Status:
COMPLETED
A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Pregnancy
Eligibility:
FEMALE
13-60 years
Phase:
PHASE1
Brief 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 ...
Detailed 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...
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.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
September 1 1998
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00000808
End Date
September 1 1998
Last Update
November 4 2021
Active Locations (16)
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1
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, United States, 920930672
2
Los Angeles County - USC Med Ctr
Los Angeles, California, United States, 90033
3
UCLA Med Ctr / Pediatric
Los Angeles, California, United States, 900951752
4
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, United States, 905022004