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Largest AIDS Treatment Study Cut Short

The largest worldwide AIDS study ever conducted ended prematurely and with some disappointment after results showed that patients on “interrupted” therapy did not fare decidedly better than those on continuous treatment. The eagerly anticipated results were presented at the 13th Conference on Retroviruses and Opportunistic Infections in Denver, CO on February 7, 2006.

Sponsored by the National Institutes of Health, the Strategies for Management of Antiretroviral Therapy (SMART) study began in 2002 and ultimately enrolled 5,472 patients from 33 countries. The purpose was to compare continuous anti-retroviral therapy (ART) in AIDS patients with an interrupted approach where treatment is only given when a patient’s viral load drops low enough to adversely affect his or her immune system. Proponents believed that the latter approach was preferable because the standard, continuous ART method did not cure infection, and serious side-effects were associated with uninterrupted therapy—such as diabetes, high cholesterol and risk of heart attack.

Advocates claimed that the benefits of the interrupted ART approach were that patients suffered from fewer side-effects, lesser development of drug resistance and the added psychological advantage of not having to take daily multiple pills for an indefinite period of time. Those favoring the interrupted ART were optimistic that the SMART study would vindicate their arguments in favor of this treatment approach, but they were disappointed when 5.4 percent of the study participants on interrupted therapy had died or developed serious complications contrasted with 3.6 percent of those patients on continuous treatment. “We all wanted so much for it to work. But that’s how science goes. You do the studies to get the answer. It is not always the answer you like,” said Mauro Schecter, professor at the Federal University of Rio de Janiero and head of a study site in Brazil.

The study ended earlier than expected when SMART leaders stopped enrolling patients based on recommendations made by a monitoring board. Some patients, medical providers and advocates believe that the SMART results and the abrupt end to the study should not signal the final word on the issue. “Our concern is that this will be considered the end of any studies of treatment strategies. We think that would be premature,” said Richard Jefferys, head of the New York-based AIDS activist organization, Treatment Action Group. “The assumption that people are just going to be on therapy for the rest of their lives is not a practical assumption,” he added.

SMART study investigators will continue to monitor patient enrollees for at least a few more years. To learn more about the study and to view a presentation of the results go to

Source: Washington Post, February 7, 2006


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