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March 22, 2002

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STATEMENT

Review of HIVNET 012
(A Clinical Trial to Determine the Efficacy of Oral AZT and the Efficacy of Oral Nevirapine for the Prevention of Vertical Transmission of HIV-1 Infection in Pregnant Ugandan Women and Their Neonates)


Since 1997, funding from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), has supported a trial known as HIVNET 012, conducted by co-investigators at Makerere University in Kampala, Uganda, and the Johns Hopkins University in Baltimore, Maryland.  The trial was designed to examine the effectiveness of nevirapine (NVP) in blocking transmission of HIV from a mother to her newborn baby by treating the mother and baby at the time of birth. NVP is approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children.

Enrollment in HIVNET012 was completed in 1999. The results, published in Lancet in 1999, concluded that NVP significantly reduced the risk of HIV transmission from mother to child during the first week of life. Other studies conducted in the United States and internationally were consistent with the results from HIVNET 012. Based on the data from these studies, a U.S. Public Health Service Task Force currently recommends NVP as an option for prevention of mother-to-child transmission (MTCT) for women and their newborns in the United States who have not received antiretroviral therapy during pregnancy.

An examination of the data to support an extension of the indication for the use of NVP to include prevention of MTCT was recently begun. Although no evidence has been found that the conclusions of HIVNET 012 are invalid or that any trial participants were placed at an increased risk of harm, certain aspects of the collection of the primary data may not conform to FDA regulatory requirements.  A comprehensive effort to access the primary data has begun to determine the applicability of the data collection processes to these regulatory requirements.

The reduction in perinatal transmission by the use of NVP, an accessible, inexpensive regimen, represents a major public health advance in resource-poor settings and NIAID believes there is no reason for programs implementing this life-saving regimen to change their practices.

NIAID is committed to ensuring the highest standards of patient safety, investigator conduct and accountability, and regulatory cooperation in all clinical trials carried out in the United States and abroad.

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Media inquiries can be directed to the NIAID OCPL media group at 301-402-1663.

Press releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

Prepared by:
Office of Communications and Public Liaison
National of Allergy and Infectious Diseases
National Institutes of Health
Bethesda, MD 20892
U.S.

Department of Health and Human Services


NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at www.niaid.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH...Turning Discovery Into Health ®

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Important note: Information on this page was accurate at the time of publication. This page is no longer being updated.
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Last Updated March 22, 2002