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

Further Study Details: 

Expected Total Enrollment:  129

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Female

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.

Alabama
      Univ of Alabama at Birmingham, Birmingham,  Alabama,  35294,  United States; Recruiting
California
      UCSD Mother, Child & Adolescent HIV Program, San Diego,  California,  92103,  United States; No longer recruiting
      San Francisco General Hosp, San Francisco,  California,  94110,  United States; Recruiting
      Los Angeles County Medical Center/USC, Los Angeles,  California,  90033,  United States; Recruiting
      UCLA School of Medicine, Los Angeles,  California,  90095-1793,  United States; Recruiting
Florida
      Univ of Florida- Health Science Ctr, Jacksonville,  Florida,  32209,  United States; Recruiting
Georgia
      Emory Univ, Atlanta,  Georgia,  30308,  United States; Recruiting
Hawaii
      University of Hawaii, Honolulu,  Hawaii,  98616-2396,  United States; Recruiting
Illinois
      Rush Presbyterian - Saint Luke's Med Ctr, Chicago,  Illinois,  60612,  United States; Recruiting
      Cook County Hosp Core Ctr, Chicago,  Illinois,  60612,  United States; Recruiting
      Northwestern University, Chicago,  Illinois,  60611-3015,  United States; Recruiting
      Chicago Childrens Memorial Hospital (Pediatric), Chicago,  Illinois,  60614,  United States; Recruiting
Indiana
      Indiana Univ Hosp, Indianapolis,  Indiana,  46202,  United States; Recruiting
Michigan
      Childrens Hospital of Michigan, Detroit,  Michigan,  48201,  United States; Recruiting
      Hutzel Hospital, Detroit,  Michigan,  48201-1427,  United States; Recruiting
Minnesota
      Hennepin County Med Clinic, Minneapolis,  Minnesota,  55455-0392,  United States; Recruiting
New Jersey
      Univ of Med & Dentistry of NJ/Univ Hosp, Newark,  New Jersey,  07103,  United States; Recruiting
New York
      Jacobi Med Ctr, Bronx,  New York,  10461,  United States; Recruiting
      State Univ of New York at Stony Brook, Stony Brook,  New York,  11794-8111,  United States; Recruiting
      NYU/Bellevue, New York,  New York,  10016-6481,  United States; Recruiting
      Columbia University, New York,  New York,  10032-3784,  United States; Recruiting
North Carolina
      Duke Univ Med Ctr, Durham,  North Carolina,  27710,  United States; Recruiting
      Univ of North Carolina, Chapel Hill,  North Carolina,  27514,  United States; Recruiting
Ohio
      Case Western Reserve Univ, Cleveland,  Ohio,  44106,  United States; Recruiting
      MetroHealth Med Ctr, Cleveland,  Ohio,  44109-1998,  United States; Recruiting
Pennsylvania
      University of Pittsburgh, Pittsburgh,  Pennsylvania,  15213-2582,  United States; Recruiting
Rhode Island
      Miriam Hosp / Brown Univ, Providence,  Rhode Island,  02906,  United States; Recruiting
Tennessee
      Comprehensive Care Clinic, Nashville,  Tennessee,  37203,  United States; Recruiting
      The Regional Med Ctr, Memphis, Memphis,  Tennessee,  38105-2794,  United States; Recruiting
Texas
      University of Texas, Southwestern Medical Center, Dallas,  Texas,  75235-9173,  United States; Recruiting
Washington
      Univ of Washington (Seattle), Seattle,  Washington,  98104,  United States; Recruiting
Puerto Rico
      San Juan City Hosp, San Juan,  Puerto Rico; Recruiting

Study chairs or principal investigators

Beverly Sha,  Study Chair
Alice Stek,  Study Chair

Study ID Numbers:  ACTG A5150; ACTG A5153s; AACTG A5150; AACTG A5153s
Record last reviewed:  March 2005
Last Updated:  April 7, 2005
Record first received:  July 19, 2002
ClinicalTrials.gov Identifier:  NCT00041964
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08