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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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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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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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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 Mycobacterium avium Complex Disease in Persons with Acquired Immunodeficiency Syndrome
2003
Overview
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).
Publisher
The University of Chicago Press,University of Chicago Press
Subject
Acquired Immunodeficiency Syndrome - complications
/ Adult
/ AIDS
/ AIDS-Related Opportunistic Infections - drug therapy
/ AIDS-Related Opportunistic Infections - microbiology
/ Antibiotics. Antiinfectious agents. Antiparasitic agents
/ Biological and medical sciences
/ Blood
/ Clarithromycin - therapeutic use
/ Ethambutol - therapeutic use
/ Female
/ HIV/AIDS
/ Human immunodeficiency virus
/ Humans
/ Male
/ Mycobacterium avium-intracellulare Infection - drug therapy
/ Mycobacterium avium-intracellulare Infection - etiology
/ Pharmacology. Drug treatments
/ Relapse
