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 May 18, 2025
Completed
Keywords
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.
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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
Patients applied
Trial Officials
Alejandro Dorenbaum
Study Chair
John Sullivan
Study Chair
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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