FDA clarifies rules, allows combining antiretrovirals in clinical trials. Food and Drug Administration.

In November the FDA wrote to all pharmaceutical companies urging them to run clinical trials for treatment-experienced patients, and clarified the rules on combining antiretroviral drugs. The FDA usually prefers that all clinical trials only test one new drug, due to safety reasons and to make the test results easier to interpret. However, HIV patients on failing multi-drug regimens, may need to take more than one experimental drug. In the past, drug companies could hide behind the FDA and resisted testing their drugs with advanced patients, who are harder to treat, and represent a smaller market for approved drugs. However, the letter makes it clear that the FDA expects more studies in these patients. Portions of the letter are included.