1. A randomized, placebo-controlled study of rifabutin added to a regimen of clarithromycin and ethambutol for treatment of disseminated infection with Mycobacterium avium complex.
- Author
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Gordin FM, Sullam PM, Shafran SD, Cohn DL, Wynne B, Paxton L, Perry K, and Horsburgh CR Jr
- Subjects
- Adolescent, Adult, Child, Drug Resistance, Microbial, Drug Therapy, Combination therapeutic use, Female, Humans, Male, Prospective Studies, Survival Analysis, AIDS-Related Opportunistic Infections drug therapy, Antitubercular Agents therapeutic use, Clarithromycin therapeutic use, Ethambutol therapeutic use, Mycobacterium avium Complex, Mycobacterium avium-intracellulare Infection drug therapy, Rifabutin therapeutic use
- Abstract
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.
- Published
- 1999
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