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POSSIBLE BENEFIT WITH MINIMAL RISK FROM A NEW TREATMENT FOR HIV.

Inosine pranobex (isoprinosine) has been used experimentally as an "immune system stimulant." Several previous studies have reported minimal benefit, if any, from its use in HIV infection. A new, larger study gives some evidence that it has benefits.

This randomized, double-blind, placebo-controlled multicenter trial enrolled 866 patients in Denmark and Sweden who were HIV-seropositive but did not have AIDS. The patients were stratified into three groups on the basis of their baseline CD4+ cell counts and were treated for 24 weeks; no follow-up thereafter was reported. The risk of developing AIDS was 8.6 times higher in the placebo group than in the isoprinosine group. The beneficial effect of the drug was observed regardless of the baseline CD4+ cell count. No serious side effects from isoprinosine were observed, and minor side effects occurred at a similar rate in both groups.

Although these results are clearly encouraging, the study did not find several other positive outcomes that might have been expected if isoprinosine were truly effective: there was no increase in CD4+ cell counts and no reduction in the development of other HIV-related conditions (except thrush). An editorial written by FDA staff states emphatically that further studies are needed before optimism is warranted.

— ALK

Published in Journal Watch General Medicine June 29, 1990

Citation(s):

Kweder SL et al. Inosine pranobex -- is a single positive trial enough. N Engl J Med 1990 Jun 21 322 1807-1809.

• Medline abstract (Free)

Pedersen C et al. The efficacy of inosine pranobex in preventing the acquired immunodeficiency syndrome in patients with human immunodeficiency virus infection. N Engl J Med 1990 Jun 21 322 1757-1763.

• Medline abstract (Free)