title: Randomized, open-label trial of azithromycin plus ethambutol vs. clarithromycin plus ethambutol as therapy for Mycobacterium avium complex bacteremia in patients with human immunodeficiency virus infection. Veterans Affairs HIV Research Consortium.
abstract: Disseminated Mycobacterium avium complex (MAC) infection continues to be a common opportunistic infection in patients infected with human immunodeficiency virus (HIV). The optimal therapy for disseminated MAC infection is unclear. We compared azithromycin plus ethambutol with clarithromycin plus ethambutol in the treatment of disseminated MAC infection in HIV type 1-infected patients, examining the frequency of bacteremia clearance, time to clearance, and study drug tolerance after 16 weeks of therapy. Fifty-nine patients for whom blood cultures were positive for MAC were enrolled in the study from 10 university-affiliated Veterans Affairs Medical Centers. Thirty-seven patients were evaluable for determination of quantitative bacteremia and clinical outcomes. Clearance of bacteremia was seen at the final visit in 37.5% of azithromycin-treated patients and in 85.7% of clarithromycin-treated patients (P = .007). The estimated median time to clearance of bacteremia was also significantly different between the two treatment arms: 4.38 weeks for clarithromycin recipients vs. > 16 weeks for azithromycin recipients (P = .0018). Only one isolate developed macrolide resistance during therapy. Abatement of symptoms, other laboratory-evident abnormalities, and adverse effects were similar in the two groups. At the doses used in this study, clarithromycin/ethambutol produced a more rapid resolution of bacteremia than did azithromycin/ethambutol, and clarithromycin/ethambutol was more effective at sterilization of blood cultures after 16 weeks of therapy.
authors.affiliation: Veterans Affairs Medical Center, Portland, Oregon 97201, USA.
authors.forename: T T
authors.initials: TT
authors.lastname: Ward
authors.forename: D
authors.initials: D
authors.lastname: Rimland
authors.forename: C
authors.initials: C
authors.lastname: Kauffman
authors.forename: M
authors.initials: M
authors.lastname: Huycke
authors.forename: T G
authors.initials: TG
authors.lastname: Evans
authors.forename: L
authors.initials: L
authors.lastname: Heifets
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000328:Adult; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000995:Antitubercular Agents / Q000627:therapeutic use; D017963:Azithromycin / Q000627:therapeutic use; D016470:Bacteremia / Q000188:drug therapy*; D017291:Clarithromycin / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D004977:Ethambutol / Q000627:therapeutic use*; D015497:HIV-1; D006801:Humans; D015269:Mycobacterium avium Complex / Q000302:isolation & purification; D015270:Mycobacterium avium-intracellulare Infection / Q000188:drug therapy*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D000995:Antitubercular Agents; D017963:Azithromycin; D004977:Ethambutol; D017291:Clarithromycin