of the samples was evaluated upon arrival at the laboratory. DBS samples were tested in parallel to liquid blood using the Amplicor~ HIV-1 DNA test vl.5 (Roche Diagnostics, Germany). Results: DBS produced from both types of paper were of good quality. Of the total samples 12 were positive and 81 were negative for HIV-1 infection. The results showed 100% concordance between the two types of filter paper, as well as 100% concordance between filter paper and liquid blood. Conclusions: Blood collection on filter paper was easily assimilated by the nurses. No change in the performance of the test was observed when this was used on DBS made from two types of filter paper. PCR diagnosis serves as a tool for treatment and care entry, establishment of follow-up programs for both HIV-positive and breast-feeding HIV-negative infants, implementation of guidelines for counselling on infant feeding, and allows treatment of exposed children in a timely manner. The DBS have a long conservation time, are easy to transport and allow the diagnosis of children from remote areas, thus constituting a feasible technique in resource-poor settings. MOPE0 119 C-reactive protein as a predictor of maternal HIV disease progression, maternal and child mortality, and mother-to-child transmission of HIV in Tanzania P. Drain', R. Kupka2, G. Msamanga3, W. Urassa4, W. Fawzis. 'University of Washington, Seattle, United States, 2Harvard School of Public Health, Nutrition, Dar es Salaam, Tanzania, United Republic of, 'Muhimbili University College of Health Sciences, Community Health, Dar es Salaam, Tanzania, United Republic of, 4Muhimbili University College of Health Sciences, Microbiology and Immunology, Dar es Salaam, Tanzania, United Republic of, sHarvard School of Public Health, Nutrition and Epidemiology, Boston, United States Background: Increased levels of C-reactive protein (CRP), an inflammatory marker, predict mortality among HIV-positive women not taking highly-active antiretroviral therapy (HAART) in developed countries. Information is needed on the role of CRP in predicting HIV disease progression, maternal and child mortality, and mother-to-child transmission of HIV among HIV-positive women in developing countries. Methods: We evaluated CRP levels among 606 HIV-infected women 4 to 10 months after they gave birth. We used Cox proportional hazards models to evaluate associations between CRP levels and risks of adverse maternal and child HIV-related outcomes. Multivariate model were adjusted for age, sociodemographic characteristics, anthropometric measurements, hemoglobin, CD4 count, HIV viral load, and, for child outcomes, breastfeeding status. No participants had received antiretroviral medications. Results: Ninety-four (15.5%) women had an elevated CRP level (>10 mg/I). During the study follow-up, 64 women progressed to WHO stage 4, 142 died from AIDS-related causes, and 188 died from any cause. Among children, 47 acquired HIV and 70 died. In separate multivariate analyses among adults, elevated CRP was significantly associated with a 1.59-fold (95% CI 1.06-2.37) greater risk of progression to stage 4 or death from AIDS-related causes, and a 1.68-fold (95% CI 1.18-2.39) greater risk of progression to stage 4 or death from any cause. In multivariate analysis among children, elevated CRP was associated with a 1.81-fold (95% CI 1.00-3.29) greater risk of child mortality. Elevated CRP was not associated with mother-to-child transmission of HIV (hazard ratio: 1.08, 95% CI 0.41-2.84). Conclusions: Elevated maternal CRP is an independent predictor of HIV disease progression, maternal mortality, and child mortality among a developingcountry HIV-positive population not taking HAART. These findings strengthen and expand the role of CRP as an independent marker of adverse maternal and child HIV-related outcomes. Additional studies are warranted to assess the predictive value of CRP among HIV-infected people taking HAART. MOPE0120 Measurements of HIV p24 antigenemia, HIV serology and CD4 T cells by hybrid flow cytometry S. Faucher, A. Sherring, D. Bogdanovic, T. Ding, M. Bergeron, P. Sandstrom, F. Mandy. Public Health Agency of Canada, National HIV and Retrovirology Laboratories, Ottawa, Canada Background: Rationalization of laboratory testing through the use of multitasking instrument constitutes a cost-effective approach to HIV monitoring. One such instrument, a hybrid flow cytometer (HFC) adapted to cellular and bead-based assays was evaluated for performing CD4 testing, HIV p24, and HIV serology. Methods: HFC (FACSArray) was used to enumerate CD4 T cells in specimens froml9 HIV-infected individuals. The same instrument was used to measure HIV antibody titers to p24, p66, gp41, gpl60, vif and HIV p24 antigen using protein and antibody bead arrays. CD4 T cell determinations were compared to a 4-color reference method. Antibody titers were determined from 2 pL of plasma (5) using HIV-1 proteins covalently coupled to fluorescent beads (Luminex Corp.). Bound antibodies were detected with biotin-anti-human IgG and streptavidin-PE. Commercial HIV-1 p24 standard preparations and 9 plasma specimens (50pL) were tested using a p24 bead-based assay using anti-p24 antibody coupled beads and biotin-anti-p24 and streptavidin-PE. Results: FACSArray CD4 T cell absolute counts showed a bias (Pollock) of - 1.68 %. The coefficient of variation from 10 replicates was 2.3 %. Antibody to all 5 HIV proteins were detected for all specimens with end-point titers of less than 200 for vif to more than 2X106 for gpl60. The HIV-1 p24 capture assay showed very good reproducibility with a detection limit below 5 pg/mL, similar to commercially available assays (4.3 pg/mL). Five out of 9 archival specimens showed p24 concentrations ranging from 5 to 386 pg/mL. Conclusions: This initial study demonstrated the excellent concordance of the HFC CD4 testing with the reference method. Antibody titers to 5 HIV proteins and HIV p24 were successfully measured using the same instrument. The successful combination of bead and cell based assays on a single hybrid instrument provides the groundwork for future development of affordable algorithms for HIV monitoring. MOPEO121 Development and evaluation of an affordable real time assay for plasma viral load determination in HIV-infected individuals A. Agarwal', M. Vajpayeel, C. Leutnegger2, V. Sreenivas3, P. Seth4, S. Dandekar'. 'AIIMS, Department of Microbiology, New Delhi, India, 2UC Davis, Department of Medicine and Epidemiology, Davis, United States, 3AIIMS, Department of Statistics, New Delhi, India, 4Seth Research Foundation, New Delhi, India, 5UC Davis, Department of Medical Microbiology and Immunology, Davis, United States Background: With the availability of generic antiretroviral drugs in developing countries, the major obstacle to treatment implementation includes high laboratory monitoring costs. CD4+ T cells counts and viral load determination are considered standard practice to monitor HIV-infected individuals. We have developed and evaluated an affordable, one-step Real time RT-PCR assay to measure plasma viral loads. Methods: The primers and probe designed are located in p-24 region of HIV-1 gag gene. Plasma viral loads from 120 HIV seropositive patients were determined, of which 33 patients were receiving anti-retroviral therapy (ART). Of these 120 subjects, 85 samples were analyzed with Roche Amplicor ver 1.5. Associations between plasma viral RNA levels and CD4 counts were assessed in the various CDC classes. Viral loads for 40 ART naive subjects obtained by the assay were also studied with CD8+CD38+T cell expression, a surrogate indicator of viral replication. Results: The primers and probe showed excellent specificity and linearity. Replicate testing of external standard RNA transcripts established the lower limit of quantitation at 214 copies/ml. Strong positive correlation were observed between Real time assay and Amplicor (p< 0.0001). The mean log10 viral loads depicted an increasing trend in the various CDC classes. The plasma viral loads of the samples showed significant negative correlations with CD4 counts in all CDC stages. The mean viral load value of the patients on ART was significantly less in comparison to ART naive patients. Positive correlation was observed for CD8+CD38+ T cell subset with log,0 plasma viral loads (p< 0.05). Conclusions: The assay shows good performance characteristics. The plasma viral load values are correlating well with the clinical and immunological status of the study subjects. The low cost of the developed assay except the initial equipment cost makes it feasible to be used for serial monitoring of viral loads in the resource-poor settings of developing countries. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  63 MOPE0122 Use of the dried blood spot sample (DBS) in epidemiological studies in Senegal A. Gueye', A. Gueye Gaye', T. Grenade2, K. Bond2, S. Mboup'. 'Laboratoire de Bacteriologie virologie, Hopital A Le Dantec, Dakar, Senegal, 2CDC, Atlanta, United States Background: the traditional sampling method (venous puncture) is difficult to use in studies at large scale such as national HIV serosurveys The study had two objectives: 1- evaluate the effectiveness of detection of the HIV using dried blood (DBS as compare to plasma sample; 2use this technique of DBS in the national HIV serosurvey in Senegal. Methods: 1810 couple of samples (plasma + DBS) from 3 different sites (VCT, MTCT, Clinic settings) were tested using two ELISA (Genscreen then -Murex) when we were evaluating of some HIV kits. The Western Blot (HIV Blot 2.2) was used as confirmatory test. Following this first study, the technique of DBS was then used to analyze 8095 DBS sample in order to measure the HIV prevalence in the general population of Senegal Results: Of the 1810 samples, 215 were HIV-1 and 2 were HIV-2. All these HIV positive samples have been identified on the 2 types of samples (plasma + DBS). There was substantial increase in initially reactive specimens when testing DBS by Genscreen (296 for plasma to 343 for DBS). Secondary testing by Murex eliminated number of false positive reactions, although, both sample sets had repeatedly reactive specimens that were not confirmed by Western blot (15 for plasma, 40 for DBS). On the 8095 DBS samples of the national survey, we have identified 65 HIV positives (0.8%) including 47 HIV-1 and 18 HIV-2. Conclusions: DBS sample can be use efficiently to identify HIV infection as for plasma samples in large scale studies. No case falsely negative was noted, however, the DBS seems to give more cases falsely reactive than the plasma (15 for plasma, 40 for DBS); therefore, it is necessary to develop procedures more adapted to the DBS. MOPE0 123 Preliminary application of Murex HIV Ag/Ab combination to screen HIV window period infection in Chinese IDUs W. Xu', Z. Tuerdi2, G. Qin3, M. Qiu', H. Yan', Y. Jiang'. 'National AIDS Reference Lab, National Center for STD/AIDS Control and Prevention, China CDC, Beijing, China, 2Xinjiang Regional Center for Disease Control and Prevention, Urumchi, China, 3Sichuan Provincial Center for Disease Control and Prevention, Chengdu, China Background: HIV combined antigen (Ag) and antibody (Ab) screening assays are believed to reduce the seroconversion window period by a few days to as much as two weeks in comparison with third-generation antibody assays. In this study, we preliminarily evaluated the performance of Murex HIV Ag/ Ab Combination (Abbott, Dartford Kent, UK) and applied it to screen serum samples from Chinese injection drug users (IDUs). Methods: Eight HIV-1 seroconversion panels (PRB924, 930, 940, 942, 943, 944, 946, 948) from Boston Biomedica Inc. (n=45) were detected with Murex HIV Ag/Ab Combination, two third-generation antibody assays (Murex HIV 1.2.0 and Beijing Jinhao anti-HIV-1/2 EIA) and Murex HIV Antigen Mab, respectively. 2210 serum samples from Chinese IDUs with anti-HIV antibody negative by third-generation antibody assays were detected with Murex HIV Ag/Ab Combination, and the positive ones were detected HIV p24 antigen with Murex HIV Antigen Mab and HIV viral load with Cobas Amplicor HIV-1 monitor test, vl.5 (Roche Molecular systems) and further followed up. Results: 1) Of 45 samples from the seroconversion panels, 35.6% (16/45) were positive with the two third-generation antibody assays, but 60% (27/45) were positive with Murex HIV Ag/Ab Combination, which reduced the window period by 6.2 days. Only 6.7% (3/45) HIV p24 antigen positive samples with Murex HIV Antigen Mab could not be detected with Murex HIV Ag/Ab Combination. 2) Among the 2210 samples from IDUs, 61 ones were positive with Murex HIV Ag/Ab Combination, and 3 of them were positive with HIV-1 p24 Ag. Among the 3 people, two were followed up to seroconversion, but the other one with HIV-1 RNA positive has not been followed up yet. Conclusions: The results show that Murex HIV Ag/Ab Combination could reduce the seroconversion window period by 6.2 days in comparison with thirdgeneration antibody assays and could play important role in screening HIV window period infection. MOPE0124 Comparison of two manual bead-based assays (dyanbeads and cytospheres) to FACScount at a public, urban clinic in Kampala, Uganda F. Lutwama', R. Wasswa', H. ShihabM, H. Mayanja', N. Kamya2, A. Ronald', T. Quinn4, L. Spacek'. 'Infectious Diseases Institute, Kampala, Uganda, 'Makerere University, Infectious Diseases Institute, Academic Alliance for AIDS Care and Prevention, Kampala, Uganda, 'University of Manitoba, Infectious Diseases Institute, Academic Alliance for AIDS Care and Prevention, Winnipeg, Canada, 4Johns Hopkins School of Medicine, National Institutes of Health, Academic Alliance for AIDS Care and Prevention, Baltimore, United States, 5Johns Hopkins School of Medicine, Division of Infectious Diseases, Baltimore, United States Background: Laboratory-based monitoring of antiretroviral therapy (ART) is essential, but adds a significant cost to HIV care. Sites providing HIV care differ according to technical infrastructure, personnel skills and budget constraints. Methods: We compared CD4 cell counts (CD4) obtained on replicate samples by two manual bead-based assays, Dynabeads (Dynal Biotech) and Cytospheres (Coulter), to those generated by FACSCount (FC) (Becton Dickinson) in Kampala, Uganda. Paired data were compared by linear regression and the Bland-Altman method. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) to predict CD4 below 200 cells/mm3 were calculated. Samples were from 503 seropositive Ugandans before and during ART and followed for 18 months. Results: We tested 1672 samples (117 prior to ART) with Dynabeads and 1445 samples (85 prior to ART) with Cytospheres. Mean CD4 was 230 cells/mm3 (SD,139) and 239 cells/mm3 (SD,140) by Dynabeads and FC, respectively. Mean CD4 was 186 cells/mm3 (SD,101) and 242 cells/mm3 (SD,136) by Cytospheres and FC, respectively. Linear regression slopes were 0.85 and 0.58 and intercepts were 28 and 45 for Dynabeads and Cytospheres, respectively with Pearson correlation coefficients of 0.85 and 0.78. The mean differences in CD4 were 8.8 and 50.4 for Dynabeads and Cytospheres, respectively with differences ranging from -409 to 501 and -399 to 583. The differences between the manual bead-based methods and FC were significantly different (p-value, 0.0001). However, prior to ART initiation, mean difference between Cytospheres and FC was not significant. For Dynabeads, sensitivity, specificity, PPV and NPV to predict CD4 below 200 cells/mm3 were 87%, 84%, 82%, and 89%, respectively. For Cytospheres, values were 93%, 59%, 64%, and 91%, respectively. Conclusions: Although Dynabeads more accurately measured CD4 than Cytospheres, both methods underestimated CD4 when compared to FC. Our results suggest that manual, lower cost methods may sacrifice accuracy when compared to automated methods. MOPE0125 HIV confirmatory test algorithm in Lagos, Nigeria C. Onwuamah', R. Audu', J. Onyewuche', M. Aniedobel, M. Uwandul, U. Sylvester-Ikondul, O. Idigbe2'. 'Nigerian Institute of Medical Reserach, Human Virology Laboratory, Lagos, Nigeria, 2Nigerian Institute of Medical Reserach, Lagos, Nigeria Background: The Nigerian national HIV testing guideline accepts the use of double ELISA (EIA) tests in lieu of Western blot (WB) for HIV sero-status confirmation in view of our resource limited setting. The Human Virology Laboratory (a reference laboratory) of the Nigerian Institute of Medical Research conducts HIV confirmatory tests based on this guideline for adolescents and adults who had been screened positive previously. Methods: In the year 2005, 2406 samples were received for HIV confirmatory testing using double EIA. Results: Using the first EIA test (Genie II) which detects HIV I/II, 1970 (81.9%) of these samples were HIV-I positive, while 3 (0.1%) and 9 (0.4%) were HIV-II and HIV-I&II positive respectively. However, 424 (17.6%) were HIV negative. A further test (Dia Pro) which detects HIV I/II and group O was used to assay the 424 negative samples and 381 were confirmed negative while 43 were found to be positive. Conclusions: There is a need to use kits that have high specificity for HIV confirmation in view of the 381/2406 (15.8%) samples that were confirmed to be HIV negative. It is possible that the 43/2406 (1.8%) positive samples on the further testing could have been HIV group O. However, further studies are required to confirm this. It is therefore recommended that laboratories involved in HIV confirmation in Nigeria and in the West African coast, where HIV group O infections have been reported, should use kits that can detect group O. MOPEO126 Evaluation of the sensitivity and specificity of one confirmation of HIV-1 antibody urine western blot test kit in China Y. Qil, S.L. Liu2, G.W. Ding'. 'National Center for HIV/AIDS Control and Prevention, China CDC, Division of Quality Control and Management, Beiing, China, 'National Center for HIV/AIDS Control and Prevention, China CDC, Division of Administration, Beijing, China Background: The purpose is to evaluate the sensitivity and specificity of one HIV-1 antibody urine western blot confirmation test kit in order to identify the essential quality of the test kit fit Chinese people status. Methods: The paired urine and serum specimens from 247 HIV positive cases at three geographically separate sites, 229 HIV-1 negative cases from normal paid blood donor, 169 non-HIV-1 medical conditions including HCV positive case, pregnant, tumor patient, and general out-patient and 125 cases ot high risk group unknow HIV status (IDUs) tested with Calypte Biomeidcal Cambridge HIV-1 urine western blot test kits and a licensed HIV BLOT 2.2 HIV1/2 western blot to confirm HIV antibody from urine and serum specimens. The evaluations were performed by at least two different operators at each of 4 ditferent confirmation laboratories in China according to the test processes provided in the kits. Results: Of 247 urine specimens from HIV antibody positive individual, 247 showed positive reaction. Of 398 urine specimens from HIV negative group, all showed negative reaction. 27 showed positive result in the 29 HIV positive IDUs cases. One of 29 HIV positive was false negative and one was showed indefinite. All showed negative result in the 96 HIV negative IDUs cases. The sensitivity of the HIV-1 urine western blot test was 99.28%. The specificity was 100%. Taking the results together, the consistent rate of HIV-1 antibody urine western blot and serum western blot was 99.74%. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  64 Monday 14 August Poster Exhibition Conclusions: The Cambridge urine WB test kit which confirmed HIV-1 antibody of urine specimens had high sensitivity and specificity and also showed almost the same results tested by a licensed WB test in China market, was reliable. It was proposed that this urine confirmation test kit could be introduced in many fields of HIV antibody in China instead of serum confirmation test. MOPE0127 A practical model: integration of HIV-infected children into the continuum of care in Cambodia C. Prang1, N. Pich2, C. Francis2, C. Natpratan2, M. Dunbar3. 'Family Health International Cambodia, Living with Hope Program, Phnom Penh, Cambodia, 2Family Health International Cambodia, Phnom Penh, Cambodia, 3Path, Phnom Penh, Cambodia Issues: There are an estimated 12,000 children under the age of 15 years living with HIV in Cambodia. Although 2,000-3,000 of these children are living with AIDS, only 1,000 children are receiving treatment. The continuum of care structure in Cambodia has a strong community component, but children are not currently integrated within this structure. There is a general perception within rural communities that HIV-infected children cannot benefit from ART. Few care providers or community-based NGOs have been trained in care and treatment of HIV-infected children. Description: Through active networking, community-based organizations in Battambang province have identified the care and support needs of HIVinfected children, and integrated the children into the existing community services network. Community members meet regularly and learn from each other. Community representation at 'Continuum of Care' (CoC) committee meetings, held at referral hospital level, has enhanced communication and strengthened relationships between health staff and the community. The meetings provide a forum for the community to advocate for services for affected children, and promote linkages of HIV-infected adults and children's services. Care providers, village volunteers and NGO staff have received training on how to treat simple opportunistic infections, teach basic health care and support children's adherence to ART. Lessons learned: Effective utilization of available care and treatment services for HIV-infected children in resource-poor settings depends on strong collaborative relationships between communities and service providers. Services for HIV-infected adults and their children need to be linked. Recommendations: Poor living conditions and a lack of nutritious food negatively affects children's response to care and treatment. Networks need to expand to encompass a holistic multi-sectoral response to this issue. Psychosocial issues of HIV-affected children and their carers need to be addressed. MOPE0128 A model for the risk of pneumocystis jiroveci pneumonia (PCP) prophylaxis discontinuation based upon total lymphocyte count (TLC) in HIV-infected adults treated with highly active antiretroviral therapy (HAART) C. Cheung'1, Y. Lo2, J. Shuter'. 'Montefiore Medical Center (MMC), Albert Einstein College of Medicine (AECOM), Bronx, New York, United States, 2AECOM/MMC, Center for AIDS Research, Bronx, New York, United States Background: PCP prophylaxis may be discontinued when CD4 is >_200 cells/ mm3 for three months in response to HAART. Unlike CD4, TLC is inexpensive and widely available in resource-constrained countries. This study modeled the risk of TLC guided discontinuation of PCP prophylaxis after immune reconstitution. Methods: Paired TLC and CD4 values of HIV-infected patients attending the MMC I.D. Clinic from 1998-2005 were analyzed by Spearman's correlation. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and receiver operating characteristics (ROC) using TLC cutpoints between 1400 and 2000 cells/mm3 to predict CD4>_200 were calculated. Specificity of TLC cutpoints for CD4 200 began to plateau at TLC 1800. Next, a cohort of patients who had a TLC<1200 and subsequently achieved TLC 1800 sustained over three months while receiving HAART were identified. Those with CD4 200 corresponding to attainment of TLC 1800 were considered at negligible risk for PCP. In those with CD4<200, the time to subsequent CD4 rise to 200 or fall in TLC to <1800 (when PCP prophylaxis would presumably be restarted) was used to determine the median duration of risk for PCP by Kaplan-Meier analysis. Results: There was significant correlation between TLC and CD4 in 46,250 observations from 4307 individuals (r =0.695, p<0.001). The area under the ROC curve (AUC) was 0.85(95%CI=0.85-0.86). There were small but significant differences in AUC between females 0.87(95%CI=0.87-0.88) and males 0.84(95%CI=0.83-0.84), p<0.001; White 0.82(95%CI=0.8 -0.84) and Black 0.86(95%CI=0.85-0.87), p<0.001; and White and Hispanic 0.85(95%CI=0.84-0.86), p=0.003. The sensitivity, specificity, PPV, and NPV for TLC-1800 to predict CD4 200 were 62%, 86%, 92%, and 46% respectively. In the cohort analysis, 81% of subjects who achieved TLC-1800 (N=185) had a corresponding CD4>200. Of those with CD4<200, the median duration of risk was 147 days. Conclusions: A sustained rise in TLC to _1800 on HAART may potentially serve as a criterion for discontinuing PCP prophylaxis in resource-constrained countries. MOPE0129 Apheresis procedure in HIV-infected and non-infected subjects: a powerful tool for the collection of peripheral blood mononuclear cells for immune and vaccine purposes C. Grignon', M.-R. Boulassel', M. Turmell, M. Delisle', C. Goupill, M. Young', J.-M. Trepanier2, R.-P. Sekaly2, J.-P. Routy'. 'McGill University Health Center, Immunodeficiency, Montreal, Canada, 2Centre Hospitalier de l'Universite de Montreal, Immunodeficiency, Montreal, Canada Background: A leukapheresis unit was established in order to collect large quantities of peripheral blood mononuclear cells (PBMCs) for HIV-specific immune and viral analyses. A recruitment strategy as well as characteristics of the participants are described. Methods: Publicity and information about the leukapheresis procedure was provided via posters and scientific and community-based meetings. Prior to the procedure, participants read and signed a consent form and serological and hematological analyses including HIV, CMV, HBV, HCV, CBC, CD4 and CD8 cell counts were performed. The procedure consists of removing PBMCs from blood using equipment which is capable of extracting PBMCs by continuous flow cell centrifugation in a closed circuit (Baxter CS 3000). The PBMCs are prepared, identified by a code and stored in liquid nitrogen. Subject characteristics, virological and immunological determinants are anonymously collected and computerized. Results: A total of 301 subjects underwent leukapheresis, including 160 infected with HIV and 141 healthy donors. Among HIV participants, 60 were chronically infected, 39 were acute/recently infected, 28 were long-term-non-progressors and 5 were co-infected with hepatitis C. Moreover, 14 HIV subjects enrolled in the vaccine study (CTN 173) had a leukapheresis procedure prior to and following the completion of therapeutic immunization. Among healthy donors, 47 were cytomegalovirus positive (CMV+), while 94 were CMV-negative. For each procedure, the blood volume processed was 7L over a period of 2 hours. The total volume of the PBMC fraction collected was 200 ml, containing about 10-15 x 109 white blood cells. 150 vials of cells (20-50 x106 / vial) and 20 vials of plasma (1.5 ml / vial) are stored for each subject. Conclusions: The leukapheresis procedure allows collection of a large number of PBMCs which can be used to standardize HIV specific laboratory tests as well as to carry out specific immune and viral analyses. MOPE0130 CD4+ T cell enumeration with a flow rate-based assay in three flow cytometers with different years in service in Thailand P. Chimma', V. Pobkeeree2, S. Lerdwana', E. Noulsri', P. Sratongno', S. Nookhai2, K. Sukapirom', K. Fox3, J. Tappero2, K. Pattanapanyasat'. 'Faculty of Medicine Siriraj Hospital, Mahidol University, Office for Research and Development, Bangkok, Thailand, 2Thailand Ministry of Public Health-U.S. CDC Collaboration, Nonthaburi, Thailand, 3Global AIDS Program, Centers for Disease Control and Prevention, Atlanta, GA, United States Background: CD4+ T-lymphocyte count remains the most important surrogate marker for management of HIV patients in resource-poor countries like Thailand. The standard single-platform (SP) bead-based flow cytometric method for CD4 testing is expensive; more affordable methods are needed. We evaluated the performance of a SP flow-rate based calibration method for determining CD4 counts, using three flow cytometers with varying numbers of years in service. Methods: CD4 counts in blood samples from 103 HIV-1 infected Thai patients were determined using a SP flow rate-based calibration method in three Becton Dickinson Biosciences flow cytometers: one with 2, one with 12, and one with 16 years in service. Results were compared to those from the standard beadbased SP 3-color TruCount flow cytometric method. Correlation and agreement were analyzed using linear regression and Bland-Altman analysis. Results: Absolute CD4' counts obtained from the flow-rate based approach in each flow cytometer showed strong correlation with results from the standard bead-based method (R2 =0.97, 0.97 and 0.96 for the 2 year-old, 12 year-old, and 16 year-old flow cytometers, respectively). The mean biases for the flowrate based approach compared with the standard bead-based method were +32.4 cells/pL (limit of agreement, LOA: -85.4 to +150.2 cells/pL) for the 2 year-old flow cytometer, -28.8 cells/iL (LOA: -133.7 to +76.1 cells/pL) for the 12 year-old flow cytometer, and -27.0 cells/FL (LOA: -151.9 to +97.9 cells/pL) for the 16 year-old flow cytometer. Conclusions: These findings demonstrate that the flow-rate based method is a reliable SP approach for determining CD4 counts, and results do not vary by age of flow cytometer. This approach provides a new cost-effective alternative for HIV patient monitoring in resource-poor settings. MOPEO131 Clinical and laboratory status of HIV/AIDS patients seen at first hospital visit in Yaounde, Cameroon G. Alemnji', J. Mbuagbaw2, A. Evina2. 'Faculty of Medicine and Biomedical Sciences, Biochemistry, Yaounde, Cameroon, 2Faculty of Medicine and Biomedical Sciences, Medicine, Yaounde, Cameroon Background: The continuous changing picture of HIV/AIDS, calls for the need to constantly review clinical and laboratory parameters of positive cases in order to promptly identify and decide those in need of medical and psychological attentions XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  65 Methods: This study consisted of use of questionnaires to collect information from patients seen at the AIDS treatment clinic of the Yaounde University Teaching Hospital between the months of May and December 2004. Data collected included information on demographic and various clinical signs and symptoms associated with HIV/AIDS as well as CD4 cell count results. Results: The population studied consisted of 556 positive cases, 58% females (323) and 42% males (233). HIV positive status were known among 89.9% of the cases following episodes of ill health while voluntary counselling and testing (VCT) diagnosed HIV only among 5% of them. Using CDC 1993 classification, cases were grouped into clinical categories as follows: A 14.5 %, B 33.2 %, C 28.2 % and 24.1% were not classified. Clinical signs and symptoms were dominated by anaemia 61 %, pneumonia 34.5 %, meningitis 9.9 %, unexplained fiver 34.4%, loss of weight more than 10%, 30.4%, tiredness 21.2 %, diarrhoea 14.2 %, and cough 11.1%. In all, 29.6% of the subjects had CD4 cell counts less than 100 cell/ mm3, while 43.3% of them had counts below 200 cells/ mm3. Statistically significant associations were established between low CD4 cell counts and various pathologies as follows: tuberculosis P<0.01, oral candidosis P<0.02, kaposi's sarcoma P<0.04, herpes zoster P<0.002 and genital herpes P<0.05. Conclusions: The present study show that majority of subjects get to know their HIV status very late, already developing clinical signs and symptoms of AIDS with very low CD4 cell counts. There is need for improvement of early HIV diagnosis strategy through education and voluntary counselling among populations in Africa. MOPE0132 Identifying acute HIV infection: potential utility of a stepwise pooling algorithm using HIV RNA PCR in a STD clinic in Durban, South Africa A.B. Kharsany, Z. Cele, K. Coetzee, H. Carrara, B.P. Ncama, S.S. Abdool Karim, Q. Abdool Karim. University of KwaZulu-Natal, Centre for the AIDS Programme of Research in South Africa, Durban, South Africa Background: Identifying individuals with acute HIV infection poses several challenges. One strategy to identify acute HIV infection, which utilizes laboratory detection of RNA by PCR in the absence of HIV antibodies, has recently been proposed but its feasibility and applicability have not been widely assessed. We assessed the potential of a multistage pooling algorithm for detection of HIV RNA by PCR as a screening tool to identify persons with acute HIV-1 subtype C infection. Methods: Between August 2005 and December 2005, 1598 clients at a STD clinic in Durban were offered voluntary counseling and HIV testing which included screening with two rapid HIV antibody tests. The one discordant and 312 seronegative patients were subsequently screened for presence of HIV RNA through a stepwise pooling algorithm using the COBAS AmpliScreen HIV1 test version 1.5 and the COBAS AMPLICOR HIV-1 MONITOR Test, v1.5. All patients testing positive on PCR were informed of their result in the context of post-test counselling. Results: The prevalence of HIV infection in this group of STD clinic clients was 55.1% (95% CI: 52.5 - 57.4). The stepwise pooling algorithm found 3 positive for RNA PCR ie. almost 1% of the HIV seronegative STD clients had acute HIV infection. Conclusions: The stepwise pooling algorithm using RNA PCR is a feasible and potentially valuable strategy for screening for acute HIV infection in populations at high risk of HIV acquisition such as STD clinic clients. MOPE0133 Long-term follow-up of HIV antibodies in HIV-infected patients with prolonged complete suppression of HIV viremia on HAART - comparison with HCV infection A. Amor', C. Toro2, V. Jimenez2, A. Sim6n2, B. Ramos2, V. Soriano2. 1Hospital Carlos III, Microbiology, Madrid, Spain, 'Hospital Carlos III, Infectious Diseases, Madrid, Spain Background: A few cases of incomplete antibody evolution or seroreversion in acutely infected subjects who received HAART shortly after primary HIVinfection have been reported. We investigated if seroreversion may also occur in chronically HIV-infected patients with prolonged complete virological suppression. Methods: HIV-infected patients under HAART and long-term non progressors (LTNP) who maintained undetectable viremia (< 50 cop/ml HIV-RNA) for at least 5 years were studied. EIA and Western blot (WB) assays were carry out in two serum samples from each patient with a mean interval of 5 years. As a control, changes of HCV antibody profile were examined in subjects positives for HCV antibodies who had eradicated HCV infection with at least 5 years of follow-up. Results: A total of 96 chronically HIV-1 infected subjects, 92 under HAART and 4 LTNP were identified. In EIA assay no significant differences in optical density was found in neither of samples of patients and all of them developed a fully reactive WB who remained without changes 5 years later, except in 1 subject who showed a significantly reduced reactivity against all WB bands and a lack of reactivity in another confirmatory tests using synthetic peptides (Pepti-lav). This patient had intiated antiretroviral therapy 8 mounts after primary infection and showed undetectable viremia for 6 years. The 25 patients identified positive for HCV antibodies who had eradicated HCV infection, either spontaneously or following treatment, showed a significantly decrease in reactivity against core and non structural protein (p<0.05). Conclusions: Although seroversion in chronically HIV-1-infected patients under HAART with long-standing undetectable viremia seems to be a rare event can occurs and be misdiagnosed in confirmatory test based on the detection of synthetic peptides. In contrast HCV antibodies tended to decline over time following HCV eradication either spontaneously or after successful treatment. MOPE0134 Human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections: seroprevalence in Douala, Cameroon M. Djuidje Ngounouel, N. Ndembi2, M. Mbangue3, H. Leundji3, H. Fosto Kuate3, M. Tonye3, C. Njopa3, M. Fotue3, R. Njouom4, P. Moundipa Fewou', L. Kaptue2. 1University of Yaounde I, Faculty of Science, Department of Biochemistry, Yaounde, Cameroon, 2University of Yaounde I, Faculty of Medicine and Biomedical Sciences, Laboratory of Haematology and Virology, Yaounde, Cameroon, 3Laquintinie Hospital, Biology, Douala, Cameroon, 4Centre Pasteur, Yaounde, Cameroon Background: HIV infection constitutes a serious Public Health problem throughout the world. Acquired Immunodeficiency Syndrome (AIDS) is the virus inducing disease characterised by a strongly depressed immunity. To the pandemic of AIDS is associated HCV infection, another Public Health problem throughout the world, especially in Africa and in Cameroon. In order to determine the seroprevalence of HIV infection in Douala and to compare the data with the national prevalence of HIV infection in Cameroon, to investigate the seroprevalence of HCV, as well as the HIV/HCV co-infection in Cameroon, a study was carried out in Laquintinie Hospital, Douala. Methods: From January to December 2005, a total of 14,742 familial and volunteer blood donors of both sexes, aged between 17 and 60 years, were screening both for antigens/antibodies to HIV, and for antibodies to HCV. We obtained the informed consent from 90% of participants. Blood samples were collected using aseptic conditions, in EDTA tubes. Plasma was separated, and stored frozen at -200C until tested. Samples were screening for Ag/Ab to HIV 1,2 using sandwich ELISA. The presence of anti HCV antibodies was checked using indirect ELISA. Comparison of data was undertaken using Fischer test, Student-t-test, and one way analysis of variances. Statistical significance was defined as P<0.05. Results: Sera from 851 (5.77%) of the 14,742 participants enrolled were positive for HIV; 362 (2.45%) were positive for HCV; 22 (0.14%) were positive both for HIV and for HCV. These values exhibit the prevalence of 2.6% of HCV infection among the HIV positive persons, and 6.07% of HIV infection among those who are HCV infected. Mean age of HIV positive participants (33.89 years) was significantly low compared to that of HIV negative and HCV positive participants (40.35 years). Conclusions: HIV infection is more prevalent in Cameroon than HCV infection; HIV-infected persons are younger than HCV infected patients. MOPE0135 Making a working clinical diagnosis of HIV infection in infants R. Ntozini, ZVITAMBO Study Group. ZVITAMBO Project, Harare, Zimbabwe Background: PMTCT/ARV programs are 'rolling out' but formal virological diagnosis of infant HIV infection is complex and expensive. Nevertheless several aspects of management are important in the first year, including cotrimoxazole prophylaxis, choice of feeding practice, and early initiation of HAART. Clinical algorithms have been incorporated into IMCI guidelines but few have been evaluated. Methods: The ZVITAMBO trial recruited and followed 14,110 mother-baby pairs for 1-2 years. Infants <18 months were HIV tested using DNA PCR. Clinical signs evaluated by nurses at follow up included: weight/failure to thrive, pneumonia, diarrhoea (acute/persistent), ear discharge, lymphadenopathy, oral thrush, and TB. Three published clinical algorithms were tested against the data. A modification was derived and evaluated. Results: At 6 weeks selection of babies <median weight-for-age halves the number of virological tests required for HIV-exposed infants, but retains 65% sensitivity. Further selection of children exhibiting 2 clinical signs reduces sensitivity to 17% but increases Positive Predictive Value from 30 to 53%. At 6 months, infants with <2 clinical signs include 89% of all those uninfected with whom the possibility of rapid early weaning can be explored. At all ages, increasing the 'cut-off' from 2 to 3 or 4 signs greatly decreases sensitivity in picking up HIV-infected babies (eg: at 12 months: 72% to 43% and 19% respectively), but correspondingly increases specificity (78% to 93% and 99%). Conclusions: Use of clinical signs alone is inevitably imperfect for diagnosing HIV infection in infants. However, in resource-poor circumstances a simple clinical algorithm can identify children to whom can be offered focussed support or referral to better equipped distant centres. Program managers can make informed choices as to the sensitivity and specificity of the criteria, and the number of criteria, they wish to use. Monday 14 August Poster Exhibition XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  66 MOPE0136 Comparative performance of four commercial HIV-1 viral load (VL) assays P. Braun', R. Ehret', F. Zabbail, R. KOhn2, S. Thamm3, G. Warnat4, H. Knechten'. 'PZB, Aachen, Germany, 2Roche Diagnostics, Mannheim, Germany, 3Abbott GmbH & Co. KG, Wiesbaden, Germany, 4Bayer Diagnostics, Fernwald, Germany Background: We compared the performance of following quantitative HIV1-assays: COBAS Amplicor-Monitor-vl.5 (Roche), Versant bDNA-3.0 (Bayer), with manual RNA isolation, ml000/m2000rt (Abbott) and COBAS-AmpliPrep/ COBAS-TaqMan (CAP/CTM, Roche) with automated RNA extraction. Methods: Intra-assay variability for real time assays (m1000/m2000rt and CAP/CTM) was measured with 10 or 20 replicates of WHO (NIBSC, UK) and PEI (Paul-Ehrlich-Inst., Germany) standard in different dilutions. Inter-assay variability was measured with dilutions from 50 to 5x105 copies/mL of one clinical sample (3x5 repeats). 20 seronegative samples and a subtype panel (A-H; NRZ, Germany) were analyzed (2 group O isolates only with m1000/ m2000rt). 97 clinical samples were tested in duplicates. Hands-on-time was documented. Deming regression and Bland Altman analysis were used for comparison. Results: All HIV-seronegative samples were analysed as negative by each system. All subtypes were detected, group O by m1000/m2000rt. The coefficients of variation (CV) for the different clinical specimen dilutions were 2.2% to 13.5% for ml000/m2000rt; 6.9% and 32% for CAP/CTM. Linear dilution magnitude for ml000/m2000rt resulted in values below and for CAP/ CTM slightly above nominal concentrations, but both ensured linearity and correlation (m1000/m2000rt: CV absolute 11.7-23.9%; R2 0.93-0.97; CAP/ CTM: CV 20-50.3%; R2 0.71-0.89). Correlations (R2) and mean differences (Bland/Altman) for all clinical samples are shown in the table. Versant Amplicor Monitor CAP/CTM mlOOO/ m2000rt Versant Amplicor Versant Monitor -- R2=0.98 0.33 logcps/ml 0.16 -0.22 logcps/ logcps/ml ml -0.10 logcps/ -0.40 logcps/ ml ml ~mIO00/ CAP/CTM m1000/ m2000rt R2=0.97 R2=0.96 R2=0.97 R2=0.95 -- R2=0.94 -0.22 logcps/ ml A reduced hands-on-time was calculated for the fully automated CAP/CTM followed by m1000/m2000rt. Conclusions: The assays were comparable in sensitivity and specificity. The VL values varied, with a mean difference between 0.1 and 0.4 log. This should be considered when monitoring the same person with different systems. MOPE0137 The new EIA assay for reliable confirmation of HIV infection T. Ulanova, E. Baranova, I. Sharipova, N. Denisova, V. Puzyrev, A. Obriadina, A. Burkov. RPC Diagnostic Systems, Nizhniy Novgorod, Russian Federation Background: The diagnostic of HIV infection is based on antibodies detection to different proteins of human immunodeficiency virus (HIV) type 1, 2 and HIV 1 antigen p 24 in sera specimens. One of the problems of EIA diagnostic HIV infection associated with the reliable confirmation of the screening assays results. The aim of present study was to evaluate new EIA test "DS-EIA-HIVAb/Ag-spectrum" as a supplemental assay for verification of the HIV positive results. Methods: Wells of microtiter plate were separately coated by recombinant proteins comprising diagnostic relevant epitopes of HIV 1 structural proteins gp41, gpl20, p24, p31 and gp36 of HIV 2 and mouse monoclonal antibodies to HIV 1 p24. Sensitivity of new test was evaluated by well defined sera samples from HIV-infected patients (n=800) and commercial available panels of sera. For specificity evaluation of the new assay, specimens of healthy blood donors (n =910), pregnant women (n=130), patients with other infections (n=224), patients with noninfectious diseases (n=64) and samples with indeterminate results (IND) in Western Blot (WB) (n=154) were investigated. Results: EIA test "DS-EIA-HIV-Ab/Ag-spectrum" is able to confirm all tested anti-HIV positive sera as positive. The new assay allow additionally detect HIV p24 antigen in the serum samples at concentration not less then 5pg/ml. Ninety nine sera with WB IND were tested as HIV positive in new assay at the initially testing and confirmed as HIV positive in WB dynamic observation. Forty five of them were positive for p24 antigen only. Diagnostic specificity of the new test has been estimated at 99,5%. Conclusions: The received results demonstrated high diagnostic efficiency of new supplemental assay. Opportunity of definition p24 antigen and high specificity allow reducing number IND received by WB. MOPE0138 Impact of WHO External Quality Assessment (EQA) program on the laboratory performance for CD4 enumeration for monitoring of ARV therapy in resource limited settings G. Vercauteren', H. Aggett2, F. Mandy3, D. Glencross2. 1World Health Organization, Essential Health Technologies, Geneva, Switzerland, 2University of the Witwatersrand and the National Health Laboratory Services of South Africa, Johannesburg, South Africa, 3Health Canada, Ottawa, Canada Background: Parallel to anti-retroviral therapy (ART) for people living with HIV/AIDS, CD4 technologies to monitor the efficacy of ART are becoming increasingly available in countries with limited resources Methods: The University of Wittwatersrand (Witts) South Africa was identified as a WHO regional centre of excellence for CD4+ T cell enumeration for Africa. In 2002, Witts established, a national EQA scheme for CD4 technologies, after 6 months it expanded the program gradually to include participants from other African countries. The WHO CD4 EQA program collaborated with the non for profit international EQA scheme run by Health Canada, called QASI. Laboratories performing CD4 counts were invited to enrol in the WHO regional EQA program for CD4 technologies for Africa and received six times/ year specimen panels for analysis and reported back results. EQA participants received 4 times/year panels prepared by Witts and two times/year from QASI. Poor performers were given technical support either by telephone or through hands-on training at Witts. Results: The number of participants in the EQA programme increased from 13 in 2002 to more than 140 laboratories in 2006. A total of 16 CD4 EQA panels have been distributed, including 5 from QASI. Return rates of results were high ranging between 88.5% - 96.1%. On average, the performance of participants improved after 3 distributions. The overall reproducibility of the CD4 absolute counts decreased from 16.4% CV to 10.6 % CV, whereas the coefficient of variation (%CV) for the CD4 percentage decreased from 10% to 4.5%. Conclusions: CD4 counts play an important role in the decision making process for initiating and monitoring ART. Thus, ensuring reliable results through investment in EQA program are key for individual patients and for cost-effective public health expenditure. MOPE0139 Short-term risk of AIDS or death among HIV-1-infected individuals prior to widespread availability of antiretroviral therapy in South Africa M.H.Y. Badri, S.D. Lawn, R. Wood. Desmond Tutu HIV Research Centre, Institute of Infectious Deseases and Molecular Medicine, Cape Town, South Africa Background: Large numbers of HIV-infected patients are accessing antiretroviral therapy (ART) in sub-Saharan Africa. However data on short-term risk of AIDS or death that would inform decisions on when to start treatment are lacking. Methods: 6-month risks (%) of death, AIDS and combined risk of AIDS and death (AIDS/death) were each calculated according to current CD4 cell count (<200, 200-350 or >350 cells/mL) and WHO stage (1 or 2 combined, 3 or 4) in untreated patients (n=1399) prior to widespread availability of ART in Cape Town. Results: Six-month risk of death ranged from 1.2% for patients with CD4 cell counts >350 cells/mL and WHO stage 1 or 2 to 22.2% for those with CD4 cell counts <200 cells/mL and WHO stage 4. Fifty two percent of death occurred among patients without AIDS. Six-month risk of progression to AIDS ranged from zero for patients with CD4 cell counts >350 cells/mL and WHO stage 1 or 2 to 17.4% for those with CD4 cell counts <200 cells/mL and WHO stage 3. Conclusions: In this study, risk of AIDS in patents with CD4 count <200 cells/ L or those with CD4 count > 350 cells/pL was similar to that previously reported from European cohorts, but among those with CD4 cell counts 200 -350 cells/IL, however, was 1.9-fold greater A high mortality rate prior to development of AIDS and a high risk of AIDS among those with CD4 cell counts 200-350 cells/tL indicate that delay in ART initiation is associated with a high morbidity and mortality. MOPE0140 The evaluation of CD4+ T lymphocytes proficiency testing program of multi-machines in China Y. Xiao', J. Feng', H. Zhang', F.F. Mandy2, Y. Jiang1. 1China CDC, National AIDS Reference Lab, National Center for STD/AIDS Control and Prevention, Beijing, China, 'National HIV Immunology Labrotory, National HIV and Retrovirology laboratories, Center for infectious disease prevention and control, Public Health Agency of Canada, Ottawa, Canada Background: Satisfactory performance in CD4+ T lymphocytes proficiency testing (PT) program is a requirement for participation in AIDS treatment. Quality assessment and proficiency testing program of national scope are important means to assure the reliability of T lymphocytes measurement. National AIDS Reference Laboratory firstly makes a systematic assessment to the proficiency testing of the flowcytometry labs in China. Methods: Stabilized two whole blood samples are sent on a regular basis (twice a year) to participating laboratories in China. They include over 60 laboratories located on the CDC and hospital. Flow Cytometric results on T lymphocytes levels are reported to the National Reference Lab of China CDC, which collated XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  67 the data and reports to all laboratories on the pooled values. Results: Data from individual laboratories are confidential. Values obtained by the laboratories participating are expressed as the mean of CD3+, CD4+ and CD8 +T lymphocytes value, and the standard deviation of these indexes. The twice PT percent of SDI great than 2 is from 7.14% to 10.34% (FACSCount), from 9.52% to 9.52% (FACSCalibur). The once PT percent of SDI great than 2 is 16.67% (COULTER Epics-XL). The twice PT CV% of CD4+T lymphocytes absolute value is from 6.7-11.9 % to 5.2-6.9% ( FACSCount), from 16.9-26.0 to 16.4-33.1 (FACSCalibur). The once PT CV% of CD4+T lymphocytes absolute value is from 22.5-27.9% (COULTER Epics-XL).Details in following tables. Conclusions: The performance of the first evaluation of CD4+ T lymphocytes proficiency testing program in China is satisfactory, and the statistic data show most Flowcytometry laboratories in China work well. Fig. 1 The results of CD4+CD3+T lymphocyte absolute values of 49 laboratories in 2005 first PT in China Type FACSCOUNT (28labs) FACSCALIBUR (21 labs) No. of labs SD No. of labs N~2(percent) 1.5<SDI<~2 CV% 2(percen (percent) 2 (7.14%) 3 (10.71%) 6.7-11.9 2 (9.52%) 0 (0%) 16.9-26.C Fig.2 The results of CD4+CD3+T /ymphocyte absolute values of 62 laboratories in 2005 second PT in China No. of labs SDI No. of labs Type > 2(po t'b SDI ~1.5<SDI<+2 CV%.percent (percent) FACSCOUNT (291abs) 3 (10.34%/) 1 (3.45%/) 5.2-6.9 FACSCALIBUR (21 labs) 2 (9.52%) COULTER Epics-XL (12 labs) 2 (16.67%) 0 (0%) 0 (0%) MOPEOI41 suPARnosticM, a novel and simple assay for monitoring HIV disease progression J. Eugen-Olsen', A. Stausgaard', L. Kahns', J. Kyhse-Andersen2, K. Teversham3. 'Copenhagen University Hospital Hvidovre, Clinical Research Unit, Hvidovre, Denmark, 2ViroGates A/S, DTU Scion, Denmark, 3ViroGates Pty Ltd, Cape Town, South Africa Background: suPAR (soluble urokinase receptor) is a plasma protein with prognostic strength similar to, and independent of, CD4 and HIV viral load. We aimed at developing an assay that carries strong prognostic value in HIV-1 infection and which is inexpensive and easy to carry out. Methods: Mice, rabbits, chickens and rats were injected with human recombinant suPAR. 31 stable Hybridoma cell-lines were established from mice and rats. From 31 anti-suPAR positive clones, 7 different monoclonal/ monoclonal or monoclonal/polyclonal ELISA's were developed. The seven ELISA's as well as the "old" monoclonal/polyclonal suPAR ELISA were used to measure plasma samples from 73 Caucasian HIV-1 patients with "pre-HAART" clinical follow-up. ELISA results were analysed using Kaplan-Meyer and Cox Regression survival analysis. Results: All eight suPAR ELISA's carried significant prognostic value. However, one monoclonal/monoclonal antibody combination (suPARnosticTM) was found to carry superior prognostic value over the 7 other ELISA's. When dividing the patients into 3 equally sized groups based on suPAR level, 0/24 patients with low suPAR, 1/24 with medium suPAR and 13/25 patients with high suPAR died within the first two years of follow-up. Both suPAR and CD4 count were strong and independent predictors of survival. The strong prognostic value of suPARnostic'TM was reproduced in a cohort of African HIV-1 infected individuals. Discussion: A simple and strongly prognostic assay of HIV-1 disease progression has been developed. Knowledge of both CD4 cell count and suPARnosticTM value may aid in clinical decision making on when to initiate ART. MOPE142 Enhancing access to antiretroviral therapy in Kenya through a specimen referral network for CD4 testing: a rural region/province experience E. Opiyo', L. Nyabiage2, M. Ernest Pancras3, J. Omondi4, B. Marstons, P. Tukei6, KEMRI/CDC Laboratory Infrastructure Support Group. 'Kenya Medical Research Institute/CDC, Treatment and Care Group, Kisumu, Kenya, 2Ministry of Health, Kenya, New Nyanza Provincial General Hospital, Kisumu, Kenya, 3Kenya Medical Research Institute/CDC, Centre for Disease Control, Nairobi, Kenya, 42, New Nyanza Provincial General Hospital, Kisumu, Kenya, sCentre for Disease Control, Traetment and Care Team, Kisumu, Kenya, 6Centre for Disease Control, Laboratory Support tTeam, Nairobi, Kenya Issues: With a prevalence of 15% in adults, Nyanza province has not only the heaviest burden of HIV, but also the highest need for rapid ART scale up in Kenya. However, only 25% of the individuals eligible for ART are presently enrolled. Although many socio- and geo-economic characteristics are associated with this low ART intake, inadequate access to CD4 cell testing facilities, most of which operate below capacity, has been identified as an important intervenable factor. Description: A two-way participatory sample and/or referral system between hard to reach ART sites and laboratory testing sites (6 government owned Fascount systems) was established. Using this system blood samples were collected on specified days from ART sites, and transported to the CD4 testing laboratories by a community volunteer. The specimens were transported and received in the testing laboratory usually less than 6 hours of collection. After every delivery, the transporter collected the results of the previous week's tests for return to the ART sites. Lessons learned: The sample referral system has increased CD4 testing capacity of the laboratories in the province. In addition, after only 5 months of operating the sample referral network, most of the sites have recorded about 35% upsurge in the uptake of ART. Excellent linkage now exists between the ART sites (Patient support Centre) and the laboratory. Cordial inter-laboratory communication now exists and provides opportunity for the establishment of the much needed QA and EQAS programs for CD4 testing in Kenya, starting from the Nyanza region. Recommendations: By taking the sample to the laboratory, rather than the laboratory to the people, linkage of the laboratory treatment and care program is achieved thereby increasing access to ART. MOPE0143 The influence of CD4 cell counts, viral loads and antiretroviral treatment of left ventricle ejection fraction of adult HIV/AIDS patients W. van den Heever, S. Steenkamp. Central University of Technology, Free State, School of Health Technology, Bloemfontein, South Africa Background: There are a few publications in the medical literature linking HIV and AIDS with left ventricular dysfunction but none in South Africa. Current knowledge is based on echocardiography and autopsy studies. There is also very little information on the impact of antiretroviral therapy on LVEF, because cardiac complications are often clinically inapparent or subtle in the initial stages, periodic screening of HIV-positive patients by ECG and echocardiogram is propably indicated. The purpose of this study was to see what the relationship between the variables was in an attempt to find a point in the course of the HIV/AIDS disease where it is necessary to do an echocardiogram on these patients to evaluate the LVEF. Methods: A total of 458 voluntary HIV-positive/AIDS patients from a private practice in Bloemfontein were included in the study after the inclusion criteria had been applied. An echocardiogram was done on the patients who gave their consent to evaluate the LVEF. The patients went for their usual blood tests and ART was given to them if it was indicated. Results: The findings show there was a direct proportional relationship between the LVEF and the CD4 cell count, and an indirect proportional relationship between the viral load and the LVEF. The prevalence of a below normal LVEF was mostly found in patients whose CD4 cell count < 100 cells/ml and/or a viral load _100 000RNA copies/mi. ART had an indirect effect on the LVEF via the CD4 cell count and the viral load. Conclusions: The physician of an adult HIV/AIDS patient should consider an echocardiogram when the CD4 count falls below 100 copies/ml, and/or when the viral load exceeds 100 000RNA copies/ml in order to identify those patients who have left ventricular dysfunction and how might therefore benefit from the treatment with appropriate medication. MOPEO144 CD4+ count testing program strategy for HIV-infected patients in Guyana: a model for resource limited settings C. Anude', M. Bateganyal, R. Guidry', L. Hardy', P. Mohammed2, S. Singh3, A. Pierce4, T. Dennys, G. Pemberton'. 'FXB Center, University of Medicine and Dentistry of New Jersey, Newark, New Jersey, Francois -Xavier Bagnoud Center, Georgetown, Guyana, 2Ministry of Health, Government of Guyana, Laboratory Department, Georgetown, Guyana, 'Ministry of Health, Government of Guyana, National AIDS Program Secretariat, Georgetown, Guyana, 4FXB Guyana / University of Medicine and Dentistry of New Jersey, Laboratroy Department, Georgetown, Guyana, sUniversity of Medicine and Dentistry of New Jersey, Laboratory Department, Newark, United States, 'University of Medicine and Dentistry of New Jersey, Francois-Xavier Bagnoud Center, Newark, United States Issues: CD4 testing optimizes HIV care and treatment. Before September 2004, CD4 testing was not available in Guyana, but with PEPFAR support, the Ministry of Health(MOH) has made CD4 testing widely available without charge for all HIV positive patients utilizing the public healthcare system. Guyana's experience can serve as a model for other resource limited countries. Description: The MOH, technical partners and laboratory experts collaborated in the plan to implement national CD4 testing challenged by the need to maximise use of technology and costly equipment requiring skilled manpower. Two FACS count machines were purchased, technicians recruited and trainied, confidential longitudinal database with unique patient identifiers created, and internal quality and external proficiency measures implemented. The MOH launched CD4 testing with public service messages encouraging HIV testing and publicizing the availability of free CD4 monitoring and treatment. Multidisciplinary lectures about CD4 testing and monitoring in HIV management were conducted.By December 2005, over 4000 CD4 tests were completed for patients at all HIV treatment and PMTCT sites. Lessons learned: Guyana centralised CD4 testing, using courier systems for XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  68 M'~nday s 14; August 't i Exhibition sample delivery from distant sites. Testing occur on the same day or the following day and results are returned within 24 hours, despite logistical challenges. Results have been confidential, timely and reliable. CD4 testing can be done in a centralized center with established high standards in delivering quality resutis. Longitudinal database systems can be developed. A multi-disciplinary approach targetting the public and private healthcare providers succeeded in gaining fast and widespread acceptance for CD4 testing throughout Guyana Recommendations: Countires with limited resources can provide high quality, sustainable CD4 testing servicies utilizing a phased approach and a network model to roll-out CD4 testing and contain costs. MOH leadership and effective partnerships for technical assistance and training are essential to scale-up of sustainable technologic advances in HIV/AIDS care in resource-constrained settings. MOPEO145 Validation of objective response to therapy criteria in smear-negative tuberculosis patients from a high HIV prevalence setting D. Wilson', C. Morroni2, J. Nachega3, R. Chaisson4, G. Maartens5. 'Edendale Hospital, University of KwaZulu Natal, Department of Medicine, Pietermaritzburg, South Africa, 2University of Cape Town, School of Public Health and Family Medicine, Cape Town, South Africa, -Johns Hopkins University, Bloomberg School of Public Health, Baltimore, United States, 4Johns Hopkins University, Department of Medicine, Baltimore, United States, 'University of Cape Town, Department of Medicine, Cape Town, South Africa Background: Sputum smear negative tuberculosis (SNTB) is a common cause of death in high HIV prevalence settings in developing countries with limited access to mycobacterial culture. Objective response to therapy (RTT) criteria in HIV-infected adults with SNTB have been developed: in an interim analysis we evaluated these criteria in SNTB patients from KwaZulu-Natal, South Africa. Methods: SNTB suspects were enrolled, induced sputum TB cultures were taken, and participants meeting one or more SNTB case definitions were started on antituberculous therapy. Changes from baseline to week 8 in weight, haemoglobin, C-reactive protein (CRP), Karnofsky performance score (KPS) and symptom count ratio (SCR) were used to evaluate RTT, and the RTT criteria were applied to participants with culture positive TB. Results: The first 160 participants were evaluated: 55.6% were male; 49.4% HIV-infected; 38.1% HIV status unknown; 12.5% HIV-uninfected. Twenty eight participants were diagnosed with culture positive SNTB: in these subjects mean weight increased from 56.8 to 58.7 kg; mean haemoglobin from 10.2 to 11.3; median KPS from 70 to 90; median SCR from 0.0 to 1.0; and median CRP decreased from 101.2 to 8.6 (P < 0.006 for all comparisons). 96% met 2 or more RTT criteria. Conclusions: RTT criteria may be a useful way of confirming SNTB in high HIV prevalence settings. MOPEOI46 The ARK EFV-test (TM): a rapid, automated immunoassay for therapeutic drug, monitoring of efavirenz M. Helms', D. Holland2, R. Espina-Quinto2, E. Stefanski2, B. Moon', J. Valdez', J. Connor2. 1ARK Diagnostics, Inc., Sunnyvale, United States, 2University of California, Pediatrics, San Diego, United States Background: Therapeutic drug monitoring (TDM) in HIV disease may increase antiretroviral (ARV) efficacy by reducing toxicity, monitoring adherence, preventing drug resistance, and managing drug-drug interactions. Measuring ARVs with current techniques (e.g. HPLC or LC/MS/MS) is costly, time consuming, and requires specialized equipment and skilled technicians. A new rapid, automated enzyme immunoassay has been developed for determining plasma efavirenz (EFV) concentrations. Results using the new method were compared to those from a standard HPLC method. Methods: ARK's EFV-TestTM is based on competitive binding to antibody between a drug in the sample and a drug-labeled enzyme. Drug concentration is measured spectrophotometrically in terms of enzyme activity using a Roche COBAS MIRA~ bench top analyzer. Each test uses 4 IpI of sample. The calibration standards ranged from 1 - 10 pg/mI. Patient samples and proficiency testing (PT) samples were run and compared to HPLC results. Results: Validation data for controls (0.75 to 8 pg/ml) show inter-assay precision of <13.4% CV (n = 20). Accuracy was -5.7% deviation at 0.75 pg/ml and within 8% for remaining controls (n = 20). Assay sensitivity was 0.3 pg/ml. No interference was noted from 10 other ARV drugs. A comparison of patient samples analyzed by HPLC and ARK's EFV-TestTM yielded strong correlation: y = 0.87x + 0.22, R2 = 0.96, n = 29. Proficiency testing samples showed excellent agreement with target values. Conclusions: ARK's EFV-TestTM for measuring efavirenz in plasma was validated. The test is an automated enzyme immunoassay (EIA) that requires minimal expertise, small sample volume, no sample pre-treatment, and provides the first result within 30 minutes. All reagents are supplied ready-to-use. This test shows good correlation with HPLC and is well-suited for routine TDM use. This test may also provide a cost-effective way to determine EFV concentrations in areas with high HIV prevalence and limited testing resources. MOPEO147 Diagnosis and monitoring of paediatric HIV-1 infection by an ultrasensitive HIV-1 p24 assay adapted to dried blood spot specimens M.C. Knuchell, B. Jullu2, C. Shah', Z. Tomasik', M. Stoeckle3, R.F. Speck4, D. Nadal', H. Mshinda2, J. BOni', M. Tanner3, J. Schupbach'. 'Swiss National Centre for Retroviruses, Zurich, Switzerland, 'Ifakara Health Research and Development Centre, Ifakara, Tanzania, United Republic of, 3Swiss Tropical Institute, Basel, Switzerland, 4University Hospital Zurich, Division of Infectious Diseases and Hospital Epidemiology, Zurich, Switzerland, 5Children Hospital of Zurich, Division of Infectious Diseases, ZOrich, Switzerland Background: Children in resource-limited countries are frequently diagnosed only at advanced stages of HIV-1 infection. Lack of adequate diagnostics and trained personnel paired with low resource conditions contribute to the poor assessment of the HIV-1 status in children. We report adaptation of the ultrasensitive HIV-1 p24 antigen assay to dried blood spots (DBS-p24) for diagnosing and monitoring paediatric HIV-1 infection. Methods: High background in DBS-p24 testing due to endogenous peroxidase was eliminated by H202 quenching. Seventy two untreated Tanzanian children, as well as 95 HIV-infected and 159 HIV-negative subjects from Switzerland were enrolled for this study. DBS-p24 results were compared to plasma-p24 results and to results obtained by real-time PCR to detect DBS HIV-1 DNA or plasma HIV-1 RNA. Results: Thirty eight Tanzanian children were diagnosed as HIV-1 infected by DBS HIV-1 DNA and/or plasma HIV-1 RNA, and 34 as uninfected. HIV-1 subtypes included 18 C, 9 A1, 8 D, 1 AC, 1 J-like, and 1 unidentified. DBSp24 antigen sensitivity for non-D subtypes was 93% (CI95% = 81 - 99%). Among subtype C (n = 18), all samples except one (389 RNA copies/mL) were DBS-p24 positive, disclosing a sensitivity of 94.4% (CI95% = 76 - 99%). Observed specificity was 100%. Correlation between DBS-p24 and plasmap24 concentrations was excellent (R2 = 0.83; P < 0.0001). False-negative results obtained with the DBS-p24 assay were clearly sequence-related and significantly associated with subtype D (P<0.01). Conclusions: In subtype C predominant areas, DBS-p24 assay is an inexpensive and valid alternative to PCR-based tests for early diagnosis of paediatric HIV-1 infection. It has the potential to promote paediatric HIV-1 care by decentralizing paediatric screening, and could substantially contribute to the rollout of paediatric programs in low-resource settings. MOPEO148 Provision of HIV care in resource-limited settings: status of HIV-infected patients at first presentation in Cameroon P. Kenmogne, D. Kamdem, C. Ngansop, N. Ndembi, L. Kaptue. The University of Yaounde -I, Hematology and Virology, Yaounde, Cameroon Background: Enumeration of CD4+ T cells constitutes an essential biological indicator in the clinical follow-up of HIV patients. Its enumeration is used to determine the classification of disease stage. To predict the progression to clinical AIDS, to assess antiretroviral treatment (ART) and to facilitate therapy to opportunistic infection. Objectives: To determine CD4+, CD8+ T cells counts of HIV-infected patients at first presentation in our laboratory. Methods: Included in the study were known HIV-infected patients referred to immuno-cytometry laboratory at Clinique Bastos in Yaounde for the first time. Socio-demographic data were collected and 10ml of blood drawn into EDTA liquid anticoagulant vacutainer tubes and processed for lymphocytes immunophenotyping by cytometry using FACSCount~/ Becton Dickinson, serological assay and biochemistry. Results: A total of 156 patients were recruited, 82/156 (52.5%) of them were male and 74/156 (47.5%) female aged 21-59 years. Sixty -eight out of 156 (43.5%) of them had TCD4+ < 200/ mm3, 50/156 (32.05%) had TCD8+ between 200 -350/ mm' and 38 (24.3%) TCD4+ >350/mm. The mean TCD4+ and TCD8+ values were 252.2/mm' and 1372,14mm', respectively against 980/ mm' and 620/ mm' of the normal population, with p-value <0.05/ mm'. Conclusions: Most cases of HIV infection seem to be diagnosed late. It also appears that low rate of patients under ART may account for this situation. The cost of antiretroviral drugs should prompt the clinician to diagnose HIV infection and initiate therapy earlier. MOPE0149 NucliSens~ easyMAG and NucliSens~ EasyQ HIV-1 combination exhibits excellent performance characteristics A. Buiting', T. Oosterlaken2, M. de Kock2, F. Simons2, I. Berghuis2. 'St. Elisabeth Hospital, Tilburg, Netherlands, 'bioMirieux, R&D Molecular Diagnostics, Boxtel, Netherlands Background: Measurement of HIV-1 viral load is a well-accepted method to monitor the course of disease and the response to antiretroviral therapy in HIV1 infected patients. The NucliSens EasyQ HIV-1 assay is an established viral load determination method, which is based on NASBA amplification and realtime detection using molecular beacon probes. Recently, two new front-end systems for magnetic nucleic acid extraction were developed: the NucliSens miniMAG and the automated NucliSens easyMAG. This performance evaluation study shows that the combination of NucliSens easyMAG and miniMAG as front XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  69 end with the NucliSens EasyQ HIV-1 assay offers state-of-the-art viral load measurements. Methods: Nucleic acids from well-characterized analytical and subtype panels were isolated using the NucliSens miniMAG and easyMAG systems. HIV-1 RNA was amplified using the NucliSens EasyQ HIV-1 assay and amplicon formation was monitored using the NucliSens EasyQ Analyzer. Assay performance was assessed by the statistical analyses of detection limit, quantitative range, subtype detection and diagnostic specificity. Results: Analyses of an analytical panel based on International Units (IU) with NucliSens EasyQ HIV-1 in combination with magnetic extraction as frontend demonstrated accurate HIV-1 viral load monitoring over a range of 161 - 3x106 IU/mi with a detection limit of 73 IU/ml. Analyses of FDA and BBI HIV-1 subtype panels showed successful detection of subtypes A through J and linearity was confirmed. Analyses of 114 HIV-1 negative donor plasma samples demonstrated a 100% diagnostic specificity. Conclusions: The combination of NucliSens miniMAG or easyMAG magnetic extraction with NucliSens EasyQ HIV-1 real-time viral load determination showed to be efficient and reliable. HIV-1 viral load monitoring is subtype independent and quantitative over a broad range. While NucliSens miniMAG extraction provides a cost efficient solution for low or medium throughput laboratories, NucliSens easyMAG extraction is optimally suited for high volume labs by offering high throughput and high level of user convenience. MOPE0150 Evaluation of dried blood spots (DBS) for HIV-1 antibody testing in Ethiopia D. Kassa, D. Tessema, H. Melese, T. Messele, W. Tamene, Z. Ahmedin, M. Tebeje, A. Adane, N. Gezahegn, D. Wolday. Ethiopian Health and Nuitrion Reserch Institute, Addis Ababa, Ethiopia Background: Seroepidemiological survey has been conducted in Ethiopia to assess the prevalence of HIV. However, as serosurvey is logistically very challenging DBS has been considered as better alternative as it is easy to transport, tolerant of high temperature and antibodies are more stable DBS. We aimed to assess the performance of DBS technology vs. plasma based EIA. Methods: 714 Paired plasma and DBS were collected from four sites. All specimens were tested in parallel with Vironostika-HIV Uniform II plus O0 (ELISA-1), Vironostika-HIV Uniform II Ag/Ab (ELISA-2) and Enzygnost HIV1/2. Discrepant results between plasma and DBS were tested with WB. Results: HIV positive of the plasma samples was 22.4%, 23.7% and 15.0% with ELISA-1, ELISA-2 and Enzygnost respectively. Out of the positive plasma samples with ELISA-1 and ELISA-2, Enzygnost had missed 14.3% and 14.2% respectively. Comparing DBS and plasma test results, there was a 100% concordance in the negative HIV test results in all three ELISAs. However, out of the total confirmed plasma HIV positive specimens with ELISA-1 (n=126), ELISA-2 (n=127) and Enzygnost (n=107), 14.3%, 14.2% and 0.9% DBS specimens were found to be negative respectively, giving an overall discrepancy of 14.3%. Indeterminate test results by WB of the specimens with discrepant plasma/DBS test results were excluded from concordance analysis. Conclusions: Our results showed DBS underestimated positive results mainly at low OD level which could be due to the low blood volume in the spot or other reasons. Although DBS is an alternative candidate for serosurvey, we suggest that further optimization of the assay should be undertaken. However, the highest concordance between DBS and plasma in the positive specimens in Enzygnost HIV-1/2 was due to the characteristic of the assay which missed most positive of DBS as well as plasma with relatively low OD values. MOPE0151 Sensitivity of total lymphocyte count as a predictor of CD4 count in ARV naive HIV patients at JUTH, Jos, Nigeria M. Akanbil, T. Babafemi2, L. Welty2, J. Idoko3, I. Samson3, N. Gwamzhi3, R. Murphy2. 1Department of Medicine, JUTH/ APIN. Jos Nigeria, Internal Medicine, Jos, Nigeria, 2North Western University, Feinberg School of Medicine., Infectious Diseases, Chicago, United States, 'Department of Medicine, JUTH/ APIN. Jos Nigeria, Infectious Diseases, Jos, Nigeria Background: The WHO recommends that in settings where CD4 enumeration cannot be performed, ART should be initiated for WHO clinical stage 2 or 3 if total lymphocyte count (TLC) is < 1200 cells/mm3. The proposed guideline change for 2005-2006 is to apply the TLC <1200 cut-off to WHO stage 2 disease only. We compared entry CD4 count and TLC among treatment-naive WHO stage 2 patients in Jos, Nigeria. Methods: Data were obtained from the records of 3,462 pre-consented HIVseropositive patients attending the APIN clinic, JUTH, Jos between January 2004 and December 2005. HIV was confirmed using western blot. CD4 was analyzed using flow cytometry, and complete blood count by an auto-analyzer. Total lymphocyte count was calculated from the complete blood count. Results were analyzed using statistical software package R, 2.1.1 Results: The CD4 and TLC counts of 1281 patients with WHO stage 2 disease were analyzed. CD4 and TLC were significantly positively correlated (Spearman's rho = 0.48, p < 0.001). Using TLC < 1200 as a predictor of CD4 < 200 resulted in 31.5% sensitivity, 96.0% specificity, 95.9% positive predictive value, and 31.6% negative predictive value. Increasing the cutoff value to 1900 resulted in 67.0% sensitivity, 67.9% specificity, 86.3% positive predictive value, and 40.4% negative predictive value. Both TLC and CD4 were highly skewed. Median TLC was 1200 (IQR = 1118, min = 180, max = 8190) and median CD4 was 108 (IQR = 154, min = 1, max = 790). There were no statistically significant differences in TLC or CD4 by gender. Conclusions: In these WHO stage 2 patients from a resource-limited setting, TLC <1200 cell/mm3 was a poor predictor of CD4 count < 200 cells/mm3. Over half of patients with CD4 count < 200 would have been inappropriately excluded by TLC-guided treatment with a cut-off of 1200. MOPE0152 Antibiotic susceptibility patterns of bacterial opportunistic respiratory pathogens in HIV/AIDS patients in Lagos, Nigeria N. Idika1, M. Aniedebe2. 'Nigerian Institute of Medical Research, Microbilogy, Yaba, Nigeria, 2Nigerian Institute of Medical Research, Yaba, Human Virology, Lagos, Nigeria Background: Approximately 40 million persons live with HIV infections worldwide while the prevalence is 5% in Nigeria. The main biological characteristic of HIV is the progressive breakdown of cellular immunity causing multiple pathological conditions that lead to opportunistic infections. They could be viral, bacterial, fungal or parasitic and are the most common causes of death in HIV/AIDS patients. Antimicrobial drug use has been reported to be a major contributor to the emergence of resistance in respiratory pathogens which vary depending on the rates of antimicrobial drug use.This study therefore was designed to investigate resistance of bacterial opportunistic respiratory pathogens in order to provide information for better management of HIV/AIDS in Nigeria. Methods: A total of 310 sputum samples from HIV patients with respiratory infections reporting at 3 anti-retroviral (A R V) clinics in Lagos, were tested and the isolates identified using standard microbiological methods. The antibiotic susceptibility patterns were determined using agar diffusion method. Results: The nature and frequency of the pathogens obtained were Morexella catarrhalis (25.1%), Staphylococcus aureus (9.2%), Streptococcus pneumoniae (8.3%) Pseudomonas aeruginosa (7.3%) and coaggulase negative Staphylococcus (6.6%).Other pathogens including some Enterobacteriacae were obtained in low percentages. Ofloxacin was the most effective antibiotic (86.8%) in this study followed by ciprofloxacin (80.2%), gentamycin (70.8%), augmentin (58%), tetracycline (27.2%), cotrimoxazole (12.8%) and erythromycin (10.7%). Conclusions: The results have shown that normal bacterial flora of the sputum and Enterobacteriacae have the potentials for respiratory infections in HIV infections. The antibiotic patterns obtained will aid the management of HIV in Nigeria. MOPE0153 HIV rapid testing for scaling up HIV prevention efforts A. Sands', G. Vercauteren', G. Beelaert2, K. Fransen2. 'World Health Organization, Essential Health Technologies, Geneva, Switzerland, 'Institute of Tropical Medicine, Microbiology, Antwerp, Belgium Background: A necessary component in efforts to achieve the goal of Universal Access to HIV prevention, treatment and care programmes for all by 2010 is the provision of reliable and accurate HIV testing. With increased availability of lesser-complexity HIV rapid tests, the quality and performance of these tests must be assessed prior to implementation in resource-limited settings. Methods: A variety of HIV rapid tests from different manufacturers were evaluated by WHO using a panel of 769 HIV positive and negative clinical specimens. Common false positive and false negative results were observed and recorded. In addition, 9 commercially acquired HIV panels were used to assess sensitivity in seroconversion and mixed titers of anti-HIV. Other factors assessed included storage conditions, ease of use, inter-reader variability. Results: The observed HIV rapid test performance characteristics included sensitivity (ranging 99.6% -100%), specificity (ranging 98.8%-100%) and inter-reader variability (as assessed by 3 independent readers) ranging 0%4.6%. Common false reactivities were observed between test kits using similar antigen preparations. The seroconversion indices on the 8 seroconversion panels ranged from 1.625 (specimens) later to equal the bench mark assay. All tests were able to identify all specimens in the mixed titer panels. The shelf life of the rapid tests ranged 6-24 months and 13 of the test kits could be stored between 20-300C. Most of the rapid tests took no more than two steps to be completed. Conclusions: A total of 19 HIV rapid tests have been evaluated by WHO and were comparable in performance to commonly available enzyme immunoassays (EIAs). The simpler rapid test procedure (relative to EIAs) means that they can be used outside the traditional laboratory settings. It is imperative that provision be made for independent evaluations of HIV rapid tests in the setting of intended use. Monday 14 August Poster Exhibition ---- - - - ------- XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  70 MOPEO154 The false positive rate of antenatal HIV screening is very high in Japan R. Yamada', T. Shima2, M. Imai2, I. Genka3, M. Ogane3, M. Kawado4, H. Taniguchis, Y. Tsukahara6, N. Inaba', Cooperative Study Group on HIV Infected Pregnant Women and Mother-to-Child Transmission in Japan, The Study Group on the Development of HIV Testing Systems in Japan. 'Kanazawa University, Obstetrics and Gynecology, kanazawa city, Japan, 2Kanagawa Prefectural Institute of Public Health, Kanagawa, Japan, 3International Medical Center of Japan, Tokyo, Japan, 4Fujita Health University, Toyoake, Japan, 5Mie Prefectual General Medical Center, Yokkaichi, Japan, 'National Center for Child Health and Development, Tokyo, Japan, 'Dokkyo University School of Medicine, Tochigi, Japan Background: The false positive rate of various HIV test kits were reported to be 0.01-1%. In Japan, the prevalence of HIV is 0.01-0.02% in pregnant women. Positive predictive value of HIV screening in this group is thought to be very low. Methods: The false positive rate of HIV was investigated using the blood samples of pregnant women from two general obstetrics hospitals. Antigenantibody combined test kit (Enzygnost HIV integral; Dade Behring Inc., USA) was used for HIV single screening and particle agglutination method (SFD HIV1/2 PA; Fujirebio Inc, Japan), Western blot method (New lay blot 1,2; Bio-Rad Laboratories, Inc., France) and polymerase chain reaction method (Amplicor HIV-1 monitor test, Ver.1.5; Roche Diagnostics, Switzerland) were used for HIV confirmatory test. Results: From September 2004 to August 2005, the number of clients who applied for HIV single screening test were 4,424 and 13 cases were positive. After HIV confirmatory test, 12 cases proved not to be infected (false positive). In other words, only one case (0.02%) was positive. Positive predictive value of the HIV single screening test was 7.7% (1/13). Conclusions: Almost all clients who are positive by HIV single screening test are false positive because the prevalence of HIV in pregnant women in Japan is very low (about 0.02%). A counseling system especially for pregnant women will be necessary before reporting the result of HIV sero-status to clients to avoid mental stress. MOPE0155 User survey on HIV load (VL) test specifications suitable for monitoring and management of patients with HIV/AIDS in resource-limited settings G. Gonsalves', M. Guillerm2, I. de Wouters', M. Dineva3, H. Lee3. 'Gay Men's Health Crisis, New York, United States, 2Medicines Sans Frontieres, Campaign for Access to Essential Medicines, Geneva, Switzerland, 3University of Cambridge, Cambridge, United Kingdom Issues: There is an unmet need for appropriately designed VL tests for diagnosis and monitoring of HIV-infected individuals in resource-poor settings, because currently available assays are complex, required expensive instruments and cold-chain shipment. In settings with limited drugs options VL testing is crucial for appropriate efficient treatment. Description: To establish needs and suitable test specifications we conducted a survey of potential users at 32 sites including 19 district or local hospitals, 10 clinics, 2 reference laboratories and one research centre involved in the monitoring and care of approximately 18,000 HIV/AIDS patients in 19 developing countries. The survey elicits information on site infrastructure, resources and current approaches to the monitoring and management of patients with HIV/AIDS. Lessons learned: The key survey data revealed that 70% of the sites do not have access to VL test and the majority of them lack basic laboratory resources and infrastructure to perform testing (only 50% had bio-safety cabinets; only 56% had access to incubators; 30 % did not have accurate pipettes, some lacked refrigerators). Frequently only non-laboratory-trained personnel are available to perform testing, prices of tests are unaffordable. Respondents desired tests with simple and rapid format that can be performed while patients are at the clinic. >90% reported a semi-qantitative dipstick-based test giving readout of clinically relevant cut-offs highly acceptable. The majority found the cost of $8/test acceptable. Recommendations: VL assay designed for resource limited settings should be rapid (result < 2 hours), simple, inexpensive, robust and stable at room temperature and high humidity, does not require complex instruments or specialized laboratory facilities. Availability of VL tests, suitable for peripheral health care levels, is crucial for infant diagnosis and treatment monitoring in the developing world, but will only be feasible if new, simple and rapid VL tests, such as visual dipstick-based assays are developed. MOPE0156 HIV real-time PCR assay COBAS AmpliPrep/COBAS TaqMan HIV-1 test in comparison to the Bayer bDNA assay versant HIV-1 RNA v3.O and the Roche COBAS amplicor HIV monitor test v1.5 H. Jaeger', E. Wolf', E. Jaegel-Guedes2, W. Chantratita3, W. Schumacher4. 'HIV Research and Clinical Care Centre Munich, Munich, Germany, 2MUC Research GmbH, Munich, Germany, 3Mahidol University, Bangkok, Thailand, 4Roche Diagnostics GmbH, Penzberg, Germany Background: The quantitative determination of plasma HIV-1 RNA levels is essentially required in the clinical management of HIV-1 infected patients. Therefore, a high-throughput assay system has been developed that is based on fully automated nucleic acid isolation using the COBAS AmpliPrep and realtime PCR technology on the COBAS TaqMan. Methods: In the present study viral load quantification using the COBAS AmpliPrep/COBAS TaqMan HIV-1 Test (CAP/CTM HIV-1) is compared to the Bayer bDNA assay VERSANT HIV-1 RNA v3.0 and the COBAS AMPLICOR HIV-1 MONITOR vl.5 (CA HIM). Large panels of clinical specimens from HIV-patients in Germany and Thailand were used for this method comparison. Results: Results obtained for 1495 specimens from a Munich HIV-laboratory demonstrated an improved clinical sensitivity of the CAP/CTM HIV-1 Test for specimens with low HIV concentration when compared to the bDNA (15% of samples with bDNA-results <50 cp/ml had a viral load between 40-942 cp/ml). Analysis of quantitative result pairs indicated that the CAP/CTM HIV-1 Test deviates by 0.2 log10 (mean) from the bDNA. The large measuring range of 6 log10 steps of the CAP/CTM HIV-1 Test is best suited to the clinical routine avoiding any laborious dilution testing. The comparison of the viral loads of 498 specimens from Bangkok using the CAP/CTM HIV-1 Test and the CA HIM vl.5 demonstrated equivalent clinical sensitivity. Bland-Altman analysis indicated that viral load determined with the CAP/CTM HIV-1 Test showed a mean deviation of +0.1 log10 compared to CA HIM/HIS Test vl.5. Conclusions: The comparison study demonstrates equivalence in the capabilities to quantify HIV viral load. The CAP/CTM HIV-1 Test is a robust real time PCR assay suited for reliable monitoring of HIV-1 viral load in EDTA plasma. The fully automated assay system combines IVD compliance with a high clinical sensitivity, specificity and broad measuring range. (note: COBAS, AmpliPrep and TaqMan are trademarks of Roche.) MOPEO157 How does the performance of HIV double rapid tests compare with western blot confirmation in resource constraint settings? G. Imadel, A. Momoh', H. Fadewarel, A. Ani', C. Mullins2, A. Sagay', D. Egah', J.-L. Sankale2, J. Idoko', P. Kanki2. 1APIN/PEPFAR Project, Jos University Teaching Hospital, Jos, Nigeria, 2APIN/PEPFAR Project, Dept. of Infectious Diseases and Immunology, Harvard School of Public Health, Boston, United States Background: HIV infection is increasing in sub-Saharan Africa. Rapid, accurate and affordable diagnosis of HIV infection is a key factor in accessing care, support and antiretroviral drugs. The problems of operational constraints such as cost of test, infrastructure, personnel and test duration associated with Western Blot is lending support for the switch to faster and cheaper tests. We set out to compare the performance of double rapid tests with Western blot for the confirmation of HIV infection between in April 2004 and November 2005 in our centre. Methods: After counseling, blood (7mls) sample was collected in EDTA from each of 544 patients (Antenatal 341 and STI 203). Plasma obtained from the blood sample was tested with 2 rapid HIV test kits (Determine HIV-1/2, Abbott, Germany and Capillus HIV-1/2, Trinity Biotech, USA) sequentially according to manufacturer's instructions. All HIV positive samples using double rapid tests were re-tested by Western blot confirmation tests using home made kits from Phyllis Kanki's Laboratory, Harvard School of Public Health, Boston, MA, USA and Immunetics, Boston, MA, USA. The tests and interpretation of results were done as recommended by the manufacturers. Results: The overall Western blot results confirmed 95.8% samples positive for HIV infection -( i.e. 513/544 (94.3%) HIV -1, 7/544 (1.3%) HIV-1 & 2 and 1/544 (0.2%) HIV-2 positive) while 3/544 (0.6%) were negative for HIV-1 & 2 and indeterminate for 20/544 (3.6%). Conclusions: With only 0.6% discordance, double rapid tests compares well with Western blot. In economically constraint settings where HIV treatment and care are being scaled up, the use of double rapid tests which are cheaper and faster is justifiable. MOPEO158 Development of an integrated database and data collation system for monitoring and evaluating the public sector antiretroviral treatment (ART) in the Free State province, South Africa L. Fairall', G. Staniland2, M. Msimanga', V. Timmerman', L. Goedele4, M. Bachmanns, C. van Vuuren6, D. Steyn6, D. Goedhals', R. Nhiwatiwa6, E. Bateman', M. Zwarenstein', C. Lombard', C. Seebregts', P. Shai-Mhatu"o, R. Chapmano. 'University of Cape Town Lung Institute, Cape Town, South Africa, Knowledge Translation Unit, Cape Town, South Africa, 2Epicentre Consulting, Cape Town, South Africa, 'Medical Research Council, Biomedical Informatics Research Division, Cape Town, South Africa, 'University of the Free State, Department of Community Health, Bloemfontein, South Africa, 'School of Medicine, University of East Anglia, Health Policy and Practice, Norwich, United Kingdom, 'University of the Free State, Department of Internal Medicine, Bloemfontein, South Africa, 'NHLS Universitas, Virology, Bloemfontein, South Africa, 'Knowledge Translation Programme, University of Toronto, Toronto, Canada, 9Medical Research Council, Biostatistics Unit, Cape Town, South Africa, "oFree State Department of Health, Bloemfontein, South Africa Issues: Paper-based structured clinical records are widely used for monitoring and evaluating the public sector HIV antiretroviral (ART) treatment program in South Africa. Computerized systems are sometimes used for operational data capture but are usually limited to individual clinics and hospitals. Important information also exists in other databases. A requirement exists to collate XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  71 information into electronic format and integrate data from a variety of sources to facilitate reporting and quality controls. Description: Handheld computers (PDA's) were used to collate data from paper records at urban and rural sites during the first nine months of the ART roll-out program in the Free State province of South Africa. Thereafter a commercial online computer system (Meditech) was implemented. A Microsoft SQL Server 2000 database server was used to deploy the information into a relational and dimensional format using Microsoft Data Transformation Services. External laboratory and resistance data were integrated as well. After 18 months 19013 patients were registered on the system, of which 2743 were ART patients. A total of 143751 forms have been captured with a median of 4 forms/nonARV patient and 26forms/ARV patient. Six quality categories with a total of 32 quality routines were implemented. The system has also been used to compile quarterly reports and national indicators. Lessons learned: PDAs compare favourably with online systems for data collection from remote rural and urban sites and are useful where online systems or connectivity are lacking. Dimensional data modelling and data warehousing techniques are fundamental for creating databases that are optimized for querying, aggregated reporting, longitudinal analysis and research. Recommendations: Data quality remains the most challenging aspect of information systems for monitoring and evaluation. The next phase will be to feed information back to the health care workers and patients to give them the benefit of information systems and to encourage better input data quality. Funding: IDRC,MRC,FS-DOH,UCT MOPE0159 Recurrence of tuberculosis (TB) in HIV-negative and HIV-infected patients after treatment with 8 month tuberculosis regimen C. Bellot', L. Jean', M.-A. Charles2, D.W. Fitzgerald2, W.D. Johnson2, J.W. Pape2'. 1Les Centres GHESKIO, HIV-TB, Port-au-Prince, Haiti, 'Les Centres GHESKIO, Cornell University, Port-au-Prince, Haiti Background: TB therapy (TBTX) with both isoniazid (INH) and rifampicin (RIF) or secondary prophylaxis with INH after successful TBX is recommended for the treatment of TB in HIV+ patients with advanced disease. However, HIV+ patients with TB in many countries receive 8 month TB regimen containing RIF only for the first 2 months. The objective is to evaluate the recurrence rate in HIV+ and HIV- patients after completion of the 8 monthTB TX. Methods: From 1/1998 to 6/2005, 3527 patients were diagnosed with TB at GHESKIO and 1109 successfully completed the 8 month Ministry of Health TB treatment protocol with 2 months of INH, RIF, PZA, EMB and 6 months of INH, EMB. This is a retrospective review of this population consisting of 1048 adults (402 HIV+ and 646 HIV-) and 61 children (10 HIV+ and 51 HIV-). All 402 HIVinfected patients with TB were CDC class A at the time of the TB diagnosis. Follow-up was passive:178 HIV+, 389 HIV- and 80 HIV+, 139 HIV- came back respectively at 12 and 24 months. Patients with TB symptoms were reevaluated for recurrence with sputum smear and culture, and chest radiograph. Results: A total of 69 episodes of recurrence were documented involving 66 patients with 3 recurring twice. The recurrence rate for adults was 28/646 (4.3%) for HIV- and 38/402 (9.5%) for HIV-infected (p< 0.001). Two out of 10 HIV-infected children recurred versus 1 /51 HIV negatives (p<0.03). The median time of recurrence was 15 months for HIV- (8-26 ) and 18 months for HIV+ (8-76). Conclusions: CDC class A HIV-infected patients with TB have very high rate of recurrence with TBTX with only 2 months of RIF. They should receive both INH and RIF during the entire duration of TB therapy. This has major implications for national TB programs. MOPE0160 Evaluation of regulatory T cells dynamics during mycobacterium tuberculosis disease in HIV-infected patients L. Gazzola', M. Saresella2, A. Bandera', I. Marventano2, G. Ferrario', F. Zanini', P. Ferrante2, A. d'Arminio Monforte', M. Clerici4, F. Franzetti', A. Gori', M. Bongiovannis. 'San Paolo Hospital, Clinic of Infectious Disease and Tropical Medicine, Milan, Italy, 'Don C. Gnocchi, Laboratory of Biology, Milan, Italy, 'Luigi Sacco Hospital, Chair of Infectious Diseases and Tropical Medicine, Departement of Clinical Sciences, Milan, Italy, 'University of Milan, Chair of Immunology, Milan, Italy, sUniversity of Milan, Clinic of Infectious Disease and Tropical Madicine, Milan, Italy Background: Many evidences support the critical role of Tregcells in the outcome of chronic infections. In our survey we prospectively evaluated Treg dynamics comparing HIV+ and HIV- patients affected by Mycobacterium tuberculosis disease. Methods: Ten HIV+ and HIV- patients were recruited at TB diagnosis. HIV+ and HIV-/PPD+ patients matched by age, CD4, HAART were also recruited as controls. Peripheral lymphocytes were stained with FITC conjugated anti CD4 and PE conjugated anti CD25 and the percentage of CD4+CD25bright was analysed by flow cytometry. The CD4+CD25bright, CD4+CD25dim and CD4+CD25- populations were purified by cell sorting. Total RNA was extracted from different CD4+ sorted populations, retrotrascripted in cDNA and used for specific Foxp3 gene expression analysis using Real-Time PCR. Immunological evaluation were performed at time of TB diagnosis and after 6 months of follow-up. Results: CD4+CD25brightTcells were characterized by a sorting purity index of >93 ~ 6%. We observed an increased expression of Foxp3 in CD4+CD25bright compared to CD4+CD25dim and to CD4+CD25-Tcells, supporting T regulatory activity of this population. Analysis of CD4+CD25bright percentage on CD4Tcells at baseline showed similar level of Tregcells among HIV+ patients, HIV- health donors and TB patients [median percentage respectively 2.3% (IQR2-4); 1.9% (IQR1.5-2.2) and 2.1% (IQR1.8-6.6)] and attested a lower percentage in HIV+/TB+ co-infected patients [median 1% (IQR1-1.3)]. After three months of HAART+anti-TB therapy we observed a 2.2 (IQRO.65 -3.45) median increase in CD4+CD25brightTcells percentage on CD4Tcells in HIV+/TB+ patients; while the difference in HIV+ controls and HIV-/TB patients were respectively -0,6 [IQR(-3,1)-1,7] and -0,2 [IQR(-5)-1,8] both IQR including zero. Conclusions: We demonstrate that in HIV+ patients TB is associated with a reduction in peripheral CD4+Tregs. This reduction followed by a prompt increase after TB-treatment suggests a possible critical role of Treg compartment in the pathogenesis of HIV/TB co-infection supporting the explanation for a more rapid HIV progression in co-infected patients. MOPE0162 Reproducibility of an IFN-y based assay and concordance with the tuberculin skin test among HIV-infected people living in a TB-endemic region K.L. Williams', K.M. Tan2, G.H. Mazurek2, T. Agizewl, S. Nyirendal, B. Mosimaneotsile', O. Motsamai3, P.H. Kilmarx4, C.D. Wells2, T. Samandari'. 'BOTUSA Project, Gaborone, Botswana, 'Centers for Disease Control and Prevention, Division of TB Elimination, Atlanta, GA, United States, 'Ministry of Health, National TB Program, Gaborone, Botswana, 4Centers for Disease Control and Prevention, Division of HIV/AIDS Prevention, Atlanta, GA, United States Background: Tuberculin skin tests (TST) can identify Mycobacterium tuberculosis (TB) infection but poor sensitivity and specificity among persons living with HIV infection (PLWH) limits its utility. The QuantiFERON-TB Gold In-Tube test (QFTGIT) may allow more accurate detection of TB infection. We evaluated the prevalence of positive TST and QFTGIT results, test concordance, and QFTGIT reproducibility in PLWH enrolling in a TB-prevention trial in Botswana where tuberculosis is endemic. Methods: Blood was drawn for QFTGIT, and TST was placed at the screening visit (SV). TST+ was defined as induration 5 mm. A second QFTGIT was performed two weeks later. Results: Among the first 227 subjects with valid test results, 30% were TST+, 25% were QFTGIT+ at SV, and 34% were QFTGIT+ two weeks later. Concordance between TST and QFTGIT at SV was 81% (kappa 0.51). Concordance between the two QFTGIT tests was 84% (kappa 0.61). Of the 62 people with CD4 <200, 16% were TST+ versus 35% (58/165) when CD4 was >200 (p=0.005). QFTGIT at SV was positive for 15% of those with CD4 <200 versus 29% when CD4 was >200 (p=0.030). QFTGIT results converted from negative to positive in 13% (29/171) and reverted from positive to negative in 14% (8/56). While 55% (16/29) of converters were TST+, 9% (12/142) of those who remained QFTGIT negative were TST+ (RR = 6.3, 95% CI: 3.4-11.6). While 63% (5/8) of reverters were TST negative, 23% (11/48) of those who remained QFTGIT+ were TST negative (RR = 4.2, 95% CI: 1.1-15.4). Conclusions: Among PLWH, concordance between QFTGIT at SV and TST was similar to previous studies, but QFTGIT reproducibility was lower than expected. People with low CD4 counts were less likely to be TST or QFTGIT positive. While boosting by TST may contribute to QFTGIT conversion, other factors may significantly impact test reproducibility. MOPE0163 Safety and efficacy of a sparfloxacillinsupplemented treatment regimen for category II tuberculosis in adult HIV-infected Nigerians D. Onwujekwe', O. Akinbami', R. Adu', P. Ezeobi', T. Gbaja-Biamilla1, O. Ezechi', N. Odunukwe', C. Onubogu2, R. Audu2, O. Idigbe3. 'Nigerian Institute of Medical Research, Clinical Sciences Division, Yaba, Nigeria, 'Nigerian Institute of Medical Research, Microbiology Division, Yaba, Nigeria, 'Nigerian Institute of Medical Research, Yaba, Nigeria Background: In Nigeria, treatment option for Category II TB is limited to the addition of Streptomycin to the standard first line regimen. A high failure rate results from this situation, with the risk of increasing the pool of drug-resistant TB. No other option is available for those who fail re-treatment. This study aimed at establishing the usefulness and safety of adding Sparfloxacillin to this regimen in this category of patients Methods: All Category II TB patients seen in our Clinic who failed re-treatment were recruited for this study. Tab. Sparfloxacillin at 200mg stat and 100mg daily, was added to Category II regimen for the re-treatment period of 8months. Follow-up was with periodic Sputum microscopy for AAFB, as in the Nigerian protocol. Cure was defined as consistently sputum-negative smears, during follow up Results: Of the 30 patients who met the inclusion criteria, all except one were HIV-1 positive. Mean age was 33.6+ 1.4 years. Mean baseline CD4 count was 182~ 28.8. Majority had pulmonary TB (73.3%) and were on ARV therapy (72.2%). Twenty-nine completed treatment while one died during the course of treatment. Of the twenty-nine that completed treatment, twenty-eight were cured, and were sputum smear negative by two months after commencement of Sparfloxacillin-based regime. No adverse drug reaction was recorded during the study period Conclusions: Sparfloxacillin based re-treatment regimen has been shown in XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  72 Monday 14 August Post i i orl this study to be efficacious and safe in HIV positive category II patients in absence of second line anti-TB drugs. However, considering the small sample size, a larger study is required to confirm this finding MOPE0165 High risk for post-partum tuberculosis (TB) among HIV-infected women and their infants: is it time to consider targeted INH prophylaxis in India? A. Gupta1, U. Nayak2, R. Bhosale3, M. Ram2, S. Patil3, A. Basavraj4, A. Kakrani4, S. Philips, J. Choi1, J. Sethi', J. Sastry5, R. Bollinger', MIT-BJMCJHU Study Group. 'Johns Hopkins University School of Medicine, Infectious Diseases, Baltimore, United States, 2Johns Hopkins Bloomberg School of Public Health, Baltimore, United States, 3BJ Medical College, OB-GYN, Pune, India, 4BJ Medical College, Medicine, Pune, India, 'MIT-BJMC-JHU, Pune, India Background: In contrast to other countries, INH prophylaxis is not recommended for HIV-infected persons in India. To assess the impact of this decision, we measured the risk of post-partum maternal and infant TB incidence in Pune, India. Methods: HIV-infected mothers and their infants were prospectively followed for up to one year post-partum. Women were offered enrollment PPD tests and evaluated during regular clinic visits for active TB. If PPD+ (_5mm) or symptoms suggested active TB, chest radiographs, clinical and laboratory information were obtained. WHO definitions for confirmed, probable and presumed TB were used. Results: Of 627 HIV-infected women followed for 476 person-years (PY), 22 incident TB cases were identified (4.62/100PY); 17 pulmonary (10 smearpositive, 7 smear-negative), and 5 extra-pulmonary. Median time to postpartum TB diagnosis was 3 months. 13 (59.1%) cases occurred in mothers with CD4 >200 cells/mm3. Among 7 mothers with CD4 <200 and positive PPD, 2 (28.6%) subsequently developed TB. Among 116 mothers with CD4 >200 and positive PPD, 5 (4.3%) subsequently developed TB. Within 12 months post-partum, 3(13.6%) mothers with TB died versus 5(0.8%) of 605 mothers without TB (OR 18.9; CI 4.67-77.97). Four (19%) infants born to mothers with TB died, compared to 19(3.2%) born to non-TB cases (OR 6.85;CI 2.23 -21.31). Among 21 viable infants born to mothers with TB, two were diagnosed with presumptive active TB and 15 (71.4%) received INH/rifampin (14) or INH (1) prophylaxis. Conclusions: Mothers with HIV-infection in Pune had a high risk of postpartum TB, with -60% of cases occurring among women with CD4>200. Maternal TB was also associated with a high risk of maternal and infant death, as well as infant TB and exposure of infants to the risks of INH/rifampin prophylaxis. Targeted use of post-partum maternal INH prophylaxis for HIVinfected women should be considered in India, to reduce maternal and infant morbidity/mortality. MOPE0166 Clinical outcomes among TB/ HIV co-infected patients enrolled in antiretroviral theraphy (ART) in Lusaka, Zambia S. Reid', J. Levy', M. Jham', D. Pankratz', N. Kancheya2, S. KaminsaKabanje', V. Jurkuvenas3, M. Kimerling3. 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia, 2University Teaching Hospital, Department of Medicine, Lusaka, Zambia, 3University of Alabama, Department of Medicine, Birmingham, United States Background: Rapid spread of HIV in sub-Saharan Africa has fueled TB incidence. In Lusaka approximately 30% of HIV patients will develop TB and co-infected patients are believed to have poor clinical outcomes. Rapid ART scale-up has been underway in the public sector since May 2004. Methods: Part of scale-up is development of a computerized patient tracking system, used to collect baseline patient characteristics and track care. Results: Of the 22,961 patients eligible for ART based on clinical or CD4 criteria, 1,527 (6.7%) were taking TB medication at enrollment. Comparison of patients "with TB" compared to those "without TB" demonstrate lower BMI in both males and females (p<0.0001 and p<0.0027 respectively), lower CD4 count (median 101 vs. 123, p<0.0001) and lower Hemoglobin (p<0.0325). Cox regression was performed among patients with stage III or IV disease on ART to evaluate the risk of death for patients entering the program already on TB therapy, stratified by CD4: < 50, 50-200, and >200. The HR for TB adjusted for anemia, gender and adherence to ART therapy were 0.88 (95% CI 0.58, 1.34), 0.78 (95% CI 0.53, 1.17), 1.04 (95% CI 0.53, 2.07) respectively. In all CD4 strata TB patients on ART have the same risk of death as non TB patients on ART with stage III and IV disease at 18 months of follow-up. Conclusions: At baseline, co-infected patients on TB therapy have significantly worse clinical profiles than non-TB patients. Despite this, TB patients diagnosed prior to placement on ART seem to have similar survival compared to non-TB patients. However, mortality may have been underestimated in the TB group as TB diagnoses were likely missed due to smear negatives and limited diagnostic capacity and these deaths would be included in the non-TB group. Active case finding with prompt diagnosis and initiation of TB therapy remain critical in this patient population. MOPEOI67 HIV/TB concomitant therapy with rifampicin: factors associated with a favorable virologic response F. Sant'Anna', M. Costal, L. Velasquel, C. Schmaltz', M.C. Lourenco2, M. Morgado3, B. Grinsztejn', V. Rolla'. 'Oswaldo Cruz Foundation, Infection Disease Department - Evandro Chagas Clinical Research Institute, Rio de Janeiro, Brazil, 20swaldo Cruz Foundation, Bacteriology Lab. - Evandro Chagas Clinical Research Institute, Rio de Janeiro, Brazil, 3Oswaldo Cruz Foundation, Immunology Lab., Rio de Janeiro, Brazil Background: The HAART efficacy in tuberculosis (TB) patients treated with rifampicin is the subject of few studies. Our aim is to evaluate HAART efficacy concomitantly to anti-TB therapy with rifampicin. Methods: TB-HIV patients were prospectively evaluated from July 2000 to march 2005. Visits were performed to diagnose TB, 15, 30, 60, 120 and 180 days after TB therapy introduction (rifampicin, isoniazid and pyrazinamide are the first line drugs). A favorable response to HAART was defined as the proportion of patients who achieved viral load (VL) <80 copies at the end of TB therapy. HAART was initiated at least 30 days after TB therapy. A multivariate analysis was performed to compare the effect of demographic and clinical variables on the antiretroviral efficacy. The confidence interval (CI) stipulated was 95% Results: We enrolled 144 patients, 68 (47%) were naive for antiretrovirals and 76 (53%) were previously exposed (PE). From the naive, 31/68 (45%) were treated with efavirenz (EFV) 600mg +2 nucleoside analogs and 18/31 (58%) obtained VL<80copies. The association RTV-SQV400-400mg (RTV-SQV) + 2 analogs was used in 26/68 (38%) patients, 12/68 (46%) tolerated the regimen, 3 of them (23%) obtained VL<80copies. OR for achieve VL<80 with EFV was 8.0 (CI=1.67-38.35, p=0.009). Adverse events occurred in 14/26 (53%) and RTV-SQV was changed to EFV (OR to achieve VL<80in this group was 5.0 (CI=0.92-26.17, p=0,06). From the 76 (53%) PE patients 59/76 (77%) used EFV and 19/59 (33%) obtained VL<80, 12/76 (15%) used RTVSQV and in 6 of them (54%) achieved a good virologic response and tolerance. In PE patients the OR was 3.08 (CI=0.65-14.6, p=0.15) in favor of RTV-SQV regimens in comparison with EFV, although not statistically significant Conclusions: In naive patients EFV regimens showed better efficacy and tolerance. A trend to a favorable virologic response and better tolerance was observed for RTV-SQV in the PE group. MOPE0168 Integration of tuberculosis (TB) and HIV care in primary health care services in Lusaka, Zambia S. Kaminsa-Kabanje', M. Jham', N. Kancheya2, V. Jurkuvenas3, M. Kimerling3, S. Reid'. 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia, 2University Teaching Hospital, Department of Medicine, Lusaka, Zambia, 3University of Alabama, Department of Medicine, Birmingham, United States Issues: Although >60% of TB patients are believed to be co-infected with HIV, links between these health services remain rudimentary at a primary care level. The ability to manage the convergence of TB/HIV epidemics is challenged by vertical approaches to care, and limitations in infrastructure and human resources. Description: We developed a model for piloting integrated TB-HIV care. We believe that integrated care would allow staff to coordinate co-treatment; improve clinical monitoring/adherence; prioritize the transfer of patients between services; and address staff shortages by defining roles and sharing responsibilities. Existing outpatient, VCT, TB, HIV, laboratory and pharmacy services were assessed at one government care facility in Lusaka, to map a strategy for services integration. A two-day clinic-based training was conducted to cross-train 28 health staff from various departments on TB-HIV and gather feedback on critical issues. Patient flow algorithms and re-formatted registers were developed for each department to clarify three elements: staff roles and responsibilities; patient flow taking into account multiple health center entry points; specimen and information flow to ensure appropriate reporting/ recording. A second clinic-based training was held to introduce revised algorithms and registers. Lessons learned: Barriers to integration included: poorly defined outpatient flow, approximately six week delay for enrollment in HIV care, lack of systems to document HIV status, and difficulties prioritizing TB patient referral for HIV care. Integration strategies discussed and adopted were: diagnostic counseling and testing, immediate CD4 measurement for newly diagnosed HIV-infected TB patients, and spot sputum sampling in several clinic departments (VCT, HIV clinic, outpatient). Staff roles and responsibilities had to be re-defined. Recommendations: Through program assessment, clinic mapping and clinicbased cross training, the integration of TB/HIV care and diagnostic screening is feasible and can improve co-management and case referral. MOPEO169 Where are the TB patients hiding? P. Maro', B. Corrigan2, D. Mandwa3. IPASADA, Medical, Dar es Salaam, Tanzania, United Republic of, 2PASADA, Medical Department, Dar es salaam, Tanzania, United Republic of, 3PASADA, Home Based Care Department, Dar es salaam, Tanzania, United Republic of Issues: According to WHO only one third of all estimated infectious cases worldwide are detected under DOTS programmes. WHO (2003)also reports that XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  73 Tanzania was one of the 22 worst affected countries. The number of expected TB patients in Tanzania, (HIV Positive prevalence rate of 34%, 15yrs -49yrs) has never been reached even though TB out patients clinics are working at top gear. Description: The PASADA home based care department has 12 home based care nurses and about 70 volunteers deployed in the Parishes of the Archdiocese of Dar es Salaam. The Nurses and volunteers have been trained to suspect Pulmonary Tuberculosis and initiate TB investigations in those patients who are bedridden at home.Thus they collect sputum specimens and transport them to appropriate laboratories for diagnosis of TB. Results for September 2005 shows that 44 out of 53 specimens of sputum collected for TB diagnosis were smear positive. Refer to the table: followed up every month for first six months and then every three months for AFB by microscopy and chest X- ray, AFB culture being done after 9 month. Results: 12 out of 88 patients had extra pulmonary MDR TB. 24 patients had co-existing diabetes. Resistance to single drug were 'H' - 100%, 'R' - 100%, 'S' - 40%, 'E' - 40% & 'Z' - 58%. 8 patients had 2 drug resistance while 38 out of 88 (43%), 35 out of 88 (40%), 17 out of 88 (19%) had 3, 4, 5 - drug resistance respectively. Sputum conversion was not seen at the end of 9 months in 14 cases of HIV, all of which were diabetic. Conclusions: There is an urgent need to revisit the use of appropriate anti-TB in both HIV & non-HIV Indian patients to prevent the rapid spread of MDR TB in the HIV cohort. MDR TB with DM is difficult to treat. Monday 14 August osterExhibition AREA Mbagala Pasada Tegeta Ukonga Mbweni TOTAL SMEAR POSITIVE 12 SMEAR NEGATIVE MOPE0172 TOTAL Antiretroviral therapy reduces risk of TB among 13 southern African gold miners 10 14 4 44 Lessons learned: The number of sputum positive among the suspected clients is too large to ignore. This high rate of smear positive detected at home also implies that many more will be smear negative and are not being diagnosed. This is simply because the clients cannot reach the health facilities. The public health concern is that many patients will be left undiagnosed and continue to transmit the tuberculosis bacilli. Recommendations: Renewed efforts must be made to find sputum positive TB patients who are sick home. Training home based care nurses to identify the patients who might have Pulmonary Tuberculosis and to initiate investigations can help in this detection campaign. Bringing in to the open the number of TB patients now "hiding" at home may bring Tanzania nearer to achieving the WHO target of TB Infections. MOPEO170 Differences in presentation, outcome and systemic involvement between HIV+ and immunocompetent patients with ocular manifestations of tuberculosis in an indigent clinic population A. Nagpal, R. Lieberman, R. Fischer. Elmhurst Hospital Center, Ophthalmology, Queens, United States Background: We describe the variety of ocular presentations and long term visual outcomes seen in both HIV+ and HIV- patients with uveitis secondary to TB. In addition, correlation and comparison was made with systemic involvement in both groups. Methods: Retrospective chart review: patient demographics, presentation of ocular disease, immune status, initial and long-term visual acuities, systemic involvement, treatment and complications. Results: 14 patients (21 eyes) were included. Three patients of the fourteen (21%) were HIV+, with CD4 counts from 46 to 480 at the time of presentation. Average follow-up was 9.9 months (range: 3 to 24). Presentations included nodular scleritis, anterior uveitis, vitritis, panuveitis, retinal vasculitis, papillitis, serous retinal detachment, and choroidal granuloma. 66% of HIV + patients had systemic involvement, compared with 36% of immunocompetent patients. All patients were treated with 4 drug therapy for 6 to 9 months. Percentage of eyes responding to treatment was 94% in the immunocompetent group, and 66% in the HIV+ group. Complications included cataract, epiretinal membrane, and immune reconstitution syndrome. Conclusions: In this series, systemic manifestations were significantly higher than those in the negative group.The final visual acuity of patients with ocular manifestations of TB treated with 4 drug therapy was excellent, with 76% of immunocompetent eyes > 20/50, and 41% > 20/25 in long term follow up (mean 7.25 months). The final visual acuity of HIV+ patients was also excellent, with 50% of eyes > 20/25 at the 12 month follow up point. Previous HAART therapy may impact on final visual acuity, although this was a small cohort. Our HIV + patients not on HAART therapy at the time of initiation of TB treatment developed more complications. Uveitis responded equally well in patients with or without documented pulmonary disease. MOPE0171 MDR-TB in HIV/AIDS - Mumbai experience S. Joshi', R. Parikh2, N. Ramraje3, J. Dikshit4, D. Kelkar4. 1Lilavati Hospital and K E M Hospital, Consultant, Mumbai, India, 2Seth G S Medical College and K E M Hospital, Endocrinology and Metabolism, Mumbai, India, 3Grant Medical College & Sir J. J. Group of Hospitals, Dept. of Chest Medicine, Mumbai, India, 4Joshi Clinic, Research Associate, Mumbai, India Background: HIV and Tuberculosis (TB) is a well established association. Multi drug resistant (MDR) TB is emerging as a challenge. Methods: A prospective study was conducted in 88 HIV-1 infected patients with associated MDR TB (100% resistance to 'H' & 'R') from 1998-2006. All patients had HIV-PCR, CD4 counts, AFB culture pre & post therapy. They were started on 2nd line medications as per WHO recommendations and were G.J. Churchyard', K.L. Fielding2, S. Charalambous3, J. Whetham4, L. Pemba3, J. Day2, A.D. Grant2. 1Aurum Institute for Health Research, Bryanston, South Africa, 2London School of Hygiene and Tropical Medicine, London, United Kingdom, 3Aurum Institute for Health Research, HIV Treatment and Care Programme, Johannesburg, South Africa, 4CAPRISA, University of KwaZulu Natal, HIV Treatment and Care Programme, Johannesburg, South Africa Background: This study compares TB incidence between HIV-infected individuals starting antiretroviral therapy (ART) in a workplace programme in South Africa, and an historical clinic cohort of individuals fulfilling criteria to start ART before it became available. Methods: Individuals in both cohorts were screened for TB at clinic entry and offered IPT according to international guidelines, which in the ART cohort may have been prior to starting ART. A Cox regression model was used to investigate the effect of baseline age, WHO stage, CD4 count and ART on TB incidence. Results: 773 HIV-infected individuals (median age 40 yrs, 97% male, median CD4 count 144 cells/pl, median follow-up 1.28 yrs) were included in the "ART" cohort. In comparison to 595 individuals in the "pre-ART" cohort (99.5% male, median CD4=193 cells/pl, median follow-up 0.74 yrs) at baseline a greater proportion had a CD4 count<200 cells/pl (ART: 69% versus pre-ART: 53%, p<0.001) and a WHO stage III / IV HIV disease (89% vs 59% respectively, p<0.001). The mean ages were similar (p=0.15). In a univariate analysis TB incidence was significantly reduced in the ART cohort compared to the pre-ART cohort (8.3/ 100 pyrs versus 14/100 pyrs, HR 0.59, 95% CI 0.42-0.81) and in the ART cohort increased with declining CD4 group (<50: 16.7/100 yrs, 51 -100: 10.6/100 yrs, 101-200: 11.3/100 yrs, 200+: 7/100yrs, ptrend =0.001). Baseline age, WHO stage and prior history of TB were not associated with TB incidence. After adjusting for age and CD4 group TB incidence was reduced by 54% in the ART cohort (HR: 0.46, 95% CIO.33-0.66). Conclusions: TB incidence was significantly reduced by ART. TB risk on ART remains strongly associated with baseline CD4 count. TB incidence on ART remains unacceptably high. Additional strategies are required to further reduce TB incidence among HIV-infected individuals on ART. MOPEO173 Acceptance of Isoniazid Preventive Therapy (IPT) by persons living with HIV-1 (PLWH) in Tanzania, 2001-2005 P. Munseri', E.A. Talbot2, S. Tvaroha2, S. Kimambo', M. Bakari', K. Pallangyo', C.F. von Reyn2. 'Muhimbili University College of Health Sciences, Dares Salaam, Tanzania, United Republic of, 2Dartmouth-Hitchcock Medical Center, Infectious Disease and International Health, Lebanon, New Hampshire, United States Background: Isoniazid (INH) can prevent tuberculosis (TB) among PLWH in TB-endemic settings. The rate of TB in Tanzania is 167/100,000, but, like most African nations, a nationwide IPT programme has not yet been fully implemented. IPT is provided to eligible PLWH in Tanzania through an ongoing Phase III TB booster vaccine trial (the DARDAR Study). The experience with IPT through this study can inform national provision of IPT in Tanzania and analogous settings. Methods: Ambulatory PLWH were screened for enrollment into the DARDAR study, which had eligibility requirements including CD4 cell count >200 cells/ mm3, the presence of a BCG scar and no active TB. PLWH enrolled into the study were then offered IPT if the tuberculin skin test (TST) was >5mm and active TB was again excluded. Results: Between September 2001 and September 2005, a total of 4974 persons were screened and 2009 (41%) were enrolled. The most common reasons for exclusion were CD4 <200 (46%), lack of BCG scar (36%), and suspicion or confirmation of active TB (10%). Of the 2009 PLWH who were enrolled, 1535 (76%) were female, and the median CD4 was 416. Of 1949 with available TST results, 638 (33%) had TST >5mm. Of 638, 561 (88%) began INH, 74 (12%) were not offered INH for various reasons, and 3 (<1%) refused. Of the 561 who began INH, 431 (77%) completed all prescribed INH, 94 (17%) are currently on INH, 3 (<1%) stopped INH due to toxicity, and 33 (6%) stopped for other reasons. Conclusions: In this ambulatory population of PLWH, acceptance of IPT was high, most were compliant with therapy, and side effects were infrequent. However, active TB was common among those screened. To avoid generation of INH resistance, access to measures to exclude active TB must exist alongside any national IPT programme. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  74 MOPEO174 Tuberculosis detected by the chest x-ray and/or symptom screening among people living with HIV/ AIDS (PLWHA) in Chiang Rai, northern Thailand S. Moolphatel, D. Chaisangrit1, T. Kulprayong', S. Sumanapun2, S. Buranabanjasatean3, S. Piyaworawong3, H. Yanail, N. Yamada4. 'TB/HIV Research Project, Chiang Rai, Thailand, 'Chiang Rai Provincial Health Office, Chiang Rai, Thailand, 'Mae Chan Hospital, Chiang Rai, Thailand, 'TB/HIV Research Project-RIT, Research Institute of Tuberculosis, Japan, Chiang Rai, Thailand Background: The cohort study has been carried out to investigate tuberculosis incidence among people living with HIV/AIDS (PLWHA) receiving comprehensive care service called day care center (DCC) in Chiang Rai, Thailand, the area which had seen a HIV epidemic in the g1990s. We report the results of tuberculosis screening at their enrolment in the cohort. Methods: The study population was comprised of PLWHA aged 15 years or over and enrolled in the cohort from September 2002 to September 2005 at 7 DCC district hospitals. TB screening was performed by chest X-ray, symptom screening and sputum smear examination. TB culture was performed when an HIV-infected person showed signs/symptoms of TB (i.e., cough/fever) and when CXR showed abnormal finding. Results: 1,442 PLWHA were included in the analysis after excluding those who were on tuberculosis treatment. The median age was 34 years (range: 17 - 64) and 576 (39.9%) were male. Prevalence rate of smear positive tuberculosis diagnosed by a combination of symptom and X- ray screening procedure was 1.1 % (16/1431) among 1,442 PLWHA and 3.2% (14/443) among PLWHA with CD4 lower than 200. Among PLWHA with CD4 lower than 200, the prevalence rate of TB obtained by X-ray screening alone was 4.9 %(10/202) and by symptom screening alone was 3.0 % (8/265). Out of these 14 smear positive tuberculosis cases detected by combination of symptom and X- ray screening procedure, 10 (71%) cases was detected by X-ray screening alone and B (57%) cases was detected by symptom screening alone. Conclusions: A combination of individual symptom screening and X-ray may be considered for TB screening as this may be useful to detect TB without typical symptoms of TB among PLWHA with low CD4. MOPEO175 Prevalence and incidence of tuberculosis in an antiretroviral treatment (ART) programme in South Africa: risk factors and impact on ART outcomes S. Lawn', L. Myer', L.-G. Bekker', R. Wood'. 'University of Cape Town, Desmond Tutu HIV Centre, Cape Town, South Africa, 'University of Cape Town, School of Public Health and Epidemiology Unit, Cape Town, South Africa Background: Incident tuberculosis (TB) during antiretroviral treatment (ART) complicates management and may compromise outcomes. We determined the burden, risk factors and impact of TB on ART outcomes within a South African ART programme. Methods: History of previous TB and diagnoses of prevalent TB were ascertained at enrolment of patients (n=944) to a community-based ART programme. Incident TB was ascertained prospectively over three years of ART. Results: At enrolment 79% of patients had WHO stage 3 or 4 disease and the median baseline CD4 cell count was 96 cells/I. 52% of patients had a previous history of TB and 238 (25%) had prevalent TB (either receiving current antituberculosis treatment [15%] or having active undiagnosed TB [10%]). Prevalent TB was strongly associated with low baseline CD4 cell count and advanced WHO stage. During ART, 81 cases of TB were diagnosed during 782 person-years of follow-up, giving an overall TB incidence rate of 10.4 cases/ 100PY (95% CI: 8.5-13.1). The rate was highest during the first 3 months of ART (22.1 cases/100PY), decreasing to a stable rate of 3.7 cases/100PY during the second and third years of ART. In multivariate analysis, incident TB was only associated with current CD4 cell count. During follow-up, a CD4 cell count increase of 100 cells/qJI was associated with a 250/ lower risk of incident TB (p=0.007). Incident TB diagnosed during the first 32 weeks of ART did not affect subsequent virological suppression rates or CD4 cell count increases at week 48. Conclusions: A huge burden of TB exists in this ART programme. TB risk decreases with increasing duration of ART and is dependent upon current CD4 cell count alone. However, TB risk reduction is incomplete and incidence rates remain >5-fold higher than background after 3 years ART. Incident TB does not, however, compromise ART outcomes in this programme. Non-tubercular mycobacterial infections in Indian AIDS patients diagnosed by genus land species specific 16S rRNA and Novel ESAT-6 polymerase chain reaction primersr S. Singh', S. Shahdad', P. Sharma2. 'All India Institute of Medical Sciences, Division of Clinical Microbiology, Department of Laboratory Medicine, New Delhi, India, 2International Center of Genetic Engineering and Biotechnology Immunology Group, New Delhi, India Background: Non-tubercular Mycobacteria are very common in AIDS patients but often UJnder diagnosed due to lack of proper diagnostic facilities. To overcome this a rapid PCR method for species specific diagnosis and differentiation of M. tuberculosis from other Mycobacteria was aimed. r Material and methods: Patients from indoor and outpatient departments of All India [Institute of Medical Sciences, New Delhi, India were included in the study. A set Of PCR primers targeting the gene encoding for excretory-secretary antigen-6 of M. tuberculosis complex (ESAT-6) was designed and standardized on [Mycobacterial standard strains and 75 recent isolates from AIDS patients and 70 isolates from HIV negative patients. All 145 fresh Mycobacterial isolates were Identified using phenotypic methods and 16S rRNA PCR followed by sequencing of hyper-variable region A. r Results: The ESAT-6 PCR could detect all the M. tuberculosis strains correctly (100% sensitivity) but none of the non-tubercular Mycobacterial species gave positive results (100% specific). Most NTM were identified in patients with AIDS (24%) followed by tubercular lymphadenitis (12.5%) and patients of pulmonary tuberculosis with treatment failure (4.3%/). Commonest nontubercular IMycobacteria isolated from AIDS patients was M. avium (6.6%) followed by M. fortuitum (5.7%), M. intracellulare and M. terrae (2.6% each). M. celatum, M. fluvalii, M. austroafricanum, M. phlei and M. flavescence were also isolated from One patient each.r Conclusions: Non-tubercular Mycobacteria are common in Indian AIDS patients. Combination of genus specific PCR primers with our ESAT-6 primer set could [provide accurate and rapid species specific diagnosis of tuberculosis which is very Important for patient management.r MOPEO177 Tuberculosis and HIV/AIDS co-infection: survival analysis on pre HAART era E.R. Lagonegro', M.R.D.O. Latorre2, R.C.M. Succi3, I.N. Cotta4, R.T. Rodrigues'. 'Centro de Referncia e Treinamento DST/AIDS, Institutional Review Board, So Paulo, Brazil, 2Faculdade de Sa6de P6blica - USP, Epidemiology, Sao Paulo, Brazil, 3Universidade Federal de So Paulo, Pediatric, Sao Paulo, Brazil, 4Centro de Referencia e Treinamento DST/ AIDS, Epidemiology, Sao Paulo, Brazil, 5Universidade Federal de Sao Paulo, Radiology, Sao Paulo, Brazil Background: A breakdown of the host's immune system caused by AIDS makes the individual susceptible to the development of tuberculosis (TB). The TB/AIDS co-infection showed high mortality rate in pre HAART era. Methods: Using prospective cohort methodology, we evaluated the probability of survival and predictive factors related to death in individuals with this coinfection in the period of December 1995 through May 1996 at Centro de Referencia e Treinamento - DST/AIDS (CRT-DST/AIDS) in Sao Paulo City. This study included patients over eighteen years of age with an HIV positive test and/or AIDS diagnosis, reported by the Epidemiologic Surveillance Service from CRT-DST/AIDS of having any type of TB and also had started specific treatment for TB in that period, as well as having a chest X Ray performed at diagnosis time. Results: The initial cohort had 150 patients, 121 (80.7%) men, 29 (19.3%) women, aged 20 through 62 years. Case definition for AIDS cases were Rio de Janeiro/Caracas criteria and modified CDC criteria, resulting in 141 (94%) cases of co-infection (TB/AIDS) and 9 (6%) cases of TB in HIV-infected individuals. In the final analysis of survival rate we could get status vitae of 129 patients. One year after starting TB treatment, 58 patients (38.6%) died and 71 (61.4%) survived. The probability of survival accumulated in 365 days was 55%. Among the predictive factors related to death, we found a significant association between death and initial AIDS diagnosis (p=0.0150) and CD4+ lymphocytes count under 200 cells (p = 0.0007). Conclusions: Nowadays, in populations where access and compliance to AIDS treatment is limited, AIDS-defining opportunistic illnesses remain the highest mortality rate cause in HAART era. Rio de Janeiro/Caracas AIDS case definition is still a good surrogate marker for underdeveloped countries that also show high prevalence of TB rate. MOPE0178 Multi-drug resistant tuberculosis (MDR TB) at an HIV voluntary counseling and testing center in Haiti P. Joseph', P. Severe', S. Ferdinand', K.S. Goh2, C. Sole', N. Rastogi', J.W. Pape', 0. Fitzgerald'. 'GHESKIO Centers, TB/HIV Unit, Port au Prince, Haiti, 'Institut Pasteur de Guadeloupe, Laboratoires de Mycobacteriologie, Pointe a Pitre,Guadeloupe, France, NGHESKIO Centers, Cornell University, United States, 'Cornell University, New York, United States Background: Haiti has among the highest rates of infection with the human immunodeficiency virus (HIV) and TB disease in the Western hemisphere: HIV prevalence is 3-5% in the general adult population and TB incidence is greater than 250/100,000 inhabitants. A study was conducted to assess the prevalence of Multi-drug resistant tuberculosis (MDR TB) in Port-au-Prince and to evaluate the risks factors associate with MDR-TB. Methods: GHESKIO operates an HIV voluntary counseling and testing (VCT) center with integrated primary care services in Port au Prince, Haiti. From January 2000 to December 2002, all patients presenting to the VCT center with cough were screened for tuberculosis. Patients older than 18 years of age with a positive culture for Mycobacterium tuberculosis were enrolled in this study. A medical history and physical, an epidemiologic questionnaire, and M. tuberculosis antibiotic sensitivity testing by the agar proportion method was done for each participant. MDRTB is defined as resistance to isoniazid and rifampin. Results: During the study period, 28,261 patients greater than 18 years old came for VCT, and 925 (3%) were diagnosed with TB. Clinical, epidemiological XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  75 and drug sensitivity testing results are available for 330 patients. Among these, 131 (40%) were HIV-infected. Of the 330 M tuberculosis isolates, 26 (8%) were MDR-TB. A prior TB history was associated with MDR-TB OR= 4.25 (P<0.001). Among patients with no past history of tuberculosis, drug resistance was more common in HIV-infected patients than in HIV uninfected people OR = 3.40 (P=0.02). Conclusions: MDR-TB was common at an HIV VCT center in Port au Prince, Haiti. The association between HIV infection and primary TB drug resistance raises concerns for a negative synergy between the emerging epidemics of drug resistant TB and HIV.Scale up of HIV counseling and testing in developing countries must be coordinated with TB control programs MOPE0179 The diagnosis and management of tuberculosis at the Mildmay Centre before and in the time of antiretroviral therapy use S. Baingana, B. Mukasa, Y. Karamagi. The Mildmay Centre, Kampala, Clinical, Kampala, Uganda Background: Tuberculosis cure rates in Uganda are 62 %, 40- 70% HIV co-infection occurs, default up to 30% is reported. The study describes the diagnosis and outcome of tuberculosis treatment at the Mlldmay Centre for HIV/AIDS care before and in the time of antiretroviral therapy use. Methods: Retrospective study of patients initiating tuberculosis treatment up to 2002 and from April to December 2004 during recruitment to antiretroviral therapy programmes.Treatment completion, number of adverse events and the effect of antiretroviral therapy are described. Analysis by the Epi Info statistical programme. Results: Total 197. Up to 2002, 90, in 2004, 107(54.3%). 54.9% female, 38.6% less than 15 years. 42.6% of adults unemployed. 41(21%)sputum positive, 58(29.7%) sputum negative, 69(35.4%) had no smear done, 27(13.8%) extra-pulmonary. 59.9% had chest xrays. There was no difference in baseline counts, diagnostic and treatment categories between the groups. Patients less than 15 years were less likely to have sputums done, p=0.0008 and had a longer duration to diagnosis -8.31weeks (SD16.35) than adults- 2.92weeks (SD 7.86)p=0.0001. Sputum negatives and those with no smears done were more likely to have chest x rays, p=0.006. 7.7% were using antiretroviral therapy at baseline, 21.8%at 6 months and 28.8% at 12 months. 85.4% in the group of 2004. 57.9% completed treatment and 29.6% defaulted with unknown outcome.10 started retreatment (5.1%). 8 deaths were reported. There was no association between group, baseline counts, age category, diagnostic and treatment type and completion of treatment. Patients using antiretroviral therapy were more likely to complete treatment. p=0.00000004 and among adults had less adverse events at 12 months,p=0.028. Patients less than 15 years had more adverse events. Conclusions: antiretroviral therapy is associated with tuberculosis treatment completion and among adults, less adverse events. Approaches to follow-up, description of the correlates of adherence in this population is required for optimal intervention. MOPE0180 Disseminated mycobacterial infections in AIDS patients: rapid species identification in haemoculture by using multiprobes real time PCR S. Foongladdal, S. Pholwat', B. Eampokalap2, P. Kiratisin', R. Sutthent1. 'Faculty of Medicine, Siriraj Hospital, Mahidol University, Microbiology, Bangkok, Thailand, 2Microbiology Laboratory, Bamrasnaradura Institute, Ministry of Public Health, Nontaburi, Thailand Background: Although an automated haemoculture system could early detect disseminated mycobacterial infection in AIDS patients, obviously, fast and reliable diagnostic tools are still required for rapid species identification in order to give appropriate treatment. Methods: Targeting the 16S rRNA gene, a set of primers and hybridization multiprobes of real-time PCR assays by using the LightCycler system for the specific detection of M. tuberculosis and M. avium in the first single-tube assay and M. intracellulare, M. simiae, M. kansasii and M. sherrisii in the second tube assay were designed and validated with 17 mycobacterial reference strains and 156 AFB positive haemoculture of AIDS patients, during August 2004 to October 2005. The lowest detected cells and the earliest times of detection in hemoculture broth before positive detection by BACTEC 9240 automated system were determined. Results: The assay could early detect mycobacteria in the haemoculture broth at 2-9 days (400-104 CFU/ml) before the automated system detection (10s CFU/ml). Sensitivity of the test is as low as 2 cells in the reaction. A result was available within 3 h of receiving a broth sample. All AFB positive haemoculture broths were detected. M. tuberculosis, 80 isolates (51.3 %) and M. avium, 65 isolates (41.7%), could be simultaneously completely identified in the first single-tube assay at their specific channels. M. intracellulare (3), M. simiae (1), M. kansasii (1), M. sherrisii (4) were identified in the second identification tubes. The specific melting temperatures of the 4 probes for these species in the same tube also provide information of the other various species. The other two species could be disguisable which were determined by sequencing as M. haemophilum and M. triple. Conclusions: The assay described here is useful for the rapid species identification of AFB positive haemoculture of AIDS patients and may be useful for the direct detection in clinical specimens. MOPEO181 Favorable outcomes of the integration of TB and HIV treatment in rural South Africa: the Sizonq'oba study N. Gandhi1, A. Moll2, R. Pawinski3, K. Zeller4, U. Lalloo3, G. Friedlands. 'Emory University School of Medicine, Infectious Diseases, Atlanta, United States, 2Church of Scotland Hospital, Tugela Ferry, South Africa, 3Nelson R. Mandela School of Medicine, Enhancing Care Initiative, Durban, South Africa, 4Brown University School of Medicine, Family Medicine, Providence, United States, 5Yale University School of Medicine, AIDS Program, Infectious Diseases, New Haven, United States Background: Tuberculosis (TB) is the leading cause of death among HIVpositive patients worldwide. In KwaZulu Natal, South Africa, two-thirds of TB patients are HIV-positive and treatment default and mortality rates are high. Strengthening existing TB DOTS infrastructure and integrating with antiretroviral therapy (ART) could be an effective, safe and efficient strategy to improve TB and HIV outcomes and provide access to ART. Methods: Observational treatment study among patients with active TB and HIV in rural, resource-poor KwaZulu Natal. co-infected patients are treated with once-daily ddl, 3TC and efavirenz concurrently with TB therapy by home-based DOT. Patients are followed for 12 months on ART for HIV and TB outcomes, drug toxicity, hospitalizations, mortality, CD4 & viral load change, adherence and ART resistance. Results: One hundred (100) HIV/TB co-infected patients will have completed 12 months follow-up on ART by August 2006. Fifty-three percent are women, mean age 34.8 years, all WHO Stage 3/4 TB, and mean CD4 cell count 104 cells/mm3. Among the first 58 patients completing 12 months follow-up, mean weight gain has been 11 kg (24 Ibs) and mean CD4 increase 247 cells/mm3; 89% have undetectable viral loads (<400 copies) and 88% have successful TB treatment completion. Ten patients have died during follow-up (10% mortality), 6 with suspected or confirmed MDR TB. ART and TB therapy have been well tolerated with only 2 immune reconstitution events. Every patient reported at least one Grade 1 adverse event, but there were only 2.5 Grade 3/4 adverse events per 100 patient-months of follow-up. Adherence to study visits was high with 96% attended on time. Conclusions: Integration of TB and HIV treatment has resulted in increased access to ART and favorable therapeutic outcomes for both HIV and TB. This integrated strategy may be effective for initiating ART in other rural resourcepoor settings where TB DOTS infrastructures already exist. MOPEO182 Tuberculous otitis media in HIV positive Ugandan children B. Nsangi Kintu', A. Kekitiinwa', M. Sekadde2, E. Namulema2, S. BakeeraKitaka2. 'Baylor International Paediatrics AIDS Initiative, Paediatrics, Houston, United States, 2Infectious Disease Institute, Kampala Uganda, Paediatrics, Kampala, Uganda Issues: Tuberculosis (TB) remains a common bacterial infection among HIVinfected patients,though ear infections have not been commonly seen. Between June and December of 2005, four cases of tuberculous otitis media (TBOM) were seen in the Paediatric Infectious Disease Clinic, Mulago in Kampala, Uganda. Classically TBOM is described as having an insidious onset with painless otorrhea, multiple tympanic membrane perforations, abundant pale granulation tissue in the middle ear, early severe hearing loss out of proportion to clinical findings and bone necrosis. The evaluation of these patients should include a history of contact, placement of a PPD skin test, culture and stain of ear drainage for AAFB, biopsy of granulation tissue for histology and culture, immune system evaluation. Treatment is primarily medical. Description: Three female and one male HIV-infected children had AAFBs on a routine examination of their ear swabs. The female patients were aged 5, 1.5 and 16 years, while the male one was 5 years. All the patients had CD4 less than 15%. None of the patients was on ART by diagnosis. All patients had presented with chronic suppurative otitis media (CSOM). One patient had suggestive history of TB with history of TB contact.. The other patients' history was not very conclusive. Only one patient had a positive TB skin test. All these patients were treated with anti-TB drugs and have since showed marked improvement. Lessons learned: TB otitis media should always be ruled out in HIV patients presenting with CSOM. This experience also introduces challenges in the management of TBOM. There's need for streamlining investigation and management of CSOM. Recommendations: Patients presenting with chronic suppurative otitis media need to be assessed more critically. In future, analyzing for AAFBs on all ear swabs is to be done and future studies should examine the incidence of TBOM. MOPE0183 Expansion of DTC services in Nyanza province, Kenya J. Onyango1, G. Akeche2, J. Odhiambo3, B. Marston4. 'CDC, Global AIDS Programme, Kisumu, Kenya, 2Ministry of Health, National T.B and Leprosy Control Programme, Kisumu, Kenya, 3CDC, Global AIDS Programme, Nairobi, Kenya, 4CDC, Global AIDS Programme, Atlanta, United States Issues: Since 2000, reported Tuberculosis (TB) has almost doubled in Nyanza Province, from 10,714 to 19,762 cases. The increase is probably related to the XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  76 Uoda growing HIV epidemic since Nyanza Province also accounts for 31% of Kenya's HIV. In 2004, 80% of TB patients tested for HIV at the Nyanza Provincial Hospital were positive. The Kenya MOH recommends routine diagnostic HIV testing (DTC) for patients with tuberculosis, Cotrimoxazole prophylaxis for HIV positives, and referral to HIV care services. Description: Based on 2004 DTC results at the Provincial Hospital chest clinic, DTC services in TB clinics were rapidly expanded through trained service providers, e.g. Health Management Team's were sensitised to the importance of the two programs collaborating, the Ministry of Health supplied test kits and Cotrimoxazole (for HIV positive patients) and HIV positive patients were referred to the closest Patient Support Center for counselling and access to ARVs. DTC service training including communication and counselling skills, HIV testing using rapid tests approved by the MOH, and management of O.I1 including TB was provided to 239 TB staff. Lessons learned: An evaluation is conducted for each training using pre- and post-test questionnaires and an observed practicum. The average pre- and post-test results are 58% and 77% respectively. From January-September, 2005, 50 (20%) of 265 TB treatment sites in Nyanza Province began DTC. Among 15,552 registered patients, 2298 (14.8%) received counselling, 1565 (68%) were tested and 1167 (75%) were positive for HIV. The greatest impediment to the scale up experienced has been the lack of regular supply of testing reagents Recommendations: Rapid scale up of DTC services is feasible in MOH facilities without increasing staff. Because of high co-infection rates, rapid scale up of HIV testing in the TB clinics is a priority intervention to assure access to cotrimoxazole prophylaxis and ARVs. advanced disease, who have a higher incidence of TB and are more likely to be TST negative. Methods: We conducted a randomized controlled trial in Cape Town, South Africa, comparing INH to placebo among TST negative adults with WHO stage 3 or 4 disease. TST positive participants were given open label INH. TB during the previous 5 years was an exclusion criterion. INH (or placebo) were administered twice weekly for 12 months by patient-nominated treatment supervisors. Participants were followed for 24 months with 6 monthly sputum culture and chest radiography. All participants received pyridoxine and cotrimoxazole. Results: One hundred and eighteen participants were enrolled; 98 were TST negative and randomised (48 to the INH and 50 to the placebo arms), and 20 were TST positive given open label INH. Baseline characteristics were similar in the two randomised arms. TB incidence in the randomized arms was 14.7 per 100 person-years: 18.0/100p-y in the INH arm compared to 11.6/100py in the placebo arm (rate ratio, 1.55, 95% CI, 0.49-5.30, p=0.417). There were no significant differences between the INH and placebo arms in mortality (p=0.318), hospitalisation (p=0.999), or CD4 decline (p=0.311). INH/placebo adherence was significantly higher (p=0.04) among participants with a workbased treatment supervisor (87.3% by pill count) compared to home- or community-based supervisors (76.7 and 71.1% respectively). Conclusions: These data suggest that IPT is not effective among TST negative individuals with advanced HIV disease. The TB incidence in the placebo arm was lower than we anticipated, possibly due to excluding patients with TB within 5 years. Good adherence was achieved with patient-nominated supervisors. MOPE0186 Theoretical outcomes of three alternative screening MOPE0184 and treatment strategies for latent TB infection Intensified case finding for pulmonary tuberculosis among HIV-infected persons in a region with high among HIV-infected persons from a voluntary drug resistance counseling and testing clinic in Addis Ababa, Ethiopia N.S. Shah', M. Demissie2, G. Teshager2, L. Lambert', E. Lemma3, E. Seife4, T. Kebede2, Z. Melakus, S. Lulseged2, C. Wells', T. Wuhib2, L. Nelson'. 'United States Centers for Disease Control and Prevention, Division of Tuberculosis Elimination, Atlanta, United States, 2United States Centers for Disease Control and Prevention, Global AIDS Program - Ethiopia, Addis Ababa, Ethiopia, 3Ethiopian Health and Nutrition Research Institute, Addis Ababa, Ethiopia, 4Zewditu Memorial Hospital, Addis Ababa, Ethiopia, 'Columbia University Mailman School of Public Health, International Center for AIDS Care and Treatment Programs - Ethiopia, Addis Ababa, Ethiopia Background: Prompt and accurate diagnosis of tuberculosis (TB) is critical to reduce the early mortality observed among HIV-infected TB patients, and is recommended before initiating antiretroviral therapy. We evaluated the diagnostic yield of commonly available pulmonary TB screening tests, using sputum culture as a gold standard, in HIV-infected persons attending a voluntary counseling and testing (VCT) clinic. Methods: We are prospectively enrolling HIV-infected persons diagnosed at an urban VCT clinic in Addis Ababa. A focused symptom screening and physical exam, three sputum specimens for smear microscopy, and chest radiograph (CXR) are performed on all persons, regardless of symptoms. Sputum is also sent for concentrated smear examination and mycobacterial culture. CXRs are read by two independent radiologists blinded to patient symptoms. TB diagnosis is based on standard microbiological or clinical case definitions. Results: From 11/24/05-12/30/05, we enrolled 94 HIV-infected persons: 58 (62%) were female, median age was 31 years (Interquartile range (IQR): 25 -39), median CD4 was 158 cells/mm3 (IQR: 90-385), and 24 (35%) were WHO clinical stage 3/4. Twenty-one (22%) persons reported TB symptoms, of whom 14 (67%) had an abnormal CXR and 12 (57%) were diagnosed with TB. Of those diagnosed with TB, 7/12 (58%) had negative sputum smears, 1/12 (8%) was smear-positive by direct method, and 4/12 (33%) were smear-positive with concentration. Median CD4 among TB patients was 84 cells/mm3 (range: 20-265). To date, no asymptomatic persons were diagnosed with TB, although culture results are pending. Conclusions: High rates of TB were identified among this population of newlydiagnosed HIV-infected persons attending a VCT clinic. Although HIV-infected TB patients may have significant immunosuppression, symptom screening appears to be high-yield for identifying TB suspects. Yield of smear microscopy improved with concentration, but remained low. More sensitive diagnostic tests and algorithms are urgently needed for improved TB screening and diagnosis in HIV-infected persons. MOPE0185 Randomized controlled trial of isoniazid preventive therapy, administered by patient-nominated supervisors, in advanced HIV disease A.A. Mohammed', L. Myer2, R. Ehrlich2, R. Wood', F. Cilliers4, G. Maartenss. 'Cape Peninsula University of Technology, HIV/AIDS Unit, Cape Town, South Africa, 2University of Cape Town, School of Public Health & Family Medicine, Cape Town, South Africa, 3University of Cape Town, Desmond Tutu HIV Center, Cape Town, South Africa, 4Department of Physiology, University of Stellenbosch, Cape Town, South Africa, 'University of Cape Town, School of Clinical Pharmacology, Cape Town, South Africa Background: Isoniazid (INH) preventive therapy has been shown to prevent tuberculosis (TB) in HIV-infected individuals with positive tuberculin skin tests (TST). However there are few data on the efficacy of IPT in individuals with E. Nardell', T. Mathew', A. Golubkov2, G.G. Peremitin3, E.N. Pronina4, R. Mazitov2, M. Rich', S. Keshavjee', I. Gelmanova2, S. Shin', J. Mukherjee', J.J. Furin'. 'Brigham and Women's Hospital, Division of Social Medicine and Health Inequalities, Boston, United States, 2Partners in Health, Russia, Moscow, Russian Federation, 3Tomsk Oblast Tuberculosis Dispensary, Tomsk Oblast, Russian Federation, 4Tomsk Oblast Polyclinic, Tomsk Oblast, Russian Federation Background: Tomsk Oblast, Siberia, population 1,000,000, has more than 1000 registered HIV patients and 81 per 100,000 cases of TB, including 32% INH (H) resistance and 11.2% MDR-TB among new cases. The official Russian strategy for treating latent TB infection (LTBI) among HIV-positive persons uses a 15 mm tuberculin skin test (TST) positive cut-off, and 3 months of isoniazid (3H). A second 3 months of H is recommended if the TST remains positive. An alternative strategy (AS) being considered uses a 5 mm cut-off and 3 months of both H and rifampin (3HR). A third possible strategy (AS2), not being considered, would eliminate TST testing and treat all HIV patients for LTBI with 3HR. We project possible outcomes of these strategies. Methods: We used modeling to estimate the efficacy of each strategy and the number of patients needed to be treated in order to prevent one TB case, based on Tomsk drug resistance data, TST-stratified risk assumptions, and treatment outcomes taken from the literature. We also assumed a high (75%) rate of acceptance and completion of therapy through direct supervision. Results: The current Russian strategy would have an efficacy of 11%, and 41 patients would be treated to prevent one TB case. The efficacy of AS was 48%, and 19 patients would be treated to prevent one case. AS2 had an efficacy of 67%, but 82 patients would need to be treated to prevent one TB case. Conclusions: These results demonstrate the importance of: 1) a TST cut-off that includes the most preventable cases, 2) a short regimen that treats H-resistant cases, and 3) high rates of acceptance and completion (i.e. full supervision) for achieving effective prevention. MOPE0187 Pattern of radiographic chest changes in HIV/AIDS patients in Ibadan E. Ekpenyong', M. Obajimi', G. Ogbole', Y. Aken'Ova2, S. Olarinoye', Y. Osuagwu'. 'University College Hospital, Radiology, Ibadan, Nigeria, 2University College Hospital, Haematology, Ibadan, Nigeria Background: The aggressive impairment of the immune defense mechanisms by Human Immunodeficiency Virus (HIV) infection leads to frequent cases of opportunistic infections and malignancies. In the variety of complications in HIV/AIDS cases, the lung is one of the most frequently involved organs. Pulmonary symptoms occur in more than 50% of HIV/AIDS patients. The pattern of disease in the chest is due to a variety of factors. Chest radiography is the investigation of choice in the initial clinical assessment of these patients. The spectrum of radiological features is well documented. However, HIV continues to alter the pathogenesis of chest diseases, greatly increasing the development and frequency of atypical radiographic manifestations, Pneumocystis carinii pneumonia and pulmonary tuberculosis being the most commonly seen. Methods: This retrospective study describes the radiographic pattern of chest manifestations in HIV/AIDS patients in Ibadan, Nigeria. Between January 2003 and December 2004, Chest radiographs of 530 symptomatic HIV-infected patients seen at the HIV/AIDS Unit of University College Hospital, Ibadan, were reviewed. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  77 Results: Patients' ages range from 3 to 69 years, 66.2% of them between 21-40 years and a male - female ratio of 1:2. 452(85.3%) presented with a history of cough. There were more radiographic changes in the left lung (53.5%) with varying opacities and cystic/cavitatory changes most common in the right upper and the left middle zones. 86 (16.2%) mostly younger patients had cardiomegaly Pulmonary tuberculosis was reported in 144(27.1%) patients and atypical pneumonic consolidation in 53(10%), while 24 had hilar/ mediastinal lymphadenopaathy Conclusions: No obvious chest radiographic pattern was seen nevertheless pulmonary tuberculosis is the commonest chest radiographic abnormality in HIV/AIDS. The importance of chest radiograph cannot be overemphasized. MOPEO188 Outcomes of DOTS among HIV/TB Co-infected. persons in a community and home-based care and support project in Pune, India J. Gogial, D. Vicharel, P. Deshpande2, M. Toshniwal2, S. Mukherjee', H. Alderfer3. 'PCI, HIV/AIDS, New Delhi, India, 2PCI, HIV/AIDS, Pune, India, 3PCI, New Delhi, India Issues: The HIV/AIDS epidemic has led to a rise in tuberculosis (TB) incidence and an epidemic of co-infection. In January 2006, Project Concern International (PCI)/India conducted a study to measure the outcomes of Directly Observed Treatment Short-Course (DOTS) implemented as part of its PATHWAY project, a community and home-based care (CHBC) project in Pune. PCI coordinated with the government (GO) on DOTS in HIV/TB co-infection, provided through the Revised National TB Control Program (RNTCP). Suspected TB cases are referred by outreach workers to RNTCP centers for diagnosis, and RNTCP centers supply TB drugs to PATHWAY DOTS centers. Description: A retrospective study was conducted of 6 HIV/TB co-infected persons enrolled in PATHWAY since December 2001. Data were abstracted from TB patient treatment cards using standard RNTCP outcome definitions (e.g., degree of co-infection, default, relapse, and cure). Structured interviews were conducted with district GO authorities to determine their views on the partnership between RNTCP and PCI and its outcomes. Lessons learned: Of the HIV/TB co-infected persons studied, 75% had pulmonary TB and 25% had extra-pulmonary TB. Sixty-five percent belonged to the sputum positive group and 35% were sputum negative. Eightysix percent belonged to category I (lesser degree of co-infection), 14% to category II. Seventy-two percent completed the treatment, 72% were cured, 25% died, 3a defaulted, and 5%a relapsed. Interviews revealed that treatment outcomes were positively influenced by regular non-governmental organization (NGO) staff training; regular monitoring by RNTCP; prompt referral; and open feedback by NGO staff. Recommendations: GO-NGO partnership in HIV/TB program coordination can positively influence early detection and initiation of DOTS for people living with HIV/AIDS. Results support the theory that integration of more than oneprogram, e.g. CHBC for HIV and DOTS for TB, makes programs more efficient and can result in more positive treatment outcomes. M0PE0189 Improving TB/HIV co-infection services in the Russian Federation V. Boguslavsky, Quality Assurance Project. University Research Co., LLC, Moscow Office, Russia, Bethesda, United States Issues: The HIV/AIDS epidemic in Russia is among the fastest growing. The incidence of tuberculosis has doubled over the past decade and remains very high. The existing vertical systems of HIV/AIDS and TB care have little coordination with each other and are inadequate to respond to the dual epidemic. Description: In 2004, the USAID-funded Quality Assurance Project (QAP) of URC and the Health Partnerships Program of the American International Health Alliance began joint work in four Russian cities (St. Petersburg, Engels, Togliatti, Orenburg) to develop an organized model for delivery of treatment, care and support to PLWHA. TB/HIV detection and treatment was identified as one of the main project components along with patient access and retention, care coordination, and patient clinical management. An improvement collaborative approach is being utilized to engage -interdisciplinary teams of providers drawn from regional AIDS Centers, city TB and narcological dispensaries, polyclinics, social service organizations and NGOs in each city to implement improvements of services. Leaders of participating organizations have created project coordination committees in each region to facilitate the decision making toward institutionalization of improved services. Lessons learned: Teams began testing changes in January 2005. Within a year the following tangible improvements were realized: regulatory documents on coordination of TB and HIV/AIDS services were adopted by health authorities in each city; a 30 percent increase in numbers of HIV positives screened for TB has been demonstrated in Engels; the coverage of HIV positives with counseling for TB/HIV co-infection in Togliatti was raised from 0 to 280/; the TB preventive treatment in patients with HIV was initiated. Recommendations: While the concept of interdisciplinary collaboration is not new, the improvement collaborative has operationalized in a purpose-oriented way that makes is effective for countries where services are fragmented due to separate budgeting and controlled by the national governments. MOPE0190 Risk of active tuberculosis (TB) and prognostic significance of tuberculosis among TAHOD patients J. Zhou', J. Elliott', R. Ditangco2, S. Pujari3, P.L. Lim4, S. Kiertiburanakul5, T. Parwati Merati6, N. Kumarasamy7, M. Law', on behalf of TREAT Asia HIV Observational Database. 'National Centre in HIV Epidemiology and Clinical Research, The University of New South Wales, Sydney, Australia, 2Research Institute for Tropical Medicine, Manila, Philippines, 3Ruby Hall Clinics, Pune, India, 4Tan Tock Seng Hospital, Singapore, Singapore, 5Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 'Infectious Diseases Section, School of Medicine, Udayana University & Sanglah Hospital, Bali, Indonesia, 7YRG Centre for AIDS Research and Education, Y.R. Gaitonde Medical and Research Foundation, Chennai, India Background: We aimed to assess factors associated with TB diagnosis, and the prognostic significance of TB in overall survival, using data from the TREAT Asia HIV Observational Database (TAHOD). Methods: The risk of TB diagnosis after entry to TAHOD was assessed in patients with prospective follow-up no previous TB diagnosis. To assess the impact of background TB prevalence rate on the risk of TB diagnosis, sites were grouped into high and low/intermediate TB burden by WHO guidelines. Baseline TB and incident TB were included as time-dependent variables in assessing overall survival. Diagnosis of CDC category B disease, single or multiple diagnoses of AIDS other than TB and antiretroviral treatment were also included as time-dependent variables. Results: Among the 2218 patients with prospective follow-up, 501 (22.6%) were diagnosed with TB prior to entry to TAHOD. Baseline CD4 counts were higher among patients with no prior AIDS (Median 313 cells/pL), than those of patients with prior AIDS but not TB (243) and patients with TB (212, p<0.001). During follow-up 33 patients developed TB (1.44 per 100 person years [PYs]). A higher CD4 count at baseline, receiving antiretroviral treatment and coming from low/intermediate TB countries were associated with a lower risk of TB diagnosis. A total of 88 patients died during 3025 years of follow-up (2.77 per 100 PYs). In multivariate analysis, compared with patients with CDC category A disease, mortality was raised in patients with CDC category B disease (hazard ratio, HR 1.80, p=0.191), TB diagnosis (HR 1.66, p=0.202), other single AIDS diagnosis (HR2.85, p=0.002), multiple other AIDS diagnoses (HR 4.51, p<0.001) and TB and AIDS diagnosis (HR 3.40, p<0.001). Conclusions: Although the overall rate of TB was higher than that seen in western countries, the risk factors identified were similar. In TAHOD, patients with TB only had better survival than patients with other AIDS illnesses. MOPEO1I Immunological response to anti-tuberculosis treatment in HIV-TB co-infected patients P. Chandrasekaran, S. Swaminathan, V. Perumal, P.A. Menon, N. Gopalan, P. Chinnaiyan, S. Subramanian. Tuberculosis Research Centre (Indian Council of Medical Research), HIV/AIDS, Chennai, India Background: Tuberculosis is known to increase the viral load as well as systemic immune activation markers in patients infected with human immunodeficiency virus (HIV). Our aim was to study the impact of tuberculosis on immune status of patients with HIV and relate it to their initial CD4 cell counts. Methods: HIV patients with newly diagnosed tuberculosis attending Tuberculosis Research centre, Chennai and Madurai units, were treated with standard short-course intermittent anti-Tuberculosis (ATT) regimens. None of them were on antiretroviral therapy. CD4 cell counts were measured at baseline and at the time of completion of ATT. Patients were classified into three immune categories and the changes in CD4 count studied by trend chi-square test. Results: CD4 cell counts were available for 208 patients both at baseline and at end of ATT. 79% were males with the mean age being 32.1 years. The median CD4 cell count at baseline was 168 cells/mm3 (range: 5-960 cells/mm3) and at the end of treatment was 184 cells/mm3 (range: 6-874 cells/mm3). Immune deterioration was more pronounced in patients with less advanced HIV disease with CD4 counts > 250 cells/mm3 (p < 0.01). C04 celcounts Number of CD4cel.esone.t.ndoftraten beoeAT patients elr sneam en ftram t Moda Same Deteriorated status status 48% 11~10 48% Improved 41% < 150 cell/ mm3 95 150-250 cells/mm3 48 > 250 cells/ mm3 65 35% 54% 31% 33% 23% 23% Deteriorated: a decrease of > 50 cells from baseline value Improved: An increase of > 50 cells from baseline value Conclusions: Tuberculosis causes a further deterioration of immune status in HIV-infected patients; this appears to be more pronounced in patients with higher CD4 cell counts (> 250 cells/mm3). These findings underscore the importance of TB prevention as well as the increased need for antiretroviral drugs once TB develops. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  78 MOPE0192 Clinical presentation and outcome of HIV-infected patients with tuberculosis in the HAART era in Rio de Janeiro, Brazil C. Schmaltz', S. Souza', F. Marinhol, M. Morgado2, C. Lourenco3, G. Lopes4, V. Rolla'. 'IPEC - Fiocruz, Tuberculosis, Rio de Janeiro, Brazil, 210C - Fiocruz, Rio de Janeiro, Brazil, 3IPEC - Fiocruz, Bacteriology, Rio de Janeiro, Brazil, 4UFRJ - HUCFF, Infectious Diseases, Rio de Janeiro, Brazil Background: Tuberculosis (TB) is a frequent disease among AIDS patients in Brazil. Our aim is to compare the clinical presentation and the outcome of patients with tuberculosis according with the use of HAART and HIV serological status among patients treated in a referral center in Rio de Janeiro, Brazil. Methods: A longitudinal study including retrospective data from HIV-infected patients complicated by tuberculosis in the pre-HAART era and prospective data from HIV-infected and HIV-negative patients that were treated for tuberculosis in our center after 2000. Results: We enrolled 407 patients, 87 HIV+ from the pre-HAART era, 162 HIV+ after the HAART era and 158 HIV negative patients. Disseminated TB was more significantly common among HIV+ patients (30% versus 2%, p<0.01). Disseminated TB was significantly less frequent among HIV-infected patients who were on HAART (21% versus 33%, p= 0.05). The proportion of patients who abandoned TB treatment in the prospective arm of the study was significantly higher among HIV-negative patients (14% versus 5%, p<0.01). Before TB diagnosis, mean CD4 cell count was 201 cell/mm3 (+206) and the mean viral load was 4.68 log (+1). After TB therapy mean viral load dropped to 3.04 log (+1, p<0.01) and mean CD4 cell count increased to 254 cell/ mm3 (+168, p<0.01). TB-related deaths were more frequent in HIV+ patients compared with HIV-negative patients (25% versus 3%, p<0.01). Among HIV+ patients, TB-related deaths were significantly more frequent in the pre-HAART cohort (42% versus 15%, p<0.01). Conclusions: Mortality among HIV-infected patients complicated with TB is lower in the HAART era. However, TB-related mortality is still significantly higher among HIV-infected patients compared with HIV-negative patients. HIV negative patients are less compliant to TB treatment than co-infected patients. MOPE0193 Treatment outcomes for HIV-infected tuberculosis patients in Latvia, 1999-2004 I. Morozova', V. Riekstina', T. Holtz2, C.D. Wells2, V. Leimane'. 'Latvia State Center for Tuberculosis and Lung Diseases, Riga, Latvia, 2U.S. Centers for Disease Control and Prevention, Division of Tuberculosis Elimination, Atlanta, United States Background: The seroprevalence of HIV infection among tuberculosis (TB) patients in Latvia increased 26-fold from 0.1% in 1998 to 2.6% in 2004. HIV seroprevalence among all multidrug-resistant (MDR) TB patients, those resistant to at least isoniazid and rifampin, sharply increased from 0% in 1998 to 5.6% in 2001, remaining stable 3 years thereafter at 5.3% in 2004. We sought to characterize the impact of HIV on treatment outcomes for TB and MDR TB. Methods: Final treatment outcomes for HIV-infected, new TB patients registered during 1999-2004 were stratified by MDR TB status and analyzed. Treatment success was defined to include cure or completion; poor treatment outcomes were defined as default, failure, or death. Results: Among 143 HIV-infected TB patients, 17 (7%) had extrapulmonary TB. Among the remaining 126 pulmonary TB patients, 28 (22%) had MDR TB. Outcomes analysis for the 98 HIV-infected non-MDR TB patients found that 74 (76%) achieved treatment success, 15 (15%) defaulted, 2 (2%) failed, and 7 (7%) died. Among the 23 HIV-infected MDR TB patients, 13 (56%) achieved treatment success, 5 (22%) defaulted, 3 (13%) failed, and 2 (9%) died. HIV-infected MDR TB patients had an 80% greater risk of experiencing poor treatment outcomes compared to those without MDR TB [Relative risk=1.8, confidence interval 1.0, 3.2; p=0.07]. Conclusions: Relatively high levels of treatment success can be achieved among HIV-infected TB patients without MDR TB under good program conditions. However, HIV-infected MDR TB patients present a difficult clininical management situation and are at considerably greater risk for treatment default, failure, or death. Further evaluation of risk factors for poor treatment outcomes among these patients and for the impact of dual treatment with antiretroviral therapy for HIV warrant further investigation. MOPE0194 Patterns and results of TB skin testing in HIV/AIDS clinics L. Kunches, N. Reinhalter, L. Hirschhorn, J. Musolino, Massachusetts Department of Public Health and Boston Public Health Commission Clinical Quality Management Group. JSI Research and Training Institute, Inc., Boston, United States Background: Guidelines call for TB skin testing (TST) of all HIV-positive patients during their initial medical assessment. The IDSA suggests that annual testing be considered for those with who are at increased risk of exposure to TB. Yet some HIV Quality programs have recommended annual TSTs for all HIV-positive patients, which can be burdensome to clinics. Since compliance with the routine annual TST requirement is relatively low (56-62% median for HIVQual 2003-04), we examined overall TST rates, positive TSTs and active TB over six years in a statewide network of HIV clinics to identify predictive factors. Methods: Chart review of 2220 randomly sampled HIV/AIDS patients in care (1999-2004) and all newly diagnosed patients (2002-03) at 21 Massachusetts clinics receiving public funding for underserved populations. Adjusted odds ratios (AORs) and 95% confidence intervals (CIs) were calculated from logistic models. Results: Most (78-81%) newly diagnosed patients without prior history of TB or positive TST were screened. Once in routine care, annual rates of TST dropped to 37-47%. Overall, new positive TSTs occurred in 5.6% of patients tested (73/1298) during the 6 years. Controlling for baseline CD4 and years in care, predictors of new positive TST included foreign birth (AOR 4.2, 2.4 -7.5) and Hispanic ethnicity (AOR 1.9, 1.0-3.8). Per test positivity rates were 2.7% overall, 6.9% for foreign-born, 2.4% for Hispanics and 5.5% for Blacks. 19% of positive reactions occurred after one or more non-reactive TSTs at the clinic. Active TB cases (n=24) occurred at a rate of 0.33/100 person-years of observation; predictors were foreign birth (AOR 4.3, 1.8-10.2), male gender (AOR 4.6, 1.5-14.0), and racial/ethnic minority status (AOR 2.7, 1.0-7.6). Conclusions: TB screening is fairly consistent in newly-diagnosed HIV patients, but ongoing TST routines vary and have low yield. In Massachusetts, recognizing risk factors for new positive TSTs and active TB can help clinics target their efforts. MOPE0195 Patient satisfaction and understanding among HIV-infected subjects in a tuberculosis vaccine trial in Tanzania J. Lyimo1, L. Adams2, L. Mtei', R. Waddell', C.F. von Reyn2. 'Muhimbili University College, Infectious Disease, Dar es Salaam, Tanzania, United Republic of, 'Dartmouth College, Infectious Disease, Hanover, NH, United States Background: Patient satisfaction and understanding are predictive of future behavior such as adherence to treatment and intent to return for care, issues which are important for the optimal conduct of clinical trials. However, there are no data on satisfaction of participants in clinical trials conducted among subjects in developing countries. Methods: Cross-sectional interview study of HIV-infected subjects in the DARDAR study, a clinical trial in Dar es Salaam, Tanzania of a new vaccine against tuberculosis. Results: 114 consecutive subjects were queried and agreed to be interviewed. Of these, 112 respondents (98%) reported satisfaction with their participation in the clinical trial and 106 (93%) respondents rated the quality of care offered by the study clinic as better than that of nearby healthcare centers. 111 respondents (97%) would recommend the trial to a friend and 112 (98%) were willing to participate in another trial. Long waiting times were the most common complaint [47 (41%)]. Respondents had a low level of understanding about the requirement to report illness during of the trial: 35 of 84 (42%) respondents who had been ill since their enrollment in the study had not visited the study clinic during their last illness Nine of 35 (26%) did not know they were supposed to report intercurrent illness, seven of eleven (64%) respondents who were hospitalized since their enrollment in the study had not informed the study about their most recent hospitalization and four of seven (57%) did not know they were supposed to report hospitalization to the study. Conclusions: Most HIV-infected subjects in a clinical trial in Tanzania were satisfied with their participation despite long waiting times. Even though the requirement to report intercurrent illness had been explained during the consent process, many subjects did not report illness and hospitalization. Improved methods are needed for encouraging subjects to report illness and hospitalization. MOPEO196 Active case finding of tuberculosis in a setting of high HIV prevalence: towards an integrated model of TB and HIV health care J. Sekandi Nabbuye, D. Neuhauser, K.A. Smyth, C.C. Whalen. Case Western reserve University, Epidemiology and Biostatistics, Cleveland, United States Issues: In the past decade, the growing tuberculosis (TB) epidemic has been partly fueled by the HIV co-infection resulting in difficulty to provide adequate and timely health care to the dually infected individuals in developing countries. In Uganda, where up to 50% of TB cases may be HIV-infected, there is a critical need to identify a point for early entry into care for the TB and HIV co-infected individuals. Description: In a community-based door-to-door survey of 930 adults residing in a peri-urban low socio-economic community in Kampala, Uganda, we estimated the proportion of undetected active TB cases and the corresponding proportion of self-reported HIV testing. Individuals who reported cough for 2 weeks submitted three sputum specimens for direct smear microscopic examination. Two Positive smear results precipitated referral to the health care system for TB treatment. Among 321 participants who reported cough, 59% (189) had a history cough for 2weeks, 69% (128) of those submitted sputum for examination from their homes and of those 26% (33) were smear positive TB cases. Lessons learned: The prevalence of undetected TB among persons with cough for >_ 2 weeks was 18.3 % in the study population. Among the individuals with active TB, 56% (18) reported that they had never had an HIV test. The XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  79 low prevalence of HIV testing among undetected TB cases supports need for integration of HIV and TB services.Symptom screening is a useful tool in identifying TB suspect cases in Active Case Finding. Recommendations: The Active TB Case Finding strategy coupled with HIV testing could be an effective approach to enhance early entry into care for TB and HIV co-infected individuals. MOPE0197 Recurrent tuberculosis from Rwandese patients with multidrug-resistant strains of M. tuberculosis A.U. Nyaruhiriral, I.C. Shamputal, M. Struelens2, E. Karita3, F. Portaels', Laboratoire de reference national, Rwanda; Hopital Saint Pierre Bruxelles. 'Institute of Tropical Medecine 1, Mycobacteriology Unit, Antwerpen, Belgium, 2Erasme Hospital 4, Department of Microbiology, Brussels, Belgium, 3Project San Francisco, Emory University, Kigali, Rwanda Background: Recurrence of active tuberculosis after treatment can be due to relapse of infection with the same strain or reinfection by a new strain of Mycobacterium tuberculosis. The proportion of recurrent TB cases caused by reinfection has varied widely in previous studies. Our aim was to analyze the role of reinfection and mixed infection in TB recurrence in a cohort study of Rwandese patients, who had successfully completed treatment for pulmonary tuberculosis. Methods: Serial M. tuberculosis isolates from patients diagnosed with multidrugresistant (MDR) tuberculosis were evaluated by phenotypic drug susceptibility testing and sequencing of rpoB, katG, inhA, and embB. Genotyping analysis was done by Spoligotyping and MIRU-VNTR. Results: During the period from September 2002 to January 2005, 815 patients resident in the epidemiological field sites (4 provinces of Rwanda) were culture positive for M. tuberculosis. Isolates from 644 of these patients were available for further analysis. Phenotypic drug-susceptibility testing classified 69 (10.7%) of them having an episode of MDR tuberculosis. DNA fingerprinting showed a single strain in sputum cultures from 47 of the 69 patients with MDR-TB. Serial sputum cultures from the remaining 22 patients showed the presence of genetically distinct strains. On the other hand, DNA fingerprinting data suggested reinfection in 4 cases (18.2%) mixed infection in 1 case (4.5%), and 17 cases (77.3%) with identical genotype suggested reactivation or failure. Reinfection, mixed infection and reactivation could be confirmed by using MIRU-VNTR method. Conclusions: Analysis of clinical data suggests that in a setting with a high risk of tuberculosis infection, HIV1/2 increases the risk of recurrent tuberculosis because of an increases risk of reinfection. Interventions to prevent recurrent disease, such as lifelong chemoprophylaxis or antiretroviral treatments in HIV positive patients are necessary and recommended. MOPE0198 Tuberculosis orificialis in two HIV positive patients (2 cases) B. Kavina, M.V. Rao, F.E. Bilimoria. Zoology Department, Gujarat University, Ahmedabad, India Background: To study the pattern of Ano-genital tuberculosis in two HIV-Positive patients. Methods and results: Patient I:- A 38 year old female patient presented with 5x3 cm sized lesion with unhealthy granulation tissue and ulcerations with crusting at a few places on Right Labia-majora. Bilateral inguinal Lymphadenopathy was present. Patient was HIV-Positive by ELISA method with CD4 counts of 150 cells/ L. Tuberculin test TT was + 20 mm. Patient II:- A 35 year old bisexual male presented with Perianal ulcerations with multiple papulonecrotic lesions on both buttocks. Patient was HIV-Positive with CD4 counts of 210 cells/pL. TT was +22 mm. Biopsy was taken from patient-I which revealed classical tuberculoid granuloma with multiple Langhan's giant cell. Conclusion: As tuberculosis is one of the most commonest opportunistic infection in HIV-Positive patients in our country, any genital slowly progressing and slowly healing lesions should be investigated for tuberculous ulceration. MOPE0199 Response to thrice weekly DOTS anti-TB treatment in HIV seropositive and HIV seronegative tuberculosis patients in Pune, India S. Tripathy', V. Inamdar2, A. Anand', M. Bhausar', A. Datte', S. Mehendale4, K. Kishore4, R. Powars, A. Risbud6, R. Paranjape'. 'National AIDS Research Institute, Clinical Sciences, Pune, India, 'Talera Hospital, TB Out Patients Department, Pune, India, 3Talera Hospital, TB Out Patient Clinic, Pune, India, 4National AIDS Research Institute, Epidemiology, Pune, India, 'National AIDS Research Institute, Data Management, Pune, India, 'National AIDS Research Institute, Microbiology, Pune, India, 'National AIDS Research Institute, Officer-in-Charge, Pune, India Background: Tuberculosis is one of the commonest opportunistic infections in HIV-infected patients in India. A study was done to determine the response of HIV seropositive and HIV seronegative pulmonary TB patients to thrfce weekly DOTS regimen given as part of the RNTCP (Revised National Tuberculosis Control Program) in the Pune region in India Methods: 261 newly diagnosed pulmonary tuberculosis patients were treated with thrice weekly Ethambutol, Isoniazid, Rifampicin and Pyrazinamide for two months followed by thrice weekly isoniazid and rifampicin for 4 months. The patients received the drugs under direct observation. All the patients were tested for HIV infection by serological test after obtaining informed consent. Results: Of 57 sputum AFB smear positive HIV-1 seropositive patients, 42 (73.7%) were cured, 8 (14%) expired during treatment, 1 (1.75%) had treatment failure and 6 (10.5%) defaulted; the corresponding figures among 100 HIV seronegative sputum smear positive patients were 91(91%), 1 (1%), 2 (2%) and 6 (6%) respectively. Among 56 sputum AFB smear negative HIV seropositive patients, 40 (71.4%) successfully completed treatment, 15 expired (26.8%), 0 (0%) had treatment failure and 1 (1.8%) defaulted.; the corresponding figures for 48 HIV seronegative sputum smear negative cases were 44 (91.7%), 3 (6.25%), 1 (2.1%) and 0 (0%) respectively. Conclusions: The cure rates in HIV-infected pulmonary TB patients (82 out of 113) were significantly lower than in the HIV negative group (135 out of 148) [(p<0.001)]. The mortality rates among HIV seropositive pulmonary TB patients were significantly higher in HIV positive patients (23 of 113) compared with that in HIV seronegative patients (4 of 148) (p<0.01). MOPE0 200 DOTS strategy is not able to achieve good treatment outcome due to the high death rate among TB patients under the integrated TB/HIV program in Thailand P. Khortwong, O. Auysin, J. Vongspanich, P. Satasit, T. Siraprapasiri. Principal Recipient Administrative Office, Department of Disease Control, MOPH, Nonthaburi Province, Thailand Issues: The emerging TB problem in Thailand is partially caused by a HIV coepidemic and poor compliance to TB treatment. The Ministry of Public Health established an integrated TB/HIV strategy for controlling and preventing TB caused by increasing HIV situation in Thailand since 2001. Additional resources supported from the Global Fund were implemented to strengthen DOTS strategy in this target population in 2003-5. Description: The project has been implemented by using TB/HIV strategic policy as a Package of Care started in 2003.The core activities were implemented as follows: 1) A capacity building for HIV/TB coordinators to operate the program; 2) Establishment and scaling up DOTS services; 3) Supervision and Monitoring; 4) Development of information education and communication materials; and 5) Collaboration between central and local levels as well as civil societies. HIV/TB integrated care services consisted of voluntary counseling and testing for TB patients, TB counseling and screening for HIV positive patients, DOTS, Identification of latent TB and OI prophylaxis. Lessons learned: 570 health care workers were trained for improving TB/HIV integrated care for TB patient and PLWHA in 44 high prevalent HIV provinces. Moreover, 60 outreach workers were employed for observing TB/HIV patient taking drug regularly under DOTS. The 5,018 PLWHA were received TB screening under this program. Meanwhile, the treatment outcome of cohort 500 TB/HIV patients was 76.70% in successful rate. The death rate was 16.64%. The default, failure, and transfer out rates were 3.33, 1.45, and 2.03 % respectively. Recommendations: The activities for integrated TB/HIV Program have been successfully implemented into local health care system. Causes of deaths among TB/HIV should be investigated in order to further improve treatment outcome in this target population. MOPEO201 Efficacy and safety of double boosted saquinavir (SQV)/lopinavir/ritonavir (LPV/r) in nucleoside pre-treated children at 48 weeks P. Kosalaraksal, T. Bunupuradah2, C. Engchanill, P. Boonrak2, J. Intasan2, S. Ubolyam2, C. Pancharoen', P. Lumbiganond', D. Burger3, K. Ruxrungtham4, M. Schutz', J. Ananworanich6, The HIV-NAT 017 Study Team. 'Khon Kaen University, Khon Kaen, Thailand, 'The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand, 'UMC St Radboud, Nijmegen, Netherlands, 'The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) and Chulalongkorn University, Bangkok, Thailand, sRoche Nutley, NJ, United States, 'The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand and South East Asia Research Collaboration with University of Hawaii (SEARCH), Bangkok, Thailand, Bangkok, Thailand Background: To assess the 48-week efficacy and safety of double boosted SQV/LPV/r combination in children who have failed NRTI/NNRTI-based regimens. Methods: 50 NRTI/NNRTI pre-treated children at Bangkok (n=20) and Khon Kaen (n=30) in Thailand were treated with BID SQV-mesylate capsule and LPV/r. CD4, viral load (VL), Cmin and fasting lipids were monitored. Having 2 VL > 400 after week 12 defined as VL failure. ITT was performed. Results: Baseline data were median age 9.3 yrs (IQR 7.1-11.2), %CDC N: A:B:C = 4:14:68:14, VL 4.8 log10 (IQR 4.5-5.1), CD4 7% (IQR 3-9.5),CD4 count 160 (IQR 43.5-286.5) cells/mm3, median TG, LDL and HDL 104, 78 and 44 mg/dl respectively. At 48 weeks, 2 died from bacterial infection and 2 stopped ARV from intolerance and noncompliance. No child had HIV disease progression. Median CD4% and CD4 count rise were 8% (IQR 4 to 15.5) and 360 (149 to 510) and median VL reduction was -2.6 log10 (IQR -3.2 to -1.3), XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  80 Monday 14 August Patter xFi Eon all p<0.001. Thirty seven (74.0 %) and 26 (52%) children had VL < 400 and < 50 with differences between sites (Bangkok: 95% and 75%; Khon Kaen: 60% and 37%). VL failure was seen in 0/20 in Bangkok and 5/30 in Khon Kaen; all failures had poor adherence. ARV-related adverse events (AE) of any grade were seen in 13 children (26%); grade I-II 69 %, grade III-IV 31%. The most common AEs were diarrhea and elevated TG. Median TG, LDL and HDL change (mg/dL) were +19.5 (IQR -22-74): p = 0.014, +18.0 (IQR 0-36.8): p = 0.006 and +3 (IQR 0-9): p= NS. Conclusions: Double boosted SQV/LPV/r showed significant CD4 rise and VL decline at 48 weeks. Poor adherence caused VL failure in 10%. No progression of HIV disease was seen. Mild ARV-related AE were common. TG and LDL were significantly increased. MOPEO202 Lack of PI resistance in children failing double boosted saquinavir (SQV)/lopinavir/ritonavir (LPV/r) combination T. Bunupuradah', P. Kosalaraksa2, C. Engchanil2, S. Sirivichayakull, J. Intasan', S. Ubolyam', C. Pancharoen3, P. Lumbiganond2, K. Ruxrungtham4, M. Schutzs, J. Ananworanich6, HIV-NAT 017 Study Team. 'The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT), Bangkok, Thailand, 2Khon Kaen University, Khon Kaen, Thailand, 3Chulalongkorn University, Bangkok, Thailand, 4The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) and Chulalongkorn University, Bangkok, Thailand, 5Roche, Nutley, NJ, United States, 6The HIV Netherlands Australia Thailand Research Collaboration (HIV-NAT) and South East Asia Research Collaboration with University of Hawaii (SEARCH), Bangkok, Thailand Background: There is no data on resistance in children upon failure with dual boosted PI therapy. Methods: Fifty reverse transcriptase inhibitor (RTI) pre-treated children at Bangkok and Khon Kaen, Thailand were treated with twice daily dosing of saquinavir-mesylate capsule (SQV) and lopinavir/ritonavir (LPV/r) in an ongoing study, HIV-NAT017. Seventeen children who had never had lamivudine also received it. Children who has VL> 1,000 copies/ml after at least 24 weeks had genotyping testing. Mutations were defined according to IAS-USA guidelines. Results: Thirty seven (74.0 %) and 26 (52%) children had VL < 400 and < 50. Eight of 50 children (16%) had viral load (VL) > 1000 after a median (IQR) follow up time of 48 (27-48) weeks. Their baseline median age was 11.5 (IQR 9-14) years, median CD4% was 5.6 (IQR 2.1-7.8), median VL log was 5.4 (IQR 4.8-5.6), 7 were females, and all were from the Khon Kaen site. Four of 8 were on 3TC. Median time spent with VL> 500 copies/ml before genotyping was 31.5 (IQR 24-45) weeks. At genotyping, median VL log was 4.0 (IQR 3.5 -4.2) and median CD4% was 14 (IQR 5-23). One of 8 samples could not be amplified. Of 7 amplified samples, none had major PI mutation and 2/7 had minor PI mutations (K20R, M36I). None showed 3TC resistance. At genotyping, 5/6 available PI levels were below the desired inhibitory concentration (LPV > 1.0 mg/dl, SQV > 0.28 mg/dl). High baseline VL (p=0.027) and poor adherence (p= 0.001) but not gender, age, duration of prior treatment and CD4, predicted having VL > 1000. After counseling, only one child improved with VL<50 copies/ml. Conclusions: No major PI mutation was found in children who failed double boosted SQV/LPV/r. Children with VL failure had low PI levels. High baseline VL and poor adherence significantly predicted VL failure. MOPEO203 Long-term safety and effectiveness of ritonavir (RTV), nelfinavir (NFV) and lopinavir/ritonavir (LPV/r) in antiretroviral (ARV) -experienced HIV-1-infected children C. Rudin', M. Burrin', Y. Shen2, R. Rode2, D. Nadal3, the Swiss Pediatric Infectious Disease Group (PIGS) and the Swiss Mother&Child HIV Cohort Study (MoCHiV) Group. 'University Children's Hospital, Pediatrics, Basel, Switzerland, 'Abbott Laboratories, Abbott Park, IL, United States, 'University Childrens Hospital, Department of Pediatric Infectious Diseases, Zurich, Switzerland Background: For the purpose of clinical research at the population level, guidelines for the use of combined ARV treatment and follow-up were developed prior to the first prescription of a protease inhibitor (PI) to Swiss children. Methods: HIV-1-infected children enrolled in MoCHiV were eligible for this observational cohort study if they received at least one PI of interest (RTV, NFV or LPV/r) between March 1996 and October 2003. Data regarding demographics, clinical disease and antiretroviral treatment history, HIV-1 RNA (copies/mi), CD4+ T cells (cells/ul and %), adverse events, clinical laboratory values, reasons for discontinuation of PIs, and concomitant medications were extracted from the database for first-, second-, and higher-line PI use. Results: 133 HIV-1-infected children were enrolled; 47% were male, mean age was 7.6 (0-16.5) yrs, and 65% (RTV), 70% (NFV) and 89% (LPV/r) were pretreated with =/> 2 nucleoside reverse transcriptase inhibitors prior to initiation of their first PI-based therapy. Regardless of line of use total duration of follow-up on RTV (n=78), NFV (n=86) and LPV/r (n=44) was 163.8, 235.0 and 46.1 patient-years, and mean duration of dosing for the first use 716 (4 -2448), 979 (9-2167) and 378 (1-897) days, respectively. First-line therapy reduced HIV-1 RNA and increased CD4+ T cell counts and percentages from baseline throughout the 288-week study (p<0.05) for RTV (introduced 3/96) and NFV (2/97) and throughout 84 weeks of use for LPV/r (11/00), introduced into treatment more recently. All PIs investigated were most effective in first line use. Only eleven PI-associated toxicities occurred requiring treatment changes or interruptions (pancreatitis, n=1; allergic reactions, n=4; visual impairment, n=3; and hyperlipidemia, n=3). There was no indication of developmental abnormalities or unexpected rare events. Conclusions: Long-term PI-based therapy appears to be safe and to provide durable virologic and immunologic effectiveness in HIV-1-infected ARVexperienced children. MOPEO204 Longitudinal assessment of bone quality by quantitative ultrasonography (Qus) in vertically HIV-infected children and adolescents R. Rosso', A. Parodi2, C. Torrisi2, E. Malfatto', F. Ginocchio', E. Repetto', C. Viscoli', M. Vignolo2. 'University of Genoa, Infectious Diseases, Genoa, Italy, 2University of Genoa, G. Gas/lini Children Hospital, Pediatric Clinic, Genoa, Italy Background: At the present time there aren't reported data about longitudinal evaluation of bone quality in HIV-infected children. Aim of the present study was to evaluate dependent speed of sound (AD-SoS) and bone transmission time (BTT) in two sessions, in vertically infected HIV-infected patients (pts), and compare them with a reference population. Methods: 40 pts (20 males, aged 3-22 years) were monitored (mean period of observation: 2.0 ys +/- 0.84 ) and compared with a reference population (3044 healthy subjects, 1513 males, aged 2-21 years). Seven patients were na/ve to any antiretroviral therapy, two were taking two NRTIs and 31 were on HAART (>= 3 antiretrovirals drugs). Seventeen pts (42.5%) showed clinical lipodystrophy. Furthermore, 30 pts (75%) showed alterations of lipid metabolism. Types of therapy and clinical characteristics did not change during the entire follow up. Results: Mean ADSOs and BTT increments in prepubertal pts were similar to the reference population (ADSoS: 107.9 % +/- 90 and BTT: 116.5 % +/- 48.6 of the expected values). During puberty, both mean ADSoS and BTT increments were significantly smaller in pts than in the control population (ADSoS: 36.0 % +/- 44.7; BTT: 76.2 % +/- 56.7 of the expected values). AD-SoS and BTT increments in pts with lipodystrophy were not significantly different from those without lipodistrophy, but their mean ADSoS-SDS and BTT-SDS were smaller both at the first and second observation. Mean AD-SoS and BTT increments and mean ADSoS-SDS and BTT-SDS at the first and second observation were not significantly different in pts treated/untreated with HAART and protease inhibitors-based HAART. Conclusions: This longitudinal study confirms the tendency towards osteopenia in HIV-infected pts, even if QUS variables increments seem to be impaired only in pubertal pts. Further studies on a longitudinal basis are required to confirm these first results. MOPEO205 Effects of therapy switch on metabolic parameters and mitochondrial DNA content in HAART-treated HIV+ children R. Rossol, E. Repettol, F. Ginocchio', E. Malfatto', M. Nasi2, M. Pinti2, E. Nemes2, L. Troiano2, C. Viscoli', A. Cossarizza2. 'University of Genoa, Infectious Diseases, Genoa, Italy, 2Univ. of Modena and Reggio Emilia, Department of Biomedical Sciences, Modena, Italy Background: Treatment with NRTIs, especially stavudine (d4T), can provoke mitochondrial (mt) damages, including decrease in mtDNA content. We have conducted a prospective study to assess the effects of the switch from d4T to TDF on immunovirological status, lipid and glycemic profile and mtDNA in CD4+ and CD8+ from HIV+ children taking HAART. Methods: 18 children (median age 10.9 years) on d4T-containing HAART (6 months at least), were randomized to maintain (arm A) or to switch from d4T to TDF (arm B), while preserving the remaining drugs. Fasting plasma glucose, triglycerides, total HDL and LDL cholesterol, insulin, Glu/Ins (<7 cut-off of Insulin resistance, IR),HOMA-IR, lactate, CD4+, and viral load were assessed at week 0, 12, 24, 48 and 72. MtDNA was quantified by real time PCR in plateletfree CD4+ and CD8+ T lymphocytes at baseline and after 24 and 72 weeks. Statistical analysis were performed by Mann Whitney and Wilcoxon tests. Results: From baseline to week 72, arm A and B did not show statistically significant differences as far as mtDNA and immunovirological responses are concerned. No patients had adverse reactions. After 24 weeks, 6 patients have modified their HAART: in 4 patients (2 for arms) PI was replaced by NNRTI (simplification), while in arm B, 2 replaced NNRTI with PI (intensification).The 2 arms were similar concerning lipid profile. At baseline, the indexes of IR were slightly impaired in arm B vs arm A (IR was found in 6 vs 2 patients and HOMAIR was 2.19 vs 1.45, respectively). After 72 weeks, IR was present in 3 vs 4 patients and HOMA IR was 2,14 vs 2,03, respectively. Conclusions: Both strategies seem to be well-tolerated in all patients and immunologic and virologic response was maintained, as shown by the analysis of classical parameters. No signs of mitochondrial toxicity were observed in any of the patients. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  81 MOPEO206 Pharmacokinetic and virological evaluations after stopping NNRTIs in children: a substudy of the PENTA 11 (TICCH) trial M. Lallemant', D. Burger2, H. Lyall3, L. Buck4, A. Compagnuccis, J.T. Ramos Amador6, M.J. Mellado Pena', F. Fregonesel, S. Campbell3, O. Rampon8, G. Castelli-Gattinara', T. Cressey1", S. Khoo", J.-M. Treluyer2, H. Green4, Y. Saidis, D. Nadal"3, C. Giaquinto8, D.M. Gibb4, on behalf of PENTA 11. 'Institut de Recherche pour le Developpement - IRD U 174, Chiang Mai, Thailand, 2UMC Nijmegen, Nijmegen, Netherlands, 3St Mary's Hospital NHS Trust, London, United Kingdom, 4MRC Clinical Trials Unit, London, United Kingdom, sINSERM SC10, Paris, France, 6Hospital 12 Octubre, Madrid, Spain, 'Instituto de Salud Carlos III, Madrid, Spain, 8University of Padova, Padova, Italy, 'Ospedale Bambin Gesu, Rome, Italy, 1"Harvard School of Publrc Health, Chiang Mai, Thailand, "University of Liverpool, Liverpool, United Kingdom, 12H6pital Saint Vincent de Paul, Paris, France, "Kinderspital Zurich, Zurich, Switzerland Background: Limited paediatric pharmacokinetic and viral evolution data are available after stopping NNRTIs. Methods: Children aged 2-15 years with plasma HIV-1 RNA viral load (VL) <50 copies/ml and CD4% >30% (ages 2-6 years) or CD4% >25% and CD4_500cells/ mm3 (7-15 years) were randomised to Planned Treatment Interruption (PTI) or continuous therapy. Children stopping NNRTIs were enrolled in a PK and virological substudy. Clinicians chose to stagger stop (SS, stop NNRTI first, continue remaining regimen for 7-14 days) or replace the NNRTI (R, switch to PI and stop all drugs after 7-14 days). NNRTI drug levels and VL were measured 0, 7, 14, and 28 days after stopping the NNRTI and HIV-1 population sequencing performed at day 28. Results: 70 children have been randomised, of whom 13 (aged 5-15 years; median age 8.7 years; 6 girls) have interrupted nevirapine (NVP) based ART at standard NVP doses per surface area. Pre-interruption drug levels in the first 11 children were therapeutic (range 3.7 -15.1 mg/L) and VL was <50c/ml in 10, and 700c/ml in one child. All 11 children stopping NVP (3 Caucasians, 3 Africans, 3 Asians and 2 mixed origin) had plasma NNRTI below 0.5mg/L at 7 days. 14 days post-interruption VL was <50c/ml (n=5; 3SS, 2R), 50 -1000c/ml (5; 3SS, 2R), >1000c/mI (1SS, with VL=700 c/ml at interruption and NVP resistance 28 days after interruption). No NVP resistance was detected in the other 6 children evaluated so far. The emergence of mutations is being evaluated in the remaining children. In addition, pharmacokinetics, pattern of VL rebound and mutations in 9 children interrupting efavirenz, and 22 interrupting lamivudine are being evaluated. Conclusions: These preliminary data suggests that adoption of staggered stop or replacement strategy for 7-14 days may be sufficient to avoid the development of resistance in suppressed children interrupting NVP. MOPEO207 Simplification of antiretroviral treatment in HIV1 vertically infected children: switching from successful first-line HAART to triple nucleoside therapy A. Martino', P. Palma2, C. Caterina2, S. Penserioso2, M. Amicosante2, M. Romiti2, S. Bernardi', P. Rossi', G. Castelli Gattinara'. 'Bambino Gesu Children Hospital, Dep. of Immunology and Infectious diseases, Rome, Italy, 2Tor Vergata University, Rome, Rome, Italy Background: To assess the immunological and virological outcome of patients switching to a simplified triple nucleoside (NRTI) regimen after long term viral suppression under protease inhibitor (PI) based HAART. Methods: Prospective, open-label, pilot study on HIV vertically infected children, treated with a PI-based HAART, shifted to a 3-NRTI regimen after more than 12 months of undetectable viral load Results: The 20 enrolled children, age 2-18 years (median 8y), were followed for a median period of 108 weeks (range 60-129). 17/20 children were CDC class N or A-i, 3 were class C and 6 class 3. At study entry 12 patients (60%) switched to ABC; 5 (25%) to 3TC; 2 (10%) to AZT, 2 to DDI (10%). All were receiving a stable PI-based HAART for a median of 4.4 years (range 2-5.5 ), with a mean period of 2.9 years of undetectable viral load before the study entry. Lymphoproliferative T cell response to HIV-specific antigens gpl20, p24, gp41, p17 (SI>3) increased significantly during time (p<0.05). CD4 and CD8 z-score remain stable during the follow-up. One virological failure was observed at week 108, related to poor compliance; 8 patients (40%) experienced blips (VL >50 and <1.000 cp/mL) which returned to undetectable levels subsequently. DNA-load remained stable at 2.4 log10 copies/106 PBMC [range 1.6-3 log10 copies/106 PBMC] between baseline and 48 weeks. Total cholesterol significantly (p<0.001) decreased from a mean of 187+52 to 151+33 mg/dl, LDL from 113+37 to 79+26 mg/dl and triglycerides from 91.8+53 to 82+64 mg/dl. No new cases of lipodystrophy were detected. Compliance and quality of life showed a significant improvement in all children Conclusions: The shift to a 3-NRTIs simplified regimen is associated with reduction of dyslypidemia, maintenance of a prolonged virological control, increase of specific immunological response. MOPEO208 Antiretroviral therapy in a hundred Burundian children with AIDS P.C. Kariyo1, M.J. Mbuzenakamwe2, E. Baramperanye2, L. Barutwanayo3, J. Nyatanyi3, S. Bahimanga3. 'ANSS-CHU de Kamenge, Pediatrie, Bujumbura, Burundi, 2ANSS, Bujumbura, Burundi, 3CHU de Bujumbura, Bujumbura, Burundi Background: Data on Paediatric antiretroviral therapy in developing countries are limited, antiretroviral therapy has recently become available in Burundi and in other developing countries. According to the Global fund to fight AIDS and Malaria, since 2004 Paediatric ARV are free through a national project. The goal of this study is to evaluate the feasibility of generic ART in a low income country. Methods: During two years, we studied the efficacy of three drugs antiretroviral therapy initiated in 100 consecutive children under 15 years of age. All the children were naive patients for ARV. The ARV regimen was based on two NRTIs and an NNRTI generic drugs, according to Burundian ART guidelines. CD4 count was done at onset and every six months, viral was performed only one time per year. Results: 100 children receiving ARV were followed since the beginning of the National programme in January 2004. All the children were of C category and had all CD4 count under 20 %. Among this cohort, 54 achieved two yearstreatment and 46 one-year treatment. The mean age is 6.2 years. The median CD4 percentage rose from 12 % at baseline to 23 % in the one-year treatment group, and from 11.6% at baseline to 260% in the second group is. The viral load was below 50 copies/ml (quantiplex method for Amplicor) for all the patients in one-year treatment group and 4 patients among 54 in the two years group had their viral load over 50 copies/ml when others were undetectable according to the same method. The main adverse effects observed are: Seven patients developed anaemia with haemoglobin below 7g/dl. 2 patients developed a rush attributable to nevirapine. 2 other patients developed lipodystropy attributable to D4T. Conclusions: This report documents the feasibility of generic antiretroviral therapy in a developing country.These results support Paediatric ART initiative for Africa. MOPEO209 Combined interventions to prevent mother to child transmission of HIV-1 in a resource limited setting F. Noel', G. Bois', R. Cassagnoll, L. Estavien', A. Jules', Y. Cadot', J. Charlemagne', M.-M. Deschamps', L. M.Antilus', J. Bonhomme', P.F. Wright2, Y. Zhu2, J.W. Pape3, R.I. Verdier4. 'Les Centres GHESKIO, Pediatric, Port-au-Prince, Haiti, 2Vanderbilt University, Pediatric departement, Port-au-Prince, Haiti, 3Les Centres GHESKIO, Administration, Port-au-Prince, Haiti, 4Les Centres GHESKIO, Port-au-Prince, Haiti Issues: At the GHESKIO Centers, pregnant HIV-infected women are enrolled in a program to prevent vertical transmission and to assure the health of the family. The model used has been one of continuous quality improvement.We report the outcome of over 5 years of enrollment and follow-up with particular emphasis on improvement in infant mortality Description: We have sequentially introduced strategies that include: 1) introduction of PMTCT services with monotherapy using AZT access to obstetrical and pediatric clinic, psychological and social support in 1999; 2) Introduction of PCR based diagnosis, replacement formula, and trimetroprimsulfamethozaxole in 2000; 3) anti-retroviral therapy for HIV-infected mothers and infants who meet the criteria and immunizations in 2002; and 4) Enhanced p24 assay for early detection of vertical transmission in 2004. Lessons learned: The administration of AZT was judged complete in 46% of mother/infant pairs. Overall 63 (16%) of infants fit a clinical and/or laboratory diagnosis of HIV. This was lower in those with complete AZT therapy (11.5%) than in those with no therapy (23%) with p=0.06 for trend. The rate of HIV vertical transmission did not change over time. A high mortality in the first 15 months of life 231/1000 continued through 2003. In infants born in 2004 the mortality dropped to 96/1000. Overall 45% of the mortality in this cohort was attributable to AIDS. In 2005, the mortality in this group dropped to 23% with p<0.01. Conclusions: To be successful PMTCT must be a broad concept of provision of care for HIV-infected and affected family members. We attribute the recent success of the program to having simple diagnostic techniques to detect vertical transmission and the capacity to treat infants on detection of infection. The ultimate goal is to assure maternal health and further limit transmission and may be achievable only through aggressive antiretroviral therapy of the pregnant woman. MOPEO210 The PMTCT practice in Shangcai county, China F. Yul, T. Wang2, B. Han3, G. Feng4, W. Xus. 'Shangcai Prevention of Mother to Child Transmission Office, Zhumadian, China, 2School of Public Health, Peking University, Beijing, China, 3Shangcai Maternal and Child Health Care Center, Zhumadian, China, 4School of Oncology, Peking University, Beijing, China, sUNICEF, China, HIV/AIDS, Beijing, China Issues: Most of HIV/AIDS in Shangcai, Henan Province in China are at the child-bearing age. Their willingness to have a child is stronger than the Monday 14 August Poster Exhibition mmmmmmmma XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  82 normal ones because of traditional thinking. The prevention of mother to child transmission[PMTCT]is of importance in the control the elevation of the epidemic in the county. Description: Under the support of UNICEF project, the county initiated a project of PMTCT. VCT were integrated into normal health checkup for marriage, pregnancy, and antenatal examination. From Oct, 2001 to May 2005, 33514 tests conducted during marriage VCT and 79 were found HIV+ including 43 females; 48127 women tested before pregnancy and 230 of them HIV+. 92 HIV+ pregnancy women took ARV treatment and bottle feeding, 6 other only took bottle feeding. Among the 102 children of those HIV+ women, there were 9 deaths, 27 HIV- and 1 HIV+ at 18-month-old test, 9 HIV+ for 9-month-old test, 43 under 9-month-old in follow up. Other 6 HIV+ pregnancy women are in the follow-up. Lessons learned: The practice of PMTCT is successful in Shangcai with one drug regimen and bottle feeding under the careful management of pregnancy and intensive VCT among child-bearing age women. Recommendations: The PMTCT practice of Shangcai is practical, the experience of can be applied to other similar situation in the country. However the ARV for infant currently is not satisfying for dosage control and administration, and many other issues need to be solved. MOPE0211 First-year experience of the prevention of MTCT transmission program supported by SOLTHIS and IMAARV in Segou, Mali F. Zahn', M. Koital, B. Jarroussel, M. Hachimi2, D. Coulibaly3, B. Sidibe4, Z. Traore4, T. Zahn', S. Tchiombiano', A.-G. Marcelin5, V. Calvez5, C. Katlama6, Comite regional de 'Initiative malienne d'acces aux antiretroviraux (IMAARV) de Segou. 'Solidaritd therapeutique et initiatives contre le Sida - SOLTHIS Mali, Segou, Mali, 2Direction regionale de la santfd, Segou, Mali, 3Centre de sante de reference, Segou, Mali, 4H6pital regional, Segou, Mali, sH6pital de la Pitie-Salpetriere, Paris, France, 6Solthis, Paris, France Background: Prevention of Mother-to-Child Transmission (PMTCT) of HIV in resource-limited countries remains, in real life, a critical and difficult issue. We report here the first-year experience of PMTCT services implemented in 8 antenatal care clinics of the district of Segou, Mali. Methods: PMTCT services included: training of nurses and midwives to counselling and rapid HIV testing (RHT), adherence-focused activities, infantfeeding counselling and safer delivery practices, training of health staff to use prophylactic ARVs and HAART, free access to ARVs and formula milk to all HIVpositive pregnant women. Infant HIV status was assessed by Roche Amplicor RNA PCR. All pregnant women seen between January 1st, and December 31, 2005 were included. Results: 8050 initial antenatal visits were registered. 6011 (74.7%) pregnant women received HIV counselling, 5618 were tested by RHT (94% acceptance rate), 146 were HIV-positive (2.6%). Among the 101 HIV positive women expected to give birth before the end of 2005, only 44 delivered in PMTCT clinics, 12 under HAART, 6 with ZDVmono (starting at W28: 2; after W32: 4) and ZDV+ NVPsd during labor, 6 with ZDV + NVPsd only during labor, 20 without any prophylaxis. Among the 40 livebirths, only 31 infants received a complete ZDV + NVPsd regimen, 3 received no prophylaxis. Virologic analysis was performed in 27 infants: 10 had 2 negative PCR, 13 were HIV negative on the first PCR, 4 were HIV positive on the first PCR. Conclusions: In our first year experience of a decentralized PMTCT program, HIV counselling and testing was a successful step. However, management of the follow-up of HIV positive pregnant women, ARV prophylaxis for mothers (including HAART) and infants, feeding practices and diagnosis of HIV in infants remained a crucial challenge to be improved in the next future. MOPEO212 Less than 2% mother to child transmission (MTCT) of HIV achievable in South Africa J. Giddy, C. Roberts2, S. Reid3. McCord Hospital, HIV Programe, Durban, Soufh Africa, 2McCord Hospital, Obstetrics and gynaecology, Durban, South Africa, SMcCord Hospifal, PMTCT, Durban, Soufh Africa Issues: 2% Mother to Child Transmission rate is possible in South Africa. Description: McCord Hospital, a state subsidized urban hospital in KwaZuluNatal, South Africa, at the epicenter of the HIV epidemic has received funding from the Elizabeth Glaser Foundation since 2004, which has been used to implement a comprehensive PMTCT program using international best practice evidence. Despite admirable efforts, transmission rates in the public sector are estimated at 18-22%.This study presents the outcomes of the PMTCT programme for 2005. Lessons learned: All pregnant women receive HIV counseling. A CD4 and viral load (VL) test is done in those who test positive, and the results determine the treatment option: if the CD4 is <200, the mother receives HAART according to the National protocol. If the CD4 is >200 and VL >1500, she receives an appropriate alternative HAART regimen. If the CD4 is >200 and VL <1500 she receives AZT monotherapy and single dose nevirapine (SD NVP) in labour. Unbooked women arriving in labour receive SD NVP. All babies receive SD NVP and AZT for 7 days. The mode of delivery depends on the VL at 36 weeks. A PCR test is done on HIV exposed babies at 6 weeks. Women exposed to SD NVP receive Combivir for 7 days. In 2005, 208 (12%) HIV-infected women were identified. 35 (18%) received SD NVP in labour. 30 (15%) received AZT and SD NVP. 125 (64%) received HAART. 123 (63%) delivered by c-section and 71 (36%) vaginally. 192 (98%) babies received AZT & NVP. 167 babies had PCR's. 2 babies (1.19%) were HIV-infected. Recommendations: MTC transmission rate can be lowered to <2% in a Developing Country context by committed staff using international best practice based protocols and with adequate external funding. MOPE0213 Maternal and perinatal cohort of HIV-infected pregnant women from Belo Horizonte, Brazil: prevention of HIV mother-to-child-transmission V.H. Melo', R.A.L.P. Aguiar', A.C.L. Lobatol, B.A.M. Andrade2, I.K.D. Cavallo', F.M. Kakehasi3, R.M.C. Romanelli3, M.C.T. Tavares4, F.J.A. Peret2, F.B. Novais', J.A. Pinto', Grupo de Pesquisa Materno-Infantil em HIV/Aids. 'Universidade Federal de Minas Gerais, Faculdade de Medicina, Belo Horizonte, Brazil, 2Maternidade Odete Valadares, FHEMIG, Belo Horizonte, Brazil, SUniversidade Federal de Minas Gerais, Hospital das Clinicas, Belo Horizonte, Brazil, 4CTRDIP Orestes Diniz, Prefeitura Municipal, Belo Horizonte, Brazil Background: Mother-to-child-transmission (MTCT) is an important issue in HIV-infected women. Adequate prenatal care and antiretroviral regimen administration has decreased MTCT. Our purpose was to evaluate maternal and neonatal results, and vertical virus transmission decreasing, in a HIV-infected pregnant women cohort during eight years of prenatal and perinatal care. Methods: prospective cohort study of 477 HIV-infected pregnant women and theirs 481 neonates, admitted at Hospital das Clinicas Maternity (Federal University of Minas Gerais) and Odete Valadares Maternity, from January 1998 through December 2005. Infants were followed from six to 18 months after birth at Centro de Treinamento e Referencia de Doengas Infecciosas e Parasitarias (CTR-DIP) Orestes Diniz. Diagnosis criteria for HIV infant disease was HIV RNA detected in plasma samples, in two different moments. Data were stored and analyzed in Epi Info 3.2. Results: HIV-infection diagnosis was made in 231 (60%) patients during gestation. Samples to detect HIV RNA viral level was drawn in 342 pregnant women around 34 weeks, in which it was below 1.000 copies/mL in 54.6% patients. Predominant antiretroviral regimen was highly active antiretroviral therapy (61.5%). Cesarean section rate was 78%, and previous cesarean and high viral load before labor were the two main indications. Prematurity rate was 14.1%. Among 477 livebirth neonates, 456 (95.6%) received zidovudine after birth. HIV infection was confirmed in 12 children, 345 (71.7%) were uninfected to HIV, and 37 are in follow up. General mother-to-child transmission rate during this period was 2.5%. However, after 2002 there was no case of HIVinfected infant in our population. Conclusions: there was a great reduction of HIV mother-to-child-transmission during this period. Current transmission rate is zero. This confirms that adopting adequate measures like antiretroviral regimen, performing cesarean section in patients with high viral load, and no breastfeding, one could prevent perinatal virus transmission. MOPEO214 Anti-tubercular drug-induced hepatotoxicity in HIVpositive and negative patients G. Aderaye', G. All2, B. Kassa Demissie3. 'Addis Ababa University, Internal Medicine, Addai Ababa, Ethiopia, 2Addis Ababa University, Pharmacology, Addis Ababa, Ethiopia, sSumeyah Primary and Secondary School, Addis Ababa, Ethiopia Background: Anti-tuberculosis drug induced hepatotoxicity (DIH) is a common problem in the management of tuberculosis. In this study therefore, we assessed and compared the prevalence, severity and prognosis of anti-TB drug induced hepatotoxicity (DIH) in HIV positive and HIV negative tuberculosis (TB) patients in Ethiopia. Methods: In this study, 103 HIV positive and 94 HIV negative TB patients were enrolled. All patients were evaluated for different risk factors and monitored biochemically and clinically for development of DIH. Results: Biochemical hepatotoxicity was observed in 17.3% of the patients and B out of the 197 (4.%a) developed clinical hepatotoxicity. Seven of the eight were HIV positive and 2 for HBsAg. Biochemical hepatotoxicity was significantly associated with HIV co-infection (p=0.002), concomitant drug intake (p=0.008), decrease in CD4 count (p=0.001), and being rapid acetylator (p=0.026). Clinical hepatotoxicity is also significantly associated with being female (p=0.027), HIV co-infection (p=0.043), concomitant drug intake (p=0.003), HBsAg (p=0.046), and decrease in CD4 count (p=0.025). However, Hepatotoxicity was observed to have no significant association with alcohol intake, age, body mass index, and type of TB. Conclusions: We conclude that anti-TB DIH is a major problem in the management of tuberculosis and there is a need for a regular biochemical and clinical follow up for those patients who are at risk. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  83 MOPEO215 MOPEO217 The living well lab: establishing a community based Selenium supplementation and HIV-1 genital research institute in Vancouver, British Columbia, shedding in Botswana Canada, to assess the impact of complementary and alternative medicine on mthe quality or iifre and rehabilitation of persons living with HIV/AIDS C. Lunny', J.E. Jones', Z. Stjepanovic', F. Ib~faiez-Carrasco3, A. Mulkins4, J. Hilliers. 'BC Persons with AIDS Society, Treatment Information, Vancouver, Canada, 2Vancouver Friends for Life Society, Executive Director, Vancouver, Canada, 'Provincial HIV/AIDS Community Based Research Capacity Building Program, BC Persons with AIDS Society, Vancouver, Canada, 4Tzu-Chi Institute for CAM, CAM, Vancouver, Canada, SNaturopathic Clinic, Toronto, Canada Issues: There is growing literature on the use of complementary health care services and HIV but little evidence of evaluation and theory around complementary and alternative medicine (CAM) programs and their relation to health performance and quality of life of people living with HIV/AIDS (PLWHAs). There is need for integrative studies that provide a cost/benefit analysis of CAM in relation to HIV and conventional treatments, especially after the advent of antiretroviral medicines. Description: To achieve a sustainable non-profit CAM clinic with a community based research (CBR) institute, a rapid assessment procedure (RAP) was conducted in two AIDS service organizations in Vancouver; Friends For Life Society and the British Columbia Persons With AIDS Society. The RAP consisted of a literature review, focus group and individual interviews on the impacts of CAM on PLWHAs. The RAP was implemented as a participatory model by a consortium of community and scientific members. Lessons learned: From the literature review, CAM benefits are identified in four broad domains: transformational (positive lifestyle changes, attitude, outlook on life); therapeutic (reduction of pain, stress); programmatic (satisfaction with services that differ from conventional medicine, reduction in medical costs); and environmental (increased social participation of PLWHAs in paid/volunteer workforce). Most CAM research is confined to modality and crude self-reported benefits without connection to broader social issues and conventional medicine. The RAP identified that practitioners and frontline workers envision a democratic and open Cam Clinic set up; however, PLWHAs express a preference for a clinic model that is not low threshold. Recommendations: Recommendations include conducting peer-governed and integrated community-based inquiries into CAM potentials by modality, illness/ health condition, and area of impact; setting safeguards to reduce "research fatigue and stress" amongst participants by forming a strong community based governance for the CAM clinic; and scientific and community values would have to be harmonized to ensure sustainability. MOPE0216 Complementary and alternative medicine (CAM) use in British Columbia, Canada: a survey of HIV positive people on antiretroviral therapy (ART) S. Dhalla', K. Chan2, J. Montaner2, R. Hogg3. 'University of British Columbia, Department of Health Care and Epidemiology, Vancouver, Canada, 2St. Paul's Hospital, British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada, 'University of British Columbia, St. Paul's Hospital, Department of Health Care and Epidemiology, British Columbia Centre for Excellence in HIV/AIDS, Vancouver, Canada Background: CAM is treatment used in conjunction with or in place of standard medical treatment. It is popular among HIV+ people, despite associated toxicities and drug interactions. Our objective was to conduct a study to evaluate types and determinants of CAM use in HIV+ people on antiretroviral therapy (ART). Methods: In 2002, we collected final detailed data on CAM use in HIV+ participants on ART. A standardized mail survey was sent to the ambulatory pharmacy, and to family physicians (FP) of potential participants, for distribution to patients in the office. The survey was resent to the FP in 3 months, for no response. Stepwise logistic regression was used to model sociodemographic variables associated with CAM use, including gender, race/ethnicity, age, education, income, employment, and housing status. Clinical variables modelled were injection drug use, CES-D score, CD4 count, viral load, current PI/NNRTI/NRTI use, and ART experience. ART side effects were categorized into: subjective/action requiring (SA), objective/action (OA), subjective/no action (SNA), and objective/no action (ONA). Results: A total of 682 men and women participated. Responders were more likely to be male, older, have an AIDS diagnosis, a higher CD4 count, an undetectable viral load, and greater ART experience than nonresponders. Among 46.5% ever CAM users, vitamins/minerals (81%), meditation/yoga (36%), massage (31%), marijuana (30%), dietary supplements (24%), and herbal medicines (19%) were most commonly used. Multivariate analysis indicated CAM users were less likely to have a low education (AOR=0.51), more likely to be unemployed (AOR=1.52), more likely to have used ART longer (AOR= 1.19), and more likely to experience OA side effects (AOR= 1.45). Conclusions: Responder characteristics were consistent with CD4 count and viral load recovery following adherence to ART. CAM use remains common. Patients and health professionals should be aware of potential risks of CAM use, as this may have an impact on safety and efficacy of ART. M.K. Baum', P. Arimi2, D. Anderson3, C. Xu3, A. Campal, P. Burns4, H. Bussman2, I. Thior2, C. Wester2, R. Marlink4, M. Essex4. 'Florida International University, Stempel School of Public Health, Miami, United States, 'Botswana Harvard School of Public Health AIDS Initiative (BHP), Gaborone, Botswana, 'Boston University, School of Medicine, Boston, United States, 4Harvard University, Boston, United States Background: Selenium (Se) deficiency has been shown to increase genital HIV-1 shedding. The effect of Se supplementation, however, has been contradictory. We evaluated the effect of Se supplementation on genital HIV1 shedding, sexually transmitted diseases (STDs) and disease stage in HIV+ women in Botswana. Methods: After obtaining consent, 50 HIV+ women were supplemented for 3 months with Se (200 micrograms daily) or placebo in a randomized double-blind trial. At baseline and 3 months, gynecological exams, plasma Se levels, CD4 count, viral load, and cervico-vaginal lavage (CVL) specimens were obtained. Results: HIV-1-RNA was detected in the genital tract of 32% of the women at baseline, and 28% at 3 months. Most of the women (N=12, 75%) with genital HIV-1 shedding at baseline were also shedding at 3 months. Normalization of Se deficiency to plasma Se > 0.085 mg/L in three months was associated with lower HIV-1-RNA shedding (OR=1.91, 95% CI = 0.8 - 5.00) after controlling for age, body mass index, and STDs. Women with detectable genital HIV-1-RNA had significantly lower CD4 cell percent (21.8% + 4.9, p<0.01) compared to those not shedding (30.2 % ~ 10.3), and significantly higher plasma viral load (4.6 ~ 0.8 log vs. 3.8 + 0.8 log, p<0.01). At baseline, 36% had vaginosis, 10% Candida albicans, 10% Trichomonas vaginalis, 6% syphilis (VDRL positive), 2% C. trachomatis, and 2% N. gonorrhea. Conclusions: Genital HIV-1 shedding is not random, since women shedding at baseline were significantly more likely to shed at 3-months. Women with detectable genital HIV-1-RNA had more advanced disease than those not shedding. Se supplementation decreased genital HIV-1 shedding, although not significantly, probably due to the small number of participants, since only 28% to 32% of the women were shedding demonstrating the need for larger studies in this critical field. MOPEO218 Serum albumin, dietary intake and viral load in early stages of HIV disease in Botswana, Africa C. Rafie1, A. Campa2, H. Bussman3, J. Makhema3, L. Xue', P. Burns4, I. Thior3, P. Arimi3, M. Zaveri', M. Essex4, R. Marlink4, M.K. Baum'. 'Florida International University, Stempel School of Public Health, Miami, United States, 'Florida International University, Department of Dietetics and Nutrition, Miami, United States, 'Botswana Harvard School of Public Health AIDS Initiative (BHP), Gaborone, Botswana, 4Harvard University, School of Public Health, Boston, United States Background: Low serum albumin has been associated with HIV disease progression and mortality. We assessed the relationship between albumin, HIV progression and nutritional parameters in an antiretroviral- naive cohort, in the early stages of HIV disease in Botswana. Methods: Upon consenting 318 HIV+ men and women, anthropometrics were collected, and blood analyzed for viral load, CD4 and CD8 count, and complete metabolic panel including albumin. Results: All participants were ARV-naive, and 79% were women. Mean values included CD4 = 459~177 cells/pl, viral load = 57,602~122,295 copies/mi and albumin = 4.1g/dl~0.42. Protein deficiency (albumin <3.5g/dl) was found in 6.3% (N=20) of the cohort. Albumin was positively related to CD4 count (OR=1.06, CI: 1.00.1.13, p=0.042) after adjusting for inflammation with LDH, and was correlated with CD4/CD8 ratio (r =0.225, p=0.001). Viral load was negatively correlated with albumin (r= - 0.165, p=0.004), and those with albumin <3.5g/dl had a higher log viral load (10.6~2.2 vs. 9.2+2.0, p=0.011). Logistic regression showed a decreased likelihood of a viral load >400copies/ml with higher albumin levels (OR=0.85, CI: 0.77, 0.94, p=0.002) after controlling for LDH, age, gender, AST and ALT. Participants with albumin <3.5g/dl had a significantly lower BMI than those with >3.5g/dl (22.5~0.9 vs. 25.0+0.31, p=0.036). Those who skipped >7meals/month had a significantly lower albumin than those who did not [3.9 (3.1, 4.4) vs 4.1 (2.9, 5.4), p=0.04]. Conclusions: Poor diet (no food eaten for >7 meals/month and low BMI) increased chances of having low plasma albumin in this ARV-naive African cohort of adults in early stages of HIV disease. Low albumin was predictive of high viral load in this cohort. Evaluation of dietary intake in early stages of HIV disease to develop adequate dietary interventions is needed, particularly in resource poor populations. Other factors contributing to low albumin such as malabsorption and diarrhea, were not present. Supported by NIDA XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  84 Uoda MOPEO219 Potential health risks of complementary alternative therapy (CAM) in HIV positive patients taking antiretroviral drugs (ARVs) D. Ladenheim', M. Phillpot2, O. Horn3, A. Murungi2, T. Visser1, C. Orkin', N. Theobald2, U. Werneke4. 1Barts and the London NHS Trust, Infection and Immunity, London, United Kingdom, 2Chelsea and Westminster Hospital, Kobler unit, London, United Kingdom, 3Kings College, Weston Education Centre, London, United Kingdom, 4Homerton University Hospital, - Department of Psychiatry, London, United Kingdom Background: Use of CAMs in patients with HIV or AIDS can be a major concern since many CAMs may interact with antiretroviral therapy thereby potentially compromising their effectiveness. The aim of this study was investigate the prevalence of CAM use in patients taking anti-retroviral therapy in three specialist HIV outpatient clinics. We determined the frequency of any potential serious interactions, relative or absolute contra-indications and warnings issued when potential health risks were identified. Methods: Cross-sectional survey of a random sample of patients taking AVRs using a multiple choice questionnaire exploring use of herbal remedies, supplements and physical complementary treatments. If potential for significant interactions with AVRs or for other adverse effects were identified a warning was issued. Results: 253 patients were included in the study. Of these 154 (60.9%) were taking herbal remedies or supplements and 88 (34.8%) were using physical treatments. 67 patients (26.5%) used a combination of both. Twentyfive (9.9%) were asked to stop their CAM because of potential serious drug interaction with their Retroviral therapy or adverse effects of the remedy used. Thirty patients (11.9%) were advised to use their remedies with caution and adequate monitoring. Of those taking CAMs, 51.3% had discussed CAM use with a healthcare professional. Conclusions: Our study suggests that the prevalence of CAM use in UK HIV positive patients is comparable to that seen in other countries. Ten percent of patients in our cohort were potentially seriously compromising their AVR treatment by taking CAMs. Medical practitioners need to be able to identify CAM use in HIV positive patients and recognize associated potential health risks. Equally, patients should be encouraged to disclose CAM use to their clinicians. MOPEO220 Safety and effect of an extract from ganoderma lucidum (reishi) on NK cell numbers in HIV+ individuals not taking antiretroviral therapy J. Leonard', I. Majd', J.P. Kassermann', C. Wenner2. 'Bastyr University, Acupuncture and Oriental Medicine, Seattle, United States, 2Bastyr University, Basic Sciences, Kenmore, United States Background: Reishi is an immunomodulatory botanical used in Traditional Chinese Medicine. Triterpenes from Reishi have shown activity against HIV-1 protease in vitro, and Reishi has been shown to increase total lymphocytes, CD4+ cells, NK cell counts and activity in cancer patients taking Reishi orally. This study investigated the safety of oral Reishi supplementation in HIV+ individuals and followed trends in HIV viral load and lymphocyte subset counts. Methods: Ten HIV+ individuals with CD4+ cell counts >200 cells/pl and plasma HIV-1 RNA levels <50,000 not currently taking antiretroviral medications were enrolled in this 4-month dose escalation study. After a baseline blood draw, subjects were given the following daily Reishi doses for one month each sequentially: 2 grams, 5 grams, and 10 grams. Plasma chemistries, HIV-1 RNA levels, CD4/CD8, NK cell counts and adverse event questionnaires were performed after each dosing month, and at a one-month washout timepoint. Results: Reishi was well-tolerated with no serious adverse events reported and no grade 3 or 4 laboratory adverse events from the study medication. Mild GI side effects were experienced by two subjects and were self-limiting. No significant trends in laboratory chemistries, CD4%, or log viral load were noted. There was a significant increase in the percentage of CD3-/CD16+ NK cells, which peaked at 5 grams/day and returned to baseline during the washout phase. Two subjects experienced significant decreases in viral load at 5 grams/ day, while three other subjects trended toward higher CD4 % while on Reishi. Conclusions: Reishi supplementation is safe and well-tolerated in HIV+ individuals not taking antiretroviral therapy. Further studies are warranted to determine which subset of NK cells are increased and whether this increase confers any advantage either in terms of delaying time to initiating antiretroviral therapy in treatment naive individuals or in restoring NK cell populations in patients under antiretroviral treatment. MOPEO221 Rapid growth rate in first 6 months in children initiating antiretroviral therapy (ARV) in Soweto, South Africa C. Egbers, H. Moultrie, T. Meyers. Wits Paediatric HIV Clinics, Harriet Shezi Children's Clinic, Johannesburg, South Africa Background: Little data exist on nutritional requirements in HIV-infected children receiving ARV in resource poor settings. Background prevalence of malnutrition is high and resources to provide nutritional intervention are scarce and need to be rationalised WHO recommends nutritional support be given early to ensure adequate energy intake. How to provide nutritional supplementation and optimal timing for this is still unclear. Methods: A retrospective review of children attending Harriet Shezi Children's Clinic, Chris Hani Baragwanath Hospital, was conducted. ARV has been available since April 2004. Children were included in this analysis if ARV was commenced before their 3rd birthday and they had completed at least one year of treatment. Anthropometric, immunological and virological measures were analyzed at baseline, 3, 6, 9 and 12 months on HAART. Results: Of a total of 1009 children initiating ARV, 37 were <3years of age and had received ARV for >_1 year. Mean age was 24 months, baseline CD4% was 10.8%, WAZ -2.7, height for age (HAZ) -3.3 and weight for height (WHZ) -0.8. WAZ showed a linear response during the first 6 months of HAART, increasing by a mean of 0.44 and 0.41 SDs in the first and second quarters respectively. In comparison the WAZ increased by only 0.27 and 0.13 SDs in the third and fourth quarters. The rate of WAZ increase between the first and second six month periods decreased by more than 50% (p=0.043). By 12 months the WAZ had increased to -1.44 (p<0.01), HAZ to -2.6 (p<0.01), CD4% to 24.4% (p<0.01) and 78% had viral loads of <400copies/ml. Conclusions: Rate of increase of WAZ is greatest in the first 6 months of ART. Early nutritional interventions are likely to assist during this recovery phase. Prospective studies assessing outcomes on ARV with nutritional intervention and optimal timing to provide this are required. MOPE0222 Acupuncture as a strategy for HIV symptom relief and improved quality of life in rural Thailand L. Louie', N. Pathanapornpandh2, U. Pultajuk2, R. Kaplan', L. Maund4, I. Hodgson', H. Greenlee6. 'Mae On Project, Vancouver, Canada, 2Mae On Hospital, Chiang Mai, Thailand, 'Albert Einstein College of Medicine, Department of Epidemiology and Population Health, Bronx, United States, 4Sangha Metta Project, Chiang Mai, Thailand, 'University of Bradford, School of Health Studies, Bradford, United Kingdom, 6Columbia University, Department of Epidemiology, New York, United States Issues: Acupuncture is a potentially useful treatment for decreasing symptoms of chronic HIV infection, reducing side effects of antiretroviral (ARV) medication and improving quality of life (QoL) among people living with HIV/AIDS (PLWHA) in resource-poor settings. Description: The Mae On Project began in April 2004 with three objectives: 1. To develop a pilot program to train medical staff in acupuncture as adjunctive treatment for PLWHA at Mae On Hospital in northern Thailand. 2. To create a hospital clinic to provide acupuncture for PLWHA. 3. To conduct a pilot study investigating the efficacy of acupuncture in this context. Two Thai nurses received 110 hours of didactic acupuncture training over 4.5 months. Clinical training consisted of treating PLWHA with weekly acupuncture over 6 months. The pilot study was a non-randomized, single-arm study. Among 32 PLWHA who attended acupuncture, only 27 with stable medication use and no significant morbidities were enrolled. All participants gave informed consent; completed pre- and post-acupuncture Quality of Life and Memorial Symptom Assessment Scale (MSAS) questionnaires; and participated in semistructured interviews. Lessons learned: At six months, participants reported a decrease in pain (p=0.03) using the MSAS. No changes were reported in the quality of life questionnaire. However, semi-structured interview data suggested 96% of participants experienced symptom relief, and 89% experienced an improvement in sense of wellness and emotional well-being. More significantly, 48% reported increased ability to work, thus decreasing financial concerns and related stress. Recommendations: This project demonstrates the feasibility of establishing a hospital-based acupuncture clinic in a rural setting for PLWHA. This low-cost intervention program was established in less than 12 months, using local nursing staff. Evaluative data suggest acupuncture may be associated with improved physical symptoms and QoL; a larger study is now being planned to elicit more sophisticated data regarding the effects of acupuncture in PLWHA. MOPE0223 Paediatric outcomes after 3 years in a primary care setting in South Africa D. Coetzee', K. Hilderbrand2, A. Boulle', P. Saranchuk2, H. Rabie', E. Goemaere2. 'University of Cape Town, School of Public Health and Family Medicine, Cape Town, South Africa, 2Mddecins Sans Frontieres, Cape Town, South Africa, 'Department of Paediatrics, University of Stellenbosch, Cape Town, South Africa Background: Less than 1% of children with HIV/AIDS live in industrialized countries, while over 90% live in sub-Saharan Africa. There is very little documented experience in treating paediatric HIV/AIDS, partly because the tools to treat children (diagnostics and drugs) are lacking. Khayelitsha was one of the first resource-limited settings where ARV care for children was decentralized to primary care, providing simplified dosing and formulations to promote adherence. We describe paediatric outcomes in 130 children after 3 years on ART Methods: Prospective cohort of study of all treatment-naive children starting ART in one of three clinics in Khayelitsha prior to the end of 2004. Median follow up was 14 (7-24) months. Regimens given were: ARV-1: AZT (58%) or d4T (42%); ARV-2: 3TC; ARV-3: EFV (43%) or NVP (57%). Results: 130 children were put on treatment in the last 3 years (median age = XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  85 52 months; 52% female). Median CD4% at baseline was 11 (IQR 6.5-19) and viral load 100,000 copeis/ml (IQR 20,000 - 350,000). Survival at 36 months was 91% (83.7-95.1 95% CI), with 8 deaths, 2 lost-to-follow-up events. Weight-for-age Z-scores improved from -1.6 at baseline to -0.3 at 36 months (figure 1), whilst %CD4 increased by 21% over the same period. Virological suppression to below 400 copies/ml was 83% (35-99.6% CI) at 36 months. Fig 1. Weight for age z-score in children on ART -2.5 _ _ 0 3 6 9 12 15 18 21 24 27 30 33 36 Duration on ART in months Number on treatment 130 124 10.. 77 57 33 Number with usable weights 128 114 105 69 52 29 Means WAZ -1I.6 -1.3 -1.1 -1.0 -0.8 -0.5 95% c 1+~03) (053) (+03) 0.3) (~0.4) +0.4) [Figure one] Conclusions: Paediatric ART provision in the primary care setting is readily achievable if appropriately supported. Viral supression compares favourably with what is achieved at hospital level. WHO-validated weight band tables will greatly simplify treatment of children. The greatest simplification will only be achieved through the development of paediatric drug formulations and in particular fixed dose combinations. MOPE0224 Scaling up pediatric antiretroviral treatment through a community-based HIV care network in Thailand, October 2004-December 2005 R. Hansudewechakul1, T. Naiwatanakul2, N. Plangraun3, M. McConnell4, F. Worawan2, K. Fox4, The Chiang Rai Pediatric ARV Team. 'Chiang Rai Regional Hospital, Ministry of Public Health, Paediatric, Chiang Rai, Thailand, 2Thailand MOPH U.S. CDC Collaboration, Nonthaburi, Thailand, 3ACCESS Foundation, ChiangRai, Thailand, 4Thailand MOPH - U.S. CDC Collaboration, Nonthaburi, Thailand and Centers for Disease Control and Prevention, Atlanta, GA, United States Issues: Since 2003, all HIV-infected children in Thailand can receive treatment through the national antiretroviral therapy (ART) program. In Chiang Rai province, 70-100 HIV-infected children become ART-eligible each year. A major barrier to pediatric ART scale-up is the limited number of skilled pediatricians and health care workers (HCW) in community settings. Description: Beginning in October 2004, Chiang Rai Regional Hospital (CRH) established a program to expand HIV care and ART to community settings. Pediatric care teams (physicians, nurses, counselors, pharmacists and persons living with HIV/AIDS [PLHAs]) were created in 9 community hospitals. Each team attends a one-day HIV care and adherence counseling training at the CRH pediatric clinic. Eligible children from community hospitals and CRH initiate ART at CRH. Once clinically improved, children are referred for follow-up at community hospitals. PLHA trained by ACCESS Foundation provide home-based care and promote ART adherence. Every six months children return to CRH for clinical evaluation. The CRH team and ACCESS provide ongoing monitoring, supervision and consultation to the community team. Lessons learned: From October 2004-June 2005, 60 HCW and PLHA were trained. Of 278 children on ART at CRH, 44 returned to community hospitals for follow-up. At a median follow-up in community hospitals of 12 months (range 7-15 months), 42 remain clinically stable with no new opportunistic infections, adverse events, or poor adherence reported. More than 300 home visits were conducted. Monitoring visits conducted by the CRH team 2-4 months after training observed that HCW were generally competent in pediatric HIV care. Recommendations: A pediatric care network can facilitate expansion of ART from tertiary care to community hospitals. Practical clinical training, technical support from a specialist team, and local community collaboration are key components of the network model. This model may be useful for pediatric ART scale-up in other resource-constrained settings. MOPE0225 Antiretroviral and anti-TB co-therapy in children < 3 years in Soweto, South Africa: outcomes in the first 6 months H. Moultrie, T. Meyers. University of the Witwatersrand, Wits Paediatric HIV Clinics, Chris Hani Baragwanath Hospital, Johannesburg, South Africa Background: TB and HIV co-infection rates in children in developing countries are poorly described. Many children initiate TB treatment empirically, and although there is concern about TB and ARV drug interactions little data exist about outcomes on co-therapy. Methods: A retrospective review of children under 3years of age commenced on a lopinavir/ritonavir + 2NRTI regimen at the Harriet Shezi Children's Clinic, Chris Hani Baragwanath hospital, between April 2004 and August 2005 was conducted. Children receiving TB treatment at the time of commencing ARV received boosted Kaletra~. Children receiving TB treatment (TB+) at time of initiation of ARV were compared in terms of demographics and response to therapy to those who were not receiving TB treatment (TB-). Results: Of the 206 children initiated on ARV in this period 78 (38%) were TB+. Median age at ARV initiation was 17 months for both TB+ and TB- groups. Baseline CD4% was 8.8% vs 12.9% in the TB+ and TB- groups (p<0.01). Viral load mean was 1.3 million and similar between the 2 groups. TB+ children had weight for age z-score(WAZ) -3.2 SD vs -2.7SD TB- (p=0.007). At 6 months CD4% almost doubled in both groups to 16.5% in TB+ vs 21.8% in TB-. In 122 children with viral load values available at 6 months, 70% suppressed in TB+ vs 79% in TB- (p=0.29). WAZ increased significantly to -2.1 (p<0.01) and -1.8 (p<0.01) respectively, with difference in WAZ no longer significant between the two groups (p=0.24). Thirteen children died; 6 TB+ and 7 TB- (p=0.47). 9 of the deaths occurred within the 1st 3 months of commencing ARV. Conclusions: High rates of dual TB/ARV treatment were present. Prolonged follow-up is needed to observe whether these apparently good outcomes on dual therapy will be sustained. Long term prospective studies including pharmacokinetic studies of dual TB/ARV combinations are urgently needed. M0PE0226 Immune responses to measles and tetanus vaccination in HIV-1-infected Kenyan children pre and post-HAART initiation S. Selig', D. Wamalwa2, B. Lohman-Payne3, J. Mabuka2, M. Majiwa2, E. Brown4, W. Sutton5, N. Haigwood5, G. John-Stewart4, C. Farquhar4. '1University of Colorado & University of Washington, Seattle, United States, 2University of Nariobi, Nairobi, Kenya, 3University of Nairobi & University of Washington, Nairobi, Kenya, 4University of Washington, Seattle, United States, sSeattle Biomedical Research Institute, Seattle, United States Background: HIV-1-infected children experience increased morbidity and mortality, the causes of which are largely infectious and often vaccinepreventable. However, studies have shown HIV-1-infected children have impaired antibody responses following immunization. Methods: We determined prevalence, magnitude, and correlates of measles and tetanus-specific immune responses in a cohort of 100 previously vaccinated HIV-1-infected Kenyan children prior to HAART initiation and after 6 months of treatment. Children were aged 18 months to 12 years and had symptomatic disease: WHO stage III/ IV or CD4%<15. At enrollment and 6 months after HAART initiation, blood was obtained for CD4 percent, plasma HIV-1 RNA, measles-specific and tetanus-specific IgG antibody titers and T cell proliferation assays. Results: Median age of children at enrollment was 4.7 years (IQR: 2.5-6.4), median CD4% was 6.2 (IQR: 2.5-9.8), and median HIV-1 viral load was 6 log10 copies/ml (IQR: 5.4-6.6). At enrollment, 30% of children were positive for anti-measles IgG and 68% were positive for anti-tetanus IgG. Older children were more likely to have a positive measles antibody response at baseline (7.4 versus 4.3 years; p=0.002). However, measles concentration was not associated with CD4% or weight for age z-score, and did not correlate with measles specific T cell proliferation. Anti-tetanus IgG positivity at baseline was not predicted by any of these factors. To date, 42 children have received HAART for 6 months. Of these, 17% had positive anti-measles IgG at baseline and this number doubled at month 6 (38%; p=.04). Conclusions: Only 1 of 3 children with symptomatic HIV-1 was protected against measles in our cohort, and 2 of 3 had protective levels of tetanus IgG. This number improves for measles following 6 months of HAART, however, the majority of children remain unprotected. These preliminary data suggest that HIV-1-infected children in Kenya are inadequately protected against measles and tetanus and may require revaccination following immune reconstitution. MOPE0227 Failure to thrive as a predictor of HIV infection in a population with high background rate of malnutrition A. Abdosh', T. Awano-Lemtuche', A. Abashawl2, B.G. Gudetta3, R. Adamu4, A. Ruff2, A. Bedri3. 'Addis Ababa University, Nigat Project, Addis Ababa, Ethiopia, 2johns Hopkins University, International Health, Baltimore, United States, 3Addis Ababa University, Pediatrics, Addis Ababa, Ethiopia, 4iohns Hopkins University, International Health, Addis Ababa, Ethiopia Background: Many HIV-infected infants have chronic problems with linear growth and weight gain and unexplained moderate and severe malnutrition are included in the WHO staging system. However, using poor growth as an indicator of HIV infection may be confounded by high background rates of malnutrition in resource-limited settings. Within a perinatal intervention study in Ethiopia, we evaluated the incidence of failure to thrive (FTT) among HIV-infected and uninfected but exposed infants to determine its utility as a predictor of HIV infection. Materials and methods: 901 HIV-infected women were enrolled in the study between September 2001 and December 2005. Their infants were followed for 1 year with regular clinical evaluations and anthropometric measurements. Infant HIV status was determined using HIV RNA PCR. Infants with weight and length below the 3rd percentile for age and sex after 6 weeks of age were considered to have failure to thrive. Results: 32/102 (31%) infected infants and 62/799 (8%) of uninfected infants experienced FTT. The sensitivity, specificity, positive and negative predictive values for FTT as an indicator of HIV infection are shown below. Monday 14 August Poster Exhibition XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  86 Sensitivity Specificity PPV NPV 91% 31% 92% 34% FTT occurred before 3 months in the majority of infected infants and after 6 months in uninfected infants Conclusions: Although more common among infected infants, FTT lacked sensitivity as an indicator of HIV-infection. In contrast, growing well, without FTT, appeared to be a better predictor of lack of HIV infection in this population. MOPE0228 The role of cognition and behavior on medication adherence in children and adolescents with HIV infection B. Kammerer', P. Williams2, G. Montepiedra2, S. Nichols3, P. Sirois4, D. Storms, 3. Farley6, K. Malee'. 'Childrens Hospital Boston, Neuropsychology, Boston, United States, 'Center for Biostatistics in AIDS Research, Biostatistics, Harvard School of Public Health, Boston, United States, 3University of California, Neurosciences, San Diego, United States, 4Tulane University Health Sciences Center, Pediatrics, New Orleans, United States, sFrancoisXavier Bagnoud Center, UMDNJ, School of Nursing, Indianapolis, United States, 6University of Maryland School of Medicine, Pediatrics, Division of Immunology, Baltimore, United States, 'Children's Memorial Hospital/ Northwestern University Feinberg School of Medicine, Infectious Diseases/ Child and Adolescent Psychiatry, Chicago, United States Background: Functionally significant neurocognitive impairment and behavioral problems may critically reduce children's ability or motivation to take medications as directed and to eventually maintain independent responsibility for this essential health behavior. The purpose of this investigation was to evaluate the impact of cognitive and behavioral functioning on successful medication adherence among children and adolescents with HIV infection. Methods: We examined cognitive functioning (n=1537) and behavioral functioning (n=1134) of perinatally HIV-infected children participating in Pediatric AIDS Clinical Trials Group (PACTG) Protocol 219C, a multicenter prospective cohort study. Medication adherence was evaluated with a validated self-report measure. Cognitive and behavioral functioning were assessed using Wechsler IQ scores and Conners' behavioral ratings. Demographic characteristics, biological markers of health, and psychosocial factors were also evaluated. Multivariate logistic regression models were used to identify associations between adherence and both cognitive and behavioral functioning, adjusting for age and other potential confounding factors. Results: Based on full scale IQ's, 17% of the 1537 subjects were classified as cognitively impaired (IQ<70), and 35% were in the Borderline/Low Average range (70-85). Children in the Borderline range receiving protease inhibitors had significantly increased odds of non- adherence as compared to those who were either cognitively impaired or achieved scores in the Average range (85-100). Conduct problems, hyperactivity, and psychosomatic problems were observed for 14%, 19%, and 22%, respectively, in the behavioral cohort. antiretroviral adherence rates were significantly lower in the presence of conduct problems (p=0.004), hyperactivity (p=0.05) and psychosomatic complaints (p=0.005). Specific psychosocial and health factors were also significantly associated with non-adherence. Conclusions: Medication adherence is a complex and dynamic process with multiple and variable influences within the child and the child/caregiver/family environment. Understanding the particular impact of the child's cognitive potential and specific behavioral issues will guide formulation of appropriate supports to initiate and maintain adherence to treatment regimens. MOPE0229 Evaluation of a program to ensure adherence to antiretroviral therapy in HIV-infected children in northern Thailand R. Hansudewechakul', G. Jourdain2, N. Plangraun3, Chiang Rai Paediatric ARV Team. 'Prachanukroh Regional Hospital, Pediatrics, Chiang Rai, Thailand, 2Harvard School of Public Health, Immunology and Infectious Diseases, Chiang Mai, Thailand, 'ACCESS Foundation, Chiang Rai, Thailand Background: Limited data is available on methods used to help children and caregivers ensure adherence to antiretroviral treatment in developing countries. Methods: HIV-infected children were offered regular clinical and laboratory follow-up and participation in an adherence program, combining cognitive, behavioural and affective interventions (HIV-care education, monthly Day Care Centre activities, drug preparation and use of pillbox, use of reminders, self reports, home visits) with the collaboration of a local NGO. Results: One-hundred and ten children, median age 9 years, initiated therapy between February 2002 and January 2004, 89% received a nevirapine based fixed dose combination. Adherence, measured by pill count, was over 95% of the scheduled drug intake in 90% of the children during the first 6 months of treatment and 91% between 6 and 12 months. One year Kaplan-Meier survival estimate was 87% (95% CI: 79%-92%). After 6 and 12 months of treatment, the median increase in CD4 percentage was 7% and 12% respectively. Viral load, assessed in a subset of 57 children was below 400 copies/ml in 77% and 88% of patients at 6 and 12 months respectively (intent to treat analysis). There was a trend in children over the median of 9 years old, children cared for by grand parents, and those who did not regularly attend trainings organized for children and caregivers to be less adherent. Conclusions: Identification of risk factors can help target appropriate interventions. Training and establishing partnerships between health care providers and children and their caregivers can be critical in achieving and maintaining adherence in children. MOPEO230 CD4 levels as criteria for ART in severely malnourished children with HIV P. Fergusson', J. Chinkhumba2, A. Tomkins3. 'University of Chester/Action Against Hunger, Chester, United Kingdom, 2Action Against Hunger, Lilongwe, Malawi, 'Centre for International Child Health, London, United Kingdom Background: There is debate surrounding the criteria for initiation of ART for HIV-infected children in resource limited settings. Where available, CD4 count (as a % of lymphocytes) gives an indication of disease progression and the need for ART. In this study we examine the CD4 levels in severely malnourished children with HIV to assess their suitability for anti-retroviral therapy (ART). Methods: Prospective cohort study. Results: In a cohort of 243 severely malnourished children admitted to 3 Nutrition Rehabilitation Units in Malawi, 41 (16.9%) were HIV-infected. The mean CD4 count (as a % of lymphocytes) was 16.5% (SD 7.9) in the HIVinfected children and 35.2% (SD 8.3 ) in the HIV uninfected children. As CD4 counts of <15% and < 20% are often used as in indication for starting ART, the data was analysed to show the % of children with CD4% <15% and < 20% in HIV-infected and uninfected children. CD4 % data was available for 179 children. 12/26 (46.2.%) of HIV-infected children and 2/153 (1.3%) of HIV uninfected children had CD4% below 15%. 5/26 (19.2%) of HIV-infected children and 6/153 (3.9%) of HIV uninfected children had CD4% between 15% and 19.9%. 9/26 (34.4%) of HIV-infected children and 145/153 (94.8%) of HIV uninfected children had CD4% above 20%. Conclusions: HIV occurs in an important proportion of severely malnourished children but not all HIV-infected children have sufficiently low CD4 counts at conventional cut-off values to merit starting ART. MOPEO231 Differences in mental health needs of youth with perinatally versus behaviorally acquired HIV S. Marhefkal, L. Koenig2, L. Orban3, R. Stein2, L. Maureen4, V. Teppers, J. Lewis3, W. Barnes4, R. LaGrange'. 'New York State Psychiatric Institute and Columbia University, HIV Center for Clinical and Behavioral Studies, New York, NY, United States, 2Centers for Disease Control and Prevention, Atlanta, GA, United States, 'New York University School of Medicine, Pediatrics, New York, NY, United States, 4Children's National Medical Center, Washington, DC, United States, sUniversity of Maryland School of Medicine, Pediatric Immunology, Baltimore, MD, United States, 'University of Maryland School of Medicine, Baltimore, MD, United States Background: In the U.S., children with perinatally acquired HIV are aging into adolescence and transitioning into clinics that primarily treat youth with behaviorally acquired HIV. Many of these clinics receive funding to provide mental health services, though the extent to which youth need such services is not well understood. Using standardized psychological instruments, we examined the emotional and behavioral functioning of youth with perinatally acquired infection (YP) versus behaviorally acquired infection (YB). Methods: Data were analyzed from the baseline assessment of Adolescent Impact, a CDC-funded intervention study of HIV-infected 13-21-year olds in New York, NY, Baltimore, MD, and Washington, DC. Study exclusion criteria included severe and acute mental illness. Participants completed the ageappropriate Achenbach behavior checklist (Youth Self Report [YSR] or Young Adult Self Report [YASR]) and the Beck Depression Inventory. Results: Of 166 enrolled adolescents, 77% were African American, 52% were female, and 58% were YP. A significantly larger proportion of YB than YP had YSR/YASR scores suggesting emotional psychopathology (12% vs 2% on Internalizing composite) and behavioral psychopathology (15% vs 5% on Externalizing composite; all p-values <.05). YB reported more problems overall (Total Problems composite), and scored higher than YP on 5 of 7 symptom subscales shared by the YSR and YASR (Anxious/Depressed, Somatic, Intrusive Thought, Aggressive and Rule-Breaking; all p-values <.05). When controlling for age and recency of learning one's HIV diagnosis, YB still reported significantly more externalizing behavior problems. YB also reported more depression symptoms (p =.01). Conclusions: YB are at greater risk for a broad range of mental health problems than YP. Unlike YP who have had life-long access to mental health services, YB may be accessing these services for the first time. Clinical programs serving HIV-infected youth should consider their unique mental health needs when developing and implementing programs. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  87 MOPE0232 Adherence to HAART in HIV-infected Ugandan children on Triomune M.G. Nalubegal, M. Mubiru1, B. Musokel, M. Namawejje', R. Kayondo', M. Luttajumwal, P. Ajunal, L. Barlow-Mosha', P. Musoke2. 1MU-JHU Research Collaboration, Kampala, Uganda, 2MU-JHU Research Collaboration/Makerere University, Department of Paediatrics and Child Health, Kampala, Uganda Background: HIV-infected children on highly active antiretroviral therapy (HAART) usually have to rely on their mothers/caretakers to effectively adhere to their medication. This observational study looked at levels of adherence to HAART in children living with at least 1 adult caretaker. Methods: A retrospective chart review of children aged 5 years ( 1-12 years) followed in an ART program (ILA) at MU-JHU, documented levels of adherence and associated factors. The children received Triomune (n=70) (adult fixed dose combination formulation) or syrups (n=8) if they were below 10kg. Adherence to HAART was estimated using; Self report by caretaker/participant, Pill counts at all routine refill visits, Unannounced pill counts at home, once every three months by a health visitor. Syrup volumes were measured at each return visit by the study nurse. Results: The overall adherence to HAART at 983 child clinic visits was 95 %, with 98% for those children on triomune and 84% for those on syrups (p =.0.0000). Adherence levels were better in older participants (> 7 years) who knew their HIV status and where the adult caretaker in the home was also on HAART. There was no significant difference in adherence to HAART in relationship to age or sex of the child, attendance at school or the caretaker being a close relative living with the child. Conclusions: Adherence to HAART was much less in the children taking syrups compared to those on an adult fixed dose combination tablet. Older children's adherence can be improved if they know their HIV status and live with adult care taker on HAART. Further studies are required to develop innovative strategies to improve and sustain good adherence in children. MOPE0233 Analysis of HIV-infected infants under 1 year starting antiretroviral treatment at the coronation paediatric HIV clinic in Coronationville, Johannesburg G. Barry'1, A. Coovadial, B. Marais', E. Malan', H. Moultrie2'. 'Wits Paediatric HIV Clinics, Paediatric HIV Clinic Coronation Hospital, Johannesburg, South Africa, 2Wits Paediatric HIV Clinics, Paediatric HIV Clinic Chris Hani Baragwanath Hospital, Johannesburg, South Africa Background: Government rollout of antiretrovirals in South Africa began on 1st April 2004. Coronation Hospital was one of the primary paediatric rollout sites. To date, 561 children have been started on antiretrovirals here. Methods: A retrospective analysis was done on all antiretroviral naive infants who were started on HAART (Highly Active antiretroviral Therapy) before 1 year of age, between April 2004 and August 2005 at Coronation Hospital, Johannesburg. The aim was to assess treatment outcomes in this subgroup of patients. Results: Over the 16 month period, 36 infants met the stipulated criteria. The mean age at initial presentation was 5.8 months and mean age of HAART initiation was 6.5 months. The majority (89%) were clinically WHO III at time of initiation. At HAART initiation the mean CD4% was 17.2% and the mean viral load was log5.8. After 6 months of treatment the mean CD4 was 24.1% (mean increase of 6.8%) and the viral load decreased to log4.2. 70% of patients still in active care were virally suppressed. Immune reconstitution syndrome was documented in 10 patients (28%): 9 cases of BCG reaction and 1 case of tuberculosis. The majority of patients were started on PI based regimens - 69% on Kaletra/stavudine/3TC, 25% on ritonavir boosted Kaletra/3TC /stavudine, 3% on ritonavir/3TC /stavudine and 3% on NVP/lamivudine/stavudine. Of the 36 patients, 4 (11%) died, 10 (27%) were lost to follow up, 2 (6%) were transferred to another centre and only 21 (58%) were still in active care at Coronation Hospital. Conclusions: Treatment outcomes were favorable with a mean increase in CD4% and a log decrease in viral load over 6 months. Of concern was the high loss to follow up and mortality rate. The current practice in this setting of starting HAART with a CD4% <20% needs to be reviewed in an attempt to decrease mortality rates. MOPE0234 Barriers to providing antiretroviral therapy (ART) to HIV-infected children in Lusaka, Zambia S.A. Dumas, B. Chi, M. Mubiana-Mbewe, C. Bolton. Centre for Infectious Disease Research in Zambia, Lusaka, Zambia Background: Although ART has been widely available in Lusaka since 2004, targets for pediatric HIV care set by WHO have not been met locally; only 7% on ART are <15 years. Methods: To investigate the barriers to enrolling children into the ARV program, a programmatic assessment was conducted in 10 Lusaka public health centers. Nearly all interviews (36 of 37) were conducted on a one-to-one basis by program staff. Discussions. were guided by a 10-question instrument, designed to capture clinic limitations for treating children, assess staff knowledge and comfort with children, and highlight perceptions of pediatric HIV within the community. Results: 41 health care providers were interviewed: 28 nurses, 9 clinical officers, 3 pharmacists, and 1 pharmacy technician. Providers cited many clinic-level barriers. The majority (62%) reported ways clinics are not conducive for treating children; they are overcrowded, and environments are generally not child-friendly. Also, clinics lacked basic equipment for monitoring child health (e.g. scales, measuring tapes, otoscopes). Commonly reported staff barriers included discomfort with pediatric phlebotomy (34%), insufficient pediatric knowledge (27%), and inexperience addressing pediatric adherence and disclosure (20%). Many of the barriers cited involved negative community perceptions towards HIV-infected children. Children are often not tested because of stigma attached to HIV; parents know the diagnosis may cause them to be ostracized by their peers (32%). Also, some parents mistakenly believe that antiretroviral drugs are harmful to children or that blood will be drawn for satanic rituals. When asked about possible solutions, providers recommended: more trainings in pediatric HIV, clinic space for children, and a children's support group. Conclusions: Despite a global emphasis on pediatric HIV care, numerous barriers to service implementation persist. Comprehensive pediatric-specific training combined with skill building, mentoring, and appropriate pediatric equipment will better prepare staff, but concerted efforts need to be made to overcome community-based barriers to care and treatment. MOPEO235 HIV infection among severely malnourished children in a conflict-affected area in north Uganda U. Langlo', C. Pierotti2, P. Atim', L. Ojom', F. Ciantia3. 'St Joseph's Hospital, Kitgum, Uganda, 2AVSI, Kitgum, Uganda, 3AVSI, Kampala, Uganda Background: North Uganda is affected by 20 years conflict resulting in internal displacement of most of the population. The consequences are poverty, inadequate sanitary facilities and high prevalence of malnutrition. This study aims at investigating HIV-prevalence in severely malnourished children in a conflict-affected region where the overall HIV-prevalence is 8.5%. Methods: 305 malnourished children aged between 1.5 and 14 years admitted to Nutrition ward of St Joseph's Hospital from March 2005 to December 2005 were screened for HIV-antibodies. We assessed HIV-prevalence by age, provenience, diagnosis and outcome. Results: HIV-prevalence among malnourished children was 23.9%. 82% of the children were from internally displaced camps. HIV-prevalence was higher among children living in Town than in those displaced (39% versus 20%). HIVinfection was most common in children aged less than 3 years (55.6%) and male to female ratio was 1.4:1. Length-Of-Stay was 28.5 days with a difference of eight days between HIV-negative and HIV-positive (27 versus 35 days). Marasmic children showed the highest HIV-prevalence (36%) and children with kwashiorkor showed least HIV-prevalence (9%). Tuberculosis was more among HIV-positive as compared to HIV-negative children (24.7% versus 9.5%). Cure rate was higher in HIV-negative than in HIV-positive children (89.7% versus 67.1%). 32.9% of HIV-infected children died, compared with 7.3% of uninfected children, and HIV-infected children constituted over 58.5% of inpatient death. Moreover, 24.7% of HIV-infected children relapsed, compared with 6.5% of uninfected children. Conclusions: HIV-infection significantly impacts morbidity and mortality in severely malnourished children. Internally displaced children have a higher risk of malnutrition, but reduced risk of HIV-infection. Intensive efforts in nursing and medical care of HIV-positive malnourished children are needed due to long admissions, opportunistic infections and more frequent relapses. Mandatory HIV testing is recommended in severely malnourished children for further management and follow up. Nutrition unit is an important entry point for comprehensive HIV/AIDS programs and antiretroviral therapy. MOPE0236 HIV point-prevalence amongst malnourished children admitted to nutritional rehabilitation units in Malawi: geographical & seasonal variations S. Thurstans', M. Kerac2, K. Maleta', T. Banda4, A. Nesbitt'. 'Action Against Hunger, Department of HIV and Nutrition, Lilongwe, Malawi, 2College of Medicine, Department of Paediatrics, Blantyre, Malawi, 'College of Medicine, Department of Community Health, Blantyre, Malawi, 'Ministry of Health, Department of Nutrition, Lilongwe, Malawi, 5College of Medicine, Department of Community Health, Department of Paediatrics, Blantyre, Malawi Background: HIV/AIDS and malnutrition are inextricably linked. Malnutrition associated with HIV presents a serious humanitarian and public health challenge in Southern Africa. However HIV care and treatment of severe malnutrition have remained largely separate and seasonal and geographic variation in presentation largely ignored. The aim of this study was to collect information to guide integrated targeted care in a resource poor setting. Methods: A cross sectional study examined 12 representative nutritional rehabilitation units (NRUs) selected from Malawi's 3 regions. During the dry and rainy (hungry) seasons, all severely malnourished children and their caretakers admitted to each NRU over a two week period were offered HIV counselling and testing. Two different rapid antibody tests were used, with PCR for discordant results. Children under 15 months were excluded, avoiding difficulties with false positive rapid test results. Results: 568 children were eligible. 529 (93.1%) of caretakers consented to HIV testing; 421 (74.1%) were themselves tested. Overall prevalence amongst children tested was 21.9% (95% confidence intervals, 18.4- 25.4%). Range XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  88 between NRUs was 1.9% (CI 0-5.6%) to 55.6% (CI 23.1-88.1%). Significant geographical prevalence variations reflected known adult prevalence patterns: Regional differences (p<0.(01): - Southern 38.8% (95% CI 31.7-45.9%) - Central 6.6% (3.6-9.6%) - Northern 22.5% (13.3-31.7%) Rural-urban differences (p<0.001): - Urban 34.8% (28.4-41.2%) - Rural 13.5% (9.8-17.2%) There were significant seasonal prevalence variations (p=0.005): - Dry 30.1% (22.6-37.6%) - Rainy 18.9% (15.0-22.8%) Conclusions: By showing there is a high prevalence of concurrent HIV infection in severely malnourished children, and that testing is acceptable, we conclude that there is need and potential for increased integration of HIV and NRU services. NRUs could act as an entry point to antiretroviral and social welfare programmes. Recognition that severe childhood malnutrition in the dry season is linked with an increased likelihood of HIV infection and that there are wide variations in the geographic prevalence of HIV, should help target limited resources MOPE0237 The influence of infant feeding choice on morbidity and mortality in HIV-exposed infants in southwestern Nigeria E. Adejuyigbel, E. Orji2. 1University, Department of Paediatrics and Child Health, Ile-Ife, Nigeria, 2University, Department of Obstetrics and Gynecology, Ile-Ife, Nigeria Background: The promotion of breastfeeding by WHO and UNICEF in the last ten years has played an important role in improving child health by providing optimum nutrition and protection against common childhood infections. This promotional effort resulted in decrease in childhood morbidity and mortality in developing countries. The AIDS epidemic now threatens breastfeeding in the developing countries where over 90% of people living with HIV/AIDS reside. This prospective study was aimed at determining the influence of maternal infant feeding practice on morbidity and mortality of HIV-exposed infants. Methods: Consenting mothers of HIV-exposed infants seen at birth or within a week of delivery in Ife-Ijesa zone of southwestern Nigeria were counseled on infant feeding options. Mother-child pairs were seen monthly for a period of six months and infant feeding practice, illnesses, hospitalization and deaths were recorded in a proforma. Gestational age and sex matched 50 HIV-unexposed infants were recruited as control. All HIV-negative mothers were encouraged to practice EBF. Results: Thirty-eight (65.5%) and 20 (34.5%) of the 58 HIV-positive mothers chose exclusive breastfeeding (EBF) and exclusive formula feeding (EFF) respectively. Eleven (61.1%) of 20 HIV-positive mothers who chose EFF introduced other foods/fluid (9 commenced breastfeeding and two introduced cereals) while 7 (38.9%) HIV-positive mothers who chose EBF were giving other foods in addition to formula feeding (p = 0.004) before the infants were 6 months of age. Twelve (24%) of the HIV-negative mothers were mixed feeding. HIV-exposed infants whose mother chose EFF were more frequently ill and admitted (p < 0.05) and mortality was higher in these group of children. The causes of ill-health were diarrhea, acute respiratory infection and sepsis. Conclusions: HIV-exposed infants of mothers who choose EFF in Ife-Ijesa zone of southwestern Nigeria are at a higher risk of mixed feeding, higher frequency of illness and death. MOPE0238 High rate of rapid progression in urban South African setting K. Technaul, G. Sherman2, A. Coovadial. 'Coronation Women and Child Hospital, University of Witwatersrand, Paediatrics, Johannesburg, South Africa, 'University of the Witwatersrand, Haematology, Johannesburg, South Africa Aim: To report on the CD4 and clinical findings of HIV-1 infected infants who were tested during routine early HIV-1 DNA PCR testing at Coronation Women and Child Hospital (CWCH), Johannesburg. The paediatric HIV burden, largely fueled by mother to child transmission, comprises a significant health problem. It has previously been reported (Coronation Hospital) that there is a high (38.5%) one year mortality rate of HIV-infected infants. Early routine testing is becoming an important and more widespread technique of identifying HIV positive infants. In the context of an anti-retroviral (ARV) roll-out programme it is important to know the rate of rapid progression of HIV-infected infants in order to tailor guidelines and practice. Methods: All records of infants who had HIV-1 PCR positive results following routine testing at CWCH during 2005 were reviewed. Clinical staging, CD4 counts, recent health as well preparation for ARV's were considered. Infants with a CD4 percentage under 20%, an absolute count of less than 750 or WHO clinical stage 3 or 4 disease are considered as rapid progressors and in need of ARV's. Results: Of 51 HIV positive infants, 41 had follow-up information available. By age 10 months 29 (71%) of the infants had met either a clinical or immunological indications for ARV's. There had been one death and only 12 of the infants were receiving ARV's or in the preparatory phase. Thirteen infants have been lost to follow-up and three are still due to return. Conclusions: There is a high percentage of HIV-infected infants requiring ARV's early. This echoes research documenting a high one year mortality rate of HIV-infected infants in the same setting. Loss to follow-up is a problem and rapid, effective preparation for ARV's must become a priority in this South African paediatric setting if infant AIDS and mortality is to be prevented. MOPE0239 Multiple challenges face adolescents with vertically acquired HIV A. Jordan, K. Technau, A. Coovadia. Coronation Women and Child Hospital, University of Witwatersrand, Paediatrics, Johannesburg, South Africa Aim: To describe the HIV-infected adolescent population emerging from the Coronation Women and Child Hospital's paediatric HIV clinic specifically with regards to virological suppression, disclosure, school attendance and nature of care-giver of those children on anti-retrovirals (ARV's). Almost two years into the comprehensive public ARV roll-out in South Africa, paediatric clinics are faced with a growing number of largely vertically infected adolescents, most of whom are on ARV's. As this time of life is often fraught with multiple challenges to the individual it poses an important challenge to health care workers to provide an appropriate and supportive environment for these young people. Methods: All available records of children aged ten years or older attending the HIV clinic were reviewed with respect to ARV treatment history, most recent viral load, schooling, disclosure and main care-giver. Results: The clinic includes 75 adolescents attending regular follow-up. 65 of these (86%) are on ARV's. All but two patients acquired HIV vertically. The median time on ARV's so far is 16 months and the majority of patients (91%) are on first line treatment with a virological suppression rate of 91% for all the adolescents on ARV's. Less than half (48%) of ARV-treated patients know their own HIV status. Only 34% of the adolescents are being looked after by their biological parents. 85% are attending school. Conclusions: The majority of adolescents attending our clinic have been on treatment for more than a year. Most of them attend school but many do not know their own status yet, nor do they still have their biological parents as guardians. This highlights the need for expanding paediatric HIV clinics to focus specific attention on this group of patients in order to assist with the challenges facing them in their transition to adulthood in the context of having acquired HIV vertically. MOPEO240 The importance of treating tuberculosis in children on ART M.A. Desulme', D. Roland', P. Paul', F. Germeille', R. Cruff', L.C. Ivers2, J. Bazile', C. Orelus', J. George', J.S. Mukherjee3. 'Zanmi Lasante, Cange, Haiti, 2Division of Social Medicine and Health Inequalities, Brigham and Women's Hospital; Harvard Medical School; Partners in Health, Boston, MA, United States, 3Division of Social Medicine and Health Inequalities, Brigham and Women's Hospital; Program in Infectious Disease and Social Change, Harvard Medical School; Partners in Health, Boston, MA, United States Background: The initiation of ART in children is complicated by the difficulty in excluding active tuberculosis and the concern of immune reconstitution syndrome in patients that start concomitantly on ART and anti-tuberculosis therapy The US-based NGO Partners In Health (PIH) launched an integrated HIV and primary care program at 6 public health centers in the Department du Centre (pop. 500,000) on August 1, 2002. This study reports the prevalence of tuberculosis among a school age and adolescent cohort of HIV-positive children enrolled in the program between August 1, 2002 and August 1, 2005. Methods: We analyzed data from 47 children with HIV between the ages 2-18 years (average 7.8 + 4.2 years). Of these children, 31 (65%) met immunologic criteria and were started on ART. Among the children started on ART, 16 (51%) had tuberculosis documented prior to beginning ART or while on ART. Children were treated for tuberculosis first unless their CD4 count was less than 200 cells/mm3, in which case, ART and antituberculosis therapy was started concomitantly. Results: Of the 16 children with co-infection, 8 had chest X-ray and clinical symptoms consistent with pulmonary tuberculosis, of whom only 2 had positive smear for acid-fast mycobacteria. 8 children had signs and symptoms of extrapulmonary TB including lymphadenopathy, hepatosplenomegaly and elevated sedimentation rate and/or PPD >5 mm. 15 recovered, are more than 6 months after TB therapy without relapse, and continue on ART. One child died of pulmonary insufficiency after 2 sequential treatments of antituberculosis therapy - and had presumptive multidrug-resistant TB. Conclusions: In this cohort of co-infected children, diagnosis was made by clinical and laboratory criteria, and most often without smear or culture confirmation. In all cases,we did not see any signs of immune reconstitution, and the children were given both ART and antituberculosis therapy when necessary. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  89 MOPEO241 MOPE0243 Decreased blood mitochondrial (mt) gene VCT acceptability in children and their caretakers in expression (CCOI/beta-actin) in the absence of the nutrition rehabilitation units in Malawi: NRUs as mitochondrial DNA (mtDNA) depletion in 1-3 days point of entry for HIV care old neonates exposed to highly active antiretroviral 4"it-..%.. " A " mP'' Ja...:_-............._ _ -oda 1Au tnerapy K(HAART) during pregnancy H. Cote', J. Forbes2, A. Alimenti2, D. Burdge2, D. Money2, E. Maan2, A. Costei3, I. Gadawski', S. Read', A. Bitnun3, S. Shen4, J. Raboud4, R. Harrigans, S. King3. 'University of British Columbia, Pathology & Laboratory Medicine, Vancouver, Canada, 'Children's & Women's Health Centre of B. C./UBC, Vancouver, Canada, 3Hospital for Sick Children, Infectious Diseases, Toronto, Canada, 4University Health Network, Toronto, Canada, sB.C Centre for Excellence in HIV/AIDS/UBC, Medicine, Vancouver, Canada Background: HAART exposed neonates have shown hyperlactatemia, suggestive of mt toxicity. We hypothesized that blood mtDNA or mtRNA depletion occurs in neonates exposed to HAART in utero. Methods: Antiretrovirals (PI or NNRTI+2NRTI, +ZDV at delivery and orally) exposed neonates where compared to controls (neonates of uninfected mothers). mtDNA and mtRNA levels at 1-3 days of life were compared using the Wilcoxon rank sum test. The relationships between length of HAART exposure and 1-month lactate vs mtDNA and mtRNA were investigated using Spearman and Pearson correlation. Results: No HAART exposed infants were infected. Blood mtDNA levels were similar in 25 exposed infants (median [IQR]) 129[117-156] and 22 controls 128[100-154], p=0.45. In contrast, there was mtRNA levels were significantly lower in subjects 4.9[3.5 - 8.5] compared to controls 13.2[4.5-26.3], p=0.03. HAART exposed neonates had lower birth weight (3085g ~ 429 vs 3536g ~ 473, p=0.001), shorter gestational age (38.6wks ~ 1.7 vs 39.7 wks~ 1.3, p=0.014) than controls and similar APGAR scores at 5min (9 vs 9). Three HIV+ mothers used drugs of addiction, two were on methadone during pregnancy, 5 were HCV+. The length of exposure to HAART (18wks[14-31]) showed no correlation with mtDNA (R=0.11, p=0.59) and a weak correlation with mtRNA (R=0.44, p=0.03). Lactate levels at 1 month of age (N=18) tended to positively correlate with neonate mtDNA levels (R=0.33, p=0.18). The 4 infants exposed to d4T and/or ddl tended to have lower mtDNA than those exposed to other NRTI (117[113-124] vs 136[119-157], p=0.14) and higher mtRNA (13.6[8.1-35.2] vs 4.7[3.2-7.3], p=0.13). Conclusions: These preliminary results show that, prior to more extensive post-natal exposure to ZDV, HAART exposed neonates (1-3 days old) showed no evidence of blood mtDNA depletion, yet had lower mt gene expression levels. Further study at 6 months of life is pending to determine whether these trends are maintained. MOPE0242 HAART can be provided safely in African HIV positive children: analysis of patients in 2 urban health centres in Kigali L. De Naeyer', J. Van Griensven2, S. Ubarijoro', T. Mushi2, G. Ntabashwa3, C. Gazille4, R. Zachariahs. 1Medecins Sans Frontieres Belgium, CdS Kimironko, Kigali, Rwanda, 2Medecins Sans Frontibres Belgium, CdS Kinyinya, Kigali, Rwanda, 'Ministere de la Sante, Medidistrict Muhima, Kigali, Rwanda, 4Medecins Sans Frontieres Belgium, Kigali, Rwanda, sMedecins Sans Frontieres Belgium, Operational Centre Brussels, Brussels, Belgium Background: To evaluate side effects of HAART among children followed in 2 urban health centres in Kigali, Rwanda. Methods: Analysis of data until January 2006 using excel~. Results: A total of 230 (11%) children (52% girls) of our cohort on HAART are children < 13 years (median 6,9 years, IQR 4,5 - 9,5; 248 patient-years of follow-up). Median CD4% at start HAART was 13 % (IQR 9%-17%, n-190). WHO stages 1, 2, 3 and 4 were respectively 14,8%, 50%, 33% and 5%. Majority (91%) started on D4T/3TC /NVP in a fixed dose combination (NVP slightly overdosed), 13 (5%) initiated on 3TC /AZT/NVP, 3 on 3TC /D4T/EFV and 4 on 3TC /AZT/EFV. 96% (n=221) are still alive and followed up. Liver function tests were performed at baseline, 2, 4 and 8 weeks and on clinical grounds. Median SGPT level at baseline was 25,9 (IQR 19,1 - 36,1; n=155). Grade 1 to 4 hepatotoxicity (PACTG 1994) at follow-up was respectively present in 27%, 3%, 0,5% and 0% (n-197) of children. Moderate grade 1 (SGPT 1,1 to 2,5 UNL) was noticed in 22%. Severe hepatic abnormalities (grade 2-4 and symptomatic grade 1) appeared in 12 cases (5,2%). Seven symptomatic (fatigue, nausea, fever, jaundice, RUQ pain and/or hepatomegaly) children changed to EFV. Four of the eight patients with grade 2-3 levels continued NVP with spontaneous recovery. Grade 3-4 skin manifestations (ACTG 1992) (with switch to EFV) were seen in 11 patients (4,8 %). Three changed to EFV due to TB. No lactic acidosis or peripheral neuropathy was reported. Conclusions: Rural health centres in Africa starting access to HAART should focus more on children given the fewer side effects and the better response to treatment in terms of morbidity and mortality compared to adults. Monitoring of LFT seems unnecessary since virtually all children switched treatment only when clinical signs were present. S. Thurstans', M. Kerac2, K. Maleta3, T. Banda4, A. Gomez', A. Nesbitt6'. 'Action Against Hunger, Department of HIV and Nutrition, Lilongwe, Malawi, 'College of Medicine, Department of Paediatrics, Blantyre, Malawi, 'Action Against Hunger, Department of Community Health, Blantyre, Malawi, 4Ministry of Health, Department of Nutrition, Lilongwe, Malawi, 'Accion Contra el Hambre, Technical Director, Madrid, Spain, 6College of Medicine, Department of Community Health, Department of Paediatrics, Blantyre, Malawi Issues: Services for paediatric malnutrition and the diagnosis and treatment of childhood HIV/AIDS in resource poor countries have to date been largely separate despite the overlap in their clinical presentation and the high prevalence of childhood HIV infection in a number of countries where severe childhood malnutrition is a significant public health problem. A contributory reason has been the perception that the identification of HIV infection in malnourished children may adversely influence their nutritional care by both clinicians and family carers, principally through stigma associated with the disease. Description: HIV counselling and testing was offered to all caretakers and eligible children (>15 months) as part of a study to determine the prevalence of HIV infection amongst severely malnourished children in Malawi. Lessons learned: Caretakers of malnourished children responded favourably to the offer of a HIV test. 138 (99.9%) caretakers in the dry season and 391 (91.1%) of caretakers in the rainy season consented to their children being tested. Many also agreed to testing for themselves (n 421; 74.1%). These findings contradict the perception that HIV testing is poorly accepted. Only 52.5% of caretakers gave consent for the results to be written in the child's clinical notes. The reasons for this need further exploration, but included concerns about confidentiality and the lack of consent from and implications for other family members. Recommendations: NRUs in Malawi provide an important setting for the identification of children and caretakers infected with HIV. By integrating VCT into the management of malnutrition, in the 48 countrywide NRUs for which we have complete user records, approximately 10,000 children and caretakers per year could access VCT and therefore gain access to prevention, treatment, and support services. Guidelines for providing VCT services to children and caretakers are urgently needed and should include empowering carers to share test results on a "need to know" basis. MOPE0244 Directly observed HAART treatment of HIV-infected children in Cambodia P.D. Myung', M.F. Brady2, S. Many3, J. Tucker', J. Harwell2, M. Lurie', D. Pugatch2'. 'University of California, Irvine, California, United States, 'Brown Medical School, Providence, Rhode Island, United States, 'Maryknoll, Little Sprouts Program, Phnom Penh, Cambodia Background: Little data exists on outcomes of HIV-infected children in the developing world who have been given directly observed HAART for more than 6 months. This study reports new data from a cohort of children treated with DOT-HAART for up to 18 months. Methods: We conducted a retrospective record review of all children in the Maryknoll HIV pediatric treatment program in Phnom Penh, Cambodia. Medical records of all children who had available CD4 percentages and received a minimum of 6 months of twice-daily directly observed therapy with a HAART regimen were included in the analyses. Children received a HAART regimen of nevirapine or efavirenz plus d4T and 3TC. Children were monitored for possible drug toxicities and for change in CD4 percentage. Results: Records of 95 children met review criteria. The mean baseline CD4 percentage was 6.8% (SD= 6.8%), and increased to 16.7% (SD= 7.8%) after 6 months of treatment (p<0.001). Sixty-eight children had 1 year of treatment at which time the mean CD4 percentage was 21.7% (SD= 7.4%) (p<0.001). Thirty-three children receiving 18 months of treatment had a mean CD4 percentage of 23.4% (SD=6.2) (p<0.001). Drug toxicities requiring antiretroviral treatment modification occurred in 9% of patients: 9 children were switched from nevirapine to efavirenz due to either rash or elevated liver enzymes. Conclusions: In this cohort of HIV-infected Cambodian children receiving DOT-HAART, substantial increases in CD4 percentage were seen at 6 months and continued in longer observation to 1 year and 18 months. Serious drug toxicities were not common, and were managed by switching from nevirapine to efavirenz. DOT-HAART appears to be a promising approach to effective treatment with sustained benefit to HIV-infection in resource-poor settings. MOPEO245 Correlation between Total Lymphocyte Count (TLC) and CD4 count in HIV exposed and infected infants B. Gudetta', Y. Mengistu2, R. Adamu3, A. Abashawl4, A. Ruff, A. Bedri'. 'Addis Ababa University, Pediatrics, Addis Ababa, Ethiopia, 'Addis Ababa University, Microbiology, Addis Ababa, Ethiopia, 'Johns Hopkins University, International Health, Addis Ababa, Ethiopia, 4Johns Hopkins University, International Health, Baltimore, United States Background: Clinical staging alone is insufficient to decide whether HIVinfected children need prophylaxis or antiretroviral treatment. CD4 counts are XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  90 required for accurate monitoring, but are expensive and often unavailable in resource limited settings. WHO recommends TLC to supplement clinical decisions in identifying HIV-infected children with immune suppression. However there are conflicting data regarding the correlation between CD4 count and TLC. This study evaluated the correlation between CD4 count and TLC and determined the sensitivity and specificity of TLC in identifying immunosuppressed HIVinfected children. Methods: We analyzed data from an ongoing perinatal intervention study in Addis Ababa, Ethiopia. TLC and CD4 counts were performed at 6 and 12 months on 640 and 543 children respectively. A Pearson's correlation coefficient was calculated for CD4 count and TLC at 6 and 12 months, overall and separately for HIV exposed and infected infants. The sensitivity and specificity of a TLC of < 4,000 (WHO) for identifying immune suppression (using age-appropriate definition of CD4 < 1,500) were calculated. Results: The Pearson's correlation coefficients between CD4 and TLC at 6 and 12 months were 0.5 and 0.6. There was no difference in correlation coefficients between exposed and infected infants. Use of TLC < 4,000 to identify CD4 < 1,500 6 months of 12 months of in HIV-infected infants age age Sensitivity Specificity 30% 94% 42% 91% Conclusions: Although there is moderate correlation between TLC and CD4 count, and TLC has high specificity, the lower sensitivity may limit its potential use as a surrogate marker of CD4 count in this population. Additional studies are needed to clarify the role of TLC in HIV-infected children in Ethiopia. MOPE0246 Efficacy of HAART in Ugandan HIV-infected children M. Nannyonga Musokel, E. Morelli2, B. Atail, E. Michelin2, M.G. Lain2, S. Marinello2, M. Bettio2, A. Mazza3, G. Putoto4, C. Giaquinto2'. 1St Francis Nsambya Hospital, Home Care Department, Kampala, Uganda, 2Padova Hospital, Department of Pediatrics, Padova, Italy, 3Santa Chiara Hospital, Trento, Italy, 4Padova Hospital, Padova, Italy Background: This study aimed to describe the effect of highly active antiretroviral therapy (HAART) in a cohort of HIV-1-infected children followed up at the St.Francis Nsambya Hospital, Kampala, Uganda. Methods: From October 2003 to December 2005, a total of 83 HIV positive children on HAART (2NRTI plus either a NNRTI or a PI) provided by the AIDS Relief Consortium, were studied at the Nsambya Home Care (NHC). Children were clinically followed up monthly. Body Mass Index for age (BMI) and total CD4 count were measured before HAART and 6 monthly during treatment. The incidence of pneumonia, acute diarrhoea and hospital admission rates were evaluated and compared before and after initiation of HAART. antiretroviral side effects were also evaluated. Results: The mean age was 9.4 years (range: 2 -18 years), 58% were female. The mean length of follow up was 17 months (range 6-26). During the follow up period 2 patients died from HIV-related illness and one was lost to followup. The pneumonia and diarrhoea rates decreased from 0.86 to 0.60/per person (P=0.11) and from 0.44 to 0.35/per person (P=0.41), respectively. The frequency of hospital admission was reduced by 58% from the beginning of HAART. The BMI for age z score increased from -1.23 to -0.69 (P = 0.06).At baseline, the median CD4 cell count was 245.9 cell/pL (range: 3-840 cell/pL). After 24 weeks of HAART, the median CD4 cell count was 511.1cell/pL (range: 64-1744 cell/pL). In general HAART was well tolerated, 4 children (5%) developed adverse reactions, two had peripheral neuropathy, one rash, one hepatic toxicity. For two of them the HAART regimen was changed. Conclusions: In resource-limited setting, it is possible to use HAART to treat African children.. HAART is safe and effective for HIV-infected children. Preliminary data suggest that treatment is as effective as in developed countries. MOPE0247 Challenges of caretakers for the HIV- infected children attending Mulago National Referral Hospital, Kampala, Uganda J. Rujumba, G. Ndeezi. Makerere University Medical School, Department of Paediatrics and Child Health, Kampala, Uganda Background: Several studies have been conducted on HIV/AIDS but none has focused on the challenges caretakers for the HIV-infected children face in Uganda yet these have implications on the care for such children. The main objective of this study was to establish the challenges faced by caretakers of HIV-infected children attending Mulago Hospital. Methods: The study was cross- sectional in nature. The study used quantitative and qualitative methods of data collection including individual interviews and Focus Group Discussions with Caretakers of HIV-infected children and key informant interviews with Health workers at the PIDC clinic. We interviewed 93 caretakers of HIV-infected Children, held 2 FGDs and 5 key informant interviews. Study participants were recruited consecutively on clinic days. Results: Large family size was a key challenge in the care for the HIVinfected children reported by 55% of the respondents. Sixty three percent of the caretakers engaged in irregular employment including petty trade, casual labour and subsistence farming with low and irregular income, insufficient to meet the needs of the HIV-infected children. Other challenges identified were unresolved sickness among children 96%, difficulties and worries about feeding the HIV-infected children to grow like others 68.8%, difficulty to disclose HIV statusl2%, social stigma and poor health status of caretakers. All these have implications on the care for HIV-infected children in Uganda. Conclusions: Caretakers of HIV-infected Children face a wide range of challenges which require multifaceted interventions including counselling, income generation support, and treatment of opportunistic and recurrent illness. There is need to adopt the family care model to address the needs of HIV-infected Children and those of their caretakers particularly the aged grandparents and biological parents living with HIV/AIDS. Study findings depict a glaring need for disclosure support in dealing with HIVinfected Children. MOPE0248 Characteristics of diagnosis and treatment of HIVinfected children in China M. Aul, F. Zhang', P. Bouey2, R. Chen3, Y. Zhao1, Y. Wen, Z. Dou'. 'Chinese Center for Disease Control and Prevention, National Center for AIDS/STD Control and Prevention, Division of Treatment and Care, Beijing, China, 2Clinton Foundation, China, Beijing, China, 3National Institute of Health, based at Chinese CDC, Beijing, China Background: The HIV epidemic in China has shifted from provinces with illegal plasma donation (IPD) to provinces with primarily intravenous drug use (IDU) in the mid-1990s. This first national study on HIV-infected children describes and compares the demographic characteristics of the surviving pediatric populations in the IPD and IDU provinces and the associated diagnostic and antiretroviral therapy (ART) efforts. Methods: A cross-sectional study was conducted in the six highest HIV prevalence provinces, four from IPD provinces and two from IDU provinces, under the direction of the Chinese Center for Disease Control/National Center for AIDS Control and Prevention. Surveys on demographics and HIV-related questions were distributed to clinicians of all national case-reported living HIVinfected children in these provinces. Descriptive and bivariate analyses were performed on the completed surveys. Results: 692 of the total 1108 surveys were returned (62.4%), of which 650 were eligible for analysis (N=572 for IPD, N=80 for IDU). Mother-to-child transmission accounted for 75.3% of all cases, followed by blood transfusion/ plasma donation (15.7%). Average age in IPD provinces (mean~SD; 8.1~3.2) was significantly older than in IDU provinces (5.4~2.2, p<0.001). Average lag time between probable date of transmission and date of diagnosis was 7.3~3.2 years in the IPD provinces and 4.3~2.0 years in the IDU provinces (p<0.001). 75.8% (135/178) of patients in all six provinces not receiving ART actually require treatment based on CD4 count or WHO staging. Conclusions: This first national pediatric survey indicates that age and time required for diagnosis were greater in HIV-infected children from IPD provinces compared to those from IDU provinces, likely due to the different epidemiology and initiation times of the treatment programs. Average time required for diagnosis and initiation of ART for both group are suboptimal. The development of aggressive, early diagnostic and treatment programs in all HIV-infected children needs to be established in China. MOPE0249 Infant HIV-1 PCR testing as part of the routine immunization clinic K. Technaul, A. Coovadia2. 'Coronation Women and Child Hospital, Discoverers Community Health Clinic, University of the Witwatersrand, Paediatrics, Johannesburg, South Africa, 2Coronation Women and Child Hospital, University of Witwatersrand, Paediatrics, Johannesburg, South Africa Aim: To report on the benefits of Infant HIV-1 DNA PCR testing as part of the routine immunization service at Discoverers Community Health Centre in Johannesburg, South Africa. Given the high one year mortality rate (38.5% reported in the Johannesburg setting) of vertically transmitted HIV-1 infection, it is essential to pick up HIV infections early in order to offer anti-retrovirals (ARV's). Large numbers of HIV exposed babies create a challenge, requiring an easily accessible point of testing if this is to be done on a large scale by clinic staff alone. Methods: Over the period of one year one doctor joined one of the two immunization clinics servicing specifically HIV exposed infants (predominantly formula fed population) and their mothers. Counseling was provided and HIV PCR testing of infants was offered for infants of known HIV positive mothers. Maternal CD4 testing was offered where necessary as well. Results: Of 118 infant/mother pairs seen, 116 mothers requested a PCR test. Seven (6%) of these were positive. Three of these seven infants had WHO stage III to IV signs of HIV progression by 14 weeks of life. 97 (86%) of the results were collected by mothers. 48 (41%) of mothers required a CD4 count. Of the CD4 counts done at the immunization clinic, 8 (16%) were less than 200 10^6/1 and the mothers were referred for ARV preparation. Conclusions: The results show that there is good uptake of testing if it is offered. Although the numbers of HIV positive infants are small, the figures echo previous research of transmission and rapid progression rates, the latter emphasizing the need for early testing. The large number of PCR results given to mothers as well as the coverage of CD4 testing provides evidence that this strategy may be a feasible intervention in the face of the South African HIV epidemic. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  91 MOPE0250O What to consider when designing supply chains for delivering pediatric ARVs A. Ombeval, E. Takang2, E. Hasselberg2, Y. Chandani2, C. Allers2. 1JSI's DELIVER Project funded by USAID, Nairobi, Kenya, 2JSI's DELIVER Project funded by USAID, Arlington, United States Issues: Supply chain management of pediatric ARV drugs combines challenges attributable to the drugs and pediatric ART service delivery requirements. Liquid formulation related issues include the increased need for storage space for bottles, cool/cold chain requirements, special handling of bottles during storage and distribution due to weight, shelf life and fragility, and more frequent ordering due to stability problems after opening or reconstitution. For service delivery, pediatric dosage regimens are based on age, weight'or body surface area and complicated for providers and logisticians to calculate. Dosage regimens change as the child grows, but growth rates are unpredictable, complicating ordering and inventory management of ARVs. National programs must ensure uninterrupted supplies of pediatric ARV regimens while minimizing wastage rates. Description: This paper describes key supply chain considerations and approaches for pediatric ARV drug management and draws on experience from National and NGO ART programs in 6 sub-Saharan African countries. Lessons learned: Supply chain management of pediatric ARVs is more complex than adult ARVs. Drug selection is limited, and dosage forms and packaging make dosing, storage and distribution even more difficult. Some considerations have been addressed in a simple tool used by supply chain managers and officers to translate numbers of pediatric patients into quantities of drugs to order or supply, based on locally defined regimens and dosing schedules. Recommendations: Programs and global partners should: - Develop and disseminate simple and standardized dosing guidance based on weight and age. - Continue to advocate for development of appropriate pediatric formulations including packaging options that allow for better palatability for children, flexible dispensing, and enhanced storage and distribution. MOPEO25 1 Mutual supporting group with adolescents and young people living with HIV/AIDS in Mozambique: a positive therapeutic and social participation strategy L. Giurao1, N. Osman2, I. Zilhao', L. Vander Veken', R. Jose2, A. Ratilal2. 'Pathfinder International, Maputo, Mozambique, 2Hospital Central de Maputo, Maputo, Mozambique Issues: The six million people aged 10-24 in Mozambique comprise 34% of the total population. This group faces high rates of early and unwanted pregnancy, STIs, and HIV. Youth account for 60% of new HIV infections. Since 1999, the multisectoral Geragqo Biz (GB) Program has worked to improve sexual and reproductive health among Mozambican youth in eight provinces. GB first established YFS at the Maputo Central Hospital, which now serves as a model clinic. Description: In April 2005, with Word Bank funding, the youth clinic at Maputo Central Hospital, added HIV/AIDS care and treatment services (youth-friendly HAART, treatment of opportunistic infections, and PMTCT) to meet the needs of young PLWHA. A weekly support group for young PLWHA started in 2005 at a YFS facility in Maputo. With a group facilitator, participants discuss themes such as treatment, how and to whom to disclose HIV status, nutrition, safe sex, HIV-positive pregnancy, self-prejudice, stigma and discrimination, and plans for the future. Lessons learned: The group started with seven young PLWHA and currently has 41 participants. Some are negative but in an HIV discordant relationship; Youth have developed skills to follow their own treatment and help other youth; Group participants receive other youth at the YFS clinic, support those that just received their diagnosis, and visit those youth at the hospital; Twenty-nine youth were trained in home visits to young PLWHA; Two representatives of the group are part of the YFS management meetings; Fourteen youth disclosed their HIV status to families and partners. Recommendations: This group was an important strategy for treatment adhesion and for improving the quality of life of young PLWHA. It shows that youth support groups are an important component of YFS treatment programs. Support groups will be formed in another Mozambican province. MOPE0252 Formulation development of novel fixed dose combination (FDC) of lamivudine, stavudine and nevirapine for pediatrics A. Singlal, A. Rampal2, M. Garg3, S. Juneja4, A. Chhabra4. 'Ranbaxy Laboratories Limited, Pharma Research - Formulations, Gurgaon, India, 2Ranbaxy Laboratories Limited, NDDS and Pharma Research, Gurgaon, India, 3Ranbaxy Laboratories Limited, Pharma Research, Gurgaon, India, 4Ranbaxy Laboratories Limited, International Marketing Development, Gurgaon, India Issues: antiretroviral therapy for children is usually long term, complicated, and involves multiple drugs that necessitate administration of inconveniently large volumes of liquids. Adult triple ARV FDC tablets have been also been used by breaking the tablets as required. However, there may be concerns on dosage accuracy and palatability. This may potentially impair adherence to therapy and lead to drug resistance. Description: To address the above issues, three ARVs (lamivudine/stavudine/ nevirapine) were formulated into Tablets For Oral Suspension (TFOS). TFOS is designed to disintegrate quickly into a uniform suspension in small volume of liquid media like water. The strength of active ingredients, based on treatment guidelines was selected to provide flexibility of dosing. To enhance - Accuracy of dosing, break line was introduced. - Adherence and palatability, flavoring agents preferred by children were incorporated. TFOS contains the active ingredients in admixture with "GRAS" pharmaceutical excipients that are suitable for its manufacture for example, diluents, granulating, lubricating and disintegrating agents. During prototype development TFOS concept and the product was challenged to various tests like dispersion time, uniformity of dispersion, taste, dissolution, potency and related substances tests. Lessons learned: TFOS designed was - Quickly dispersing into a uniform suspension in 5mi of water within 2 minutes - Having similar in-vitro dissolution media profile as that of individual products introduced simultaneously as separate liquids - Stable under accelerated conditions - Having palatable orange flavor Recommendations: Based on the above studies, the FDC will undergo Bioequivalence studies to demonstrate that TFOS attains the same level of medication in the blood as achieved when individual Reference products are dosed as separate liquids. On successful completion of development program, the FDC will be submitted for approval with regulatory agencies and WHO's prequalification program. The findings will be presented at the 16th International AIDS Conference in Toronto in 2006. MOPE0253 A glimpse into the African child's future in an era of HIV/AIDS: the case for Zambia S. Chishimbal, G. Kaela2'. 1Pan-African Academy for Health and Social Sciences, Administration, Lusaka, Zambia, 2Pan-African Forum for Children and Women Empowerment, Projects, Lusaka, Zambia Issues: Wars, poverty, HIV/AIDS among others have rendered the future of the African child bleak. Policy makers and implementers have insufficiently challenged the status quo. In Zambia, the countrywide school health services programme collapsed in the mid 1980s. Later, an integrated school health programme was revived in 1997 in line with health reforms. The 102 community schools with 19, 000 Orphans and Vulnerable Children (OVCs) have not benefited from the program in Lusaka District. Without these services, OVCs will continue to die needlessly. Description: In 2003, The Commonwealth ACT-Zambia with the Lusaka District Health Management Team designed a project called "Extension of School Health Services to OVC's in community schools and Integrated Management of HIV/ AIDS" whose components were: Physical examination, Treatment of Childhood Infections, medical examinations, education on life skills, HIV/AIDS and STIs treatment to the children and their guardians, Immunization, Micronutrients supplementation, ARV management among OVC's living with HIV/AIDS, and advocacy against child sexual abuse. Lessons learned: The school health programme is a vital tool to increase Orphans and Vulnerable Children's accessibility to ARVs. Through the school health programme, mothers or guardians living with HIV/AIDS can be reached and included on Prevention of Mother to Child Transmission of HIV programme. Recommendations: In order for antiretroviral therapy, overall care and support to be accessible to OVCs, the school health services and HIV/AIDS management projects should be scaled-up to all community schools. This is also critical for the success of putting many People with AIDS on ARVs as prayed by WHO and UNAIDS. Precisely, schools should be used as the starting and entry point for reaching out to communities in ART promotion, care and support. MOPE0254 Excellent outcomes can be achieved in children on highly active antiretroviral treatment under program conditions in Cambodia: the experience from two hospitals in Siem Reap and Takeo, Cambodia B. Raleigh', S. Soeung2, K. Akao2, V. Te', J. Gupta', S. Khem4, B. Janssens4, R. Zachariah'. 'Medecins sans Frontieres, Cambodia, Siem Reap, Cambodia, 'Angkor Hospital for Children, Siem Reap, Cambodia, 'Takeo Provincial Hospital, Takeo, Cambodia, 4Medecins sans Frontieres, Cambodia, Phnom Penh, Cambodia, 'Medecins sans Frontieres, Operational Centre Brussels, Brussels, Belgium Background: In parallel with efforts to scale up access to highly active antiretroviral treatment (HAART) for adults in Cambodia, AIDS care and HAART has also been offered to children in the provincial towns of Siem Reap and Takeo. We present outcomes in children placed on HAART under routine programme conditions in these two settings. Methods: Analysis of cumulative data gathered between 2002 and January 2006 using the FUCHIA monitoring software (Epicentre-MSF). XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  92 Uoda Results: A total of 384 children aged less than 13 years were placed on HAART of whom 177 (45%) were females. The median age was 6 years (IQR: 4 -8). All but 2 were older than 18 months. At initiation, CDC stages N, A, B and C were respectively 13%, 26%, 43%, and 17%. 303 (79%) of children had a CD4 count <15%. WHO recommended first line regimens were used in all children. The median time on HAART was 9.7 months (IQR: 5.3-15.4). 165 children had been on HAART for over 12 months. Treatment outcomes in January 2006 included: 355 (92.4%) alive and on HAART, 17 (4.5%) deaths, and 10 (2.7%) lost to follow-up. The median CD4% gain from baseline was 7.3% at 6 (~ 2) months and 13% at 12(~ 2) months. The 12 month survival rate was 90% (CI 95%:83-93). The overall mortality was 5 per 100 personyears (CI:95%: 2.7-7.1). Only one child required second-line therapy. Results of viral load measurements in all children who have been on follow up for at least 12 months will be available at the conference. Conclusions: This data shows excellent outcomes among children offered HAART under routine programme conditions in Cambodia. Our findings give strong support to actively include children within the scaling-up process in the country. There is an urgent need to improve early HIV diagnosis and access to HAART in children under 18 months of age. MOPEO255 Neonatal factors associated with HIV long term progressors in a cohort of vertically infected children in Rio de Janeiro, Brazil ("Peixe" Project) C.B. Hofer', A. Pala2, R.H. Oliveira3, L. Evangelista3, E. Machado4, C. Sepulvedas, N.R. Lopess, T. Abreu5. 'Universidade Federal do Rio de Janeiro, Infectious Diseases, Rio de Janeiro, Brazil, 2Universidade Federal do Rio de Janeiro, Pediatrics, Rio de Janeiro, Brazil, 3Instituto de Puericultura e Pediatria MartagBo Gesteira-IPPMG, Pediatrics, Rio de Janeiro, Brazil, 4Hospital Universitario Clementino Fraga Filho-HUCFF, Infectious Diseases, Rio de Janeiro, Brazil, sInstituto de Puericultura e Pediatria Martagao GesteiraIPPMG, Infectious Diseases, Rio de Janeiro, Brazil Background: There is scarce data on risk factors for HIV progression in vertically infected children in developing countries. The aim of this study is to describe factors associated with neonatal period for long term progression (LTP), in a Brazilian cohort. Methods: Cohort study, data was systematically collected from "Peixe" Cohort (Cohort Study of children followed at the biggest HIV Pediatric Center in Rio de Janeiro, Brazil, from 1996 to 2005). Children who were vertically infected and started their follow up at 5 years old or younger were included in this analysis. Main endpoint: LTP- defined as reaching category 4 or severe immunosupression (interim WHO clinical stage, 2005) after 5 years old. Neonatal and demographic factors were studied. Variables with p-value<0.15 were included in a logistic regression model. Results: 213 patients were included, 42% (89/213) were classified as LTP. Variables associated with LTP were: Maternal age at birth (LTP= 27 vs. 25 years old, p=0.06); admission viral load-log (LTP=4.49 vs. 4.85, p=0.12); being female (RR=1.36, p=0.03); Use of antiretroviral therapy (ART) before reaching category 4 or severe immunosupression (RR=4.50, p<0.01); Maternal use of antiretroviral at pregnancy/labor (RR=2.80, p=0.04); zidovudine (ZDV) use at newborn period (RR=2.75, p<0.01); Not breastfed (RR=1.18, p<0.01); Maternal membranes ruptured for <4 hours (RR=1.18, p=0.08); Age of initiating follow up (LTP=26 vs. 20 months, p=0.06). In the multivariate analysis the variables associated with LTP were: Not breastfed (OR= 4.06, 95%CI=1.01 -16.33); Age of initiating follow up-per month (OR= 1.03, 95%CI=1.01-1.06); ZDV use at newborn period (OR= 3.43, 95%CI=0.87-13.56); Use of ART before classification 4 or severe immunosupression (OR= 6.04, 95%CI=2.19-16.66). Conclusions: Adjusting for age at the follow up initiation, practices that were unsuccessfully used to prevent maternal-to-child transmission (ZDV use in neonatal period and not breastfeeding) were associated with better prognosis. ARTs initiation before category 4 or severe immunosupression was also associated with LTP. MOPEO256 Prevalence of HBV antibody reponse (anti-HBs) in a cohort of HIV-infected adolescents in Rio de Janeiro, Brazil, who received hepatitis B vaccination during infancy E.S. Machado, C.B. Hofer. Hospital Universitario Clementino Fraga Filho, Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil Background: Response rates for hepatitis B vaccination in HIV-infected children range from 20% to 78% and is also poor in adolescents reaching only 41%. As many HIV+ children are surviving into adolescence, evaluation of the presence of protective levels of antibody to HBV is important to prevent HBV co-infection in this population Methods: From a cohort of 53 adolescents followed-up at University Hospital of Federal University of Rio de Janeiro, Brazil, we selected 27 patients who were followed since childhood (mean age of start of follow-up = 7.1 + 0.6 yrs) and received at least 3 doses of hepatitis B vaccine. Qualitative measurement of anti-HBs was assessed at the time the patients were transferred to the HIV+ adolescent outpatient unit. Results: Anti-HBs seropositivity was found in 26% of the patients (7/27). Mean age at vaccination was 9.5 yrs. Time between the last dose of vaccine and assessment of anti-HBs response was similar in both responders and nonresponders group (5.6 ~ 3.1 yrs and 4.5 ~ 2.6 yrs; p=0.98). Mean CD4% at the time of vaccination was 14.5 + 9.5 and 19 ~ 10.1 for responders and non-responders, respectively (p= 0.42). Most of the children received 3 doses of vaccine, three received 4 or 5 doses (1 responder). One patient had an antiHBs positive one year after vaccination that became negative 5 years later. Conclusions: Only 26% of HIV-infected children with past history of vaccination to HBV reach adolescence with anti-HBs positive. Anti-HBs antibodies should be re-assessed in adolescence to establish hepatitis B vaccination efficiency. These results confirm the suboptimal response to hepatitis B immunization in HIV-infected children and suggest that anti-HBs positivity can evade with time. Further studies are needed to determine the optimal protocol for hepatitis B immunization in HIV children who did not respond to a first course of vaccination. MOPE0257 Paediatric ART in Sub-Saharan Africa: program characteristics in the multi-center international KIDS-ART-LINC collaboration D. Mbori-Ngacha', D. Kyabayinze2, E. Arrive3, B. Marquis2, N. Tumwesigye2, M.P. Kieffer4, V. Leroy3, F. Dabis3, KIDS ART LINC Collaboration. 'African Network for the Care of Children Affected by AIDS (ANECCA), Nairobi, Kenya, 2Regional Centre For Quality of Health Care, HIV/AIDS, Kampala, Uganda, 3Institut de Sante Publique, Epiddmiologie et Ddveloppement (ISPED), Unitd INSERM 593, Bordeaux, France, 4USAID / REDSO-ESA, Office for Regional HIV/AIDS Programs, Nairobi, Kenya Background: The Paediatric HIV burden in sub-Saharan Africa is currently estimated at 2.1 million children <15 years and significantly contributes to under-five mortality. Pediatric ART services in Africa are in their infancy and experience has not been documented. Paediatric antiretroviral Treatment Programs in Lower-Income Countries (KIDS-ART-LINC) collaboration aims to document and improve paediatric ART programs and practices in Africa. Methods: Seventeen of the 26 participating treatment programs were assessed in 2006 using a standardized tool during site visits in 13 countries. Results: Approximately 3,000 children receive HAART in the 17 clinics, 14 of which are based in public facilities. Five programs exclusively treat children. The minimum care package offered by all programs includes medical consultation, cotrimoxazole prophylaxis, HAART, CD4 monitoring and CBC. All but one program provide free ARVs. Six research based programs perform viral load estimates and 12 offer early infant HIV diagnosis at clinic sites. Standardized record forms are used in 15 sites, but only 10 have a computerized data management system. Clinical criteria for starting HAART essentially correspond to WHO guidelines. Lack of paediatric formulations delayed HAART initiation in 8 programs. There is active follow-up of children on HAART 11 programs. The first-line HAART regimen for fifteen programs is NNRTI-based (10 nevirapine, 5 efavirenz) while 2 provide PI-boosted lopinavir and nelfinavir as first-line. NRTI drugs used are lamivudine and either zidovudine or stavudine. Conclusions: There is good standardization of clinical practices in the paediatric treatment programs across sub-Saharan Africa. Information systems to accurately estimate and document the impact of HAART in children in developing countries are lacking. Programs connected to research projects allow for more expensive laboratory testing. Lessons learned in these sites will be essential to other sites beginning pediatric treatment. KIDS-ARTLINC will enhance information systems and evaluate the impact of program characteristics on treatment outcomes. MOPE0258 Pediatric HIV needs assessment in Rwanda M. Fabril, M. Cohen', M. Black', J. Hakizimana3, B. Mulinda-Shambo', A.-C. d'Adesky4. 'Heartland Alliance for Human Needs & Human Rights, Marjorie Kovler Center for the Treatment of Survivors of Torture, Chicago, United States, 2Core Center of Chicago, Chicago, United States, 3Women's Equity in Access to Care and Treatment, Kigali, Rwanda, 4Women's Equity in Access to Care and Treatment, San Francisco, United States Issues: The Rwandan Ministry of Health reports an estimated 60,000 Rwandan children with HIV. Anticipated demand for pediatric HIV care will identify psychosocial needs inherent in providing quality medical care to poor children. Description: Women's Equity in Access to Care and Treatment (WE-ACTx), a global initiative to improve women's HIV treatment has been working in Kigali, Rwanda since 2004. To respond to the medical and psychosocial needs of HIV positive children and their families, a needs assessment was conducted through structured interviews, group discussions, and observations. Health care providers, parents, grandparents, guardians, children, and representatives of nongovernmental and governmental organizations involved in the care of HIV positive women were interviewed one-on-one or in focus groups by an HIV care physician and clinical psychologist assisted by an interpreter. Children were engaged in play activities with an occupational therapist assisted by an interpreter to assess developmental and relational functioning. Older children were engaged in dialogue about their perceived needs when appropriate. Lessons learned: Consistently across the interviewed sectors were five key needs. The most pressing issue was the need for food; followed by school fees; access to HIV/AIDS health education and free medication; social activities to combat feelings of isolation, anger, fear, and stigmatization; and family concerns such as disclosure and preparation for death of a parent. Recommendations: In developing HIV services for children in Rwanda, issues inherent in poverty must be addressed. Family-centered models of care require a multidisciplinary team to attend to the many levels of care that need to be addressed in pediatric HIV treatment. Appropriate environmental stimuli in clinic settings may create a welcoming atmosphere and allay fears. Support XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  93 groups for caretakers, and developmentally appropriate groups for children will provide information, support, and social interaction. MOPE0259 Large paediatric experience of antiretroviral treatment in Maputo Public Hospital, Mozambique P. Vaz', B. Thome', E. Macassa', I. Jani2, S. Sergio', G. Biberfeld', S. Andersson3, S. Blanche4. 1Paediatric day Hospital, Paediatrics, Maputo, Mozambique, 2Immunology Laboratory, National Institue for Health, Maputo, Mozambique, 3Karolinska Institute, Immunology, Stockholm, Sweden, 4Faculte Necker, Immunohematology, Paris, France Background: To describe the results of antiretroviral therapy in HIV-infected children in a high HIV prevalence and low resource setting context, in an urban public sector center - the Paediatric Day Hospital in Maputo, where all the children in need of treatment will receive it. Methods: Observational cohorts of 1650 HIV-infected children, of whom 423 are on HAART, from December 2002 to December 2005. NNRTI based combination was used in 96% of the children, as a fixed dose combination (Triomune~) or AZT, 3TC and NVP paediatric formulations. Prospective collection of clinical and biological parameters including CD4 cell count and %, haemoglobin, neutrophils, total lymphocyte count and alanine transferase (ALT) were measured before HAART and then at the first month and every 3 months, during HAART. Viral load was not available. Results: Only 21(4,9%) children are lost to follow-up. Mortality rate under treatment is 9,4%. Several clinical and biological parameters clearly showed an improvement of global health status of children such as weight for age Z score (WAZ), weight for height (WHZ), height for age Z score (HAZ) and haemoglobin (ongoing analysis). The most prevalent OIs were chronic lymphocyte pneumonitis, acute pneumonia, skin infections, acute upper respiratory infections and pulmonary tuberculosis with respectively 0,62, 0,61, 0,20, 0,18, 0,17 events / patient/ year. The major side effects that necessitated a change in HAART were 3 Stevens Johnson's syndrome by nevirapine, 2 peripheral neuropathies and 1 clinically evident lipoatrophy syndrome probably caused by stavudine. Conclusions: Provision to children of nevirapine based HAART by the public sector in this high prevalent low resource setting is linked to an improvement of clinical and biological parameters and low mortality rate. MOPEO260 Vertically-HIV-infected children becoming young adults C. Thorne, M.-L. Newell, European Collaborative Study. Institute of Child Health, University College London, London, United Kingdom Background: In resource-rich settings, paediatric HIV infection is now recognized as a chronic childhood disease. Provision of appropriate care for this group of HIV-infected youth is challenging, not only because of increasingly complicated therapeutic management, but also regarding their developing psycho-social needs. Methods: Data on vertically-infected adolescents aged >16 years by December 2005 and followed up from birth in the European Collaborative Study, an ongoing cohort started in 1986, were analyzed. Results: The 21 adolescents (12 male, 9 female) had a median age of 18.2 years (range, 15.8 - 20.8 years). Median height and weight Z-scores were - 0.6 (range, -2.8 tol.8) and -0.4 (range, -3.1 to 2.1) respectively. CDC clinical staging at last visit was: 1 (5%) N, 4 (19%) A, 12 (57%) B and 4 (19%) C. No adolescent had clinical symptoms at their most recent follow-up visit and median CD4 count was 660 cells/mm3 (range, 80-1430 cells/mm3). Ten (48%) adolescents had undetectable HIV RNA levels at their most recent followup visit; median HIV RNA load among the remaining 11 was 5,030 copies/ ml (maximum, 750,000 copies/ml). Eighteen adolescents were currently receiving HAART, one was on double therapy (and had been on the same therapy (D4T+3TC) for 7 years), and 2 were not receiving any ART (one had never received ART and the other had stopped all ART two years previously). Regarding social circumstances, 8 adolescents were living with one or both biological parent(s), 4 with adoptive parents, 8 with other relatives and 1 with foster parents. Conclusions: With increasing use of HAART from an early age, a growing proportion of vertically-infected children are likely to survive into adolescence and young adulthood. This group of HIV-infected individuals will need support with a range of issues including treatment decisions, coping with HAART, disclosure and sexual health issues. MOPEO261 Long term response to highly active antiretroviral therapy among treatment naive children in Botswana G.M. Anabwani', E. Lowenthal', M. Marapel, H.B. Jibril2, M. Sechele', H. Schwarzwald3, J. Millon3, K. Jobarteh3, M. Kline3. 'Botswana-Baylor Children's Clinical Centre of Excellence, Gaborone, Botswana, 2Princess Marina Hospital, Gaborone, Botswana, 'Baylor College of Medicine, Texas, United States Issues: HIV-infected children are under-represented in treatment programs in Africa. Key underlying reasons include their low prioritization in care programs, lack of infrastructure and inadequate training. Little is known regarding the long-term response to HAART in African children. Construction of the BotswanaBaylor Children's Clinical Centre of Excellence (COE) has rapidly improved children's access to care and treatment using standardized guidelines. COE treatment outcomes provide important information regarding the potential for successful treatment of HIV-infected children in Africa. Description: Key COE activities are care and treatment, training and clinical research. We report our experience in treating HIV-infected children since 2002. Lessons learned: Training included all COE staff. Of 1086 patients who completed >6 months of treatment, 163 were transferred out, 82 were lost to follow-up and 55 (5%) are known deaths. The remaining 787 children - 401 (52%) male and 386 female - had a median age 5 years; 387 (49%) were in CDC category C while 255 (32%) were in category B. Baseline median VL was 5.6 log but 38.6% had VL >5.9 log. After 6 month treatment 81% of patients had VL<400 RNA copies/ml and by 36 months 71% of 165 patients had a VL<400 copies/ml. Median CD4% counts rose froml5% at baseline to 27%, 30% and 32% at 6, 12, and 36 months, respectively. Mean weight and height percentage increases at 12, and 36 months were 20% and 8% and 43% and 19%, respectively. One hundred twenty five (16%) were switched to a secondline regimen for virological failure due to poor adherence. Recommendations: Training and improved infrastructure are critical in improving access to care and treatment. HAART in African chidren results in improved survival and quality of life for children that are similar to those in western countries. These two points should be used to advocate for HIVinfected African children. MOPE0262 Screening for thyroid abnormalities in children with perinatal HIV infection S.-A. Bailey', N. Desai2, J. Godfrey', J. Quintos2'. 1Kings County Hospital Center, Pediatrics, Brooklyn, United States, 2Kings County Hospital Center & SUNY Downstate Medical College, Pediatrics, Brooklyn, United States Background: Abnormalities in thyroid function have been reported in adults with HIV/AIDS. The prevalence of either hypo/hyperthyroidism is approximately 1-4% in adolescents and adults in the general US population. There is scant literature on this in children with perinatal HIV infection. We report the results of screening tests for thyroid function in a closely followed cohort of children with perinatal HIV. Methods: Free T4 ( FT4) and TSH were used to screen for thyroid dysfunction in a population of 63 patients with proven perinatal HIV. (Age 6.1-20.5; median 13.5) Values were correlated with concurrent data on CD4 counts, viral load (VL), BMI % and treatment history. All patients with abnormalities in one or both of the two screening tests had repeat tests performed, while patients with abnormalities in both (either the first time or on repeat) were referred to the pediatric endocrinologist. Results: Abnormal FT4 was found in 9/63 (14.3%). Mean age 14.4y, CD4 19.2% and BMI 57.1%. Abnormal TSH was found in 4/63 (6.3%). Abnormalities of both FT4 and TSH was found in 3.2% (n=2). Of the group with any abnormal thyroid screening tests the median age was 15.1y, mean CD4 22.3%, mean BMI 48.8%. The patients without any thyroid abnormalities median age 13.1ly; mean CD4, VL and BMI were 26%, 69487 and 42.91% respectively. Overall 4/63 (6.3%) of patients were found to have clinically significant thyroid dysfunction. Two with clinical hypothyroidism requiring replacement therapy, and two with subclinical hyperthyroidism (one with raised antithyroid antibodies). All these 4 patients were on HAART. Conclusions: Abnormalities of thyroid function are seen in 6.3% of children with perinatal HIV infection, which is higher than reported in the general population suggesting a need for screening. Two simple tests appear to successfully screen for abnormalities, especially when both tests are abnormal. MOPE0263 Challenges and opportunities of providing counselling and testing services to HIV-infected children in Kabarole and Kampala districts, Uganda J. Rujumba, C.L. Mbasalaaki-Mwaka, G. Ndeezi. Makerere University Medical School, Department of Paediatrics and Child Health, Kampala, Uganda Background: Delivery of counseling and testing services for children is a key component of care and support. In 2003, the Uganda Ministry of Health developed policy guidelines on HIV voluntary counseling and testing which were reviewed in 2004 to include special consideration for children. Despite these advances the delivery of VCT for children remains an uphill task. Thus we under took the study to establish the challenges and opportunities of providing testing and counseling services to HIV-infected children and their families with reference to AIDS Information Centre and major Hospitals in Kampala and Kabarole districts, in Uganda. Methods: A descriptive Cross -sectional design was adopted for the study. Use was made of both quantitative and qualitative methods of data collection including individual interviews, key informant interviews and focus group discussions with doctors, nurses, counselors, social workers and administrators involved in the care for such children. The study covered 10 health facilities and 78 health workers. Results: Difficulty by children to express them selves 14%, their dependency 10%, children having many fears and requiring more time were key child related challenges. Caretakers' unwillingness & difficulty to disclose 25%, their inconsistency 10% and old age/sickness were othe challenges. Limited coun Uoda XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

Page  94 seling skills 24% and difficulty to facilitate disclosure 5% and heavy work load were health worker limitations. Institutional constraints included limited capacity to meet varied caretaker & child needs, lack/cost of testing, heavy work load, limited space and other logistics. The key opportunities to seize in enhancing the delivery of CVT for children were availability of free ARVs, experienced staff, willingness of donors and existing support services. Conclusions: The study findings indicate the need to address child, caretaker, health worker and institutional challenges as well as the availability of fee ARVs, experienced staff and willing donors as opportunities in the delivery of VCT for Children. MOPE0264 HIV-infected adolescents in Latin America: a subpopulation of National Institute of Child Health and Human Development (NICHD) International Site Development Initiative (NISDI) pediatric study M.L. Cruz', J. Byrne2, J. Korelitz2, L. Serchuck3, Pediatric NISDI. 'Hospital dos Servidores do Estado - Rio de Janeiro, Infectious Diseases, Rio de Janeiro, Brazil,:Westat, Rockville, United States, sNICHD, Bethesda, United States Background: UNAIDS estimates 610,000 people aged 15 to 24 years are living with HIV/AIDS in Latin America where 50% of youth under 17 year are sexually active and 20% of deliveries are in women younger than 20. HIV programs directed at adolescents are needed to develop strategies responding to the need for specialized care. Little data is available regarding this population. Methods: NISDI is an observational study including adolescents infected through perinatal (P) sexual (S) and other horizontal means (H) at 15 sites in Mexico, Argentina and Brazil. Results: From September 2002 to September 2004, 120 subjects 12 to 21 were enrolled. HIV was acquired through perinatal (69, 57%), sexual (33, 28%), and other horizontal means (18, 15%; 10 transfusion; 8 unknown). Mean age at HIV diagnosis was 6.5 years for P, 10.5 for H and 17.8 for S. BMI was <18 kg/m2 in 45% of P, 42% of H and 6% of S acquisition. BMI >25 kg/m in 37% with S vs 6% P. Adolescents with S acquisition were most likely to be asymptomatic (78% S vs 16% H and 13% P). Severe immunosuppression occurred more often for H (58%); then for P (35%) or S (19%). HIV RNA was >10,000 copies in 34-38% in all groups. ART use differed considerably by transmission group with 72% of S, 16% of H and 6% P youth not on ART at enrollment; however, 28% of S, 16% H and 4% P were completely ART-naive. Conclusions: The population of HIV-infected adolescents in care in Latin America is heterogeneous. Differences by transmission status are seen in age of HIV acquisition, BMI, immunosuppression, and ARV use. Further research is needed as specialized programs are developed and increasing numbers of HIV+ adolescents are properly included in health care system. MOPEO265 Impact on weight and height with the use of HAART in HIV-infected children R. Resino1, S. Guillen2, J.T. Ramos2, J. Beceiro3, C. Calvo4, M.I. de Jose's, M.D. Gurbindo6, J. Martinez-Perez', P. Martin-Fontelos8, M.J. Mellados, M.A. Mufioz', M.L. Navarro', M.A. Roa1~, B. Rubio", Cohort of Madrid. 'Hospital Gregorio Maraiidn, Immnulogy, Madrid, Spain, 2Hospital 12 de Octubre, Pediatrics, Madrid, Spain, 'Hospital Alcala de Henares, Pediatrics, Madrid, Spain, 'Hospital Severo Ochoa, Pediatrics, Madrid, Spain, 'Hospital La Paz, Pediatrics, Madrid, Spain, 6Hospital Gregorio Maranon, Pediatrics, Madrid, Spain, 'Hospital del Nino Jesus, Pediatrics, Madrid, Spain, ~Hospital Carlos III, Pediatrics, Madrid, Spain, 9Hospital Gregorio Maranon, Immunology, Madrid, Spain, "Hospital de Mdstoles, Pediatrics, Madrid, Spain, "Hospital de Getafe, Pediatrics, Madrid, Spain Background: There are scant data on the long-term effects of HAART on weight and height in HIV-infected children. Our objective was to assess the effect of HAART on weight and height over time of HIV-infected children in the Madrid cohort and analyze some possible variables associated with growth. Methods: HIV-infected children starting HAART since 1997 were included in this retrospective longitudinal study. Measurements of weight, height and BMI were done and converted to z-scores using the Spanish revised reference data. Changes from baseline in weight, height and BMI at 12, 24, 48 and 60 months were determined. Associations of z-scores at last visit with immunological (CD4 percentage above 25%) and virological response (more than 50% of samples below 400 copies/ml), CDC category and presence and type of lipodystrophy were examined. Results: 212 children, 97% vertically-infected started HAART since 1997 for a median of 71 months (4-102). Median age at initiation of HAART was 6 years (1month-18 years). 39% were antiretroviral naive, and 61% were had prior NRTI therapy. 32% and 53% were on CDC class C and 3, respectively. 51% were virological responders. Any sign of lipodystrophy was observed in 39%. At baseline, median z-score for weight, height and BMI were -0.45, -0.60 and -0.33. HAART was associated with significant increases in z-scores of weight and height but not BMI at all different timepoints. Virological non-responders had significantly lower z-scores for weight and height but not BMI. CDC class C was associated with lower z-scores for height. No differences were observed related to baseline CD4, immunological response or lipoatrophy, children with lipohypertophy experienced significantly higher measurement of BMI at last visit. Conclusions: HIV-infected children experienced continued catch up to 5 years in weight and height after starting HAART. Virological control is related to sustained growth. Lipohypertrophy is associated with greater BMI gain in HIV-infected children. MOPE0266 Review of programs and policies addressing orphans and vulnerable children in Andhra Pradesh, India P. Gandhi', K. Krishnan2, S. Uppalapathi2, S.S. Raghavan3. 'SAATHII, Chicago, United States, 2SAATHII, Hyderabad, India, 3SAATHII, Chennai, India Issues: The state of Andhra Pradesh (AP) in India is estimated to have above 400, 000 people living with HIV/AIDS and 50,000 orphans affected by HIV/ AIDS. A review of existing data on Orphans and Vulnerable Children (OVC) is vital to map existing information, identify gaps and interpret local needs and to ultimately reduce the impact of HIV/AIDS on OVC. Description: A review of data drawn from published and unpublished reports on OVC from government and non-government sources, newspapers articles, and internet sites and key informant interviews with twenty individuals from ten organizations serving children in the state was conducted to inform policymaking and program design. Lessons learned: There is inadequate data on OVC estimations, insufficient documentation of vulnerability and abuses on OVC and limited services catering to the care, support and treatment of OVC. These children are reported to be at high risk for malnutrition, physical and psychosocial trauma and impaired cognitive and emotional development which hamper their overall survival, growth and development. Currently the governments' care, support and treatment centers cater primarily to adults and have no specific provision/program to meet the needs of OVC. The NGO response is scattered to a few blocks in high prevalent districts and often limited to prevention and awareness activities, with few providing care, support, treatment, education and recreation services. Recommendations: There is an urgent need to develop systems to estimate OVC, frame OVC policy and program guidelines and scale-up services to increase coverage. Multi-sectoral programs addressing the multiple needs of OVC including health care, education, nutrition, psycho-social support, home and community based care, protection, vocational support and economic stability, succession planning, AIDS prevention and stigma and discrimination are of critical need. MOPE0267 Exhaled Nitric Oxide (eNO) levels in children with HIV/AIDS O. Asimolowo1, H. Muzumdar', N. Desai2, M. Nowakowski3, M. Rao'. 'SUNY Downstate College of Medicine, Pediatrics, Brooklyn, NY, United States, 2Kings County Hospital Center and SUNY Downstate, Pediatrics, Brooklyn, NY, United States, sSUNY Downstate College of Medicine, Microbiology, Brooklyn, NY, United States Background: Highly Active Anti- Retroviral Therapy (HAART) reverses immune changes of HIV and may influence eNO levels in children with HIV. Long term HAART leads to metabolic, mitochondrial, and physical adverse effects. HAART, itself, may affect the levels of eNO independent of immune reconstitution. Altered levels of NO could offer a simple non-invasive means of monitoring airway immunity/inflammation in HIV patients. Methods: eNO levels were prospectively obtained from children with an online collection apparatus by chemiluminescence (280A Nitric Oxide Analyzer Sievers, Boulder, CO) according to American Thoracic Society guidelines. 3 samples from each subject were collected and the average recorded. Children with asthma were excluded. Current medication, AIDS staging, CD4 count, viral load, lactate levels, and lipodystrophy were recorded. Children with category C illness were labeled "AIDS", children with CD4 in category 3 were labeled "CD4 deficient" and children with a viral load less than 50 copies/ ml were labeled undetectable viral load. eNO samples from healthy children without asthma in the same age group served as controls. Results: 20 children age 9-19 (12M and 8 F) participated. Seven had an undetectable viral load, four were CD4 deficient, nine had AIDS, four had lipodystrophy and two had lactic acidosis. The eNO levels of all the children with HIV and controls is presented in Table 1. Children with HIV infection had significantly lower eNO levels (mean 6.2) as compared to controls (mean 15.1), p< 0.01. Age Range Male/ Female Average eNO/ Range/ SD HIV Patients 9 -19 12/8 6.2 /1.8-10.7/2.2 Controls 10-21 1/4 15.1/11.7 -17.3/2.1(p<0.01) Conclusions: HIV infection is associated with significantly reduced exhaled NO levels, but is not changed with AIDS, viral load, CD4 levels. The reduction of eNO levels by HIV infection could potentially confound evaluation of airway inflammation by eNO levels in children with HIV infection and asthma. XVI INTERNATIONAL AIDS CONFERENCE * 13-18 AUGUST 2006 * TORONTO CANADA * ABSTRACT BOOK VOLUME 1

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