Comparison of ribavirin and placebo in CDC group III human immunodeficiency virus infection. Spanish Ribavirin Trial Group.

To assess the efficacy and safety of ribavirin in patients with human immunodeficiency virus (HIV) infection a multicentre, placebo-controlled, prospectively randomised trial was conducted in CDC group III HIV-infected individuals between February, 1988, and October, 1989. Mean treatment time was 39 weeks (range 6-52); 152 individuals were enrolled, of whom 133 could be evaluated. The two treatment groups were similar at baseline and 66% of all subjects had intravenous drug abuse as the main risk factor for HIV infection. Ribavirin was given at a dose of 15 mg/kg daily by mouth (average daily dose 1000 mg). 9 of 67 patients in the placebo group (13.4%) progressed to CDC Groups IVA, C1, or D vs 6 of 66 (9%) in the ribavirin group. Progressions to group IVC2 were 7 (10.4%) and 9 (13.6%), respectively. These differences are not statistically significant. There were no clinically or statistically significant differences in CD4 cell counts, total lymphocytes, total white cells, or CD4/CD8 ratios between the two groups during treatment, and no clinically important side-effects were noted.