title: 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.affiliation: Division of Infectious Diseases, University of Colorado Health Sciences Center, Denver, USA.
authors.forename: Constance A
authors.initials: CA
authors.lastname: Benson
authors.forename: Paige L
authors.initials: PL
authors.lastname: Williams
authors.forename: Judith S
authors.initials: JS
authors.lastname: Currier
authors.forename: Fiona
authors.initials: F
authors.lastname: Holland
authors.forename: Laura F
authors.initials: LF
authors.lastname: Mahon
authors.forename: Rob Roy
authors.initials: RR
authors.lastname: MacGregor
authors.forename: Clark B
authors.initials: CB
authors.lastname: Inderlied
authors.forename: Charles
authors.initials: C
authors.lastname: Flexner
authors.forename: Judith
authors.initials: J
authors.lastname: Neidig
authors.forename: Richard
authors.initials: R
authors.lastname: Chaisson
authors.forename: Gerard F
authors.initials: GF
authors.lastname: Notario
authors.forename: Richard
authors.initials: R
authors.lastname: Hafner
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000382:microbiology; D000163:Acquired Immunodeficiency Syndrome / Q000150:complications*; D000328:Adult; D017291:Clarithromycin / Q000627:therapeutic use*; D004311:Double-Blind Method; D024881:Drug Resistance, Bacterial; D004359:Drug Therapy, Combination; D004977:Ethambutol / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D015269:Mycobacterium avium Complex; D015270:Mycobacterium avium-intracellulare Infection / Q000188:drug therapy* / Q000209:etiology; D011446:Prospective Studies; D017828:Rifabutin / Q000627:therapeutic use*
chemical_list: D017828:Rifabutin; D004977:Ethambutol; D017291:Clarithromycin