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A Study of Nevirapine for the Prevention of HIV Transmission From Mothers to Their Babies

Primary Purpose

HIV Infections, Pregnancy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Nevirapine
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring Pregnancy Trimester, Third, Placebos, Pregnancy, Pregnancy Complications, Infectious, Administration, Oral, Nevirapine, Disease Transmission, Vertical, Reverse Transcriptase Inhibitors, Anti-HIV Agents

Eligibility Criteria

13 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Women may be eligible for this study if they: 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 Women will not be eligible for this study if they: 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.

Sites / Locations

  • Univ of Alabama at Birmingham - Pediatric
  • Univ of South Alabama
  • UCSD Med Ctr / Pediatrics / Clinical Sciences
  • Long Beach Memorial (Pediatric)
  • Los Angeles County - USC Med Ctr
  • UCLA Med Ctr / Pediatric
  • Harbor - UCLA Med Ctr / UCLA School of Medicine
  • San Francisco Gen Hosp
  • UCSF / Moffitt Hosp - Pediatric
  • Children's Hosp of Denver
  • Connecticut Children's Med Ctr
  • Univ of Connecticut / Farmington
  • Washington Hosp Ctr
  • Howard Univ Hosp
  • North Broward Hosp District
  • Univ of Florida Gainesville
  • Univ of Florida Health Science Ctr / Pediatrics
  • Univ of Miami / Jackson Memorial Hosp
  • Univ of Miami (Pediatric)
  • Med College of Georgia
  • The Med Ctr Inc
  • Cook County Hosp
  • Univ of Illinois College of Medicine / Pediatrics
  • Chicago Children's Memorial Hosp
  • Univ of Chicago Children's Hosp
  • Tulane Univ / Charity Hosp of New Orleans
  • Tulane Univ Hosp of New Orleans
  • Univ Hosp
  • Univ of Maryland at Baltimore / Univ Med Ctr
  • Johns Hopkins Hosp - Pediatric
  • Children's Hosp of Boston
  • Brigham and Women's Hosp
  • Boston City Hosp / Pediatrics
  • Baystate Med Ctr of Springfield
  • Univ of Massachusetts Med School
  • Children's Hosp of Michigan
  • Univ of Mississippi Med Ctr
  • Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
  • UMDNJ - Robert Wood Johnson Med School / Pediatrics
  • St Peter's Med Ctr
  • Univ of Medicine & Dentistry of New Jersey / Univ Hosp
  • Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
  • Children's Hosp at Albany Med Ctr
  • Bronx Lebanon Hosp Ctr
  • Bronx Municipal Hosp Ctr/Jacobi Med Ctr
  • North Shore Univ Hosp
  • Bellevue Hosp / New York Univ Med Ctr
  • Metropolitan Hosp Ctr
  • Columbia Presbyterian Med Ctr
  • Univ of Rochester Med Ctr
  • SUNY Health Sciences Ctr at Syracuse / Pediatrics
  • Duke Univ Med Ctr
  • Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
  • Children's Hosp of Philadelphia
  • Hosp of the Univ of Pennsylvania
  • Saint Christopher's Hosp for Children
  • Temple Univ School of Medicine
  • Med Univ of South Carolina
  • Regional Med Ctr at Memphis
  • Methodist Hosp Central
  • Saint Jude Children's Research Hosp of Memphis
  • Vanderbilt Univ Med Ctr
  • Children's Med Ctr of Dallas
  • Texas Children's Hosp / Baylor Univ
  • Children's Hosp of the King's Daughters
  • Senetara Norfolk Gen Hosp
  • Med College of Virginia
  • Children's Hospital & Medical Center / Seattle ACTU
  • Tacoma Gen Hosp
  • Ramon Ruiz Arnau Univ Hosp / Pediatrics
  • Univ of Puerto Rico / Univ Children's Hosp AIDS
  • San Juan City Hosp

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00000869
Brief Title
A Study of Nevirapine for the Prevention of HIV Transmission From Mothers to Their Babies
Official Title
A Phase III Randomized, Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2001 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to see if giving the anti-HIV drug nevirapine (NVP) to HIV-positive pregnant women and their babies can help reduce the chance that a mother will give HIV to her baby during delivery. This study will also test the safety of the drug and see how well it is tolerated by the mother and her baby. Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies.
Detailed Description
Nevirapine 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 suggested that nevirapine would be rapidly absorbed and transferred to the infant in utero when given during labor and delivery. In addition, nevirapine 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 nevirapine suggest that treatment of an HIV-infected pregnant woman in labor with an oral dose of nevirapine may provide a prophylactic level of nevirapine in the infant during the time of exposure to virus in the birth canal and/or maternal blood. In addition, nevirapine may inactivate the virion-associated RT present in cell-free virions in the genital tract or breast milk. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Pregnancy
Keywords
Pregnancy Trimester, Third, Placebos, Pregnancy, Pregnancy Complications, Infectious, Administration, Oral, Nevirapine, Disease Transmission, Vertical, Reverse Transcriptase Inhibitors, Anti-HIV Agents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Enrollment
2009 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nevirapine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Women may be eligible for this study if they: 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 Women will not be eligible for this study if they: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alejandro Dorenbaum
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John Sullivan
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Alabama at Birmingham - Pediatric
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Univ of South Alabama
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
UCSD Med Ctr / Pediatrics / Clinical Sciences
City
La Jolla
State/Province
California
ZIP/Postal Code
920930672
Country
United States
Facility Name
Long Beach Memorial (Pediatric)
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Los Angeles County - USC Med Ctr
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
UCLA Med Ctr / Pediatric
City
Los Angeles
State/Province
California
ZIP/Postal Code
900951752
Country
United States
Facility Name
Harbor - UCLA Med Ctr / UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
905022004
Country
United States
Facility Name
San Francisco Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
UCSF / Moffitt Hosp - Pediatric
City
San Francisco
State/Province
California
ZIP/Postal Code
941430105
Country
United States
Facility Name
Children's Hosp of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
802181088
Country
United States
Facility Name
Connecticut Children's Med Ctr
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
060303805
Country
United States
Facility Name
Univ of Connecticut / Farmington
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
Washington Hosp Ctr
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
200102931
Country
United States
Facility Name
Howard Univ Hosp
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
North Broward Hosp District
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Univ of Florida Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Univ of Florida Health Science Ctr / Pediatrics
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Univ of Miami / Jackson Memorial Hosp
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Univ of Miami (Pediatric)
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Med College of Georgia
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
The Med Ctr Inc
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31901
Country
United States
Facility Name
Cook County Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Univ of Illinois College of Medicine / Pediatrics
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Chicago Children's Memorial Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606143394
Country
United States
Facility Name
Univ of Chicago Children's Hosp
City
Chicago
State/Province
Illinois
ZIP/Postal Code
606371470
Country
United States
Facility Name
Tulane Univ / Charity Hosp of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Tulane Univ Hosp of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
701122699
Country
United States
Facility Name
Univ Hosp
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Univ of Maryland at Baltimore / Univ Med Ctr
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Hosp - Pediatric
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
212874933
Country
United States
Facility Name
Children's Hosp of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
021155724
Country
United States
Facility Name
Brigham and Women's Hosp
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston City Hosp / Pediatrics
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Baystate Med Ctr of Springfield
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
Univ of Massachusetts Med School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
016550001
Country
United States
Facility Name
Children's Hosp of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Univ of Mississippi Med Ctr
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39213
Country
United States
Facility Name
Cooper Hosp - Univ Med Ctr / UMDNJ - New Jersey Med Schl
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
UMDNJ - Robert Wood Johnson Med School / Pediatrics
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
089030019
Country
United States
Facility Name
St Peter's Med Ctr
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
City
Newark
State/Province
New Jersey
ZIP/Postal Code
071032714
Country
United States
Facility Name
Saint Joseph's Hosp and Med Ctr/UMDNJ - New Jersey Med Schl
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
Children's Hosp at Albany Med Ctr
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Bronx Lebanon Hosp Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10457
Country
United States
Facility Name
Bronx Municipal Hosp Ctr/Jacobi Med Ctr
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
North Shore Univ Hosp
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Bellevue Hosp / New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Metropolitan Hosp Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia Presbyterian Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Univ of Rochester Med Ctr
City
Rochester
State/Province
New York
ZIP/Postal Code
146420001
Country
United States
Facility Name
SUNY Health Sciences Ctr at Syracuse / Pediatrics
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
277103499
Country
United States
Facility Name
Univ of North Carolina at Chapel Hill / Duke Univ Med Ctr
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Children's Hosp of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191044318
Country
United States
Facility Name
Hosp of the Univ of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Saint Christopher's Hosp for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191341095
Country
United States
Facility Name
Temple Univ School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191341095
Country
United States
Facility Name
Med Univ of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
294253312
Country
United States
Facility Name
Regional Med Ctr at Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38103
Country
United States
Facility Name
Methodist Hosp Central
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
381052794
Country
United States
Facility Name
Saint Jude Children's Research Hosp of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
381052794
Country
United States
Facility Name
Vanderbilt Univ Med Ctr
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
372322581
Country
United States
Facility Name
Children's Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
Texas Children's Hosp / Baylor Univ
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Children's Hosp of the King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Senetara Norfolk Gen Hosp
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Med College of Virginia
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
Children's Hospital & Medical Center / Seattle ACTU
City
Seattle
State/Province
Washington
ZIP/Postal Code
981050371
Country
United States
Facility Name
Tacoma Gen Hosp
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Ramon Ruiz Arnau Univ Hosp / Pediatrics
City
Bayamon
ZIP/Postal Code
00956
Country
Puerto Rico
Facility Name
Univ of Puerto Rico / Univ Children's Hosp AIDS
City
San Juan
ZIP/Postal Code
009365067
Country
Puerto Rico
Facility Name
San Juan City Hosp
City
San Juan
ZIP/Postal Code
009367344
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
Citation
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)
Results Reference
background
PubMed Identifier
12134253
Citation
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.
Results Reference
background
PubMed Identifier
12794547
Citation
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.
Results Reference
background
PubMed Identifier
15213563
Citation
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.
Results Reference
background
PubMed Identifier
14981398
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. doi: 10.1016/j.ajog.2003.07.018.
Results Reference
background
PubMed Identifier
17584491
Citation
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.
Results Reference
result

Learn more about this trial

A Study of Nevirapine for the Prevention of HIV Transmission From Mothers to Their Babies

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