Search / Trial NCT00000869

A Study of Nevirapine for the Prevention of HIV Transmission From Mothers to Their Babies

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

Trial Information

Current as of December 26, 2024

Completed

Keywords

Pregnancy Trimester, Third Placebos Pregnancy Pregnancy Complications, Infectious Administration, Oral Nevirapine Disease Transmission, Vertical Reverse Transcriptase Inhibitors Anti Hiv Agents

ClinConnect Summary

Nevirapine 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 suggested that nevirapine would be rapidly absorbed and transferred to the infant in utero when given during labor and delivery. In addition, nevirapine has been shown to penetrate cell-free virions and inactivate virion-associated reverse transcriptase (RT) in situ. This property would be potentially useful in inactivating cell-free virions in the genital tract as well as in breast milk....

Gender

ALL

Eligibility criteria

  • Inclusion Criteria
  • Women may be eligible for this study if they:
  • Are HIV-positive.
  • Are at least 20 weeks pregnant. (This study has been changed. Women no longer have to be 28 weeks pregnant.)
  • Have consent from the child's father (if available).
  • Are at least 13 years old (consent of parent or guardian required if under 18).
  • Exclusion Criteria
  • Women will not be eligible for this study if they:
  • Have ever taken NNRTIs (nonnucleoside reverse transcriptase inhibitors).
  • Are enrolled in another pregnancy treatment study.
  • Are allergic to benzodiazepines.
  • Have liver disease.
  • Plan to breast-feed.

Trial Officials

Alejandro Dorenbaum

Study Chair

John Sullivan

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

Los Angeles, California, United States

Springfield, Massachusetts, United States

San Francisco, California, United States

Seattle, Washington, United States

Bronx, New York, United States

La Jolla, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Los Angeles, California, United States

San Francisco, California, United States

Denver, Colorado, United States

Washington, District Of Columbia, United States

Miami, Florida, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Chicago, Illinois, United States

Baltimore, Maryland, United States

Baltimore, Maryland, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Detroit, Michigan, United States

New Brunswick, New Jersey, United States

Newark, New Jersey, United States

Albany, New York, United States

Great Neck, New York, United States

New York, New York, United States

New York, New York, United States

New York, New York, United States

Syracuse, New York, United States

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Charleston, South Carolina, United States

Memphis, Tennessee, United States

Dallas, Texas, United States

Houston, Texas, United States

Bayamon, , Puerto Rico

San Juan, , Puerto Rico

San Juan, , Puerto Rico

Newark, New Jersey, United States

Bronx, New York, United States

Memphis, Tennessee, United States

Augusta, Georgia, United States

Farmington, Connecticut, United States

New Orleans, Louisiana, United States

Worcester, Massachusetts, United States

Washington, District Of Columbia, United States

Jacksonville, Florida, United States

New Orleans, Louisiana, United States

Boston, Massachusetts, United States

Durham, North Carolina, United States

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Memphis, Tennessee, United States

Rochester, New York, United States

Miami, Florida, United States

Birmingham, Alabama, United States

Mobile, Alabama, United States

Farmington, Connecticut, United States

Fort Lauderdale, Florida, United States

Gainesville, Florida, United States

Jackson, Mississippi, United States

Camden, New Jersey, United States

Nashville, Tennessee, United States

Norfolk, Virginia, United States

Richmond, Virginia, United States

Columbus, Georgia, United States

New Orleans, Louisiana, United States

New Brunswick, New Jersey, United States

Norfolk, Virginia, United States

Tacoma, Washington, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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