A Phase 4 interventional study of Ethambutol hydrochloride and Rifabutin in Mycobacterium Avium-Intracellulare Infection and HIV Infections, sponsored by Pharmacia. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.
Sponsored by Pharmacia · Phase 4, Interventional, and Treatment
To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.
Patients are randomized to receive oral rifabutin alone or rifabutin/ethambutol daily for 12 months, with possible continuation of medicine lifelong. Doses will be adjusted to maintain minimum blood levels of the drugs.
6,686 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 200 is above the median of 120 across 4,199 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:
Required:
Allowed:
Patients must have:
Prior Medication:
Required:
Allowed:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following prior conditions are excluded:
Known hypersensitivity to rifabutin, rifampin, or other rifamycins and/or ethambutol.
Prior Medication:
Excluded within 4 weeks prior to study entry:
This study is completed, as verified in Jun 1997. You cannot join it, but the record below documents what was studied.
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Pharmacia