A Study of Nevirapine for the Prevention of HIV Transmission From Mothers to Their Babies
NCT ID: NCT00000869
Last Updated: 2021-10-28
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
2009 participants
INTERVENTIONAL
2001-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Women are randomized to receive either NVP or the corresponding placebo in active labor. Women are randomized at any time after their 32nd week gestation \[AS PER AMENDMENT 1/13/98: 28th week gestation\] \[AS PER AMENDMENT 2/23/00: 20th week gestation\]. The randomization is stratified using two factors: (1) use of \[AS PER AMENDMENT 2/23/00: current or anticipated\] antiretroviral therapy during the current pregnancy (no therapy at all; monotherapy for any duration; multi-agent therapy for any duration), and (2) CD4 cell count at the time of randomization (less than 200 cells; 200 - 399 cells; 400 cells or greater). Mothers are followed on study for 4 to 6 weeks postpartum. Mothers are also encouraged to follow the regimen of zidovudine (ZDV) outlined in the Office of Public Health and Science (PHS) treatment guidelines for both themselves and their infants. Infants are administered either NVP or placebo 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 the study drug according to their randomization group regardless of whether the mother received the study drug. Infants are followed for 4 to 6 weeks, and are tested for HIV at 4 to 6 weeks, 3 months, and 6 months.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Nevirapine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Are HIV-positive.
* Are at least 20 weeks pregnant. (This study has been changed. Women no longer have to be 28 weeks pregnant.)
* Have consent from the child's father (if available).
* Are at least 13 years old (consent of parent or guardian required if under 18).
Exclusion Criteria
* Have ever taken NNRTIs (nonnucleoside reverse transcriptase inhibitors).
* Are enrolled in another pregnancy treatment study.
* Are allergic to benzodiazepines.
* Have liver disease.
* Plan to breast-feed.
13 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alejandro Dorenbaum
Role: STUDY_CHAIR
John Sullivan
Role: STUDY_CHAIR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Univ of Alabama at Birmingham - Pediatric
Birmingham, Alabama, United States
Univ of South Alabama
Mobile, Alabama, United States
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States
Long Beach Memorial (Pediatric)
Long Beach, California, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States
San Francisco Gen Hosp
San Francisco, California, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, United States
Children's Hosp of Denver
Denver, Colorado, United States
Connecticut Children's Med Ctr
Farmington, Connecticut, United States
Univ of Connecticut / Farmington
Farmington, Connecticut, United States
Washington Hosp Ctr
Washington D.C., District of Columbia, United States
Howard Univ Hosp
Washington D.C., District of Columbia, United States
North Broward Hosp District
Fort Lauderdale, Florida, United States
Univ of Florida Gainesville
Gainesville, Florida, United States
Univ of Florida Health Science Ctr / Pediatrics
Jacksonville, Florida, United States
Univ of Miami / Jackson Memorial Hosp
Miami, Florida, United States
Univ of Miami (Pediatric)
Miami, Florida, United States
Med College of Georgia
Augusta, Georgia, United States
The Med Ctr Inc
Columbus, Georgia, United States
Cook County Hosp
Chicago, Illinois, United States
Univ of Illinois College of Medicine / Pediatrics
Chicago, Illinois, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, United States
Tulane Univ / Charity Hosp of New Orleans
New Orleans, Louisiana, United States
Tulane Univ Hosp of New Orleans
New Orleans, Louisiana, United States
Univ Hosp
New Orleans, Louisiana, United States
Univ of Maryland at Baltimore / Univ Med Ctr
Baltimore, Maryland, United States
Johns Hopkins Hosp - Pediatric
Baltimore, Maryland, United States
Children's Hosp of Boston
Boston, Massachusetts, United States
Brigham and Women's Hosp
Boston, Massachusetts, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, United States
Baystate Med Ctr of Springfield
Springfield, Massachusetts, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, United States
Children's Hosp of Michigan
Detroit, Michigan, United States
Univ of Mississippi Med Ctr
Jackson, Mississippi, United States
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
Camden, New Jersey, United States
UMDNJ - Robert Wood Johnson Med School / Pediatrics
New Brunswick, New Jersey, United States
St Peter's Med Ctr
New Brunswick, New Jersey, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, United States
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
Newark, New Jersey, United States
Children's Hosp at Albany Med Ctr
Albany, New York, United States
North Shore Univ Hosp
Great Neck, New York, United States
Bellevue Hosp / New York Univ Med Ctr
New York, New York, United States
Metropolitan Hosp Ctr
New York, New York, United States
Columbia Presbyterian Med Ctr
New York, New York, United States
Univ of Rochester Med Ctr
Rochester, New York, United States
SUNY Health Sciences Ctr at Syracuse / Pediatrics
Syracuse, New York, United States
Bronx Lebanon Hosp Ctr
The Bronx, New York, United States
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
The Bronx, New York, United States
Duke Univ Med Ctr
Durham, North Carolina, United States
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
Durham, North Carolina, United States
Children's Hosp of Philadelphia
Philadelphia, Pennsylvania, United States
Hosp of the Univ of Pennsylvania
Philadelphia, Pennsylvania, United States
Saint Christopher's Hosp for Children
Philadelphia, Pennsylvania, United States
Temple Univ School of Medicine
Philadelphia, Pennsylvania, United States
Med Univ of South Carolina
Charleston, South Carolina, United States
Regional Med Ctr at Memphis
Memphis, Tennessee, United States
Methodist Hosp Central
Memphis, Tennessee, United States
Saint Jude Children's Research Hosp of Memphis
Memphis, Tennessee, United States
Vanderbilt Univ Med Ctr
Nashville, Tennessee, United States
Children's Med Ctr of Dallas
Dallas, Texas, United States
Texas Children's Hosp / Baylor Univ
Houston, Texas, United States
Children's Hosp of the King's Daughters
Norfolk, Virginia, United States
Senetara Norfolk Gen Hosp
Norfolk, Virginia, United States
Med College of Virginia
Richmond, Virginia, United States
Children's Hospital & Medical Center / Seattle ACTU
Seattle, Washington, United States
Tacoma Gen Hosp
Tacoma, Washington, United States
Ramon Ruiz Arnau Univ Hosp / Pediatrics
Bayamón, , Puerto Rico
Univ of Puerto Rico / Univ Children's Hosp AIDS
San Juan, , Puerto Rico
San Juan City Hosp
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Cunningham CK, Britto P, Gelber R, Dorenbaum A, Mofenson L, Culnane M, Sullivan JL. Genotypic resistance analysis in women participating in PACTG 316 with HIV-1 RNA >400 copies/ml. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 712)
Mirochnick M, Dorenbaum A, Cunningham-Schrader B, Cunningham C, Gelber R, Mofenson L, Sullivan J. Cord blood protease inhibitor (PI) concentrations in infants born to mothers receiving PIs. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no 710)
Dorenbaum A. Report of results of PACTG 316: an international phase III trial of standard antiretroviral (ARV) prophylaxis plus nevirapine (NVP) for prevention of perinatal HIV transmission. 8th Conf Retro and Opportun Infect. 2001 Feb 4-8 (abstract no LB7)
Cunningham CK, Chaix ML, Rekacewicz C, Britto P, Rouzioux C, Gelber RD, Dorenbaum A, Delfraissy JF, Bazin B, Mofenson L, Sullivan JL. Development of resistance mutations in women receiving standard antiretroviral therapy who received intrapartum nevirapine to prevent perinatal human immunodeficiency virus type 1 transmission: a substudy of pediatric AIDS clinical trials group protocol 316. J Infect Dis. 2002 Jul 15;186(2):181-8. doi: 10.1086/341300. Epub 2002 Jun 26.
Mirochnick M, Dorenbaum A, Blanchard S, Cunningham CK, Gelber RD, Mofenson L, Culnane M, Sullivan JL. Predose infant nevirapine concentration with the two-dose intrapartum neonatal nevirapine regimen: association with timing of maternal intrapartum nevirapine dose. J Acquir Immune Defic Syndr. 2003 Jun 1;33(2):153-6. doi: 10.1097/00126334-200306010-00006.
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.
Newell ML, Huang S, Fiore S, Thorne C, Mandelbrot L, Sullivan JL, Maupin R, Delke I, Watts DH, Gelber RD, Cunningham CK; PACTG 316 Study Team. Characteristics and management of HIV-1-infected pregnant women enrolled in a randomised trial: differences between Europe and the USA. BMC Infect Dis. 2007 Jun 20;7:60. doi: 10.1186/1471-2334-7-60.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
11290
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 316
Identifier Type: -
Identifier Source: org_study_id