A New Attempt to Solve One of AIDS's Biggest Riddles

By David Brown
Washington Post Staff Writer
Sunday, January 7, 2007

In the past 20 years, just about everything has changed in the treatment of HIV infection except that there is still no answer to the question: When should it start?

The answer is easy in the case of many diseases, but not for infection with the AIDS virus, whose course is languid -- and lethal.

For most people with HIV, there are few problems and almost no symptoms for years after they acquire the virus. But the disease is incurable, and without treatment, it is eventually fatal for almost everyone who has it.

Treatment consists of a combination of three or more drugs, known generically as antiretroviral therapy (ART). But the drugs are not without a downside. They are costly, they have side effects, and, once started, they must be taken for the rest of the patient's life.

Tens of billions of dollars in health-care costs around the world -- and in foreign aid and charity -- hinge on knowing the best time to start treatment.

"This is like the holy grail of AIDS research," said Fred Gordin, an AIDS specialist at the Washington Veterans Affairs Medical Center. "People pretty much thought it couldn't be studied."

This month, Gordin and a group of researchers will ask the government to underwrite an audacious effort to answer the "when-to-start" question.

On Jan. 17 they plan to propose to the National Institutes of Health an international study that would enroll more than 9,000 people, children and adults, from poor and rich countries. Each would be randomly assigned to start AIDS treatment either soon after infection or after the virus has begun to measurably erode their immune systems. Participants would be followed and studied for five years to see who fares best -- and who dies prematurely.

"Universally, people feel this is an important question," said Anthony S. Fauci, head of the National Institute of Allergy and Infectious Diseases, whose Division of AIDS will consider the request.

Paula Munderi, of the Uganda Virus Research Institute in Entebbe, agreed. "The rationale for doing this is clearly global. It is useful for everyone," she said recently.

While a previous attempt to answer the question failed, and the rapid treatment advances of the past decade made similar studies impossible, the current enthusiasm for a when-to-start study shows there are seasons in the lives of diseases as well as of men.

Starting antiretroviral therapy requires tradeoffs in lifestyle, economics, self-image and possibly health, since early in the course of infection the drugs' side effects can outweigh the immune-system benefits. Nobody knows when in the long downhill course of infection the balance finally tips in favor of treatment.

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