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

NCT00000942 | Completed Phase 3

• 2 other identifiers: ACTG 316A11291
• Study Type: interventional
• Target: 1,244
• Locations: 4 countries
• Sites: 5

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

Conditions

HIV Infections; Pregnancy

Keywords

Placebos; Pregnancy; Pregnancy Complications, Infectious; Nevirapine; Disease Transmission, Vertical; Labor; Anti-HIV Agents

Interventions

Nevirapine DRUG

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 drugs).

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (5)

Hopital Hotel Dieu de Lyon

Lyon, France

Location

CHRU de Nantes

Nantes, France

Location

Universita Frederico II

Napoli, Italy

Location

Hosp Doce De Octubre

Madrid, Spain

Location

Princess Margaret Hosp

Nassau, The Bahamas

Location

Related Publications (2)

• 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.

  PMID: 15213563 BACKGROUND

• 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.

  PMID: 14981398 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Pregnancy Complications, Infectious

Interventions

Nevirapine

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Alejandro Dorenbaum, MD

  STUDY CHAIR

• John L. Sullivan, MD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 1999
• First Posted: August 31, 2001
• Study Completion: May 1, 2001
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

IT (1); ES (1); TH (1); FR (2)