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.