A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
NCT ID: NCT00000808
Last Updated: 2021-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
49 participants
INTERVENTIONAL
1998-09-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Nevirapine
Eligibility Criteria
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Inclusion Criteria
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
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.
13 Years
60 Years
FEMALE
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Sullivan JL
Role: STUDY_CHAIR
Sperling R
Role: STUDY_CHAIR
Locations
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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
Countries
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References
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Vazquez E. Two bucks a baby. Posit Aware. 1997 Mar-Apr;8(2):15.
Benson M, Shannon M. Nevirapine: ethical dilemmas and care for HIV-infected mothers. Focus. 1995 Jun;10(7):5-6.
McKinney 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
Mirochnick 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)
Mirochnick 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.
Other Identifiers
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11227
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACTG 250
Identifier Type: -
Identifier Source: org_study_id