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.

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety