A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS

Launched by PHARMACIA · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Concurrent Medication:
• Required:
• • AZT, d4T, ddI, or ddC.
• • Antipneumocystis prophylaxis.
• Allowed:
• • Short course (\< 14 days) of ciprofloxacin for acute infections.
• Patients must have:
• • AIDS.
• • CD4 count \<= 100 cells/mm3.
• • NO prior or current MAC infection.
• Prior Medication:
• Required:
• • Antipneumocystis prophylaxis for at least 4 weeks prior to study entry.
• Allowed:
• • Prior rifabutin.
• • Prior ethambutol.
• • Prior clarithromycin.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Positive tuberculin skin test (PPD \> 5 mm).
• • Active M. tuberculosis.
• • Perceived as unreliable or unavailable for frequent monitoring.
• Concurrent Medication:
• Excluded:
• • Other antiretrovirals not specifically allowed.
• • All investigational drugs.
• • Other antimycobacterial therapy, such as clarithromycin, azithromycin, rifampin, clofazimine, amikacin, streptomycin, isoniazid, cycloserine, ethionamide, and ciprofloxacin (\>= 14 days).
• 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:
• • Rifampin.
• • Isoniazid.
• • Clofazimine.
• • Cycloserine.
• • Ethionamide.
• • Amikacin.
• • Ciprofloxacin.