title: 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.
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.
  
  
  METHODS
  A randomized, open-labeled, comparative trial.
  
  
  METHODS
  Outpatient clinics.
  
  
  METHODS
  Seventy-four patients with HIV and symptomatic bacteremic M. avium infection.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
authors.affiliation: George Washington University Medical Center, Washington, DC 20037, USA.
authors.forename: D M
authors.initials: DM
authors.lastname: Parenti
authors.forename: P L
authors.initials: PL
authors.lastname: Williams
authors.forename: R
authors.initials: R
authors.lastname: Hafner
authors.forename: M R
authors.initials: MR
authors.lastname: Jacobs
authors.forename: P
authors.initials: P
authors.lastname: Hojczyk
authors.forename: T M
authors.initials: TM
authors.lastname: Hooton
authors.forename: T W
authors.initials: TW
authors.lastname: Barber
authors.forename: G
authors.initials: G
authors.lastname: Simpson
authors.forename: C
authors.initials: C
authors.lastname: van der Horst
authors.forename: J
authors.initials: J
authors.lastname: Currier
authors.forename: W G
authors.initials: WG
authors.lastname: Powderly
authors.forename: M
authors.initials: M
authors.lastname: Limjoco
authors.forename: J J
authors.initials: JJ
authors.lastname: Ellner
mesh_terms: D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy* / Q000382:microbiology; D000328:Adult; D000583:Amikacin / Q000627:therapeutic use*; D016470:Bacteremia / Q000188:drug therapy / Q000382:microbiology; D002939:Ciprofloxacin / Q000627:therapeutic use; D002991:Clofazimine / Q000627:therapeutic use; D015169:Colony Count, Microbial; D004359:Drug Therapy, Combination / Q000627:therapeutic use*; D004977:Ethambutol / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D015269:Mycobacterium avium Complex / Q000187:drug effects / Q000302:isolation & purification; D015270:Mycobacterium avium-intracellulare Infection / Q000188:drug therapy*; D012293:Rifampin / Q000627:therapeutic use
chemical_list: D002939:Ciprofloxacin; D000583:Amikacin; D004977:Ethambutol; D002991:Clofazimine; D012293:Rifampin