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.
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.
Parenti
D M
DM
George Washington University Medical Center, Washington, DC 20037, USA.
Williams
P L
PL
Hafner
R
R
Jacobs
M R
MR
Hojczyk
P
P
Hooton
T M
TM
Barber
T W
TW
Simpson
G
G
van der Horst
C
C
Currier
J
J
Powderly
W G
WG
Limjoco
M
M
Ellner
J J
JJ
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
D002939:Ciprofloxacin; D000583:Amikacin; D004977:Ethambutol; D002991:Clofazimine; D012293:Rifampin