Federal AIDS study stopped abruptly

Federal disease specialists yesterday abruptly halted a major AIDS study designed to determine whether patients could skip their potent drugs for months at a time without serious health consequences.

Instead, researchers found that patients in the international study who volunteered to forgo their drugs were more than twice as likely to suffer serious complications than participants who continued to take their pills.

Those findings, and the decision to immediately discontinue the experiment, delivered a devastating blow to efforts to spare AIDS patients from a lifetime of toxic medications -- and, potentially, to make more medication available in Africa and Asia, regions that have disproportionately borne the burden of HIV.

''This strategy of simply stopping has too much risk," said Dr. Calvin Cohen, a Boston AIDS specialist who is a member of the executive committee overseeing the drug trial.

A class of pills known as protease inhibitors revolutionized AIDS treatment a decade ago. The medicine became the anchor for powerful drug cocktails that dramatically reduced deaths from HIV in the developed world.

But those drugs come at a steep cost, both financially and physically: The annual price tag for the medications regularly exceeds $10,000, and there can be significant side effects, including heart disease and disfiguring deposits of fat.

So doctors and patients alike wanted to know whether it would be possible to stop taking drugs completely once patients' immune systems had been restored by the medications.

''The answer appears to be a resounding 'no' based on this study," said Cohen, research director of Community Research Initiative of New England, which performs trials of AIDS drugs.

A periodic review of results from the study, which had enrolled nearly 5,500 volunteers in 33 countries, revealed what researchers considered an unacceptably high level of side effects among patients who had stopped taking their pills for more than a year.

Those patients were substantially more likely to develop serious symptoms of AIDS as well as experience complications such as cardiovascular, kidney, and liver disease -- some of the very same complications the drugs are believed to cause.

The National Institute of Allergy and Infectious Disease, which paid for the study, announced yesterday that it was ending the experiment. About 80 of the participants are from Massachusetts, Cohen said.

''All around, it's disappointing news," said Jose Zuniga, president of the International Association of Physicians in AIDS Care.

AIDS specialists have long recognized that patients on their own sometimes take what are called ''drug holidays," breaks from their medication regimens.

The findings of the study that was halted yesterday show ''it does not appear prudent to get off" the drugs for extended periods, said Dr. Sandra Lehrman of the federal AIDS institute.

Instead, researchers in Boston and in Africa continue to investigate whether a more limited approach to skipping AIDS drugs could hold promise for patients.

That strategy involves giving patients every weekend off from their pills once their immune systems have rebounded. A study by the Community Research Initiative found that 23 of 26 patients who took their drugs just five days a week continued to be virus-free.

Material from the Associated Press was used in this report.