A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections Pregnancy |
Drug: Nevirapine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Pharmacokinetics Study Primary Purpose: Treatment |
| Official Title: | A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers |
| Estimated Enrollment: | 49 |
| Study Completion Date: | September 1998 |
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.
Eligibility| Ages Eligible for Study: | 13 Years to 60 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, California | |
| UCSD Med Ctr / Pediatrics / Clinical Sciences | |
| La Jolla, California, United States, 920930672 | |
| UCLA Med Ctr / Pediatric | |
| Los Angeles, California, United States, 900951752 | |
| Harbor - UCLA Med Ctr / UCLA School of Medicine | |
| Los Angeles, California, United States, 905022004 | |
| Los Angeles County - USC Med Ctr | |
| Los Angeles, California, United States, 90033 | |
| San Francisco Gen Hosp | |
| San Francisco, California, United States, 94110 | |
| UCSF / Moffitt Hosp - Pediatric | |
| San Francisco, California, United States, 941430105 | |
| United States, Connecticut | |
| Univ of Connecticut / Farmington | |
| Farmington, Connecticut, United States, 06032 | |
| Connecticut Children's Med Ctr - Pediatric | |
| Hartford, Connecticut, United States, 06106 | |
| United States, Illinois | |
| Chicago Children's Memorial Hosp | |
| Chicago, Illinois, United States, 606143394 | |
| Univ of Chicago Children's Hosp | |
| Chicago, Illinois, United States, 606371470 | |
| United States, Massachusetts | |
| Children's Hosp of Boston | |
| Boston, Massachusetts, United States, 021155724 | |
| Boston City Hosp / Pediatrics | |
| Boston, Massachusetts, United States, 02118 | |
| Univ of Massachusetts Med School | |
| Worcester, Massachusetts, United States, 016550001 | |
| United States, New Jersey | |
| Univ of Medicine & Dentistry of New Jersey / Univ Hosp | |
| Newark, New Jersey, United States, 071032714 | |
| United States, New York | |
| Mount Sinai Med Ctr / Pediatrics | |
| New York, New York, United States, 10029 | |
| Puerto Rico | |
| San Juan City Hosp | |
| San Juan, Puerto Rico, 009367344 | |
| Study Chair: | Sullivan JL | |
| Study Chair: | Sperling R |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00000808 History of Changes |
| Other Study ID Numbers: | ACTG 250, 11227 |
| Study First Received: | November 2, 1999 |
| Last Updated: | March 30, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
|
Pregnancy Pregnancy Complications, Infectious Acquired Immunodeficiency Syndrome AIDS-Related Complex Nevirapine |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Nevirapine Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013