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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Pregnant women in active labor receive single doses of oral nevirapine. The neonates of the first 4-6 (PER AMENDMENT 8/27/96, was 4) mothers receive no drug, while the neonates of the second 4-6 (PER AMENDMENT 8/27/96, was 4) patient cohort receive a single dose of nevirapine. If neonatal antiviral levels of nevirapine are not sustained for 7 days after the single dose, a...

Gender

FEMALE

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.