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

Autor: Benson, Constance A., Williams, Paige L., Currier, Judith S., Holland, Fiona, Mahon, Laura F., MacGregor, Rob Roy, Inderlied, Clark B., Flexner, Charles, Neidig, Judith, Chaisson, Richard, Notario, Gerard F., Hafner, Richard
Předmět:
Zdroj: Clinical Infectious Diseases; 11/1/2003, Vol. 37 Issue 9, p1234-1243, 10p
Abstrakt: 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 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+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). [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index