title: A randomized, placebo-controlled study of rifabutin added to a regimen of clarithromycin and ethambutol for treatment of disseminated infection with Mycobacterium avium complex.
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.
authors.affiliation: Veterans Affairs Medical Center and Georgetown University, Washington, DC, USA.
authors.forename: F M
authors.initials: FM
authors.lastname: Gordin
authors.forename: P M
authors.initials: PM
authors.lastname: Sullam
authors.forename: S D
authors.initials: SD
authors.lastname: Shafran
authors.forename: D L
authors.initials: DL
authors.lastname: Cohn
authors.forename: B
authors.initials: B
authors.lastname: Wynne
authors.forename: L
authors.initials: L
authors.lastname: Paxton
authors.forename: K
authors.initials: K
authors.lastname: Perry
authors.forename: C R
authors.initials: CR
authors.lastname: Horsburgh
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000293:Adolescent; D000328:Adult; D000995:Antitubercular Agents / Q000627:therapeutic use*; D002648:Child; D017291:Clarithromycin / Q000627:therapeutic use*; D004352:Drug Resistance, Microbial; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D004977:Ethambutol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D015269:Mycobacterium avium Complex; D015270:Mycobacterium avium-intracellulare Infection / Q000188:drug therapy*; D011446:Prospective Studies; D017828:Rifabutin / Q000627:therapeutic use*; D016019:Survival Analysis
chemical_list: D000995:Antitubercular Agents; D017828:Rifabutin; D004977:Ethambutol; D017291:Clarithromycin