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A randomized, placebo-controlled study of rifabutin added to a regimen of clarithromycin and ethambutol for treatment of disseminated infection with Mycobacterium avium complex.


Clin Infect Dis. 1999 May;28(5):1080-5. Unique Identifier : AIDSLINE

Current guidelines suggest that disseminated Mycobacterium avium complex (MAC) infection be treated with a macrolide plus ethambutol or rifabutin or both. From 1993 to 1996, 198 AIDS patients with MAC bacteremia participated in a prospective, placebo-controlled trial of clarithromycin (500 mg b.i.d.) plus ethambutol (1,200 mg/d), with or without rifabutin (300 mg/d). At 16 weeks, 63% of patients in the rifabutin group and 61% in the placebo group (P = .81) had responded bacteriologically. Changes in clinical symptoms and time to survival were similar in both groups. Development of clarithromycin resistance during therapy was similar in the two groups; of patients who had a bacteriologic response, however, only 1 of 44 (2%) receiving rifabutin developed clarithromycin resistance, vs. 6 of 42 (14%) in the placebo group (P = .055). Thus, rifabutin had no impact on bacteriologic response or survival but may protect against development of clarithromycin resistance in those who respond to therapy.

CLINICAL TRIAL JOURNAL ARTICLE RANDOMIZED CONTROLLED TRIAL Adolescence Adult Antibiotics, Combined/THERAPEUTIC USE Antitubercular Agents/*THERAPEUTIC USE AIDS-Related Opportunistic Infections/*DRUG THERAPY Child Clarithromycin/*THERAPEUTIC USE Drug Resistance, Microbial Drug Therapy, Combination Ethambutol/*THERAPEUTIC USE Female Human Male *Mycobacterium avium Complex Mycobacterium avium-intracellulare Infection/*DRUG THERAPY Prospective Studies Rifabutin/*THERAPEUTIC USE Support, Non-U.S. Gov't Survival Analysis


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