Effect of adding clofazimine to combined clarithromycin-ethambutol therapy for Mycobacterium avium complex septicemia in AIDS patients.
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.
Fournier
S
S
Department of Infectious Diseases, Hôpital Saint-Louis, Paris, France.
Burguière
A M
AM
Flahault
A
A
Vincent
V
V
Treilhou
M P
MP
Eliaszewicz
M
M
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use*; D016470:Bacteremia / Q000188:drug therapy*; D017291:Clarithromycin / Q000627:therapeutic use*; D002991:Clofazimine / Q000627:therapeutic use*; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D004977:Ethambutol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015269:Mycobacterium avium Complex; D015270:Mycobacterium avium-intracellulare Infection / Q000188:drug therapy*; D016019:Survival Analysis
D000894:Anti-Inflammatory Agents, Non-Steroidal; D004977:Ethambutol; D002991:Clofazimine; D017291:Clarithromycin