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A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00000808
First received: November 2, 1999
Last updated: March 30, 2012
Last verified: March 2012

November 2, 1999
March 30, 2012
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Complete list of historical versions of study NCT00000808 on ClinicalTrials.gov Archive Site
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A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers
A Phase I Study of Safety and Pharmacokinetics of Nevirapine in HIV-1 Infected Pregnant Women and Neonates Born to HIV-1 Infected Mothers

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.

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.

Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Primary Purpose: Treatment
  • HIV Infections
  • Pregnancy
Drug: Nevirapine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
September 1998
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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.

Female
13 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00000808
ACTG 250, 11227
Not Provided
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Allergy and Infectious Diseases (NIAID)
Not Provided
Study Chair: Sullivan JL
Study Chair: Sperling R
National Institute of Allergy and Infectious Diseases (NIAID)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP