The Safety of Nevirapine When Given to Breast-Feeding Babies From Birth to Age 6 Months
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Pregnancy Complications, Infectious, Dose-Response Relationship, Drug, Drug Administration Schedule, Nevirapine, Disease Transmission, Vertical, Reverse Transcriptase Inhibitors, Anti-HIV Agents, Breast Feeding
Eligibility Criteria
Inclusion Criteria Mothers may be eligible for this study if they: Receive prenatal care at King Edward VIII Hospital, Durban, or St. Mary's Hospital, Marianhill, South Africa; or polyclinics in Chitungwiza District, Zimbabwe. Are pregnant for at least 30 weeks before giving birth. Are at least 18 years of age. Are HIV-positive by 2 ELISA tests. Have no serious current or previous problems in pregnancy (e.g., seizures). Have a fixed home and/or work address. Plan to deliver the baby at a hospital or clinic where the study is based. Plan to breast-feed their babies. Infants may be eligible for this study if they: Are born to women participating in this study. Weigh at least 2.5 kg at birth. Begin breast-feeding by 48 hours. Exclusion Criteria Mothers will not be eligible for this study if they: Have AIDS or any other serious illness. Are using illegal drugs or have been using alcohol for a long time. Are sensitive to NVP. Have taken any nonnucleoside reverse transcriptase inhibitors in the past. Are using rifampin, rifabutin, ketoconazole, macrolides, or cimetidine. Infants will not be eligible for this study if they: Have jaundice (yellowing of the skin and whites of eyes) that requires a blood transfusion. Have any serious or life-threatening condition(s).
Sites / Locations
- Kathy George