A Phase 3 interventional study of Ethambutol hydrochloride and Clarithromycin in Mycobacterium Avium-Intracellulare Infection and HIV Infections, sponsored by Pharmacia. Completed at 44 sites in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Pharmacia · Phase 3, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 450 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Pharmacia is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Concurrent Medication:
Allowed:
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior condition are excluded:
History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol.
Prior Medication:
Excluded within 7 days prior to study entry:
Excluded within 14 days prior to study entry:
This study is completed, as verified in Jun 1999. You cannot join it, but the record below documents what was studied.
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