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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

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
History of Changes
  Purpose

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.


Condition Intervention Phase
Mycobacterium Avium-Intracellulare Infection
HIV Infections
 Drug: Ethambutol hydrochloride
Drug: Clarithromycin
Drug: Rifabutin
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 450
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   13 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002101

  Show 44 Study Locations
Sponsors and Collaborators
Pharmacia
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002101     History of Changes
Other Study ID Numbers: 048D, CS 087250-999
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Rifabutin
Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
 Ethambutol
Acquired Immunodeficiency Syndrome
Clarithromycin

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Bacteremia
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Bacterial Infections
 Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Actinomycetales Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections, Atypical
Ethambutol
Rifabutin
Clarithromycin
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013