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NCT00001135 Clinical Trial

A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Infants

HIV Infections Clinical Trial

Official title:
A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00001135
Other study ID # ACTG 316B
Secondary ID 11292
Status Completed
Phase Phase 3
First received
Last updated
Est. completion date May 2001

Study information
Verified date October 2021
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their infants can help reduce the chance that a mother will give HIV to her baby during delivery. NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their infants. NVP is inexpensive and is easily absorbed by the mother and transferred to the infant. It is thought that even a single dose to the mother and infant may provide enough protection to the baby during the time of exposure to HIV at birth.

Description:

NVP has several properties that make it an attractive candidate for antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early postpartum period. The pharmacokinetic profile suggests that NVP would be rapidly absorbed by the mother and transferred to the infant in utero when given during labor and delivery. The HIV-1 antiviral activity is rapid with significant reduction in plasma virus occurring within a few days of drug administration. In addition, NVP has been shown to penetrate cell-free virions and inactivate virion-associated reverse transcriptase (RT) in situ. This property would be potentially useful in inactivating cell-free virions in the genital tract as well as in breast milk. These characteristics of NVP suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of NVP may provide a prophylactic level of NVP in the infant during the time of exposure to virus in the birth canal and/or in the maternal blood. In addition, NVP may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk. Mothers are randomized to receive either a single oral dose of NVP during labor or the corresponding NVP placebo. Randomization occurs at any time after the 28th week of gestation. To assure balance between the treatment groups, the randomization is stratified using 2 factors: (1) antiretroviral therapy during the current pregnancy (no antiretroviral therapy at all, monotherapy [with no multi-agent therapy] for any duration, or multi-agent therapy for any duration), and (2) CD4 cell count at the time of randomization (less than 200 cells, 200 to 399 cells, or 400 cells or greater). Mothers are followed on-study for 4 to 6 weeks postpartum. All mothers are required to incorporate zidovudine (ZDV) into their current treatment regimen and should continue ZDV during delivery and give ZDV to their infants as recommended. ZDV will not be provided as part of the study. Infants receive a single oral dose of NVP (or the corresponding placebo) administered between 48 and 72 hours of life. The infant's study drug is the same as the mother's randomized treatment assignment. Infants are dosed with study drug according to their randomization group regardless of whether the mother received study drug or not. Infants are followed for 6 months of life and are tested for HIV at birth, 4 to 6 weeks of life, 3 months of life, and 6 months of life.

Recruitment information / eligibility
Status Completed
Enrollment 2009
Est. completion date May 2001
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 13 Years and older
Eligibility Inclusion Criteria You may be eligible for this study if you: - Are an HIV-positive pregnant woman. - Have been pregnant for at least 28 weeks. - Are at least 13 years of age (consent of parent or guardian is required if under 18). Exclusion Criteria You will not be eligible for this study if: - You intend to breast-feed. - You are allergic to benzodiazepines (a type of tranquilizer). - You have a liver disorder. - You have received nonnucleoside reverse transcriptase inhibitors (NNRTIs), a class of anti-HIV drugs. - You refuse to take ZDV.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Nevirapine

Locations
Country Name City State
Puerto Rico Univ of Puerto Rico / Univ Children's Hosp AIDS San Juan
United States Johns Hopkins Hosp - Pediatric Baltimore Maryland
United States Univ of Alabama at Birmingham - Pediatric Birmingham Alabama
United States Children's Hosp of Boston Boston Massachusetts
United States Chicago Children's Memorial Hosp Chicago Illinois
United States Duke Univ Med Ctr Durham North Carolina
United States Texas Children's Hosp / Baylor Univ Houston Texas
United States UCSD Med Ctr / Pediatrics / Clinical Sciences La Jolla California
United States UCLA Med Ctr / Pediatric Los Angeles California
United States Saint Jude Children's Research Hosp of Memphis Memphis Tennessee
United States Univ of Miami (Pediatric) Miami Florida
United States Tulane Univ / Charity Hosp of New Orleans New Orleans Louisiana
United States Bellevue Hosp / New York Univ Med Ctr New York New York
United States Columbia Presbyterian Med Ctr New York New York
United States Univ of Medicine & Dentistry of New Jersey / Univ Hosp Newark New Jersey
United States Children's Hosp of Philadelphia Philadelphia Pennsylvania
United States UCSF / Moffitt Hosp - Pediatric San Francisco California
United States Children's Hospital & Medical Center / Seattle ACTU Seattle Washington
United States Children's Hosp of Washington DC Washington District of Columbia
United States Univ of Massachusetts Med School Worcester Massachusetts

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 (2)

Cunningham CK, Balasubramanian R, Delke I, Maupin R, Mofenson L, Dorenbaum A, Sullivan JL, Gonzalez-Garcia A, Thorpe E, Rathore M, Gelber RD. The impact of race/ethnicity on mother-to-child HIV transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316. J Acquir Immune Defic Syndr. 2004 Jul 1;36(3):800-7. — View Citation

Watts DH, Balasubramanian R, Maupin RT Jr, Delke I, Dorenbaum A, Fiore S, Newell ML, Delfraissy JF, Gelber RD, Mofenson LM, Culnane M, Cunningham CK; PACTG 316 Study Team. Maternal toxicity and pregnancy complications in human immunodeficiency virus-infected women receiving antiretroviral therapy: PACTG 316. Am J Obstet Gynecol. 2004 Feb;190(2):506-16. — View Citation

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