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

National Institute of Allergy and Infectious Diseases (NIAID)

Status and phase: Completed; Phase 1

Conditions: HIV Infections; Pregnancy

Treatments: Drug: Nevirapine

Study type: Interventional

Funder types: NIH

Identifiers

NCT00000808

ACTG 250

11227 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

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 third cohort of 4-6 (PER AMENDMENT 8/27/96, was 4) pregnant women will receive a single dose of nevirapine and their neonates will receive multiple doses of nevirapine to maintain an antiviral effect for 7 days.

Sex: Female

Ages: 13 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.