September 30, 2005 cover of Science -----
Clinical trials of drugs intended to prevent HIV infection in high-risk populations must be developed and carried out in close collaboration with the local communities and national governments of the countries in which they are conducted, according to 18 international leaders in HIV prevention writing in the current (Sept. 30, 2005) issue of Science.
Oral, daily use of the antiretroviral drug tenofovir is considered a key potential strategy for preventing infection of HIV. Clinical trials of the drug are in progress or proposed in numerous countries, including the U.S.
The co-authors advocate early involvement of community leaders and local investigators in the development of HIV-prophylaxis clinical trials, clear communication of research information, and the involvement of the local leaders and investigators in the development of local prevention and treatment infrastructures.
All too often, they note, studies in the last several years were marked by misinformation and miscommunication between these key constituencies. The commentary outlines key issues involved, pointing out that, in those cases, questions about how the research should be carried out proved to be more controversial than the idea of the clinical trial itself.
“These recommended measures will help to build the type of local community trust that is the basis of successful research to find ways to stop the spread of HIV/AIDS,” says lead author Robert Grant, MD, MPH, an associate investigator at the Gladstone Institute of Virology and Immunology and associate professor of medicine at the University of California, San Francisco (UCSF). “HIV pre-exposure chemoprophylaxis research is built on partnerships between sponsors, investigators, communities and governments.”
The commentary is titled “Promote HIV Chemoprophylaxis Research, Don’t Prevent It.” The authors are affiliated with such institutions as the AIDS Research Consortium of Atlanta, the Peruvian-based Associacion Impacta Salud y Educacion and Red Peruana de Mujeres que Viven con VIH/Sida, Cornell University, New York, Family Health International, Research Triangle Park, North Carolina, the New York-based Gay Men’s Health Crisis and the Treatment Action Group, the Ghana Health Service, the McGill University AIDS Center, Montreal, the San Francisco Department of Public Health, UCLA, UCSF, and the University of North Carolina, Chapel Hill.
UCSF is a leading university that consistently defines health care worldwide by conducting advanced biomedical research, educating graduate students in health care, and providing complex patient care.
The Gladstone Institute of Virology and Immunology is one of three research institutes of The J. David Gladstone Institutes, an independent, nonprofit biomedical research institution affiliated with UCSF. For further information, visit www.gladstone.ucsf.edu.