Symptom-reduction trials at FDA clinical trials workshop. Food and Drug Administration.

In September, the Food and Drug Administration (FDA) clinical trials workshop proposed the development of symptom-reduction trials. Participants in these trials must have a certain, carefully chosen indicator symptom, a symptom or condition believed to be caused by immune deficiency or otherwise by HIV infection, and which is unlikely to resolve on its own. The subjects are treated with antiviral agents, immunomodulators, or other drugs to see if the symptom goes away. This type of study differs in that the conventional trial measures disease progression by waiting for new symptoms or conditions to appear, which usually takes a great deal of time. It is hoped that this type of trial will validate various markers of improvement over months, rather than years.