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
NCT ID: NCT00002101
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
450 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Ethambutol hydrochloride
Clarithromycin
Rifabutin
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Isoniazid for TB prophylaxis ONLY.
Patients must have:
* HIV infection.
* MAC infection.
* Life expectancy of at least 16 weeks.
Exclusion Criteria
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.
13 Years
ALL
No
Sponsors
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Pharmacia
INDUSTRY
Locations
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McDowell Clinic
Phoenix, Arizona, United States
Maricopa Med Research Foundation
Phoenix, Arizona, United States
Bay Harbor Hosp
Harbor City, California, United States
Ctr for Special Immunology
Irvine, California, United States
Combat Group
Los Angeles, California, United States
Cedars Sinai Med Ctr
Los Angeles, California, United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 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
George Washington Univ Med Ctr
Washington D.C., District of Columbia, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, United States
Infectious Disease Consultants
Altamonte Springs, Florida, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, United States
Dr Frank Tornaka
Fort Lauderdale, Florida, United States
Gary Richmond MD
Fort Lauderdale, Florida, United States
Dr Nelson Zide
Hollywood, Florida, United States
Ctr for Special Immunology
Miami Beach, Florida, United States
Dr Barry Rodwick
Safety Harbor, Florida, United States
Bay Area AIDS Consortium
Tampa, Florida, United States
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, United States
Dr Daniel Berger
Chicago, Illinois, United States
Univ of Kansas School of Medicine
Wichita, Kansas, United States
Tulane Univ Med School
New Orleans, Louisiana, United States
Dr Arnold Markowitz
Keego Harbor, Michigan, United States
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, United States
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Long Island Jewish Med Ctr
New Hyde Park, New York, United States
Chelsea Village Med Ctr / Saint Vincent's Hosp
New York, New York, United States
Community Health Network
Rochester, New York, United States
Nalle Clinic
Charlotte, North Carolina, United States
Polyclinic Med Ctr
Harrisburg, Pennsylvania, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Charleston Veterans Administration Med Ctr
Charleston, South Carolina, United States
Dr Alfred F Burnside Jr
Columbia, South Carolina, United States
Central Texas Med Foundation
Austin, Texas, United States
Houston Veterans Administration Med Ctr
Houston, Texas, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States
Infectious Disease Physicians Inc
Annandale, Virginia, United States
Univ of Wisconsin School of Medicine
Madison, Wisconsin, United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CS 087250-999
Identifier Type: -
Identifier Source: secondary_id
048D
Identifier Type: -
Identifier Source: org_study_id