Isoprinosine reduced clinical progression in HIV infected patients in a double blind placebo controlled study

OBJECTIVE: To determine the influence of isoprinosine (Imunovir) on the clinical course of HIV infection. METHODS: A total of 866 HIV infected patients from Sweden and Denmark were randomised and stratified according to CD4-count to receive either isoprinosine 1 g t.i.d. (n=429) or matching placebo (n=437) for 6 months. At baseline the study population consisted of 765 asymptomatic patients and 101 symptomatic patients. Patients with AIDS were not included. RESULTS: Eight hundred and thirty-three patients were eligible for efficacy analysis. There were no significant differences between the two groups with respect to CD4-count or clinical status at baseline. Progression to AIDS according to CDC revised definition: TABULAR DATA, SEE ABSTRACT VOLUME. During treatment no significant differences in CD4-count occurred. No serious side effects were observed. Minor adverse reactions occurred with equal frequencies in both groups. CONCLUSION: Isoprinosine offers a potential treatment modality, particularly in the asymptomatic HIV infected patients. However, the mode of action remains to be clarified.