HIV Infections Clinical Trial
Official title:
A Prospective Observational Study of Virologic and Immunologic Changes in HIV-Infected Women During the Postpartum Period
The purpose of this study is to find out if HIV-infected pregnant women taking anti-HIV
drugs have an increased amount of HIV in their blood (viral load) after having the baby.
The purpose of A5153s, a substudy of A5150, is to characterize two anti-HIV drugs
(nelfinavir [NFV] and lopinavir/ritonavir [LPV/r]) in HIV-infected women during pregnancy
and after childbirth.
Sometimes pregnant women have an increase in their HIV viral load after their baby is born.
This study will try to find out how often this happens. It will also examine possible
reasons why the increase in viral load occurs.
Limited data suggest that HIV-infected pregnant women develop postpartum viral rebound.
However, viral load changes in the postpartum period have not been adequately characterized.
Changes in adherence to antiretroviral therapy, pregnancy-related changes in
pharmacokinetics of antiretroviral medications, and decline in immune competence are
mechanisms by which postpartum viral load rebound may occur. This study is designed to
characterize the incidence and magnitude of postpartum viral rebound during the initial 24
weeks postpartum and to explore the mechanisms and consequences of viral rebound.
Eligible patients are evaluated at gestational weeks 34 and 36, at delivery, and at regular
visits for 96 weeks postpartum. Most evaluations include a medical history, physical exam,
laboratory tests, and adherence and quality-of-life questionnaires. Viral load and CD4/CD8
cell counts are measured frequently.
Patients are expected to receive at least 8 weeks of stable HAART before delivery, and to
continue HAART throughout the remainder of the study. The choice of HAART is left to the
primary provider. No antiretroviral drugs are provided by this study.
Patients participating in the A5153s substudy receive either NFV or LPV/r as part of their
HAART. Pharmacokinetic blood sampling takes place at 36 weeks gestation, 6 weeks postpartum,
and 24 weeks postpartum. Patients record the administration times and doses of their NFV or
LPV/r for 48 hours prior to each substudy visit, and hold their regularly scheduled doses of
antiretroviral medications on substudy days. Patients arrive at the clinic fasting (no food
or drink for the previous 8 hours) and are given a standardized breakfast prior to
supervised administration of their NFV or LPV/r dose. An intravenous catheter is placed in
an arm vein for blood collection at pre-dose and 1, 2, 4, and 6 hours post-dose.
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