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NCT00041964 Clinical Trial

A Study of HIV Levels During Pregnancy and After Childbirth

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00041964
Other study ID # ACTG A5150
Secondary ID ACTG A5153sAACTG
Status Completed
Phase N/A
First received July 19, 2002
Last updated July 23, 2012

Study information
Verified date July 2012
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Completed
Enrollment 129
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 13 Years and older
Eligibility 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 Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
Puerto Rico San Juan City Hosp San Juan
United States Emory Univ Atlanta Georgia
United States Univ of Alabama at Birmingham Birmingham Alabama
United States Jacobi Med Ctr Bronx New York
United States Univ of North Carolina Chapel Hill North Carolina
United States Chicago Childrens Memorial Hospital (Pediatric) Chicago Illinois
United States Cook County Hosp Core Ctr Chicago Illinois
United States Northwestern University Chicago Illinois
United States Rush Presbyterian - Saint Luke's Med Ctr Chicago Illinois
United States Case Western Reserve Univ Cleveland Ohio
United States MetroHealth Med Ctr Cleveland Ohio
United States University of Texas, Southwestern Medical Center Dallas Texas
United States Childrens Hospital of Michigan Detroit Michigan
United States Hutzel Hospital Detroit Michigan
United States Duke Univ Med Ctr Durham North Carolina
United States University of Hawaii Honolulu Hawaii
United States Indiana Univ Hosp Indianapolis Indiana
United States Univ of Florida- Health Science Ctr Jacksonville Florida
United States Los Angeles County Medical Center/USC Los Angeles California
United States UCLA School of Medicine Los Angeles California
United States The Regional Med Ctr, Memphis Memphis Tennessee
United States Hennepin County Med Clinic Minneapolis Minnesota
United States Comprehensive Care Clinic Nashville Tennessee
United States Columbia University New York New York
United States NYU/Bellevue New York, New York
United States Univ of Med & Dentistry of NJ/Univ Hosp Newark New Jersey
United States University of Pittsburgh Pittsburgh Pennsylvania
United States Miriam Hosp / Brown Univ Providence Rhode Island
United States UCSD Mother, Child & Adolescent HIV Program San Diego California
United States San Francisco General Hosp San Francisco California
United States Univ of Washington (Seattle) Seattle Washington
United States State Univ of New York at Stony Brook Stony Brook New York

Sponsors (1)
Lead Sponsor Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

References & Publications (5)

Burns DN, Landesman S, Minkoff H, Wright DJ, Waters D, Mitchell RM, Rubinstein A, Willoughby A, Goedert JJ. The influence of pregnancy on human immunodeficiency virus type 1 infection: antepartum and postpartum changes in human immunodeficiency virus type 1 viral load. Am J Obstet Gynecol. 1998 Feb;178(2):355-9. — View Citation

Cao Y, Krogstad P, Korber BT, Koup RA, Muldoon M, Macken C, Song JL, Jin Z, Zhao JQ, Clapp S, Chen IS, Ho DD, Ammann AJ. Maternal HIV-1 viral load and vertical transmission of infection: the Ariel Project for the prevention of HIV transmission from mother to infant. Nat Med. 1997 May;3(5):549-52. — View Citation

Melvin AJ, Burchett SK, Watts DH, Hitti J, Hughes JP, McLellan CL, King PD, Johnson EJ, Williams BL, Frenkel LM, Coombs RW. Effect of pregnancy and zidovudine therapy on viral load in HIV-1-infected women. J Acquir Immune Defic Syndr Hum Retrovirol. 1997 Mar 1;14(3):232-6. — View Citation

Rich KC, Siegel JN, Jennings C, Rydman RJ, Landay AL. CD4+ lymphocytes in perinatal human immunodeficiency virus (HIV) infection: evidence for pregnancy-induced immune depression in uninfected and HIV-infected women. J Infect Dis. 1995 Nov;172(5):1221-7. — View Citation

Sha BE, Tierney C, Cohn SE, Sun X, Coombs RW, Frenkel LM, Kalams SA, Aweeka FT, Bastow B, Bardeguez A, Kmack A, Stek A; Aids Clinical Trials Group ACTG A5150 Team. Postpartum viral load rebound in HIV-1-infected women treated with highly active antiretrov — View Citation

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