A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
2 other identifiers
interventional
49
2 countries
16
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 hiv-infections
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
September 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 27, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
UCSD Med Ctr / Pediatrics / Clinical Sciences
La Jolla, California, 920930672, United States
Los Angeles County - USC Med Ctr
Los Angeles, California, 90033, United States
UCLA Med Ctr / Pediatric
Los Angeles, California, 900951752, United States
Harbor - UCLA Med Ctr / UCLA School of Medicine
Los Angeles, California, 905022004, United States
San Francisco Gen Hosp
San Francisco, California, 94110, United States
UCSF / Moffitt Hosp - Pediatric
San Francisco, California, 941430105, United States
Univ of Connecticut / Farmington
Farmington, Connecticut, 06032, United States
Connecticut Children's Med Ctr - Pediatric
Hartford, Connecticut, 06106, United States
Chicago Children's Memorial Hosp
Chicago, Illinois, 606143394, United States
Univ of Chicago Children's Hosp
Chicago, Illinois, 606371470, United States
Children's Hosp of Boston
Boston, Massachusetts, 021155724, United States
Boston City Hosp / Pediatrics
Boston, Massachusetts, 02118, United States
Univ of Massachusetts Med School
Worcester, Massachusetts, 016550001, United States
Univ of Medicine & Dentistry of New Jersey / Univ Hosp
Newark, New Jersey, 071032714, United States
Mount Sinai Med Ctr / Pediatrics
New York, New York, 10029, United States
San Juan City Hosp
San Juan, 009367344, Puerto Rico
Related Publications (5)
Vazquez E. Two bucks a baby. Posit Aware. 1997 Mar-Apr;8(2):15.
PMID: 11364450BACKGROUNDBenson M, Shannon M. Nevirapine: ethical dilemmas and care for HIV-infected mothers. Focus. 1995 Jun;10(7):5-6.
PMID: 11362587BACKGROUNDMcKinney RE Jr. Ongoing and future trials of antiretroviral therapy in the pediatric AIDS clinical trials group (PACTG). Conf Retroviruses Opportunistic Infect. 1996 Jan 28-Feb 1;3rd:173
BACKGROUNDMirochnick M, Sullivan J, Cort S, Mcnamara J, Fenton T, Sperling R. Safety and pharmacokinetics (pk) of nevirapine (NVP) in HIV-I infected pregnant women and their newborns. ACTG Protocol 250 Team. American Pediatric Association and Society for Pediatric Research annual meeting; 1996 May 6-10; Washington, D.C. Pediatr AIDS HIV Infect. 1996 Aug;7(4):280 (unnumbered abstract)
BACKGROUNDMirochnick M, Fenton T, Gagnier P, Pav J, Gwynne M, Siminski S, Sperling RS, Beckerman K, Jimenez E, Yogev R, Spector SA, Sullivan JL. Pharmacokinetics of nevirapine in human immunodeficiency virus type 1-infected pregnant women and their neonates. Pediatric AIDS Clinical Trials Group Protocol 250 Team. J Infect Dis. 1998 Aug;178(2):368-74. doi: 10.1086/515641.
PMID: 9697716BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Sullivan JL
- STUDY CHAIR
Sperling R