Abstract Book Vol. 2 [International Conference on AIDS (14th: 2002: Barcelona, Spain)]

490 Abstracts ThOrD1427-ThOrD1l430

XIV International AIDS Conference

Presenting author: Boris Renjifo, Harvard AIDS Institute, 651 Huntington Av,
Boston, MA 02115, United States Territory, Tel.: [phone], Fax: [phone], E-mail: brenjifo @ aol.com
ThOrDi14271 Neonatal post-exposure prophylaxis with
Snevirapine and zidovudine reduces mother-to-child
transmission of HIV
T.E. Taha1, N. Kumwenda1, A. Gibbons1, D. Hoover2, S. Fiscus3, V. Lema4,
G. Liomba4, R. Broadhead4. 1Johns Hopkins University School of Public Health,
Baltimore, MD, United States; 2Rutgers University, Piscataway, United States;
3University of N. Carolina, Chapel-Hill, United States; I University of Malawi
College of Medicine, Blantyre, Malawi
Background: We hypothesized that a combined regimen of oral NVP and Zidovudine (ZDV) given directly to the newborn alone could reduce mother-to-child
transmission (MTCT) of HIV.
Methods: An open-label randomized clinical trial is in progress in Blantyre,
Malawi. Counseling of women for HIV testing and enrollment was conducted postnatally. Infant cord blood samples from all deliveries were stored until a signed
informed consent for testing was obtained. Babies of HIV positive women arriving
very late for delivery were randomized to receive either NVP plus ZDV or NVP
alone. Both NVP (2mg/Kg weight single dose) and ZDV (4mg/Kg weight twice
daily for a week) were administered orally soon after birth. Babies were monitored
for adverse events at birth, 1 week, 6 weeks, and 3,6,9 and 12 months. Venous
blood samples from the baby were collected at birth and 6 weeks to detect HIV
infection using RNA PCR. Proportions infected at 6 weeks among all babies and
among those HIV negative at birth were estimated.
Results: To this date, 1059 (of 1180 sample needed) babies have been enrolled
(531 randomized to NVP+ZDV and 528 randomized to NVP alone). Of these, 809
have so far been PCR-tested for HIV through 6 weeks (408 in the NVP+ZDV arm
and 401 in the NVP only arm). At 6 weeks, 14.7% (60/408) were HIV positive
among those randomized to NVP+ZDV and 22.7% (91/401) among those randomized to NVP only (p=0.004, exact test). Among babies who were negative at
birth but positive at 6 weeks, 7.2% (27/375) were in the NVP+ZDV arm and 12.1%
(43/355) were in the NVP only arm (p=0.02, exact test). Serious adverse events
were rare (about 2% in each arm).
Conclusions: Compared to NVP only, this post-exposure NVP+ZDV prophylactic
regimen reduced overall MTCT of HIV by about 35% and by about 41% among
those not infected at birth. This regimen is simple and targets only the baby, avoiding complexities of maternal regimens including development of drug resistance.
Presenting author: Taha Taha, Rm E6140, 615 N. Wolfe St., Baltimore, MD
21205, United States, Tel.: [phone], Fax: [phone], E-mail: ttaha
@jhsph.edu
ThOrD1428 Effectiveness of a short course of zidovudine +
nevirapine to prevent mother-to-child transmission
(PMTCT) of HIV-1: The Ditrame Plus ANRS 1201
Project in Abidjan, Cote d'lvoire
F. Dabis1, V. Leroy1, L. Bequet2, D.K. Ekouevi2, I. Viho2, A. Horo2,
M. Timitb-Konan3, C. Welffens-Ekra3. 1Unitd Inserm 330, Universitd Bordeaux 2,
Universite Victor Segalen, Bordeaux, France; 2Project Ditrame Plus, Programme
PACCI, Abidjan, Cote dIvoire; 3CHU Yopougon, Abidjan, Cote dIvoire
Background: In Africa, short regimens of monotherapy of either zidovudine
(ZDV) or nevirapine (NVP) have demonstrated their efficacy for PMTCT. The aim
of this study is to evaluate the effectiveness and tolerance of a short regimen of
ZDV + NVP for peripartum PMTCT.
Methods: A non randomized therapeutic cohort in Abidjan, Cote d'lvoire was
initiated in March 2001. Consenting women diagnosed with HIV-1 infection and
informed of their serostatus start treatment (ZDV 300 mg bid orally) >= 36 weeks
of amenorrhea and no later than beginning of labour when an oral loading dose
of 600 mg ZDV and 200 mg of NVP is given. The neonate is treated for one week
with a syrup of ZDV (2 mg/kg every 6 hours), and a single dose of syrup of 2 mg/kg
of NVP on Day 3. The woman receives a supplementation in multivitamins, iron
and folates, and a malaria chemoprohylaxis. Children are diagnosed as having
HIV infection when viral load is >5000 HIV RNA copies/ml at 4 weeks measured
by branched DNA (Chiron). The reference for comparison will be the pooled cohort treated by a short regimen of ZDV monotherapy beginning at 36 weeks and
recruited in two randomized trials in Abidjan and Bobo Dioulasso, ANRS 049 and
CDC (N=319, with an estimated six week MTCT rate of 14.7% [Leroy et al. AIDS
in press]).
Results: A total of 204 HIV+ pregnant women have been included in the project
as of Dec. 31th 2001. Median age was 26 years and median CD4 count 365/mm3
(70% <500/mm3). 171 women delivered 178 children live-births (5 twins and 1
triplet). Eight of the 141 children with four week follow-up have been diagnosed
with HIV infection: transmission rate was 5.7% (95% Confidence Interval: 2.5 -10.9%). 7/8 transmitting mothers had CD4 <500/mm3. Four neonates (2.2%)

died within the first 28 days of life. Enrollment continues up to 400.
Conclusions: Early findings of the Ditrame Plus project show a low rate of peripartum transmission from mother-to-child with ZDV + Nevirapine.
Presenting author: F Dabis, Unite Inserm 330, Universite Victor Segalen, 146
rue Leo Saignat, 33076 Bordeaux Cedex, France, Tel.: [phone], Fax:
[phone], E-mail: [email protected]

ThOrD 429 Missed opportunities of perinatal HIV prevention
among HIV-exposed infants born 1996-2000,
Pediatric Spectrum of HIV Disease Cohort
V.B. Peters1, P. Thomas 1, K.L. Liu1, B. Gill1, K.L. Dominguez2, T. Frederick3,
S. Melville4, H. Hsu 5, J.C. Orengo 6, T. Rakusan7, RS.D. The Pediatric
Spectrum of HIV Disease Consortium8. I New York City, Department of Health,
346 Broadway, Room 706, New York, New York, United States; 2Centers for
Disease Control and Prevention, Atlanta, GA, United States; 3Los Angeles
County Department of Health Services, Los Angeles, CA, United States; 4Texas
Department of Health, Austin, TX, United States; 5Massachusetts State
Laboratories Institute, Jamaica Plain, MA, United States; 6Departamento de
Salud, San Juan, PR, United States; 7Children's National Medical Center,
Washington, DC, United States; The PSD Project, US, United States
Background: We describe trends in perinatal HIV prevention methods, transmission rates, and the contribution of missed opportunities of prevention in infants
enrolled in CDC's Pediatric Spectrum of HIV Disease Project (PSD).
Methods: We analyzed data from infant medical records on 5,054 HIV-exposed
deliveries, 1996-00, from 6 U.S. sites in the PSD project.
Results: Overall, 423 (8.4%) infants were HIV-infected (HIV+), 3,706 (73.3%)
HIV-uninfected (HIV-), and 925 (18.3%) HIV-indeterminate. 92% of 4,409 women
with data on prenatal care (PNC) had PNC. Lack of PNC was associated with maternal intravenous and street drug use: 17% of 1,119 women with reported drug
use had no PNC vs. 5% of 3,935 women with no reported drug use (O.R. 4.0, 95%
C.I. 3.2-5.0). 90% of 4,038 women with PNC had a prenatal (PN) HIV test. From
1996-00, use of PN zidovudine (ZDV) alone decreased from 59% to 9% and use
of PN ZDV with other antiretrovirals (ARVs) (combo ZDV) increased from 4% to
63%. 3,215 deliveries had complete data on maternal and neonatal (neo) ARVs:
perinatal HIV transmission was 2.5% in 1,699 deliveries with PN combo ZDV +
intrapartum (IP) ZDV+ neo ZDV, 5.4% in 1,101 deliveries with PN ZDV + IP ZDV
+ neo ZDV and 28% in 415 deliveries with no PN, IP, and neo ARVs. Complete
data on prenatal events were available in 306 HIV+ and 3,129 HIV-infants. 57%
of mothers of HIV+ infants had missed opportunities for perinatal HIV prevention
(19% lacked PNC; 29% had PNC but had no PN HIV test; and 9% tested prenatally did not receive ARVs) vs. 16% of mothers of HIV- infants (8% lacked PNC;
4% had PNC but had no PN HIV test; and 4% tested prenatally did not receive
ARVs) (OR 6.82, 95% C.I. 5.3-8.8).
Conclusion: Missed opportunities for perinatal HIV prevention contributed to over
half of cases of HIV+ infants. Lack of PNC, highly associated with drug abuse, and
lack of PN HIV testing are major missed opportunities for perinatal HIV prevention.
Presenting author: Vicki Peters, 346 Broadway, Room 706, New York, New
York, United States, Tel.: [phone], Fax: [phone], E-mail: vpeters
@worldnet.att.net
ThOrD1430 Acceptance of and adherence to zidovudine and
infant formula for preventing mother-child HIV
transmission, Bangkok, Thailand
U. Chaovarindr1, A. Chalermchokcharoenkit2, S. Asavapiriyanont1, K. Sirimai2,
M. Culnane3, A. Teeraratkul3, R.J. Simonds4, J.W. Tappero3. 1Rajavithi
Hospital, Bangkok, Thailand; 2Faculty of Medicine, Siriraj Hospital, Mahidol
University, Bangkok, Thailand; 3 Thai MOPH-Centers for Disease Control and
Prevention, Nonthaburi, Thailand; 4Centers for Disease Control and Prevention,
Atlanta, United States
Introduction: At Rajavithi and Siriraj Hospitals in Bangkok, standard practice for
preventing mother-child HIV transmission (PMTCT) includes voluntary counseling
and HIV testing for all pregnant women, and short-course zidovudine (ZDV) twice
daily from 34-36 weeks' gestation, 4 weeks of infant ZDV, and infant formula. We
sought to understand women's acceptance, adherence, and concerns about this
program.
Methods: Consenting HIV+ mothers who delivered between 11/99-10/01 were
interviewed at 1-3 days and 1 month postpartum.
Results: Of 690 HIV+ women giving birth during this period, 494 (72%) agreed
to participate. Of participants, 448 (91%) had antenatal care and 350 (71%) took
ZDV. Of those taking ZDV, 31% reported that ZDV reminded them of their HIV+
status; 26% feared that relatives or friends might see them taking ZDV; 23%
feared that ZDV might harm themselves or their babies; and 15% reported missing any ZDV doses. Common reasons for missing doses were forgetting (33%),
travel or hospitalization (17%) and running out of pills (12%). Intrapartum oral
ZDV was received by 341 (69%). All 501 infants born to the 494 women took
ZDV. Of the 460 infants followed at 1 month, 31% were reported to have missed a
dose. The most common reasons were mother forgetting (59%), and infant sleeping (30%). 22 (2%) infants were breastfed; 12 by their mothers, and 10 by others.
The most common reason for breast feeding was urging by relatives or friends.
Conclusions: PMTCT interventions can be routinely implemented in busy urban
hospitals with good adherence. Programs may be improved by addressing the

women's concerns and helping improve strategies for adherence through counseling.
Presenting author: Mary Culnane, Thai - US CDC Collaboration, PO BOX 139,
DMS 6 Building - MOPH, Nonthaburi 11000, Thailand, Tel.: [phone], Fax:
[phone], E-mail: [email protected]