Daily Nevirapine to Prevent Mother to Infant Transmission of HIV

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

Infants who are breast-fed by HIV infected mothers have an increased risk of becoming infected with HIV. Standard therapy for the prevention of HIV infections in infants included zidovudine (ZDV) prior to the onset of labor, a single dose of nevirapine (NVP) for women during labor, and a single dose of NVP for newborns given 72 hours after birth. This study will determine if giving low dose daily NVP to breastfed infants of HIV infected mothers, in addition to standard therapy, will be more effective than standard therapy alone at preventing HIV infections in these infants.

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

Details

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

Criteria

Inclusion Criteria for Pregnant or Postpartum Mothers

• HIV infected

• Planning to breastfeed

• Able to tolerate oral drugs and available for 12 months of postpartum follow-up

Exclusion Criteria

• Significant physical or emotional distress

• Infant with serious or life threatening disease or severe fetal abnormality

• Obstetrical complications affecting maternal health

• Prior antiretroviral drugs (except antenatal ZDV or intrapartum (NVP)