A Study of HIV Levels During Pregnancy and After Childbirth

July 23, 2012 updated by: National Institute of Allergy and Infectious Diseases (NIAID)

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment

129

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico
        • San Juan City Hosp
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Univ of Alabama at Birmingham
    • California
      • Los Angeles, California, United States, 90095-1793
        • UCLA School of Medicine
      • Los Angeles, California, United States, 90033
        • Los Angeles County Medical Center/USC
      • San Diego, California, United States, 92103
        • UCSD Mother, Child & Adolescent HIV Program
      • San Francisco, California, United States, 94110
        • San Francisco General Hosp
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Univ of Florida- Health Science Ctr
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory Univ
    • Hawaii
      • Honolulu, Hawaii, United States, 98616-2396
        • University of Hawaii
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Presbyterian - Saint Luke's Med Ctr
      • Chicago, Illinois, United States, 60611-3015
        • Northwestern University
      • Chicago, Illinois, United States, 60612
        • Cook County Hosp Core Ctr
      • Chicago, Illinois, United States, 60614
        • Chicago Childrens Memorial Hospital (Pediatric)
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ Hosp
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Childrens Hospital of Michigan
      • Detroit, Michigan, United States, 48201-1427
        • Hutzel Hospital
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455-0392
        • Hennepin County Med Clinic
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • Univ of Med & Dentistry of NJ/Univ Hosp
    • New York
      • Bronx, New York, United States, 10461
        • Jacobi Med Ctr
      • New York, New York, United States, 10032-3784
        • Columbia University
      • New York,, New York, United States, 10016-6481
        • NYU/Bellevue
      • Stony Brook, New York, United States, 11794-8111
        • State Univ of New York at Stony Brook
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Univ of North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Univ Med Ctr
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve Univ
      • Cleveland, Ohio, United States, 44109-1998
        • MetroHealth Med Ctr
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213-2582
        • University of Pittsburgh
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • Miriam Hosp / Brown Univ
    • Tennessee
      • Memphis, Tennessee, United States, 38105-2794
        • The Regional Med Ctr, Memphis
      • Nashville, Tennessee, United States, 37203
        • Comprehensive Care Clinic
    • Texas
      • Dallas, Texas, United States, 75235-9173
        • University of Texas, Southwestern Medical Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Univ of Washington (Seattle)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria

Patients may be eligible for this study if they:

  • Are age 13 or older.
  • Are between 22 and 30 weeks pregnant.
  • Have had their pregnancy confirmed by ultrasound at 14 weeks gestation or later.
  • Are infected with HIV.
  • Are planning to receive at least 8 weeks of highly active antiretroviral therapy (HAART) by the time they have their baby.
  • Are available for follow-up for the duration of the study.

Exclusion Criteria

Patients may not be eligible for this study if they:

  • Intend to terminate their pregnancy.
  • Intend to breast-feed their baby.
  • Are carrying a baby with major abnormalities, including spina bifida, anencephaly, hydrops, or ascites.
  • Have taken certain medications.
  • Are enrolled in other studies that require large blood draws.
  • Will be taking anti-HIV drugs only to prevent mother-to-child transmission of HIV, and not to treat the maternal infection itself.
  • Actively abuse drugs or alcohol in a way that would interfere with participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

  • Study Chair: Beverly Sha
  • Study Chair: Alice Stek

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

July 19, 2002

First Submitted That Met QC Criteria

July 19, 2002

First Posted (Estimate)

July 22, 2002

Study Record Updates

Last Update Posted (Estimate)

July 24, 2012

Last Update Submitted That Met QC Criteria

July 23, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTG A5150
  • ACTG A5153s
  • AACTG A5150
  • AACTG A5153s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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