A Study of HIV Levels During Pregnancy and After Childbirth
- Conditions
- HIV InfectionsPregnancy
- Registration Number
- NCT00041964
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 129
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (32)
Univ of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Los Angeles County Medical Center/USC
🇺🇸Los Angeles, California, United States
UCLA School of Medicine
🇺🇸Los Angeles, California, United States
UCSD Mother, Child & Adolescent HIV Program
🇺🇸San Diego, California, United States
San Francisco General Hosp
🇺🇸San Francisco, California, United States
Univ of Florida- Health Science Ctr
🇺🇸Jacksonville, Florida, United States
Emory Univ
🇺🇸Atlanta, Georgia, United States
University of Hawaii
🇺🇸Honolulu, Hawaii, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Cook County Hosp Core Ctr
🇺🇸Chicago, Illinois, United States
Scroll for more (22 remaining)Univ of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States