Multicenter clinical trial of oral ribavirin in symptomatic HIV-infected patients. The Ribavirin ARC Study Group.
A double-blind, randomized, placebo-controlled trial comparing two daily doses of oral ribavirin (600 mg and 800 mg) and placebo was conducted at six medical centers. Two hundred fifteen adults were enrolled over a 5-month period and randomized to receive ribavirin 800 mg daily (74 subjects), ribavirin 600 mg (71 subjects), or placebo (70 subjects). Active treatment was administered for 24 weeks followed by a 4-week wash-out period. Fifteen patients receiving placebo, 10 receiving ribavirin 600 mg, and 18 receiving ribavirin 800 mg developed AIDS during the 28-week study period. Ribavirin at daily doses of 600 mg or 800 mg for 24 weeks did not significantly affect the rate of progression to AIDS as defined by the Centers for Disease Control, in univariate analysis, Kaplan-Meier survival analysis, or Cox proportional hazards modeling. Although in the proportional hazards analysis, the dose-response regression coefficients indicated a reduction of 43% in the hazard of progression to AIDS among patients on active treatment, it was not statistically significant (p = 0.19). Furthermore, there was no evidence that ribavirin had a significant effect upon any immunologic or virologic parameter measured, including CD4 count, CD4:CD8 ratio, lymphocyte proliferative response, skin test reactivity, interferon-gamma production, peripheral blood mononuclear cell culture for human immunodeficiency virus (HIV), or level of HIV p24 antigen in serum. The most prominent adverse effect of ribavirin was induction of a mild reversible hemolytic anemia (mean fall in hematocrit, 5%). No severe or unremitting drug reaction was documented.
D000386:AIDS-Related Complex / Q000188:drug therapy; D000163:Acquired Immunodeficiency Syndrome / Q000517:prevention & control*; D000284:Administration, Oral; D000328:Adult; D004311:Double-Blind Method; D005260:Female; D015658:HIV Infections / Q000097:blood / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D012254:Ribavirin / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*
D012254:Ribavirin