FDA Community Meeting May 16: Clinical Trials and Viral Load

On April 28 the FDA announced a public meeting to discuss possible use of viral load instead of "clinical endpoints"(usually death or the development of an AIDS-defining illness) in certain clinical trials of antiretrovirals. Persons can also submit a position paper or list of questions, in advance of the meeting.

The meeting will be held on Friday, May 16, from 1:00 to 4:00 in Conference Room G of the Parklawn Conference Center, located on the third floor of the Parklawn Building, 5600 Fishers Lane, Rockville, Maryland. The building is wheelchair accessible, and can be reached by the Washington D.C. Metro. Because of security measures, persons should allow at least 15 minutes extra time for arriving. You will need a photo ID to enter the building.

A written position paper may be submitted before the meeting to Richard Klein, HIV/AIDS Program, Office of Special HealthIssues, HF-12, 5600 Fishers Lane, Rockville, MD 20857, or by fax to 301/443-4555.

If you have questions about the meeting, you can call Richard Klein at 301/827-4460, or send email to Rklein@bangate.fda.gov.

Comment

This community forum concerns a mid-July meeting of the Antiviral Drugs Advisory Committee -- not yet officially announced -- which will examine possible changes to regulations to allow sustained reductions in viral load to substitute for "clinical endpoints" (deaths or serious disease progression) now required for proof of antiretroviral drug efficacy in confirmatory clinical trials. It is widely believed that the FDA wants to make this change, and will do so after the July Advisory Committee meetings.

Under current "Accelerated Approval" regulations,antiretrovirals can be approved for marketing based on viral load reductions and similar evidence that they work. But the drugs approved this way must then go through large, long-lasting clinical-endpoint trials to prove that the viral load and other blood-test improvements translate to real benefit to patients. Due to advances in recent years in the understanding of HIV disease, these trials have become increasingly ethically problematic, and are seen by many as ahuge misdirection of resources -- money, trained professionals, and not least, the trial volunteers -- which should be focused instead on more practical trials which seek answers which physicians need today.

Note: For an in-depth look at the rapidly changing thinking about AIDS clinical trials, see two articles in the current issue of SCIENCE (volume 276, April 25, 1997) -- "AIDS Trials Ethics Questioned," by Jon Cohen, pages 520-523 and "Current Problems and the Future of Antiretroviral Drug Trials," pages 548-550, by Dr. Joep M.A. Lange.