Washington – People infected with the AIDS virus who periodically interrupt their drug treatment run a higher risk of falling ill and dying of AIDS and other diseases compared with people who stay on medicines.
That is the conclusion of the largest and most expensive AIDS treatment study ever conducted, and it comes as a surprise and bitter disappointment to thousands of people who flocked to the study in hopes of finding a way around lifelong use of the drug combinations.
Although the hazards are small – about a 5 percent chance of falling ill, and a 1.5 percent chance of dying over a little more than a year – they are large enough that patients probably should never stop their medicines if they can help it.
The study, called SMART, was unexpectedly ended last month even before it finished enrolling volunteers. Virtually no details were released at the time, other than that people cycling on and off anti-retroviral AIDS drugs were faring worse.
Details of the experiment – which had 5,472 subjects in 33 countries – are being presented today at the 13th Conference on Retroviruses and Opportunistic Infections in Denver. They were previously presented to the AIDS Research Advisory Committee at the National Institutes of Health, which has spent $73 million on the study.
The physicians running SMART, which stands for Strategies for Management of Antiretroviral Therapy, are struggling to come to terms with the results. The study not only reached the opposite conclusion of what many expected, it reached it in one-quarter of the anticipated time.
“We all wanted so much for it to work. But that’s how science goes,” said Mauro Schechter, a professor at the Federal University of Rio de Janeiro and the head of the Brazilian study site. “You do the studies to get the answer. It is not always the answer you like.”
The idea behind SMART was that people with HIV might need the drugs only when their immune systems were clearly losing the battle with the virus. They would take the drugs until their immunity rebounded.
