Search / Trial NCT00002343

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 December 26, 2024

Completed

Keywords

Rifabutin Mycobacterium Avium Intracellulare Infection Drug Therapy, Combination Ethambutol Acquired Immunodeficiency Syndrome

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.

Locations

Sacramento, California, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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