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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002101
• Other study ID #: 048D
• Secondary ID: CS 087250-999
• Status: Completed
• Phase: Phase 3
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacteremia
• Communicable Diseases
• HIV Infections
• Infection
• Mycobacterium Avium-Intracellulare Infection
• Mycobacterium Infections

Intervention

Drug:
• Ethambutol hydrochloride

• Clarithromycin

• Rifabutin

Locations

Country	Name	City	State
United States	Infectious Disease Consultants	Altamonte Springs	Florida
United States	Infectious Disease Physicians Inc	Annandale	Virginia
United States	Infectious Disease Research Consortium of Georgia	Atlanta	Georgia
United States	Central Texas Med Foundation	Austin	Texas
United States	Charleston Veterans Administration Med Ctr	Charleston	South Carolina
United States	Nalle Clinic	Charlotte	North Carolina
United States	Dr Daniel Berger	Chicago	Illinois
United States	Dr Alfred F Burnside Jr	Columbia	South Carolina
United States	East Orange Veterans Administration Med Ctr	East Orange	New Jersey
United States	Dr Frank Tornaka	Fort Lauderdale	Florida
United States	Gary Richmond MD	Fort Lauderdale	Florida
United States	TheraFirst Med Ctrs Inc	Fort Lauderdale	Florida
United States	Bay Harbor Hosp	Harbor City	California
United States	Polyclinic Med Ctr	Harrisburg	Pennsylvania
United States	Dr Nelson Zide	Hollywood	Florida
United States	Houston Veterans Administration Med Ctr	Houston	Texas
United States	Ctr for Special Immunology	Irvine	California
United States	Dr Arnold Markowitz	Keego Harbor	Michigan
United States	Cedars Sinai Med Ctr	Los Angeles	California
United States	Combat Group	Los Angeles	California
United States	Univ of Wisconsin School of Medicine	Madison	Wisconsin
United States	Ctr for Special Immunology	Miami Beach	Florida
United States	Milwaukee County Med Complex	Milwaukee	Wisconsin
United States	Long Island Jewish Med Ctr	New Hyde Park	New York
United States	Tulane Univ Med School	New Orleans	Louisiana
United States	Chelsea Village Med Ctr / Saint Vincent's Hosp	New York	New York
United States	North Jersey Community Research Initiative	Newark	New Jersey
United States	Highland Gen Hosp / San Francisco Gen Hosp	Oakland	California
United States	Univ of Nebraska Med Ctr / HIV Clinic	Omaha	Nebraska
United States	Buckley Braffman Stern Med Associates	Philadelphia	Pennsylvania
United States	Maricopa Med Research Foundation	Phoenix	Arizona
United States	McDowell Clinic	Phoenix	Arizona
United States	Community Health Network	Rochester	New York
United States	Dr Barry Rodwick	Safety Harbor	Florida
United States	Univ TX San Antonio Health Science Ctr	San Antonio	Texas
United States	HIV Research Group	San Diego	California
United States	UCSD / Ctr for Special Immunology	San Diego	California
United States	Saint Francis Mem Hosp	San Francisco	California
United States	San Francisco Veterans Administration Med Ctr	San Francisco	California
United States	Sunnyvale Med Clinic	Sunnyvale	California
United States	Bay Area AIDS Consortium	Tampa	Florida
United States	George Washington Univ Med Ctr	Washington	District of Columbia
United States	Veterans Administration Med Ctr	Washington	District of Columbia
United States	Univ of Kansas School of Medicine	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Pharmacia

Country where clinical trial is conducted

United States,