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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
  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:


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

ClinicalTrials.gov processed this record on November 27, 2014