A phase II/III trial of antimicrobial therapy with or without amikacin in the treatment of disseminated Mycobacterium avium infection in HIV-infected individuals

David M. Parenti, Paige L. Williams, Richard Hafner, Michael R. Jacobs, Peter Hojczyk, Thomas M. Hooton, Thomas W. Barber, Gail Simpson, Charles Van Der Horst, Judith Currier, William G. Powderly, Marissa Limjoco, Jerrold J. Ellner

Research output: Contribution to journalArticle

Abstract

Objective: To determine the clinical and microbiologic benefit of adding amikacin to a four-drug oral regimen for treatment of disseminated Mycobacterium avium infection in HIV-infected patients. Design: A randomized, open-labeled, comparative trial. Setting: Outpatient clinics. Patients: Seventy-four patients with HIV and symptomatic bacteremic M. avium infection. Interventions: Rifampin 10 mg/kg daily, ciprofloxacin 500 mg twice daily, clofazimine 100 mg every day, and ethambutol 15 mg/kg orally daily for 24 weeks, with or without amikacin 10 mg/kg intravenously or intramuscularly 5 days weekly for the first 4 weeks. Main outcome measure: Clinical and microbiologic response at 4 weeks; quantitative level of bacteremia with M. avium. Results: No difference in clinical response was noted with the addition of amikacin to the four-drug oral regimen, and only 25% in either group had a complete or partial response at 4 weeks. A comparable quantitative decrease in bacteremia was noted in both treatment groups, with 16% of patients being culture-negative at 4 weeks and 38% at 12 weeks. Toxicities were mainly gastrointestinal. Amikacin was well tolerated. Median survival was 30 weeks in both groups. Conclusions: The addition of amikacin to a four-drug oral regimen of rifampin, ciprofloxin, clofazimine, and ethambutol did not provide clinical or microbiologic benefit.

Original languageEnglish (US)
Pages (from-to)2439-2446
Number of pages8
JournalAIDS
Volume12
Issue number18
StatePublished - Dec 24 1998
Externally publishedYes

Fingerprint

Mycobacterium avium
Mycobacterium Infections
Amikacin
HIV
Clofazimine
Ethambutol
Rifampin
Bacteremia
Pharmaceutical Preparations
Therapeutics
Ciprofloxacin
Ambulatory Care Facilities
Outcome Assessment (Health Care)
Survival

Keywords

  • AIDS
  • Amikacin
  • Bacteremia
  • HIV
  • MAC
  • Mycobacterium avium

ASJC Scopus subject areas

  • Immunology and Allergy
  • Immunology

Cite this

Parenti, D. M., Williams, P. L., Hafner, R., Jacobs, M. R., Hojczyk, P., Hooton, T. M., ... Ellner, J. J. (1998). A phase II/III trial of antimicrobial therapy with or without amikacin in the treatment of disseminated Mycobacterium avium infection in HIV-infected individuals. AIDS, 12(18), 2439-2446.

A phase II/III trial of antimicrobial therapy with or without amikacin in the treatment of disseminated Mycobacterium avium infection in HIV-infected individuals. / Parenti, David M.; Williams, Paige L.; Hafner, Richard; Jacobs, Michael R.; Hojczyk, Peter; Hooton, Thomas M.; Barber, Thomas W.; Simpson, Gail; Van Der Horst, Charles; Currier, Judith; Powderly, William G.; Limjoco, Marissa; Ellner, Jerrold J.

In: AIDS, Vol. 12, No. 18, 24.12.1998, p. 2439-2446.

Research output: Contribution to journalArticle

Parenti, DM, Williams, PL, Hafner, R, Jacobs, MR, Hojczyk, P, Hooton, TM, Barber, TW, Simpson, G, Van Der Horst, C, Currier, J, Powderly, WG, Limjoco, M & Ellner, JJ 1998, 'A phase II/III trial of antimicrobial therapy with or without amikacin in the treatment of disseminated Mycobacterium avium infection in HIV-infected individuals', AIDS, vol. 12, no. 18, pp. 2439-2446.
Parenti, David M. ; Williams, Paige L. ; Hafner, Richard ; Jacobs, Michael R. ; Hojczyk, Peter ; Hooton, Thomas M. ; Barber, Thomas W. ; Simpson, Gail ; Van Der Horst, Charles ; Currier, Judith ; Powderly, William G. ; Limjoco, Marissa ; Ellner, Jerrold J. / A phase II/III trial of antimicrobial therapy with or without amikacin in the treatment of disseminated Mycobacterium avium infection in HIV-infected individuals. In: AIDS. 1998 ; Vol. 12, No. 18. pp. 2439-2446.
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abstract = "Objective: To determine the clinical and microbiologic benefit of adding amikacin to a four-drug oral regimen for treatment of disseminated Mycobacterium avium infection in HIV-infected patients. Design: A randomized, open-labeled, comparative trial. Setting: Outpatient clinics. Patients: Seventy-four patients with HIV and symptomatic bacteremic M. avium infection. Interventions: Rifampin 10 mg/kg daily, ciprofloxacin 500 mg twice daily, clofazimine 100 mg every day, and ethambutol 15 mg/kg orally daily for 24 weeks, with or without amikacin 10 mg/kg intravenously or intramuscularly 5 days weekly for the first 4 weeks. Main outcome measure: Clinical and microbiologic response at 4 weeks; quantitative level of bacteremia with M. avium. Results: No difference in clinical response was noted with the addition of amikacin to the four-drug oral regimen, and only 25{\%} in either group had a complete or partial response at 4 weeks. A comparable quantitative decrease in bacteremia was noted in both treatment groups, with 16{\%} of patients being culture-negative at 4 weeks and 38{\%} at 12 weeks. Toxicities were mainly gastrointestinal. Amikacin was well tolerated. Median survival was 30 weeks in both groups. Conclusions: The addition of amikacin to a four-drug oral regimen of rifampin, ciprofloxin, clofazimine, and ethambutol did not provide clinical or microbiologic benefit.",
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AU - Jacobs, Michael R.

AU - Hojczyk, Peter

AU - Hooton, Thomas M.

AU - Barber, Thomas W.

AU - Simpson, Gail

AU - Van Der Horst, Charles

AU - Currier, Judith

AU - Powderly, William G.

AU - Limjoco, Marissa

AU - Ellner, Jerrold J.

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N2 - Objective: To determine the clinical and microbiologic benefit of adding amikacin to a four-drug oral regimen for treatment of disseminated Mycobacterium avium infection in HIV-infected patients. Design: A randomized, open-labeled, comparative trial. Setting: Outpatient clinics. Patients: Seventy-four patients with HIV and symptomatic bacteremic M. avium infection. Interventions: Rifampin 10 mg/kg daily, ciprofloxacin 500 mg twice daily, clofazimine 100 mg every day, and ethambutol 15 mg/kg orally daily for 24 weeks, with or without amikacin 10 mg/kg intravenously or intramuscularly 5 days weekly for the first 4 weeks. Main outcome measure: Clinical and microbiologic response at 4 weeks; quantitative level of bacteremia with M. avium. Results: No difference in clinical response was noted with the addition of amikacin to the four-drug oral regimen, and only 25% in either group had a complete or partial response at 4 weeks. A comparable quantitative decrease in bacteremia was noted in both treatment groups, with 16% of patients being culture-negative at 4 weeks and 38% at 12 weeks. Toxicities were mainly gastrointestinal. Amikacin was well tolerated. Median survival was 30 weeks in both groups. Conclusions: The addition of amikacin to a four-drug oral regimen of rifampin, ciprofloxin, clofazimine, and ethambutol did not provide clinical or microbiologic benefit.

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