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

Completed · Phase 3

Conditions studied: HIV Infections, Pregnancy

In brief

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.

Key facts

Study ID

NCT00001135

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

2009

Expected to finish

2001-05-01

Last updated by the study team

2021-11-01

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

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:
• 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.

Where it is running

• Univ of Alabama at Birmingham - Pediatric — Birmingham, Alabama, United States
• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States
• UCLA Med Ctr / Pediatric — Los Angeles, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Children's Hosp of Washington DC — Washington D.C., District of Columbia, United States
• Univ of Miami (Pediatric) — Miami, Florida, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Tulane Univ / Charity Hosp of New Orleans — New Orleans, Louisiana, United States
• Johns Hopkins Hosp - Pediatric — Baltimore, Maryland, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Univ of Massachusetts Med School — Worcester, Massachusetts, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• Bellevue Hosp / New York Univ Med Ctr — New York, New York, United States
• Columbia Presbyterian Med Ctr — New York, New York, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Children's Hosp of Philadelphia — Philadelphia, Pennsylvania, United States
• Saint Jude Children's Research Hosp of Memphis — Memphis, Tennessee, United States
• Texas Children's Hosp / Baylor Univ — Houston, Texas, United States
• Children's Hospital & Medical Center / Seattle ACTU — Seattle, Washington, United States
• Univ of Puerto Rico / Univ Children's Hosp AIDS — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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