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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002101
Recruitment Status : Completed
First Posted : August 31, 2001
Last Update Posted : June 24, 2005
Information provided by:
NIH AIDS Clinical Trials Information Service

Brief 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.

Condition or disease Intervention/treatment Phase
Mycobacterium Avium-Intracellulare Infection HIV Infections Drug: Ethambutol hydrochloride Drug: Clarithromycin Drug: Rifabutin Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 450 participants
Masking: Double
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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

Concurrent Medication:


  • 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:


  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00002101

  Hide Study 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
Combat Group
Los Angeles, California, United States, 90028
Cedars Sinai Med Ctr
Los Angeles, California, United States, 90048
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, United States, 946021018
HIV Research Group
San Diego, California, United States, 92102
UCSD / Ctr for Special Immunology
San Diego, California, United States, 92103
Saint Francis Mem Hosp
San Francisco, California, United States, 94109
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States, 94121
Sunnyvale Med Clinic
Sunnyvale, California, United States, 94086
United States, District of Columbia
George Washington Univ Med Ctr
Washington, District of Columbia, United States, 20037
Veterans Administration Med Ctr
Washington, District of Columbia, United States, 20422
United States, Florida
Infectious Disease Consultants
Altamonte Springs, Florida, United States, 32701
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, United States, 33308
Dr Frank Tornaka
Fort Lauderdale, Florida, United States, 33316
Gary Richmond MD
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 Identifier: NCT00002101     History of Changes
Other Study ID Numbers: 048D
CS 087250-999
First Posted: August 31, 2001    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 1999

Keywords provided by NIH AIDS Clinical Trials Information Service:
Mycobacterium avium-intracellulare Infection
Drug Therapy, Combination
Acquired Immunodeficiency Syndrome

Additional relevant MeSH terms:
Communicable Diseases
HIV Infections
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
Bacterial Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Actinomycetales Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections, Nontuberculous
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action