Multicenter, randomized, placebo-controlled study of ditiocarb (Imuthiol) in human immunodeficiency virus-infected asymptomatic and minimally symptomatic patients. The HIV87 Study Group.
Ditiocarb sodium has been reported to reduce the progression of human immunodeficiency virus (HIV) infection. To confirm this therapeutic activity and to evaluate the effect of ditiocarb sodium in the early stages of HIV infection, we conducted a randomized, double-blind, placebo-controlled trial in asymptomatic or minimally symptomatic adults with HIV infection. Patients were followed during a 24 mo period, with a clinical and laboratory evaluation every 4 mo. Of 1333 patients who continued therapy after day 1, 669 were randomized to ditiocarb and 664 to placebo. The two treatment groups were comparable at entry, except for the CD4+ cell count, which was lower in the ditiocarb (median 416/mm3) than in the placebo group (median 458/mm3). Acquired immunodeficiency syndrome (AIDS) developed in 106 patients in the ditiocarb group as compared with 68 in the placebo group; 285 patients progressed to AIDS-related complex (157 ditiocarb, 128 placebo); 55 patients died (34 ditiocarb; 21 placebo). The risk of progression to AIDS, after adjustment for baseline CD4+ cell count, was significantly higher in the ditiocarb than in the placebo group (adjusted relative risk = 1.41; p = 0.027). A decrease in CD4+ cell counts was observed, with no significant difference between the ditiocarb and the placebo group. A positive effect of ditiocarb given in the condition of this study can be excluded. Although previous studies have shown opposite results, this study suggests that the use of ditiocarb in HIV-infected patients should be discontinued.
D000386:AIDS-Related Complex / Q000188:drug therapy / Q000276:immunology; D000163:Acquired Immunodeficiency Syndrome / Q000188:drug therapy* / Q000276:immunology; D000328:Adult; D000368:Aged; D015496:CD4-Positive T-Lymphocytes; D004050:Ditiocarb / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology; D006801:Humans; D007958:Leukocyte Count; D008297:Male; D008875:Middle Aged
D004050:Ditiocarb