Ditiocarb sodium (diethyldithiocarbamate) therapy in patients with symptomatic HIV infection and AIDS. A randomized, double-blind, placebo-controlled, multicenter study
E. M. Hersh, G. Brewton, D. Abrams, J. Bartlett, J. Galpin, P. Gill, R. Gorter, M. Gottlieb, J. J. Jonikas, S. Landesman and al. et
University of Arizona, Arizona Cancer Center, Tucson 85724.
We randomized 389 symptomatic patients with human immunodeficiency virus
(HIV) infection to ditiocarb sodium (400 mg/m2 orally for 24 weeks) or a
placebo. Patients were well balanced according to Centers for Disease
Control (CDC) group, CD4+ cell number, and duration of disease prior to
entry. Ten new acquired immunodeficiency syndrome (AIDS)-defining
opportunistic infections occurred in the treated patients and 21 in the
controls. Reduction of new opportunistic infections in the ditiocarb group
was significant in all patients (relative risk [RR], 0.44) and in patients
with AIDS (CDC groups IV-C1 and IV-D) (RR, 0.12). The size of the effect of
ditiocarb was maintained when data were reanalyzed after exclusion of a
patient who progressed to Pneumocystis carinii pneumonia who was not
strictly CDC-defined (RR, 0.46), or when considering as new opportunistic
infections three events, which were clinically active at entry, but for
which the definitive diagnosis was made during study (RR, 0.49). The
administration of ditiocarb did not induce any major adverse clinical or
biological reactions. We conclude that, in this study, ditiocarb was safe
and reduced the incidence of opportunistic infections in patients with
symptomatic HIV infection.
