Bridging the Gap: Conference Record [Abstract book, International Conference on AIDS (12th: 1998: Geneva, Switzerland)]

12th World AIDS Conference

Abstracts 42248-42253 823

42248 HIV-Related research among diverse patient populations
Linda Dean', A.F. Fuchs Amy2, M.J.G. Gold Maria J.3, A.O. Osborne Arthur3,
A.S. Sinler Allison3, J.W. Witek James3, Infectious Diseases Group4. 'AUHS -
Hahnemann MS 405 HIV - AIDS Medicine Broad & Vine Streets Phila. PA
19102; 2AUHS - Infectious Disease Philadelphia PA; 3AUHS - HIV - AIDS
Medicine Philadelphia PA; 4AUHS - MCP & Hahnemann Philadelphia PA, USA
The demographics of the HIV/AIDS epidemic in the United States have changed
markedly over the past 5 years. Despite this change, certain populations continue to be significantly under represented in HIV-related clinical research. The
Partnership Comprehensive Care Practice (Partnership) at Allegheny University
Hospital, Philadelphia, Pennsylvania is a multi-disciplinary program that provides
care to 1200 adult men and women with HIV infection at two major practice sites
in Philadelphia. The demographics of the patients who receive care from the
Partnership reflect the changing face of the HIV epidemic nationally, and include
27.5% women, 80% people of color, 33% injection drug users. Approximately
15% of the patients are, or have a history of being homeless. The majority of the
patients are either uninsured, or insured by the state Medicaid program.
The Partnership, believing that research in this patient population can provide
valuable information, is committed to participating in clinical research activities.
In November, 1996, Partnership providers, in collaboration with other Infectious
Diseases faculty, conducted a phase I industry trial of a new immune-based,
parenteral, anti-HIV therapy. The trial was a study with both outpatient and
inpatient components, requiring the study participants to adhere to a rigorous
follow-up schedule for a period of 30 days. After a review of the Partnership
patient database, 51 patients were identified for study screening. Ultimately 28
patients were enrolled during 4 enrollment periods of one week each.
Despite the demanding schedule, Partnership patients demonstrated 100% adherence to the rigorous requirements, and completed all aspects of the study. This
experience demonstrated that clinical research can be successfully conducted
among traditionally undeserved patient populations, yielding data that accurately
reflects the racial, ethnic, and socioeconomic composition of the HIV epidemic.
42249 1 Meeting the needs of clinical trial participants: A survey
of clinical trial participants conducted by HIV positive
support group leaders
Junsuda Suwunjundee. c/o Power of Life Group (EH1) 6 Sukothai Road, Dusit,
Bangkok, Thailand
Issue: HIV positive persons enrolled in clinical trials for drug therapies are raising questions concerning lack of information provided to them and inadequate
follow-up after completion of drug trials.
Project: Twenty interviews were conducted and 100 questionnaires were answered among HIV positive persons who had been enrolled in clinical trials.
Questions examined their level of satisfaction with information provided prior,
during and after the trials, as well as enrollee's degree of involvement in decision
making.
Results: A significant number of clinical trial participants expressed dissatisfaction with the information they received. They felt that the drug therapy offered
through clinical trials was their only choice in order to prolong their life. They
particularly felt there were limited treatment options available on a continual
basis, and therefore were willing to take the drug therapy for the limited time
period. Problems arose when drug trials were completed and participants had
to continue taking these costly drugs at their own expense. They felt the drug
companies should be responsible in supplying the drug therapies throughout their
life, since clinical trial participants were relatively few in number and were risking
their health to participate in the drug trial. They were also aware of drug trials
being conducted in developed countries where trial participants were provided
the drugs on a life-long basis, even after the trial was completed.
Conclusion: HIV positive clinical trial participants should have access to complete information on research being conducted on them, as well as access to
adequate medical follow-up. This will empower participants to make decisions
which greatly affect their lives. If there are no long term benefits provided to participants of clinical trials, HIV positive persons will feel exploited by researchers and
drug companies. HIV positive research subjects are demanding have a greater
role in the research process.
42250 Communication, an important tool in clinical trials
Rosette Galiwango', A.D. Okwera2, R.D.M. Mugerwa3, J.J.E. Ellner4,
B.W. Bagundire', M.M.T. Mwanje'. 'Uganda CWRU Research Collaboration P
0 Box 663 Kampala-Uganda; 2Head TB/Chest Unit Mulago Hospital; 3Makerere
University Kampala, Uganda; Case Western Reserve University, Cleveland, OH,
USA
Issues: Importance of HIV/AIDS counselling, Health Education and Good communication in clinical trials.
Project: Case Western Reserve University is collaborating with Makerere University in different tuberculosis clinical trials conducted by Tuberculosis Research

Unit (TBRU) at Old Mulago hospital.
75% of the clients compose of young men and women who are HIV positive.
These patients are expected to live positively especially while on TB treatment,
report to the clinic at interim visits and swallow their drugs regularly. Counselling
and Health Education is offered before enrollment and throughout the study
follow-up. (follow-up ranges from 12-36 months).

Results: Through interpersonal counselling, group counselling and focus
Health Education. High compliance to clinical trials improves tremendously.
Focusing on the different challenges like high illiteracy rate, how family incomes
thus little money available for regular clinic disruptions, good health education,
counselling and clear communication given in the right way throughout follow-up
have been a cornerstone to the success of different clinical trials.
42251 | AIDS outreach education targeting 15-49 age groups
through personal testimonies, music, dramas, role plays
by NAPHAM
Dickien Kolondo. NAPHAM (National Association of PLWHAS Private Bag 355,
Lilongwe 3, Malawi
Issue: Composing music, drama, role plays, production of picture codes with
HIV/AIDS messages as an effective mode of dissemination of HIV/AIDS information to the productive age groups.
Project: HIV/AIDS education outreach program for productive age groups using
personal testimonies, Music, Dramas, Role Plays and Picture Codes was started
in October 1996 in Malawi by NAPHAM. The productive age groups 15-49 are
grown ups who do not need fiction but realities. Therefore the program gives
facial image, and personal experiencies to productive groups on issues related to
HIV/AIDS. The programme has been conducted for the past one and half years.
Result: The programme has benefited 5906 in-school and out-of-school youth,
5472 men, 3088 women of productive age. PLWAs involved in the program have
become role modes in Malawi and a darling of productive age groups. For the
one and a half years the program has conducted 92 outreaches.
Lesson Learnt: AIDS information through testimonies of PLWAs, their music,
dramas, role plays can reach the productive age groups easier than any other
mode of information dissemination.
142252 Evaluating smoked marijuana in patients with HIV:
Proteases pave path-bridging the gap between science
and policy
Donald Abrams', T.F. Mitchell2, C.C. Child2. 13180 18th Street, Suite 201 San
Francisco, CA 94110; 2Community Consortium; University of California San
Francisco San Francisco CA, USA
Issues: Increasing use of smoked marijuana in the San Francisco Bay Area as
a treatment for HIV-related anorexia and weight loss as well as nausea related
to prescribed therapy prompted the design of a clinical trial to evaluate the safety
and effectiveness of this controlled substance.
Project: In 1993 we designed a pilot outpatient evaluation to compare the
safety and activity of oral tetrahydrocannabinol (THC) [dronabinol] to three different THC strengths of smoked marijuana. The study received an IND from the
FDA and approval from our university institutional review board. A legal source of
marijuana could not be identified. In order to obtain a legal source of marijuana,
we submitted the protocol to the National Institute of Drug Abuse (NIDA) which
rejected the protocol for scientific reasons. In 1996, we submitted a protocol to the
National Institute of Allergy and Infectious Diseases (NIAID) that was designed
as an in-patient placebo-controlled investigation of inhaled THC to assure against
diversion of the study drug and enable strict monitoring of caloric intake. Primary
endpoints included caloric intake, energy expenditure, and changes in weight and
body composition. Proposed safety parameters included HIV viral load, immune
function, testosterone levels, pulmonary functions and neuropsychiatric testing.
NIAID reviewers were perplexed by our choice to study such a "toxic" substance
and did not give the proposal a priority score. In 1997 we submitted a protocol to
NIDA to evaluate the pharmacokinetics of oral and smoked THC and indinavir, as
both THC and indinavir utilize the cytochrome P450 system. Many of the same
safety and effectiveness endpoints that were included in the previous protocol
were included in the protocol submitted to NIDA.
Results: The proposal was awarded full funding in September 1997. Studyrequired marijuana cigarettes are being provided by NIDA. The first randomization
is scheduled to occur in March 1998.
Lessons Learned: When politically sensitive research proposals include sound
and credible science, they are likely to prevail if investigators are willing and able
to persist in redesigning and resubmitting such proposals.
42253 A survey of policy and practice of therapeutic
interventions for HIV-infected children in Europe
Marie-Louise Newell1, Stefania Bernardi3, C.G. Gabiano4, C.G. Giaquinto5,
M.A. Debre7, D.G. Gibb7, M.M. De-Martino6, A.B. Bailey1, C.T. Thorne1,
P.R. Rossi3, C.P. Peckham'. 1 Child Health Institute, Dept Epidemiology Pae. 30
Guilford Street, London; 2MRC Trial Centre UCL, London, UK; 3Bambinogesu
Children's Hospital, Immun. Inf. Dpt., Roma, IT, 4Clinica Pediatrica, Universita di
Torino, Torino, IT, 5Clinica Pediatrica, Universita dir Padova, Torino, IT, 6Clinica
Pediatrica III, Universita Firenze Florence, IT, Italy; 7H6pital Necker Enfants
Malades, Paris Cedex, FR, France

Background: Antiretroviral therapy also for HIV infected children is increasingly
being used and introduced at an early stage of infection. Although the optimal
dose and timing of initiation has not been determined and there is no European
policy and guidelines reflect the availability of drugs and the expertise of local
clinicians.