A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Infants
NCT ID: NCT00001135
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
2009 participants
INTERVENTIONAL
2001-05-31
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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PREVENTION
DOUBLE
Interventions
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Nevirapine
Eligibility Criteria
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Inclusion Criteria
* 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 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.
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Dorenbaum A
Role: STUDY_CHAIR
Sullivan JL
Role: STUDY_CHAIR
Locations
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Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Children's Hosp of Washington DC
Washington D.C., District of Columbia, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 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
Duke Univ Med Ctr
Durham, North Carolina, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
Countries
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References
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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. doi: 10.1097/00126334-200407010-00006.
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. doi: 10.1016/j.ajog.2003.07.018.
Other Identifiers
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11292
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 316B
Identifier Type: -
Identifier Source: org_study_id