A Study of HIV Levels During Pregnancy and After Childbirth

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00041964
First received: July 19, 2002
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

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.


Condition
HIV Infections
Pregnancy

Study Type: Observational
Official Title: A Prospective Observational Study of Virologic and Immunologic Changes in HIV-Infected Women During the Postpartum Period

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Estimated Enrollment: 129
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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041964

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

Additional Information:
Publications:

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00041964     History of Changes
Other Study ID Numbers: ACTG A5150, ACTG A5153s, AACTG A5150, AACTG A5153s
Study First Received: July 19, 2002
Last Updated: July 23, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Lopinavir
Pregnancy Trimester, Third
Pregnancy Complications, Infectious
HIV Protease Inhibitors
Ritonavir
Nelfinavir
Viral Load
puerperium

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 10, 2014