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 - Full Text View

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

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

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