Clinical Trials


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

This study has been completed

Information provided by (Responsible Party)
NIH AIDS Clinical Trials Information Service Identifier

First received: November 2, 1999
Last updated: June 23, 2005
Last Verified: June 1997
History of Changes


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.

Condition Intervention Phase
Mycobacterium Avium-Intracellulare Infection
HIV Infections

Drug : Ethambutol hydrochloride
Drug : Rifabutin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: An Open-Label Randomized Pharmacokinetic/Pharmacodynamic Study of Mycobutin (Rifabutin) or Rifabutin in Combination With Myambutol (Ethambutol) for Prophylaxis of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts <= 100 Cells/mm3

Further study details as provided by NIH AIDS Clinical Trials Information Service:

Enrollment: 200

Detailed Description:

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.



Ages Eligible for Study: 18 Years and older  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: No  


Inclusion Criteria
Concurrent Medication:

  • 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:
  • 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:
  • 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.

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00002343


United States, California
Univ of California - Davis Med Ctr / CARES
Sacramento, California, United States, 95817

Sponsors and Collaborators

More Information

More Information

Responsible Party: Pharmacia Identifier: NCT00002343   History of Changes  
Other Study ID Numbers: 048E  
  CS 087287-000  
Study First Received: November 2, 1999  
Last Updated: June 23, 2005  

Keywords provided by NIH AIDS Clinical Trials Information Service:

Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Communicable Diseases
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Rifabutin processed this data on June 01, 2020
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