Clinical Trials


A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Babies

This study has been completed
National Institute of Allergy and Infectious Diseases (NIAID)

Information provided by (Responsible Party)
National Institute of Allergy and Infectious Diseases (NIAID) Identifier

First received: November 2, 1999
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 babies can help reduce the chance that a mother will give HIV to her baby during delivery.

Previous studies suggest that NVP is a promising medication for blocking HIV transmission from HIV-positive mothers to their babies.

Condition Intervention Phase
HIV Infections

Drug : Nevirapine
Phase 3

Study Type: Interventional
Study Design: Masking: Double
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):

Enrollment: 1244
Study Completion Date: May 2001

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 post-partum period. The pharmacokinetic profile suggests that NVP would be rapidly absorbed 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 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 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) use of antiretroviral therapy during the current pregnancy (no antiretroviral therapy at all; monotherapy [with no multi-agent therapy] for any duration; multi-agent therapy for any duration), and 2) CD4 cell count at the time of randomization (less than 200 cells; 200 to 399 cells; 400 cells or greater). Mothers are followed on-study for 4 to 6 weeks postpartum.
Due to the results of ACTG 076 and 185, all women for entry into ACTG 316 are encouraged to incorporate a regimen of zidovudine (ZDV) into their current treatment regimen and should continue ZDV during delivery and to their neonates (for at least 6 weeks post-birth).
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  


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:
  • Your baby will not live.
  • You intend to breast-feed.
  • You are allergic to benzodiazepines (a tranquilizer).
  • You have a liver disorder.
  • You have received non-nucleoside reverse transcriptase inhibitors (a class of anti-HIV

contacts and locations

Contacts and Locations

Choosing 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 identifier: NCT00000942


Princess Margaret Hosp
Nassau, Bahamas
Hopital Hotel Dieu de Lyon
Lyon, France
CHRU de Nantes
Nantes, France
Universita Frederico II
Napoli, Italy
Hosp Doce De Octubre
Madrid, Spain

Sponsors and Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)


Study Chair: Alejandro Dorenbaum, MD
Study Chair: John L. Sullivan, MD
More Information

More Information

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID) Identifier: NCT00000942   History of Changes  
Other Study ID Numbers: ACTG 316A  
Study First Received: November 2, 1999  
Last Updated: March 30, 2012  

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):

Pregnancy Complications, Infectious
Disease Transmission, Vertical
Anti-HIV Agents

Additional relevant MeSH terms:
HIV Infections
Nevirapine processed this data on March 27, 2020
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