Effect of adding clofazimine to combined clarithromycin-ethambutol therapyfor Mycobacterium avium complex septicemia in AIDS patients

This study compared the efficacies of clarithromycin-ethambutol and clarith romycin-ethambutol-clofazimine for the treatment of Mycobacterium avium com plex (MAC) in AIDS patients. Thirty-four patients were randomized into two groups to receive clarithromycin 2 g/day and ethambutol 20 mg/kg/day, with or without clofazimine 200 mg/day. The evaluation was based primarily on bl ood cultures becoming negative after 2 months of therapy, but survival at 1 2 months and clinical evolution were also assessed. Inclusions were prematu rely stopped because of a communication reporting increased mortality assoc iated with clofazimine. At 2 months, the blood cultures of 55% of the clari thromycin-ethambutol group patients versus 81% of the clarithromycin-ethamb utol-clofazimine group were negative, this difference is not significant (P = 0.42). Only one relapse was observed during the study. No clarithromycin -resistant strain was isolated. No apparent difference in either survival o r clinical evolution was observed in this small number of patients (median survival, 144 days in the clarithromycin-ethambutol group and 236 days in t he clarithromycin-ethambutol-clofazimine group. P = 0.04). The clarithromyc in-ethambutol combination appears to be an effective and well-tolerated fir st-line therapy against MAC infections in AIDS patients.