A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
Nevirapine
Blood-Borne Infections+17
+ Urogenital Diseases
+ Genital Diseases
Treatment Study
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 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.49 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 13 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 16 locations
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, United StatesOpen UCSD Med Ctr / Pediatrics / Clinical Sciences in Google MapsLos Angeles County - USC Med Ctr
Los Angeles, United StatesUCLA Med Ctr / Pediatric
Los Angeles, United StatesHarbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, United States