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

Completed · Phase 1

Conditions studied: HIV Infections, Pregnancy

In brief

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.

Key facts

Study ID

NCT00000808

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

49

Expected to finish

1998-09-01

Last updated by the study team

2021-11-04

Who can join

Age: 13 and older, up to 60. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCSD Med Ctr / Pediatrics / Clinical Sciences — La Jolla, California, United States
• Los Angeles County - USC Med Ctr — Los Angeles, California, United States
• UCLA Med Ctr / Pediatric — Los Angeles, California, United States
• Harbor - UCLA Med Ctr / UCLA School of Medicine — Los Angeles, California, United States
• San Francisco Gen Hosp — San Francisco, California, United States
• UCSF / Moffitt Hosp - Pediatric — San Francisco, California, United States
• Univ of Connecticut / Farmington — Farmington, Connecticut, United States
• Connecticut Children's Med Ctr - Pediatric — Hartford, Connecticut, United States
• Chicago Children's Memorial Hosp — Chicago, Illinois, United States
• Univ of Chicago Children's Hosp — Chicago, Illinois, United States
• Children's Hosp of Boston — Boston, Massachusetts, United States
• Boston City Hosp / Pediatrics — Boston, Massachusetts, United States
• Univ of Massachusetts Med School — Worcester, Massachusetts, United States
• Univ of Medicine & Dentistry of New Jersey / Univ Hosp — Newark, New Jersey, United States
• Mount Sinai Med Ctr / Pediatrics — New York, New York, United States
• San Juan City Hosp — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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