Update on HIVNET 012 Study on Nevirapine – April 8, 2005

A study conducted in Uganda in the late 1990s, known as HIVNET 012, showed that the antiretroviral drug nevirapine is a safe, effective way to prevent mother-to-child transmission of HIV. In this study, a single dose of nevirapine taken by a mother at the onset of labor and another dose administered to her newborn child within 72 hours of birth reduced the risk of HIV transmission by about 50 percent.

The Institute of Medicine (IOM) issued a report April 7, 2005 on the HIVNET 012 study, following questions raised in the press about the conduct of the trial. The thorough and objective analysis, conducted over 9 months by the highly respected IOM, found that the trial was sound. Its key findings — that nevirapine is effective and safe in preventing HIV transmission from mother to unborn child during birth — were strongly supported by this careful IOM review.

"We determined that the HIVNET 012 trial's findings about the effectiveness of nevirapine are sound and fully supported by the data," stated Mark W. Kline, M.D., Professor of Pediatrics and Director of the AIDS International Training and Research Program at Baylor College of Medicine and member of the IOM Committee on Reviewing the HIVNET 012 Perinatal HIV Prevention Study, in an opening statement at an April 7 news conference in Washington. "The comparative safety analyses as reported by the investigators are sound. And the trial was conducted in accordance with international norms for the ethical conduct of clinical trials and complied with Institutional Review Board and FDA requirements."

Family Health International, which was a partner on the HIVNET team that conducted the study, is proud of our role in this crucial work. In the resource-poor settings where FHI works, nevirapine is often the only available and feasible option available to women. Since the results of the HIVNET 012 study were first published in the Lancet in 1999, use of nevirapine by HIV-infected mothers during labor has saved tens of thousands of infant lives.

For information on the Institute of Medicine (IOM) report, see:

• IOM Overview
• IOM Press Release
• Opening Statement of the Committee Conducting the Independent Review
• Reuters News article
• National Public Radio piece

For other statements on nevirapine and PMTCT, see:

• Elizabeth Glaser Pediatric AIDS Foundation on Issue of Prevention of Mother-to-Child Transmission of HIV/AIDS and Single-Dose Nevirapine
• National Institute of Allergy and
  Infectious Diseases, NIH

For more information on FHI's work on nevirapine, see:

• Affordable drug offers hope for PMTCT
• Nevirapine results quickly put into practice
• Nevirapine: The story of one woman

Family Health International (FHI) is dedicated to improving lives, knowledge, and understanding worldwide through a highly diversified program of research, education, and services in family health and HIV/AIDS prevention and care. FHI conducts research and programs in accordance with international ethical principles, provides technical assistance to partners in the conduct of ethical research (medical and behavioral), and develops materials that provide guidance in establishing, monitoring, and maintaining high ethical standards in conducting projects or research involving people.