The US Food and Drug Administration is writing to all companies testing experimental anti-HIV drugs encouraging them to collaborate in designing `salvage therapy' studies which include more than one new drug.
In a letter posted to the FDA website on September 30, Heidi Jolson of the FDA's Office of Drug Evaluation told drug developers that `factorial' studies which can distinguish the contribution of different agents will be necessary, but that trial participants should nevertheless have the opportunity to receive several potentially active drugs.
This advice implies that new drugs like ABT-378, tenofovir, T-20 and lodenosine could be offered together in clinical trials next year if their manufacturers can agree on how they should be studied. It is thought that these drugs will be more effective in highly treatment-experienced people than any of the drugs currently available if they are used in combinations of two or more.
In Europe, licensing authorities have yet to review the question of how salvage studies should be conducted.