To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.
Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
450
McDowell Clinic
Phoenix, Arizona, United States
Maricopa Med Research Foundation
Phoenix, Arizona, United States
Bay Harbor Hosp
Harbor City, California, United States
Ctr for Special Immunology
Irvine, California, United States
Combat Group
Los Angeles, California, United States
Cedars Sinai Med Ctr
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Los Angeles, California, United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, United States
HIV Research Group
San Diego, California, United States
UCSD / Ctr for Special Immunology
San Diego, California, United States
Saint Francis Mem Hosp
San Francisco, California, United States
...and 34 more locations