Clarithromycin or rifabutin alone or in combination for primary prophylaxis of Mycobacterium avium complex disease in patients with AIDS: A randomized, double-blind, placebo-controlled trial. The AIDS Clinical Trials Group 196/Terry Beirn Community Programs for Clinical Research on AIDS 009 Protocol Team.

Important note: Information in this article was accurate in 2000. The state of the art may have changed since the publication date.

J Infect Dis. 2000 Apr;181(4):1289-97. Unique Identifier : AIDSLINE MED/20227750
Benson CA; Williams PL; Cohn DL; Becker S; Hojczyk P; Nevin T; Korvick JA; Heifets L; Child CC; Lederman MM; Reichman RC; Powderly WG; Notario GF; Wynne BA; Hafner R; Rush Medical College/Rush-Presbyterian-St. Luke's Medical Center,; Chicago, IL, USA. constance.benson@uchsc.edu

Abstract: The efficacy and safety of clarithromycin and rifabutin alone and in combination for prevention of Mycobacterium avium complex (MAC) disease were compared in 1178 patients with AIDS who had < or =100 CD4 T cells/microL in a randomized, double-blind, placebo-controlled trial. MAC disease occurred in 9%, 15%, and 7% of those randomized to clarithromycin or rifabutin alone or in combination, respectively; time-adjusted event rates per 100 patient-years (95% confidence interval [CI]) were 6.3 (4.2-8.3), 10.5 (7.8-13.2), and 4. 7 (2.9-6.5). Risk of MAC disease was reduced by 44% with clarithromycin (risk ratio [RR], 0.56; 95% CI, 0.37-0.84; P=.005) and by 57% with combination therapy (RR, 0.43; 95% CI, 0.27-0.69; P=. 0003), versus rifabutin. Combination therapy was not more effective than clarithromycin (RR, 0.79; 95% CI, 0.48-1.31; P=.36). Of those in whom clarithromycin or combination therapy failed, 29% and 27% of MAC isolates, respectively, were resistant to clarithromycin. There were no survival differences. Clarithromycin and combination therapy were more effective than rifabutin for prevention of MAC disease, but combination therapy was associated with more adverse effects (31%; P<.001).

Keywords: CLINICAL TRIAL JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL Adult Antibiotics, Antitubercular/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Antibiotics, Macrolide/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE AIDS-Related Opportunistic Infections/*DRUG THERAPY/MICROBIOLOGY Clarithromycin/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Double-Blind Method Drug Resistance, Microbial Drug Therapy, Combination Female Human Male Microbial Sensitivity Tests Mycobacterium avium Complex/DRUG EFFECTS/ISOLATION & PURIF Mycobacterium avium-intracellulare Infection/*DRUG THERAPY/ MICROBIOLOGY Prospective Studies Rifabutin/ADMINISTRATION & DOSAGE/*THERAPEUTIC USE Support, Non-U.S. Gov't Support, U.S. Gov't, P.H.S.

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