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

About this trial
This is an interventional treatment trial for HIV Infections focused on measuring Pregnancy, Pregnancy Complications, Infectious, Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Nevirapine
Eligibility Criteria
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.
Sites / Locations
- UCSD Med Ctr / Pediatrics / Clinical Sciences
- Los Angeles County - USC Med Ctr
- UCLA Med Ctr / Pediatric
- Harbor - UCLA Med Ctr / UCLA School of Medicine
- San Francisco Gen Hosp
- UCSF / Moffitt Hosp - Pediatric
- Univ of Connecticut / Farmington
- Connecticut Children's Med Ctr - Pediatric
- Chicago Children's Memorial Hosp
- Univ of Chicago Children's Hosp
- Children's Hosp of Boston
- Boston City Hosp / Pediatrics
- Univ of Massachusetts Med School
- Univ of Medicine & Dentistry of New Jersey / Univ Hosp
- Mount Sinai Med Ctr / Pediatrics
- San Juan City Hosp