A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Infants
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID)
First received: January 23, 2000
Last updated: March 30, 2012
Last Verified: March 2012
History of Changes
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.
Drug : Nevirapine
Primary Purpose: Prevention
|Official Title:||A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women|
Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):
|Study Completion Date:||May 2001|
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.
|Ages Eligible for Study:||13 Years and older|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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).
- 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.
You will not be eligible for this study if:
Contacts and LocationsChoosing 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: NCT00001135
Locations Show More
|United States, Alabama|
|Univ of Alabama at Birmingham - Pediatric|
|Birmingham, Alabama, United States, 35233|
|United States, California|
|UCSD Med Ctr / Pediatrics / Clinical Sciences|
|La Jolla, California, United States, 920930672|
|UCLA Med Ctr / Pediatric|
|Los Angeles, California, United States, 900951752|
|UCSF / Moffitt Hosp - Pediatric|
|San Francisco, California, United States, 941430105|
|United States, District of Columbia|
|Children's Hosp of Washington DC|
|Washington, District of Columbia, United States, 200102916|
|United States, Florida|
|Univ of Miami (Pediatric)|
|Miami, Florida, United States, 33161|
|United States, Illinois|
|Chicago Children's Memorial Hosp|
|Chicago, Illinois, United States, 606143394|
|United States, Louisiana|
|Tulane Univ / Charity Hosp of New Orleans|
|New Orleans, Louisiana, United States, 701122699|
|United States, Maryland|
|Johns Hopkins Hosp - Pediatric|
|Baltimore, Maryland, United States, 212874933|
|United States, Massachusetts|
|Children's Hosp of Boston|
|Boston, Massachusetts, United States, 021155724|
|Univ of Massachusetts Med School|
|Worcester, Massachusetts, United States, 016550001|
|United States, New Jersey|
|Univ of Medicine & Dentistry of New Jersey / Univ Hosp|
|Newark, New Jersey, United States, 071032714|
|United States, New York|
|Bellevue Hosp / New York Univ Med Ctr|
|New York, New York, United States, 10016|
|Columbia Presbyterian Med Ctr|
|New York, New York, United States, 10032|
|United States, North Carolina|
|Duke Univ Med Ctr|
|Durham, North Carolina, United States, 277103499|
|United States, Pennsylvania|
|Children's Hosp of Philadelphia|
|Philadelphia, Pennsylvania, United States, 191044318|
|United States, Tennessee|
|Saint Jude Children's Research Hosp of Memphis|
|Memphis, Tennessee, United States, 381052794|
|United States, Texas|
|Texas Children's Hosp / Baylor Univ|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Children's Hospital & Medical Center / Seattle ACTU|
|Seattle, Washington, United States, 981050371|
|Univ of Puerto Rico / Univ Children's Hosp AIDS|
|San Juan, Puerto Rico, 009365067|
Sponsors and CollaboratorsNational Institute of Allergy and Infectious Diseases (NIAID)
|Study Chair:||Dorenbaum A|
|Study Chair:||Sullivan JL|
|Responsible Party:||National Institute of Allergy and Infectious Diseases (NIAID)|
|ClinicalTrials.gov Identifier:||NCT00001135 History of Changes|
|Other Study ID Numbers:||ACTG 316B|
|Study First Received:||January 23, 2000|
|Last Updated:||March 30, 2012|
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):Placebos
Pregnancy Complications, Infectious
Disease Transmission, Vertical
Additional relevant MeSH terms:
ClinicalTrials.gov processed this data on June 20, 2018
This information is provided by ClinicalTrials.gov.