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

• Status: Completed
• Trial end date: 2001-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Nevirapine

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.