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.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002343
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1997

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002343 on ClinicalTrials.gov Archive Site
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A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS
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

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.

Interventional
Phase 4
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
  • Drug: Ethambutol hydrochloride
  • Drug: Rifabutin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
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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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002343
048E, CS 087287-000
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Pharmacia
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NIH AIDS Clinical Trials Information Service
June 1997

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP