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

  Hide Study Locations
Locations
United States, Arizona
McDowell Clinic
Phoenix, Arizona, United States, 85006
Maricopa Med Research Foundation
Phoenix, Arizona, United States, 85008
United States, California
Bay Harbor Hosp
Harbor City, California, United States, 90710
Ctr for Special Immunology
Irvine, California, United States, 92718
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
Combat Group
Los Angeles, California, United States, 90028
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, United States, 946021018
UCSD / Ctr for Special Immunology
San Diego, California, United States, 92103
HIV Research Group
San Diego, California, United States, 92102
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
Saint Francis Mem Hosp
San Francisco, California, United States, 94109
Sunnyvale Med Clinic
Sunnyvale, California, United States, 94086
United States, District of Columbia
Veterans Administration Med Ctr
Washington, District of Columbia, United States, 20422
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
United States, Florida
Infectious Disease Consultants
Altamonte Springs, Florida, United States, 32701
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, United States, 33308
Gary Richmond MD
Fort Lauderdale, Florida, United States, 33316
Dr Frank Tornaka
Fort Lauderdale, Florida, United States, 33316
Dr Nelson Zide
Hollywood, Florida, United States, 33021
Ctr for Special Immunology
Miami Beach, Florida, United States, 33140
Dr Barry Rodwick
Safety Harbor, Florida, United States, 34695
Bay Area AIDS Consortium
Tampa, Florida, United States, 33609
United States, Georgia
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, United States, 30345
United States, Illinois
Dr Daniel Berger
Chicago, Illinois, United States, 60657
United States, Kansas
Univ of Kansas School of Medicine
Wichita, Kansas, United States, 67214
United States, Louisiana
Tulane Univ Med School
New Orleans, Louisiana, United States, 701122699
United States, Michigan
Dr Arnold Markowitz
Keego Harbor, Michigan, United States, 48320
United States, Nebraska
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, United States, 681985130
United States, New Jersey
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, United States, 07018
North Jersey Community Research Initiative
Newark, New Jersey, United States, 071032842
United States, New York
Long Island Jewish Med Ctr
New Hyde Park, New York, United States, 11042
Chelsea Village Med Ctr / Saint Vincent's Hosp
New York, New York, United States, 10014
Community Health Network
Rochester, New York, United States, 14620
United States, North Carolina
Nalle Clinic
Charlotte, North Carolina, United States, 28207
United States, Pennsylvania
Polyclinic Med Ctr
Harrisburg, Pennsylvania, United States, 17110
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Charleston Veterans Administration Med Ctr
Charleston, South Carolina, United States, 294015799
Dr Alfred F Burnside Jr
Columbia, South Carolina, United States, 29204
United States, Texas
Central Texas Med Foundation
Austin, Texas, United States, 78751
Houston Veterans Administration Med Ctr
Houston, Texas, United States, 77030
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States, 78284
United States, Virginia
Infectious Disease Physicians Inc
Annandale, Virginia, United States, 22203
United States, Wisconsin
Univ of Wisconsin School of Medicine
Madison, Wisconsin, United States, 53792
Milwaukee County Med Complex
Milwaukee, Wisconsin, United States, 53226
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:
HIV Infections
Acquired Immunodeficiency Syndrome
Bacteremia
Mycobacterium Infections
Mycobacterium avium-intracellulare Infection
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Actinomycetales Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections, Nontuberculous
Ethambutol
Rifabutin
Clarithromycin
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014