Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection

Richard E. Chaisson, Philip Keiser, Mark Pierce, W. Jeffrey Fessel, Joel Ruskin, Christopher Lahart, Constance A. Benson, Kysa Meek, Nancy Siepman, J. Carl Craft

Research output: Contribution to journalArticle

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Abstract

Objective: To compare the efficacy of two- and three-drug regimens for treating Mycobacterium avium complex (MAC) bacteremia in patients with AIDS. Design: Randomized open-label clinical trial. Setting: Outpatient HIV specialty centers' clinics. Patients: A total of 106 adults with AIDS and MAC bacteremia. Interventions: Patients were treated with clarithromycin 500 mg twice daily and ethambutol 800-1000 mg daily and were randomized to receive clofazimine 100 mg daily or no clofazimine. Main outcome measures: Quantitative blood MAC cultures, symptoms, adverse reactions and survival. Results: Patients randomly assigned to three drugs had significantly higher baseline colony counts of MAC in blood than patients receiving two drugs. The proportion of patients becoming culture-negative was 65% in the two-drug group and 54% in the three-drug group. The median time to negative culture was 58 days for patients in the two-drug group and 63 days for the three-drug group. At the last visit during treatment, the mean reduction in colony forming units/ml of MAC in blood was 1.8 log10 for the two-drug group and 2.3 log10 for the three-drug group. Improvement in fever and night sweats was reported by 87 and 89% of the two-drug patients and 84 and 86% of the three-drug patients. During the study, 38% of two-drug patients and 61% of three-drug patients died (P = 0.032), and time to death was shorter in patients treated with three drugs (P = 0.012). In a multivariate analysis, both assignment to clofazimine and high baseline colony counts of MAC bacteremia were significantly associated with death (P < 0.05). Conclusion: The addition of clofazimine to a regimen of clarithromycin and ethambutol for MAC bacteremia in AIDS patients does not contribute to clinical response and is associated with higher mortality.

Original languageEnglish (US)
Pages (from-to)311-317
Number of pages7
JournalAIDS
Volume11
Issue number3
DOIs
StatePublished - 1997
Externally publishedYes

Fingerprint

Clofazimine
Mycobacterium avium Complex
Ethambutol
Clarithromycin
HIV Infections
Pharmaceutical Preparations
Bacteremia
Therapeutics
Acquired Immunodeficiency Syndrome
Sweat

Keywords

  • Clarithromycin
  • Clinical trials
  • Clofazimine
  • Ethambutol
  • HIV
  • Mycobacterium avium complex
  • Survival

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. / Chaisson, Richard E.; Keiser, Philip; Pierce, Mark; Fessel, W. Jeffrey; Ruskin, Joel; Lahart, Christopher; Benson, Constance A.; Meek, Kysa; Siepman, Nancy; Craft, J. Carl.

In: AIDS, Vol. 11, No. 3, 1997, p. 311-317.

Research output: Contribution to journalArticle

Chaisson, Richard E. ; Keiser, Philip ; Pierce, Mark ; Fessel, W. Jeffrey ; Ruskin, Joel ; Lahart, Christopher ; Benson, Constance A. ; Meek, Kysa ; Siepman, Nancy ; Craft, J. Carl. / Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection. In: AIDS. 1997 ; Vol. 11, No. 3. pp. 311-317.
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abstract = "Objective: To compare the efficacy of two- and three-drug regimens for treating Mycobacterium avium complex (MAC) bacteremia in patients with AIDS. Design: Randomized open-label clinical trial. Setting: Outpatient HIV specialty centers' clinics. Patients: A total of 106 adults with AIDS and MAC bacteremia. Interventions: Patients were treated with clarithromycin 500 mg twice daily and ethambutol 800-1000 mg daily and were randomized to receive clofazimine 100 mg daily or no clofazimine. Main outcome measures: Quantitative blood MAC cultures, symptoms, adverse reactions and survival. Results: Patients randomly assigned to three drugs had significantly higher baseline colony counts of MAC in blood than patients receiving two drugs. The proportion of patients becoming culture-negative was 65{\%} in the two-drug group and 54{\%} in the three-drug group. The median time to negative culture was 58 days for patients in the two-drug group and 63 days for the three-drug group. At the last visit during treatment, the mean reduction in colony forming units/ml of MAC in blood was 1.8 log10 for the two-drug group and 2.3 log10 for the three-drug group. Improvement in fever and night sweats was reported by 87 and 89{\%} of the two-drug patients and 84 and 86{\%} of the three-drug patients. During the study, 38{\%} of two-drug patients and 61{\%} of three-drug patients died (P = 0.032), and time to death was shorter in patients treated with three drugs (P = 0.012). In a multivariate analysis, both assignment to clofazimine and high baseline colony counts of MAC bacteremia were significantly associated with death (P < 0.05). Conclusion: The addition of clofazimine to a regimen of clarithromycin and ethambutol for MAC bacteremia in AIDS patients does not contribute to clinical response and is associated with higher mortality.",
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T1 - Clarithromycin and ethambutol with or without clofazimine for the treatment of bacteremic Mycobacterium avium complex disease in patients with HIV infection

AU - Chaisson, Richard E.

AU - Keiser, Philip

AU - Pierce, Mark

AU - Fessel, W. Jeffrey

AU - Ruskin, Joel

AU - Lahart, Christopher

AU - Benson, Constance A.

AU - Meek, Kysa

AU - Siepman, Nancy

AU - Craft, J. Carl

PY - 1997

Y1 - 1997

N2 - Objective: To compare the efficacy of two- and three-drug regimens for treating Mycobacterium avium complex (MAC) bacteremia in patients with AIDS. Design: Randomized open-label clinical trial. Setting: Outpatient HIV specialty centers' clinics. Patients: A total of 106 adults with AIDS and MAC bacteremia. Interventions: Patients were treated with clarithromycin 500 mg twice daily and ethambutol 800-1000 mg daily and were randomized to receive clofazimine 100 mg daily or no clofazimine. Main outcome measures: Quantitative blood MAC cultures, symptoms, adverse reactions and survival. Results: Patients randomly assigned to three drugs had significantly higher baseline colony counts of MAC in blood than patients receiving two drugs. The proportion of patients becoming culture-negative was 65% in the two-drug group and 54% in the three-drug group. The median time to negative culture was 58 days for patients in the two-drug group and 63 days for the three-drug group. At the last visit during treatment, the mean reduction in colony forming units/ml of MAC in blood was 1.8 log10 for the two-drug group and 2.3 log10 for the three-drug group. Improvement in fever and night sweats was reported by 87 and 89% of the two-drug patients and 84 and 86% of the three-drug patients. During the study, 38% of two-drug patients and 61% of three-drug patients died (P = 0.032), and time to death was shorter in patients treated with three drugs (P = 0.012). In a multivariate analysis, both assignment to clofazimine and high baseline colony counts of MAC bacteremia were significantly associated with death (P < 0.05). Conclusion: The addition of clofazimine to a regimen of clarithromycin and ethambutol for MAC bacteremia in AIDS patients does not contribute to clinical response and is associated with higher mortality.

AB - Objective: To compare the efficacy of two- and three-drug regimens for treating Mycobacterium avium complex (MAC) bacteremia in patients with AIDS. Design: Randomized open-label clinical trial. Setting: Outpatient HIV specialty centers' clinics. Patients: A total of 106 adults with AIDS and MAC bacteremia. Interventions: Patients were treated with clarithromycin 500 mg twice daily and ethambutol 800-1000 mg daily and were randomized to receive clofazimine 100 mg daily or no clofazimine. Main outcome measures: Quantitative blood MAC cultures, symptoms, adverse reactions and survival. Results: Patients randomly assigned to three drugs had significantly higher baseline colony counts of MAC in blood than patients receiving two drugs. The proportion of patients becoming culture-negative was 65% in the two-drug group and 54% in the three-drug group. The median time to negative culture was 58 days for patients in the two-drug group and 63 days for the three-drug group. At the last visit during treatment, the mean reduction in colony forming units/ml of MAC in blood was 1.8 log10 for the two-drug group and 2.3 log10 for the three-drug group. Improvement in fever and night sweats was reported by 87 and 89% of the two-drug patients and 84 and 86% of the three-drug patients. During the study, 38% of two-drug patients and 61% of three-drug patients died (P = 0.032), and time to death was shorter in patients treated with three drugs (P = 0.012). In a multivariate analysis, both assignment to clofazimine and high baseline colony counts of MAC bacteremia were significantly associated with death (P < 0.05). Conclusion: The addition of clofazimine to a regimen of clarithromycin and ethambutol for MAC bacteremia in AIDS patients does not contribute to clinical response and is associated with higher mortality.

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