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Veterans Medical Affairs Researchers to Request NIH Funding for Study Examining Best Time to Start Antiretroviral Treatment

January 8, 2007

Researchers at the Washington Veterans Affairs Medical Center this month plan to submit a funding proposal to NIH for a study aimed at determining the best time to start antiretroviral therapy, the Washington Post reports. According to the Post, the study would enroll more than 9,000 adults and children from wealthy and developing countries and would follow participants for five years. Participants each would be randomly assigned to start antiretroviral therapy either soon after HIV transmission or after the virus has begun to significantly affect the immune system, the Post reports. The study "would actually be two studies in one," according to the Post -- one part would enroll participants with CD4+ T cell counts higher than 500 and randomly assign them either to start treatment immediately or to start treatment when their CD4 counts reach the 300 to 350 range. The other part would include participants with lower CD4 counts and assign them either to start immediate treatment or to wait until their CD4 counts reach the 200 to 250 range. "This is like the holy grail of AIDS research," Fred Gordin of the Veterans Affairs Medical Center said, adding, "People pretty much thought it couldn't be studied." Anthony Fauci, head of NIH's National Institute of Allergy and Infectious Diseases, said, "Universally, people feel this is an important question." Many guidelines, including those from the U.S. government and the World Health Organization, recommend that HIV-positive people start treatment when their CD4 counts fall between 350 and 200, and some doctors believe that treatment should start at a count of 500, according to the Post. Although the "pendulum ... swung away from early treatment" after research conducted in the 1990s indicated that long-term treatment might increase the risk of developing drug resistance, "now it is swinging back" for several reasons, the Post reports. Most antiretroviral treatment regimens allow HIV-positive people to take one pill daily, newer drugs have fewer side effects and there are "hundreds of possible combinations of the nearly two dozen antiretrovirals on the market," according to the Post. In addition, results from the Strategies for Management of Antiretroviral Therapy, which indicated that suppressing HIV levels in the bloodstream might benefit the entire body and not just the immune system, "offered one more reason to consider early treatment," the Post reports (Brown, Washington Post, 1/7).

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