Search / Trial NCT00001135

A Study of Nevirapine to Prevent HIV Transmission From Mothers to Their Infants

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

Trial Information

Current as of December 14, 2024

Completed

Keywords

Placebos Pregnancy Pregnancy Complications, Infectious Nevirapine Disease Transmission, Vertical Labor Anti Hiv Agents

ClinConnect Summary

NVP has several properties that make it an attractive candidate for antiretroviral therapy to interrupt HIV-1 transmission in the intrapartum and early postpartum period. The pharmacokinetic profile suggests that NVP would be rapidly absorbed by the mother and transferred to the infant in utero when given during labor and delivery. The HIV-1 antiviral activity is rapid with significant reduction in plasma virus occurring within a few days of drug administration. In addition, NVP has been shown to penetrate cell-free virions and inactivate virion-associated reverse transcriptase (RT) in situ...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • You may be eligible for this study if you:
  • Are an HIV-positive pregnant woman.
  • Have been pregnant for at least 28 weeks.
  • Are at least 13 years of age (consent of parent or guardian is required if under 18).
  • Exclusion Criteria
  • You will not be eligible for this study if:
  • You intend to breast-feed.
  • You are allergic to benzodiazepines (a type of tranquilizer).
  • You have a liver disorder.
  • You have received nonnucleoside reverse transcriptase inhibitors (NNRTIs), a class of anti-HIV drugs.
  • You refuse to take ZDV.

Trial Officials

Dorenbaum A

Study Chair

Sullivan JL

Study Chair

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Seattle, Washington, United States

La Jolla, California, United States

Los Angeles, California, United States

San Francisco, California, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

New York, New York, United States

New York, New York, United States

Philadelphia, Pennsylvania, United States

Memphis, Tennessee, United States

Houston, Texas, United States

San Juan, , Puerto Rico

Newark, New Jersey, United States

Durham, North Carolina, United States

New Orleans, Louisiana, United States

Worcester, Massachusetts, United States

Birmingham, Alabama, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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