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.

Abstract

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).

• Authors: 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, Richard Hafner, AIDS Clinical Trials Group 223 Protocol Team
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America (Clin Infect Dis) Vol. 37 Issue 9 Pg. 1234-43 (Nov 01 2003) ISSN: 1537-6591 [Electronic] United States
• PMID: 14557969 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Rifabutin
• Ethambutol
• Clarithromycin

Topics

• AIDS-Related Opportunistic Infections (drug therapy, microbiology)
• Acquired Immunodeficiency Syndrome (complications)
• Adult
• Clarithromycin (therapeutic use)
• Double-Blind Method
• Drug Resistance, Bacterial
• Drug Therapy, Combination
• Ethambutol (therapeutic use)
• Female
• Humans
• Male
• Middle Aged
• Mycobacterium avium Complex
• Mycobacterium avium-intracellulare Infection (drug therapy, etiology)
• Prospective Studies
• Rifabutin (therapeutic use)