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

70 Abstracts WePeB5962-WePeB5965

XIV International AIDS Conference

the effectiveness of AR treatment. However, the benefit and risk must be balanced. Large registers of woman-infant pairs are needed to determine the safety
of AR in the mother and newborn and to assess the current transmission rate.
Objectives: To describe the different AR regimens used and its safety and effectiveness during pregnancy for the mother and infants.
Methods: Mother-infant pairs were followed from early 2000 to the end of 2001
in 12 Spanish, according to a standardised protocol. 334 seropositive pregnant
women and their 344 offspring have been prospectively enrolled in a descriptive
study. In 275 children the infection status was known based upon HIV-PCR result
after 3 months of age.
Results: Median maternal age was 31.5 years (10% immigrants). Heterosexual
transmission was the risk factor in 52%. Mothers were on classes C and 3 in
5.6 and 4.7%. Coinfection with hepatitis C occurred in 40%. At first trimester median CD4 and plasma VL were 471 cells/mm3 and 3.2 log10. In 254 mothers AR
treatment was given during pregnancy, 86% with HAART (63% with PI-containing
regimens, mostly nelfinavir). Near delivery, 61% had a VL below 400 cp/ml. Median gestational age was 38. The prematurity rate was 18.7%, not significantly
different with regard to the type of therapy. Elective C-section was performed in
76%. The tolerance and compliance with HAART were deemed good. At the third
trimester, 10% had glucose intolerance. 3 women died postpartum (2 shortly after delivery) and 5 children became infected (transmission rate:1.8%, 95% CI =
0.59-4.19).
Conclusions: In this study, heterosexual is the most common route of infection
for the HIV-infected pregnant women. Most seropositive pregnant women receive
HAART, generally with good tolerance. Glucose intolerance appears to be more
common in HAART treated patients. Prematurity has not been more frequently
observed in PI-containing regimens.
Presenting author: Isabel Solis Villamarzo, Unidad de Inmunodeficiencias. Departamento de Pedriatria, Hospital Doce de Octubre, Carretera de Andalucia,
Km. 5,4, 28041 Madrid, Spain, Tel.: [phone], Fax: [phone],
E-mail: [email protected]
WePeB5962 Comparison of virologic response in a cohort of
women and men treated with Nelfinavir containing
HAART regimens
P. Keiser', N.N. Nassar', G. Koen2, S. Moreno2. 'UTSouthwestern Medical
Center, Dallas, TX; 2Parkland Health and Hospital System, Dallas, United
States
Objectives: There is little clinical data on the response by women to anti-retroviral
therapy (ART). The over-whelming majority of subjects in clinical trials are men.
In addition, cohort studies suggest that women have more aggressive HIV infection than men. We performed a cohort study to compare virologic response ART
in men and women.
Methods: The Parkland HIV Database was queried for patients ART naive
patients treated with Nelfinavir (NLF) containing regimens. This observational
database contains demographic, pharmacy, and clinic visit data, as well as CD4
counts and HIV-1 plasma RNA (VL). Women subjects were paired with male subjects in a 1:2 match. The primary endpoint was the time to treatment failure. Secondary endpoints were the time to first HIV-1 plasma RNA < 400 copies/ml and
the proportion of patients with VL < 400 copies at 1 and 2 years on intention to
treat analysis (ITT).
Results: 162 anti-retroviral naive women treated with NLF containing regimen
were matched by CD4 count and VL to 3
24 ART naive men treated with NLF There were no differences in baseline CD4
counts, VL and rates of compliance but women were more likely to be African
American and to receive ZDV-3TC nucleoside combinations. Time to treatment
failure was longer in women compared to men (295 days vs. 236 days, P< 0.01).
Time to VL < 400 copies/ml was more rapid in women compared to men (77
days vs. 115 days, P < 0.01). Percentage of patients with VL < 400 copies/ml
was greater in women than men at 1 (48% vs. 34%, P < 0.01) and 2 years (36%
vs. 25%, P = 0.01) on ITT. Multivariate analysis using Cox model adjusting for
baseline differences in the two groups demonstrated decreased risk of failure in
women (OR = 0.75, P = 0.019)
Conclusions: Anti-retroviral naive women treated with NLF containing regimens
did better than men as measured by time to treatment failure, time to VL < 400
copies/ml and percentage of subjects with VL at 1 and 2 years.
Presenting author: Philip Keiser, 1936 Amelia Court, Dallas, Texas, 75235,
United States, Tel.: [phone], E-mail: [email protected]
WePeB5963 Medically eligible women not reporting use of
HAART
M.H. Cohen', J.A. Cook2, D. Grey2, S.J. Gange3, M. Young4, L. Hannau5,
e Tien6, A. Levine 7 Te CORE Center, Cook County Hospital The CORE
Center, 2020 W Harrison, Chicago IL 60612, United States; 2University of
Illinois, Chicago, United States; 3johns Hopkins School of Hygiene and Public

Health, Baltimore, United States; 4 Georgetown University Medical Center,
Washington DC, United States; 5Montefiore Medical Center, New York, United
States; 6University of California at San Francisco, San Francisco, United States;
7University of Southern California, Los Angeles, United States
Background: Women with human immunodeficiency virus (HIV) for whom highly
active antiretroviral therapy (HAART) is indicated may not receive appropriate an
tiretroviral therapy. We investigated the prevalence and predictors of US women
who were eligible but not reporting HAART use.
Methods: Data from the seropositive sample of the Women's Interagency HIV
Study (WIHS), a multi-center study of HIV disease progression in 6 US cities, collected semiannually were used in this analysis. Pearson correlations were used
to examine zero-order relationships and multiple logistic regression analysis was
used to examine multivariate predictors of no HAART use.
Results: Of the 1219 HIV infected women seen at study visits between October
2000 and April 2001, 253 women for whom HAART was clinically indicated(CD4
count <350 and/or a viral load>50,000) reported not taking HAART Another 635
reported HAART use, and 331 women for whom HAART was not indicated reported no therapy, mono therapy or combination therapy. Among women indicated
for therapy, no HAART use was higher among women of color, and those who
recently used crack/cocaine/heroin, used drugs prior to baseline, experienced
physical abuse, were not employed, were not living in their own home/apartment,
did not have high income, and did not have private insurance. In the multivariate analysis, controlling for study site and other relevant variables, recent
crack/cocaine/heroin use, being non-white and experiencing physical or sexual
abuse increased the likelihood of no HAART use
Conclusions: During one recent visit cycle, one out of four women in WIHS for
whom HAART was indicated reported not taking this therapy. Race, current drug
use and a history of physical and sexual abuse were associated with not using
HAART. Providing drug treatment, abuse identification and referrals may positively impact HIV disease care in women.
Presenting author: Mardge Cohen, The CORE Center, 2020 W. Harrison,
Chicago IL 60612, United States, Tel.: [phone], Fax: [phone],
E-mail: [email protected]
WePeB5964 Gender bias in clinical trials of AIDS drugs
M.A. Pardo', M.T. Ruiz', A. Gimeno 2, L. Navarro2, A. Garcia3, M.V. Tarazona4,
M.T. Aznar5. ' Dep. Salud Piblica. Universidad de Alicante, Servicio de
Farmacia., Hospital Universitario de San Juan, Crta. de Valencia s/n, Alicante,
Spain; 2 Servicio de Microbiologia. Hospital de Alicante., Alicante, Spain;
3Servicio de Farmacia. Hospital de Alicante., Alicante, Spain; 4Servicio de
Farmacia. Hospital de Alcoy, Alicante, Spain; 5Servicio de Farmacia. Hospital
Universitario de San Juan, Alicante, Spain
Background: There is historical evidence that women have been underrepresented in medical research. The objective of this study is to assess the women
representation in clinical trials of AIDS drugs and reporting the information from
the gender perspective.
Methods: It was developed a systematic review of 49 randomized and controlled
clinical trials of antiretroviral therapy efficacy in adults, indexed in the Cochrane
Controlled Trials Register (1990 -2000). The information recovered was: a) Sex distribution: number of men and
women in the trial. b) If data of men and women are presented separately to facilitate meta-analyses c) If the statistical analyses developed had been stratify by
sex to determine possible differences in the results between men and women. d)
Gender-related information in Discussion section.
Results: The number of participants enrolled was 15,612. Mean =
318.61 (15-1775). In 3 of the reports (909 patients enrolled) provided no information about sex distribution of their samples. In the other 46 papers, participated
14,703 patients (12,767 were men and 1,936 women). Mean 277 (13-1571) and
42.09 (0-277) respectively
The proportional mean of women in the trials was 12.25%. Analyses by sex were
provided in none of the trials. Only 2 trials (4.08%) specified a stratified analysis
by sex to determine differences. And only one (2.04%) of the 49 articles mentioned some gender related information in discussion section.
Conclusions: Women have been poorly represented in the randomized controlled trials of AIDS drugs analyzed. The design of the trials does not allow obtain
gender related information because it is not adequately presented.
Presenting author: Ma Angeles Pardo, Servicio de Farmacia., Hospital Universitario de San Juan, Crta. de Valencia s/n, Alicante, Spain, Tel.: [phone],
Fax: [phone], E-mail: [email protected]
WePeB5965 Gender but not ethnicity predicts CD4 cell
increase in response to sustained virologic
suppression (SVS) from highly active antiretroviral
therapy (HAART)
T.P. Giordano', F Visnegarwala', J.A. Wright1, A. Adu-Oppong2, E.A. Graviss'.
'Baylor College of Medicine, baylor college of medicine, bcm 286 room N 1319,
houston, texas 77030, United States; 2The Thomas Street Clinic, Houston, TX,
United States
Background: Little data exist to determine if CD4 response to SVS from HAART
differs by gender or ethnicity.

Methods: A retrospective cohort of patients from the Thomas Street Clinic who
were antiretroviral naive, had complete baseline (BL) viral load (VL) and CD4
data, and had a SVS from HAART at 6 months was identified. SVS was defined
as <400 copies/mL on at least 2 consecutive occasions, the last of which was
120-240 days after HAART began.
Results: Among 79 men and 24 women, BL characteristics were: 50% African
American, 31% Hispanic, 19% white; mean age 39 years; 37% men who have sex