- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00001135
A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Infants
A Phase III Randomized, Double-Blinded Study of Nevirapine for the Prevention of Maternal-Fetal Transmission in Pregnant HIV-Infected Women
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.
Study Overview
Detailed 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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
San Juan, Puerto Rico, 009365067
- Univ of Puerto Rico / Univ Children's Hosp AIDS
-
-
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- Univ of Alabama at Birmingham - Pediatric
-
-
California
-
La Jolla, California, United States, 920930672
- UCSD Med Ctr / Pediatrics / Clinical Sciences
-
Los Angeles, California, United States, 900951752
- UCLA Med Ctr / Pediatric
-
San Francisco, California, United States, 941430105
- UCSF / Moffitt Hosp - Pediatric
-
-
District of Columbia
-
Washington, District of Columbia, United States, 200102916
- Children's Hosp of Washington DC
-
-
Florida
-
Miami, Florida, United States, 33161
- Univ of Miami (Pediatric)
-
-
Illinois
-
Chicago, Illinois, United States, 606143394
- Chicago Children's Memorial Hosp
-
-
Louisiana
-
New Orleans, Louisiana, United States, 701122699
- Tulane Univ / Charity Hosp of New Orleans
-
-
Maryland
-
Baltimore, Maryland, United States, 212874933
- Johns Hopkins Hosp - Pediatric
-
-
Massachusetts
-
Boston, Massachusetts, United States, 021155724
- Children's Hosp of Boston
-
Worcester, Massachusetts, United States, 016550001
- Univ of Massachusetts Med School
-
-
New Jersey
-
Newark, New Jersey, United States, 071032714
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
-
-
New York
-
New York, New York, United States, 10016
- Bellevue Hosp / New York Univ Med Ctr
-
New York, New York, United States, 10032
- Columbia Presbyterian Med Ctr
-
-
North Carolina
-
Durham, North Carolina, United States, 277103499
- Duke Univ Med Ctr
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 191044318
- Children's Hosp of Philadelphia
-
-
Tennessee
-
Memphis, Tennessee, United States, 381052794
- Saint Jude Children's Research Hosp of Memphis
-
-
Texas
-
Houston, Texas, United States, 77030
- Texas Children's Hosp / Baylor Univ
-
-
Washington
-
Seattle, Washington, United States, 981050371
- Children's Hospital & Medical Center / Seattle ACTU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Masking: Double
Collaborators and Investigators
Investigators
- Study Chair: Sullivan JL
- Study Chair: Dorenbaum A
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immunologic Deficiency Syndromes
- Immune System Diseases
- HIV Infections
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-HIV Agents
- Anti-Retroviral Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Nevirapine
Other Study ID Numbers
- ACTG 316B
- 11292 (DAIDS ES Registry Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
Gérond'ifRecruiting
-
University of California, DavisCompleted
-
University of California, San DiegoNational Center for Complementary and Integrative Health (NCCIH)CompletedHIV PositiveUnited States
-
University of ChicagoUniversity of Athens; National Development and Research Institutes, Inc.Completed
-
HIV Prevention Trials NetworkNational Institute on Drug Abuse (NIDA); National Institute of Allergy and...CompletedHIV PositiveIndonesia, Ukraine, Vietnam
-
University of ZimbabweCompleted
-
Florida International UniversityCompleted
-
Boston Children's HospitalNational Institute on Minority Health and Health Disparities (NIMHD)Completed
Clinical Trials on Nevirapine
-
Boehringer IngelheimCompletedHIV InfectionsUnited States, Botswana, Germany, South Africa
-
Boehringer IngelheimCompletedHIV InfectionsUnited States, France, Germany, United Kingdom
-
Boehringer IngelheimCompletedHIV InfectionsUnited States, Argentina, Australia, Belgium, Botswana, Canada, France, Germany, Ireland, Italy, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Switzerland, United Kingdom
-
Boehringer IngelheimCompleted
-
Peking Union Medical CollegeMinistry of Science and Technology of the People´s Republic of ChinaCompleted
-
Boehringer IngelheimCompleted
-
Makerere UniversityUniversity of LiverpoolCompletedHIV Infections | TuberculosisUganda
-
Boehringer IngelheimCompletedHIV InfectionsArgentina, Germany, Italy, Mexico, Poland, Portugal, Romania, Spain, Switzerland, United Kingdom
-
Elim Pediatric Pharmaceuticals Inc.Unknown