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.