If successful, the new strategy - a structured stop-and-start drug regimen - would permit health agencies in resource-poor countries overburdened by the AIDS epidemic to extend care to many more patients with the same quantity of drugs, thus saving lives. Individual patients on the protocol in both the developed and developing worlds would benefit from reduced exposure to the toxicities associated with HIV drugs.
That's the good news. The bad news is that funding guidelines set by the NIAID do not permit that agency, which oversees most U.S.-supported AIDS research, to cover the cost of the drugs needed to conduct any AIDS research study. So the researchers will need to find the money for the needed drugs from an alternate source. Even at the reduced prices at which drug companies are now making their HIV drugs available in South Africa and other parts of the developing world, the cost could be well over $1 million - a significant burden for a team of nonprofit scientists. (In the U.S., the same drugs would cost approximately ten times as much.) The consequence of this situation is that this promising study with important public-health implications may never happen.
"As an academic research institution, we've gone as far as we can go with the government," says Luis J. Montaner, D.V.M., D.Phil., an associate professor in the immunology program at The Wistar Institute and principal investigator on the study. "Now we're knocking on other doors to try to keep this study on track. Most people, including myself, would never have expected such a crucial study to be in peril at this stage of development."
The reasoning behind the NIH policy is that the high cost of providing drugs for studies would limit the agency's overall capacity for supporting international AIDS research. Also, the agency and researchers alike agree that an important ethical consideration is to address this issue of providing continuing access after a study to the live-saving drugs offered in the course of the study. Although there are different ways to address this concern, all agree that the additional costs of ongoing care for study participants must be factored into the planning for such studies.
If Montaner's study is derailed by the team's inability to find additional funding to purchase the needed drugs, a significant opportunity may be delayed or lost.
In the last four years, Montaner and his colleagues have shown in a U.S. clinical trial that cycles of brief interruptions of anti-HIV drug therapy do not lead to adverse medical outcomes of any kind. A structured start-and-stop regimen allows patients to suppress their HIV infections effectively while on therapy and maintain their immune systems while not giving rise to drug-resistant strains of the virus. The data from this clinical trial underpinned the NIH's approval of the South Africa trial.
The institutions involved in the study are The Wistar Institute and the University of Pennsylvania in the U.S. and the University of Witwatersrand and the National Institute for Communicable Diseases in South Africa.
The Wistar Institute is an independent nonprofit biomedical research institution dedicated to discovering the causes and cures for major diseases, including cancer, cardiovascular disease, autoimmune disorders, and infectious diseases. Founded in 1892 as the first institution of its kind in the nation, The Wistar Institute today is a National Cancer Institute-designated Cancer Center - one of only eight focused on basic research. Discoveries at Wistar have led to the development of vaccines for such diseases as rabies and rubella, the identification of genes associated with breast, lung, and prostate cancer, and the development of monoclonal antibodies and other significant research technologies and tools.
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