A randomized, placebo-controlled study of rifabutin added to a regimen of clarithromycin and ethambutol for treatment of disseminated infection with Mycobacterium avium complex. NLM AIDSLINE Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.

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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 MED/99379707
Gordin FM; Sullam PM; Shafran SD; Cohn DL; Wynne B; Paxton L; Perry K; Horsburgh CR Jr; Veterans Affairs Medical Center and Georgetown University,; Washington, DC, USA.


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.
Keywords: 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 AnalysisKWDclinicaltrialjournalarticlerandomizedcontrolledtrialadolescenceadultantibiotics,combined/therapeuticuseantitubercularagents/KWDtherapeuticuseaids-relatedopportunisticinfections/KWDdrugtherapychildclarithromycin/KWDtherapeuticusedrugresistance,microbialdrugtherapy,combinationethambutol/KWDtherapeuticusefemalehumanmaleKWDmycobacteriumaviumcomplexmycobacteriumavium-intracellulareinfection/KWDdrugtherapyprospectivestudiesrifabutin/KWDtherapeuticusesupport,non-uKWDsKWDgov'tsurvivalanalysis
991230
A99C1042

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