Text: U.S. Health Institutes Release HIV/AIDS Drug Trials Statement

22 March 2002

Text: U.S. Health Institutes Release HIV/AIDS Drug Trials Statement

Prestigious institutes issue statement on Ugandan clinical trials

The U.S. National Institute of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH) released a statement March 22 on a clinical trial conducted in Uganda to determine the efficacy of oral HIV/AIDS drugs.

The trial, conducted by co-investigators at Makerere University in Kampala, Uganda, and the Johns Hopkins University in Baltimore, Maryland, was funded by NIAID and NIH. It tested the efficacy of oral AZT (zidovudine) and oral nevirapine (NVP) drugs for the prevention of transmission of HIV-1 infection from pregnant Ugandan mothers to their newborn babies and concluded that NVP significantly reduced the risk of HIV transmission from mother to child during the first week of life.

According to the statement, an examination of the trial data was recently begun to support an extension of the indication for the use of nevirapine to include prevention of mother-to-child transmission (MTCT). Nevertheless, NIAID says that "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."

Nevirapine is approved by the U.S. Food and Drug Administration (FDA) for the treatment of HIV infection in adults and children, but not yet for the prevention of perinatal transmission.

Following is the text of the statement:

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National Institute of Allergy and Infectious Diseases
National Institutes of Health

March 22, 2002

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.

NIAID is a component of the NIH. NIAID supports basic and applied research to prevent, diagnose, and treat infectious and immune-mediated illnesses, including HIV/AIDS and other sexually transmitted diseases, illness from potential agents of bioterrorism, tuberculosis, malaria, autoimmune disorders, asthma and allergies.

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