A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002101
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1999

November 2, 1999
June 23, 2005
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Complete list of historical versions of study NCT00002101 on ClinicalTrials.gov Archive Site
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A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo
A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.

Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.

Interventional
Phase 3
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
  • Mycobacterium Avium-Intracellulare Infection
  • HIV Infections
  • Drug: Ethambutol hydrochloride
  • Drug: Clarithromycin
  • 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
450
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Inclusion Criteria

Concurrent Medication:

Allowed:

  • Isoniazid for TB prophylaxis ONLY.

Patients must have:

  • HIV infection.
  • MAC infection.
  • Life expectancy of at least 16 weeks.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Perceived unreliability or unavailability for frequent monitoring.

Concurrent Medication:

Excluded:

  • Antimycobacterial drugs other than the study drugs.
  • Carbamazepine.
  • Terfenadine.
  • Theophylline.

Patients with the following prior condition are excluded:

History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol.

Prior Medication:

Excluded within 7 days prior to study entry:

  • Rifabutin.
  • Rifampin.
  • Ethionamide.
  • Cycloserine.
  • Clofazimine.
  • Ethambutol.
  • Amikacin.
  • Ciprofloxacin.
  • Ofloxacin.
  • Sparfloxacin.
  • Azithromycin.
  • Clarithromycin.
  • Pyrazinamide.

Excluded within 14 days prior to study entry:

  • Carbamazepine.
  • Terfenadine.
  • Theophylline.
Both
13 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002101
048D, CS 087250-999
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Pharmacia
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NIH AIDS Clinical Trials Information Service
June 1999

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