• Eur. J. Clin. Microbiol. Infect. Dis. · Jan 1999

    Randomized Controlled Trial Comparative Study Clinical Trial

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

    • S Fournier, A M Burguière, A Flahault, V Vincent, M P Treilhou, and M Eliaszewicz.
    • Department of Infectious Diseases, Hôpital Saint-Louis, Paris, France.
    • Eur. J. Clin. Microbiol. Infect. Dis. 1999 Jan 1;18(1):16-22.

    AbstractThis study compared the efficacies of clarithromycin-ethambutol and clarithromycin-ethambutol-clofazimine for the treatment of Mycobacterium avium complex (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 blood cultures becoming negative after 2 months of therapy, but survival at 12 months and clinical evolution were also assessed. Inclusions were prematurely stopped because of a communication reporting increased mortality associated with clofazimine. At 2 months, the blood cultures of 55% of the clarithromycin-ethambutol group patients versus 81% of the clarithromycin-ethambutol-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 or clinical evolution was observed in this small number of patients (median survival, 144 days in the clarithromycin-ethambutol group and 236 days in the clarithromycin-ethambutol-clofazimine group, P=0.44). The clarithromycin-ethambutol combination appears to be an effective and well-tolerated first-line therapy against MAC infections in AIDS patients.

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