A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers

Inclusion Criteria Concurrent Medication: Allowed: AZT (mothers and neonates). Oral asthma inhalers (mothers). Concurrent Treatment: Allowed: Phototherapy (neonates). MOTHERS must have: HIV infection. Estimated gestational age >= 34 weeks. No active opportunistic infection at study entry. PER AMENDMENT 8/27/96: A pre-enrollment plasma HIV-1 RNA level greater than 10,000 copies/ml. Exclusion Criteria Co-existing Condition: MOTHERS with the following symptoms or conditions are excluded: Intrauterine growth retardation. Fetal anomaly incompatible with life as determined by pre-entry ultrasound. Participation during current pregnancy in any other therapeutic or vaccine perinatal trial. Known hypersensitivity to any benzodiazepine. Serious bacterial infection. Concurrent Medication: Excluded: Any antiretroviral other than AZT. Corticosteroids (other than oral asthma inhalers). Anticoagulants. Any clavulanic acid-containing formulation (e.g., Augmentin, Timentin). Benzodiazepines other than study drug. Phenobarbital. Barbiturates. Antacids. Magnesium sulfate. Prior Medication: Excluded: Prior nevirapine. Current use of illicit substances and/or active chronic alcohol use.