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

Lancet. 1991 Jul 6;338(8758):6-9.


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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acquired Immunodeficiency Syndrome / prevention & control*
  • Adult
  • Analysis of Variance
  • CD4-Positive T-Lymphocytes / drug effects
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • HIV Infections / blood
  • HIV Infections / drug therapy*
  • HIV Infections / physiopathology
  • Hemoglobins / drug effects
  • Humans
  • Leukocyte Count / drug effects
  • Life Tables
  • Male
  • Ribavirin / adverse effects
  • Ribavirin / therapeutic use*


  • Hemoglobins
  • Ribavirin