UGANDAN STUDY

March 22, 2002

UGANDAN STUDY

Johns Hopkins University scientists and their colleagues at the University of Washington and at Makerere University in Kampala, Uganda, appreciate the National Institute of Allergy and Infectious Diseases’ ongoing support of the validity of their study demonstrating that transmission of HIV from mother to infant during the first weeks of life could be reduced by nearly 50 percent with a simple, inexpensive drug regimen. NIAID calls this "a major public health advance in resource poor settings."

It’s been estimated that implementing the drug regimen, which involves giving one dose of neviripine to the mother at the time of delivery and one dose to the infant after birth, potentially could save many of the approximately 600,000 infants worldwide who are infected by HIV every year.

In this country, the drug is approved by the Food and Drug Administration (FDA) as an antiretroviral treatment for adult and pediatric HIV infection, but not for use to prevent mother-to-child transmission. When data from the study were examined to support the manufacturer’s application to the FDA for this expanded use, it seemed that certain aspects of the collection of primary data may not have conformed to FDA requirements. NIAID will initiate a more comprehensive follow-up review, and has the full cooperation of the study investigators and their institutions in doing so.

Above all, there is no evidence of any under-reporting of deaths, or of deaths or harm among the mothers and babies in the study that can be attributed to the drugs used in the study. Nor is there any evidence to question the validity of the original results of this crucial study, published in the British medical journal, The Lancet, in 1999.

Hopkins especially welcomes a complete review, not only because we fully support all efforts to protect human subjects and the fight to control infant HIV in Africa, but also because early results of the study have so clearly demonstrated success in saving children’s lives. We remain committed to human subjects protection for those enrolled in any study conducted by Hopkins faculty, whether the participants are in the U.S. or abroad.

We also are gratified that the drug’s manufacturer, Boehringer Ingelheim, Inc., has announced that it will continue to offer the drug to developing countries for the prevention of mother-to-child transmission of HIV as part of its VIRAMUNE donation program. (VIRAMUNE is the trade name for nevirapine.)

Those who designed and conducted the study were sensitive to the differences between the Ugandan health care system and resources and those in the United States. Uganda is a country with epidemic HIV infection and a health care system that is valiantly struggling with the disease’s impact. The study, known as HIVNET 012, completed enrollment in 1999. All subjects continue in long-term follow-up to collect information on the state of their health.

Articles about the importance of this research, the reasons for conducting the study in Uganda, and press releases from the National Institutes of Health about the study can be found at: http://www.nih.gov/news/pr/jul99/index.htm

http://www.hopkinsmedicine.org/hmn/S01/feature.html

http://www.hopkinsmedicine.org/press/2001/SEPTEMBER/010929.htm

http://www.niaid.nih.gov/cgi-shl/simple/release.cfm

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