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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.

Sponsored by: Pharmacia
Information provided by: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier: NCT00002101
  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 III

MedlinePlus related topics:   AIDS   

Drug Information available for:   Rifabutin    Ethambutol hydrochloride    Ethambutol    Clarithromycin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Double-Blind, Efficacy Study
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

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  Show 44 Study Locations

Sponsors and Collaborators
Pharmacia
  More Information


Study ID Numbers:   048D, CS 087250-999
First Received:   November 2, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00002101
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

Study placed in the following topic categories:
Bacterial Infections
Systemic Inflammatory Response Syndrome
Sexually Transmitted Diseases, Viral
Rifabutin
Acquired Immunodeficiency Syndrome
Bacteremia
Mycobacterium Infections, Atypical
Immunologic Deficiency Syndromes
Inflammation
Mycobacterium avium-intracellulare Infection
Virus Diseases
Clarithromycin
Gram-Positive Bacterial Infections
Sepsis
HIV Infections
Sexually Transmitted Diseases
Mycobacterium Infections
Ethambutol
Mycobacterium avium complex infection
Retroviridae Infections

Additional relevant MeSH terms:
Communicable Diseases
Anti-Infective Agents
RNA Virus Infections
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Infection
Actinomycetales Infections
Pharmacologic Actions
Antibiotics, Antitubercular
Protein Synthesis Inhibitors
Anti-Bacterial Agents
Pathologic Processes
Therapeutic Uses
Lentivirus Infections
Antitubercular Agents

ClinicalTrials.gov processed this record on December 03, 2008




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