Journal Article

A Prospective, Randomized Trial Examining the Efficacy and Safety of Clarithromycin in Combination with Ethambutol, Rifabutin, or Both for the Treatment of Disseminated <i>Mycobacterium avium</i> Complex Disease in Persons with Acquired Immunodeficiency Syndrome

Constance A. Benson, Paige L. Williams, Judith S. Currier, Fiona Holland, Laura F. Mahon, Rob Roy MacGregor, Clark B. Inderlied, Charles Flexner, Judith Neidig, Richard Chaisson, Gerard F. Notario and Richard Hafner

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 37, issue 9, pages 1234-1243
Published in print November 2003 | ISSN: 1058-4838
Published online November 2003 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/378807
A Prospective, Randomized Trial Examining the Efficacy and Safety of Clarithromycin in Combination with Ethambutol, Rifabutin, or Both for the Treatment of Disseminated Mycobacterium avium Complex Disease in Persons with Acquired Immunodeficiency Syndrome

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This multicenter, randomized, open-label phase 3 clinical trial compared the safety and efficacy of 3 clarithromycin-containing combination regimens for the treatment of disseminated Mycobacterium avium complex (MAC) disease in persons with acquired immunodeficiency syndrome. A total of 160 eligible patients with bacteremic MAC disease were randomized to receive clarithromycin with either ethambutol (C+E), rifabutin (C+R), or both (C+E+R) for 48 weeks. After 12 weeks of treatment, the proportion of subjects with a complete microbiologic response was not statistically significantly different among treatment arms: the proportion was 40% in the C+E group, 42% in the C+R group, and 51% in the C+E+R group (P = .454). The proportion of patients with complete or partial responses who experienced a relapse while receiving C+R (24%) was significantly higher than that of patients receiving C+E+R (6%; P = .027) and marginally higher than that of patients receiving C+E (7%; P = .057). Subjects in the C+E+R group had improved survival, compared with the C+E group (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.23–0.83) and the C+R group (HR, 0.49; 95% CI, 0.26–0.92).

Journal Article.  4869 words.  Illustrated.

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

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