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
Trial Information
Current as of July 11, 2025
Completed
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.
About Pharmacia
Pharmacia is a global biopharmaceutical company dedicated to advancing healthcare through innovative research and development. With a strong focus on delivering effective therapies for a range of medical conditions, Pharmacia harnesses cutting-edge science and technology to create solutions that enhance patient outcomes. The company is committed to conducting rigorous clinical trials that adhere to the highest ethical and scientific standards, ensuring the safety and well-being of participants while contributing to the advancement of medical knowledge. Through collaboration with healthcare professionals and regulatory bodies, Pharmacia strives to bring transformative treatments to market that address unmet medical needs and improve the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sacramento, California, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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