Nevirapine (NVP) Use to Prevent Mother-to-Child Transmission of HIV

• Status: Completed
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

HIV can be transmitted from an HIV infected mother to her infant through her breast milk. The purpose of this study is to determine whether giving infants of HIV infected mothers the anti-HIV drug nevirapine (NVP) for six weeks will reduce the risk of HIV transmission.

Study hypothesis: Six weeks of nevirapine prophylaxis provided to the infant will decrease HIV transmission through breastfeeding.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

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

Criteria

Inclusion Criteria:

• HIV infection, documented on two separate specimens

• Estimated gestational age at enrollment of 32 weeks or more as indicated by last menstrual cycle and fundal height

• Permanent residency in Addis Ababa

• Plan to deliver at a hospital affliated with the study (Tikur Anbessa Hospital, Gandhi hospital, or St. Paul's Hospital)

• Hemoglobin >= 7.5 gm/dl within 4 weeks prior to study entry

• Serum glutamic pyruvic transaminase (SGPT) < 5 times upper limit of normal within 4 weeks prior to study entry

• Serum creatinine < 1.5 mg/dl within 4 weeks prior to study entry

• Consent form signed by the mother and, when possible, by the father, prior to the onset of labor