A COMPARISON OF 2 REGIMENS FOR THE TREATMENT OF MYCOBACTERIUM-AVIUM COMPLEX BACTEREMIA IN AIDS - RIFABUTIN, ETHAMBUTOL, AND CLARITHROMYCIN VERSUS RIFAMPIN, ETHAMBUTOL, CLOFAZIMINE, AND CIPROFLOXACIN

Background Bacteremia with the Mycobacterium avium complex is common i n patients with the acquired immunodeficiency syndrome (AIDS), but the most effective treatment for this infection remains unclear. Methods We randomly assigned 229 patients with AIDS and M. avium complex bacte remia to receive either rifampin (600 mg daily), ethambutol (approxima tely 15 mg per kilogram of body weight daily), clofazimine (100 mg dai ly), and ciprofloxacin (750 mg twice daily) (the four-drug group) or r ifabutin (600 mg daily), ethambutol (as above), and clarithromycin (10 00 mg twice daily) (the three-drug group). In the three-drug group the dose of rifabutin was reduced by half after 125 patients were randomi zed, because 24 of 63 patients had uveitis. Results Among 187 patients who could be evaluated, blood cultures became negative more often in the three-drug group than in the four-drug group (69 percent vs. 29 pe rcent, P<0.001). Among patients treated for at least four weeks, the b acteremia resolved more frequently in the three-drug group (78 percent vs. 40 percent, P<0.001). In the three-drug group, bacteremia resolve d more often with the 600-mg dose of rifabutin than with the 300-mg do se (P=0.025), but the latter regimen was more effective than the four- drug regimen (P<0.05). The median survival was 8.6 months in the three -drug group and 5.2 months in the four-drug group (P=0.001). The media n Karnofsky performance score was higher in the three-drug group than in the four-drug group from week 2 to week 16 (P<0.05). Mild uveitis d eveloped in 3 of the 53 patients receiving the 300-mg dose of rifabuti n, an incidence about one quarter that observed with the 600-mg dose ( P<0.001). Conclusions In patients with AIDS and M. avium complex bacte remia, treatment with the three-drug regimen of rifabutin, ethambutol, and clarithromycin leads to resolution of the bacteremia more frequen tly and more rapidly than treatment with rifampin, ethambutol, clofazi mine, and ciprofloxacin, and survival rates are better. (C) 1996, Mass achusetts Medical Society.