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

• Status: Completed
• Trial end date: 1998-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

To determine the bioavailability, pharmacokinetics, and short-term safety and tolerance of nevirapine in HIV-1 infected pregnant women and their newborns when nevirapine is given to the mother during active labor, and when their neonates are dosed during the first week of life. To determine the short-term safety profile of mothers receiving zidovudine (AZT) who received nevirapine during active labor, and their neonates who received no dose, a single dose, or multiple doses of nevirapine and who are receiving AZT during the first 6 weeks of life.

Treatment of HIV-1 infected pregnant women during active labor may result in therapeutic levels of nevirapine in the neonate at the time of exposure to HIV-1 during parturition, decreasing the neonate's risk of infection.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

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

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.