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 Clinical Trials Group Protocol 135 Study Team

AIDS. 1998 Dec 24;12(18):2439-46. doi: 10.1097/00002030-199818000-00013.


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, ciprofloxacin, clofazimine, and ethambutol did not provide clinical or microbiologic benefit.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase II
  • Clinical Trial, Phase III
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • AIDS-Related Opportunistic Infections / drug therapy*
  • AIDS-Related Opportunistic Infections / microbiology
  • Adult
  • Amikacin / therapeutic use*
  • Bacteremia / drug therapy
  • Bacteremia / microbiology
  • Ciprofloxacin / therapeutic use
  • Clofazimine / therapeutic use
  • Colony Count, Microbial
  • Drug Therapy, Combination / therapeutic use*
  • Ethambutol / therapeutic use
  • Female
  • Humans
  • Male
  • Microbial Sensitivity Tests
  • Mycobacterium avium Complex / drug effects
  • Mycobacterium avium Complex / isolation & purification
  • Mycobacterium avium-intracellulare Infection / drug therapy*
  • Rifampin / therapeutic use


  • Ciprofloxacin
  • Amikacin
  • Ethambutol
  • Clofazimine
  • Rifampin