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.

First Received: November 2, 1999 Last Updated: June 23, 2005 History of Changes

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: AIDS

Drug Information available for: Rifabutin Clarithromycin Ethambutol Ethambutol hydrochloride

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

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

Bacterial Infections
Anti-Infective Agents
Communicable Diseases
Sexually Transmitted Diseases, Viral
Rifabutin
Slow Virus Diseases
Molecular Mechanisms of Pharmacological Action
Infection
Anti-Bacterial Agents
Clarithromycin
Gram-Positive Bacterial Infections
Pathologic Processes
Therapeutic Uses
Retroviridae Infections
Systemic Inflammatory Response Syndrome

RNA Virus Infections
Immune System Diseases
Acquired Immunodeficiency Syndrome
Bacteremia
Enzyme Inhibitors
Pharmacologic Actions
Immunologic Deficiency Syndromes
Actinomycetales Infections
Mycobacterium Infections, Atypical
Antibiotics, Antitubercular
Mycobacterium avium-intracellulare Infection
Inflammation
Virus Diseases
Protein Synthesis Inhibitors
Sepsis

ClinicalTrials.gov processed this record on November 27, 2009