AIDS ANTIVIRAL MULTICENTER CLINICAL TRIALS

AIDS ANTIVIRAL MULTICENTER CLINICAL TRIALS should be planned but not started until more specific dosing information can be determined and incorporated into the design of a large scale testing program, Natl. Institute for Allergies and Infectious Diseases Director Anthony Fauci, MD, indicated at a June 3 AIDS Antiviral Agent Workshop held at NIH. "What I am afraid of," Fauci stated, "is because we are so desperate -- all of us who are treating these patients -- is that we would jump in with a multicenter study without having an appropriate design [for] it. If we had more information about dose, dose regimen, etc.," we would be "in a better position to design a large multicenter study where we have a large number of patients." The NIH workshop examined current research into the therapeutic effects of antiviral agents in the treatment of retroviral infections. Specifically, presentations ware made concerning the limited clinical experiences with six drugs that have been shown to have in vitro activity against AIDS-related viruses: surarmn, HPA 23, ribavirin, foscarnet, ansamycin and Isorinosine. Designed as an information exchange, the workshop did not make formal recommendations. Martin Hirsch, MD, Massachusetts General Hospital, urged that multicenter clinical testing of the drugs begin promptly. "Patients are going down the tubes all over the world very rapidly," he declared. "I think once you've demonstrated that there is some antiviral effect of the drug, I think you can go ahead with the [large-scale] studies. I really think that it is time to have a multicenter group . . . and start studying the drugs." Fauci replied, "I also believe that soon we should be doing larger clinical trials to detemine the clinical efficacy" of these drugs. However, he said, "I'm afraid of taking an agent that has some potential for use, using it not as correctly as we could, then five years down the line have thousands of patients we've treated and not really have the answer. I think we need some more information on the earlier phases of the study." Noting that the lead time before implementation of a multicenter trial is usually six months to a year, Hirsch and Fauci suggested that planning activities begin as soon as possible. "Six months from now I would hope you would have enough data, at the rate it is being accumulated with the current studies going on, to really move into clinical trials," Hirsch said.

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