Journal Article

A Randomized, Placebo-Controlled Study of Rifabutin Added to a Regimen of Clarithromycin and Ethambutol for Treatment of Disseminated Infection with <i>Mycobacterium avium</i> Complex

Fred M. Gordin, Paul M. Sullam, Stephen D. Shafran, David L. Cohn, Beverley Wynne, Linda Paxton, Kim Perry and C. R. Horsburgh

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 28, issue 5, pages 1080-1085
Published in print May 1999 | ISSN: 1058-4838
Published online May 1999 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/514748
A Randomized, Placebo-Controlled Study of Rifabutin Added to a Regimen of Clarithromycin and Ethambutol for Treatment of Disseminated Infection with Mycobacterium avium Complex

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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.

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Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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