Journal Article

A Randomized, Double-Blind Trial Comparing Azithromycin and Clarithromycin in the Treatment of Disseminated <i>Mycobacterium avium</i> Infection in Patients with Human Immunodeficiency Virus

M. Dunne, J. Fessel, P. Kumar, G. Dickenson, P. Keiser, M. Boulos, M. Mogyros, A. C. White, P. Cahn, M. O'Connor, D. Lewi, S. Green, J. Tilles, C. Hicks, J. Bissett, M. M. E. Schneider and R. Benner

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 31, issue 5, pages 1245-1252
Published in print November 2000 | ISSN: 1058-4838
Published online November 2000 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/317468
A Randomized, Double-Blind Trial Comparing Azithromycin and Clarithromycin in the Treatment of Disseminated Mycobacterium avium Infection in Patients with Human Immunodeficiency Virus

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Two hundred and forty-six patients infected with human immunodeficiency virus (HIV) who also had disseminated Mycobacterium avium complex received either azithromycin 250 mg every day, azithromycin 600 mg every day, or clarithromycin 500 mg twice a day, each combined with ethambutol, for 24 weeks. Samples drawn from patients were cultured and clinically assessed every 3 weeks up to week 12, then monthly thereafter through week 24 of double-blind therapy and every 3 months while on open-label therapy through the conclusion of the trial. The azithromycin 250 mg arm of the study was dropped after an interim analysis showed a lower rate of clearance of bacteremia. At 24 weeks of therapy, the likelihood of patients' developing 2 consecutive negative cultures (46% vs. 56%, P = .24) or 1 negative culture (59% vs. 61%, P = .80) was similar for azithromycin 600 mg (n = 68) and clarithromycin (n = 57), respectively. The likelihood of relapse was 39% versus 27% (P = .21) on azithromycin compared with clarithromycin, respectively. Of the 6 patients who experienced relapse, those randomized to azithromycin developed isolates resistant to macrolides, compared with 2 of 3 patients randomized to clarithromycin. Mortality was similar in patients comprising each arm of the study (69% vs. 63%; hazard, 95.1% confidence interval, 1.1 [0.7, 1.7]). Azithromycin 600 mg, when given in combination with ethambutol, is an effective agent for the treatment of disseminated M. avium disease in patients infected with HIV.

Journal Article.  4759 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

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