A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus

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

Research output: Contribution to journalArticle

49 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1245-1252
Number of pages8
JournalClinical Infectious Diseases
Volume31
Issue number5
DOIs
StatePublished - 2000
Externally publishedYes

Fingerprint

Mycobacterium avium
Mycobacterium Infections
Azithromycin
Clarithromycin
HIV
Ethambutol
Therapeutics
Recurrence
Mycobacterium avium Complex
Macrolides
Bacteremia
Confidence Intervals
Mortality

ASJC Scopus subject areas

  • Immunology

Cite this

A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus. / Dunne, M.; Fessel, J.; Kumar, P.; Dickenson, G.; Keiser, Philip; Boulos, M.; Mogyros, M.; White, A. Clinton; Cahn, P.; O'Connor, M.; Lewi, D.; Green, S.; Tilles, J.; Hicks, C.; Bissett, J.; Schneider, M. M E; Benner, R.

In: Clinical Infectious Diseases, Vol. 31, No. 5, 2000, p. 1245-1252.

Research output: Contribution to journalArticle

Dunne, M, Fessel, J, Kumar, P, Dickenson, G, Keiser, P, Boulos, M, Mogyros, M, White, AC, Cahn, P, O'Connor, M, Lewi, D, Green, S, Tilles, J, Hicks, C, Bissett, J, Schneider, MME & Benner, R 2000, 'A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus', Clinical Infectious Diseases, vol. 31, no. 5, pp. 1245-1252. https://doi.org/10.1086/317468
Dunne, M. ; Fessel, J. ; Kumar, P. ; Dickenson, G. ; Keiser, Philip ; Boulos, M. ; Mogyros, M. ; White, A. Clinton ; Cahn, P. ; O'Connor, M. ; Lewi, D. ; Green, S. ; Tilles, J. ; Hicks, C. ; Bissett, J. ; Schneider, M. M E ; Benner, R. / A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus. In: Clinical Infectious Diseases. 2000 ; Vol. 31, No. 5. pp. 1245-1252.
@article{5ef2f8e54ee14fa487136a6ce0e4c369,
title = "A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus",
abstract = "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.",
author = "M. Dunne and J. Fessel and P. Kumar and G. Dickenson and Philip Keiser and M. Boulos and M. Mogyros and White, {A. Clinton} and P. Cahn and M. O'Connor and D. Lewi and S. Green and J. Tilles and C. Hicks and J. Bissett and Schneider, {M. M E} and R. Benner",
year = "2000",
doi = "10.1086/317468",
language = "English (US)",
volume = "31",
pages = "1245--1252",
journal = "Clinical Infectious Diseases",
issn = "1058-4838",
publisher = "Oxford University Press",
number = "5",

}

TY - JOUR

T1 - A randomized, double-blind trial comparing azithromycin and clarithromycin in the treatment of disseminated Mycobacterium avium infection in patients with human immunodeficiency virus

AU - Dunne, M.

AU - Fessel, J.

AU - Kumar, P.

AU - Dickenson, G.

AU - Keiser, Philip

AU - Boulos, M.

AU - Mogyros, M.

AU - White, A. Clinton

AU - Cahn, P.

AU - O'Connor, M.

AU - Lewi, D.

AU - Green, S.

AU - Tilles, J.

AU - Hicks, C.

AU - Bissett, J.

AU - Schneider, M. M E

AU - Benner, R.

PY - 2000

Y1 - 2000

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=0034456966&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0034456966&partnerID=8YFLogxK

U2 - 10.1086/317468

DO - 10.1086/317468

M3 - Article

C2 - 11073759

AN - SCOPUS:0034456966

VL - 31

SP - 1245

EP - 1252

JO - Clinical Infectious Diseases

JF - Clinical Infectious Diseases

SN - 1058-4838

IS - 5

ER -