Search / Trial NCT00000808

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

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Trial Information

Current as of May 23, 2024

Completed

Keywords

Pregnancy Pregnancy Complications, Infectious Acquired Immunodeficiency Syndrome Aids Related Complex Nevirapine

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'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...

Gender

Female

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.

Attachments

readout_NCT00000808_2024-05-23.pdf

4.5 MB

NCT00000808_study_protocol.pdf

4.5 MB

About company

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

Los Angeles, California, United States

San Francisco, California, United States

La Jolla, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

San Francisco, California, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

New York, New York, United States

San Juan, , Puerto Rico

Newark, New Jersey, United States

Farmington, Connecticut, United States

Worcester, Massachusetts, United States

Hartford, Connecticut, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Reviews (48)

4.6

All reviews come from applied patients

5 stars
41
4 stars
6
3 stars
2
2 stars
0
1 stars
0
Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Michael Foster
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Dries Vincent
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

Leslie Alexander
20 September 2023

Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum?

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