After reviewing a recent journal report describing use of the experimental drug isoprinosine to treat patients infected with the AIDS virus (HIV), FDA concluded that more studies are needed to determine its value to patients. A Scandinavian study, reported in the June 21 New England Journal of Medicine, indicated that the immune system modulator isoprinosine significantly slowed disease progression. According to the report, of the 866 HIV-infected patients in the study, those given isoprinosine were significantly less likely to progress to AIDS than patients given the placebo. During the 24-week trial, 17 patients on placebo developed AIDS as opposed to two patients given isoprinosine.

Previous studies of isoprinosine for HIV-infected patients, however, showed no significant effect in slowing disease progression, and FDA's division of antiviral drug products believes additional clinical testing of the drug is needed. Recommended tests could incorporate approved therapies for preventing Pneumocystis carinii pneumonia and anti-viral treatments to determine how isoprinosine might be best used if proven effective.

The drug's sponsor, Newport Pharmaceuticals Inc. of Laguna Beach, Calif., is currently reanalyzing data from an earlier study that showed no significant benefit of isoprinosine in order to evaluate the discrepancies in results of the two trials.
FDA noted some concerns about the design and analysis of the Scandinavian study that may have affected the results. The agency also noted that 24 weeks is a relatively short study period.

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