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

Eur J Clin Microbiol Infect Dis. 1999 Jan;18(1):16-22. doi: 10.1007/s100960050220.

Abstract

This 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.

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • AIDS-Related Opportunistic Infections / drug therapy*
  • Aged
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Bacteremia / drug therapy*
  • Clarithromycin / therapeutic use*
  • Clofazimine / therapeutic use*
  • Drug Therapy, Combination / therapeutic use
  • Ethambutol / therapeutic use*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Mycobacterium avium Complex
  • Mycobacterium avium-intracellulare Infection / drug therapy*
  • Survival Analysis

Substances

  • Anti-Inflammatory Agents, Non-Steroidal
  • Ethambutol
  • Clofazimine
  • Clarithromycin