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
2 other identifiers
interventional
450
1 country
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
June 1, 1999
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- Allowed:
- Isoniazid for TB prophylaxis ONLY.
- Patients must have:
- HIV infection.
- MAC infection.
- Life expectancy of at least 16 weeks.
You may not qualify if:
- 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.
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmacialead
Study Sites (44)
McDowell Clinic
Phoenix, Arizona, 85006, United States
Maricopa Med Research Foundation
Phoenix, Arizona, 85008, United States
Bay Harbor Hosp
Harbor City, California, 90710, United States
Ctr for Special Immunology
Irvine, California, 92718, United States
Combat Group
Los Angeles, California, 90028, United States
Cedars Sinai Med Ctr
Los Angeles, California, 90048, United States
Highland Gen Hosp / San Francisco Gen Hosp
Oakland, California, 946021018, United States
HIV Research Group
San Diego, California, 92102, United States
UCSD / Ctr for Special Immunology
San Diego, California, 92103, United States
Saint Francis Mem Hosp
San Francisco, California, 94109, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
Sunnyvale Med Clinic
Sunnyvale, California, 94086, United States
George Washington Univ Med Ctr
Washington D.C., District of Columbia, 20037, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422, United States
Infectious Disease Consultants
Altamonte Springs, Florida, 32701, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308, United States
Dr Frank Tornaka
Fort Lauderdale, Florida, 33316, United States
Gary Richmond MD
Fort Lauderdale, Florida, 33316, United States
Dr Nelson Zide
Hollywood, Florida, 33021, United States
Ctr for Special Immunology
Miami Beach, Florida, 33140, United States
Dr Barry Rodwick
Safety Harbor, Florida, 34695, United States
Bay Area AIDS Consortium
Tampa, Florida, 33609, United States
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, 30345, United States
Dr Daniel Berger
Chicago, Illinois, 60657, United States
Univ of Kansas School of Medicine
Wichita, Kansas, 67214, United States
Tulane Univ Med School
New Orleans, Louisiana, 701122699, United States
Dr Arnold Markowitz
Keego Harbor, Michigan, 48320, United States
Univ of Nebraska Med Ctr / HIV Clinic
Omaha, Nebraska, 681985130, United States
East Orange Veterans Administration Med Ctr
East Orange, New Jersey, 07018, United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842, United States
Long Island Jewish Med Ctr
New Hyde Park, New York, 11042, United States
Chelsea Village Med Ctr / Saint Vincent's Hosp
New York, New York, 10014, United States
Community Health Network
Rochester, New York, 14620, United States
Nalle Clinic
Charlotte, North Carolina, 28207, United States
Polyclinic Med Ctr
Harrisburg, Pennsylvania, 17110, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Charleston Veterans Administration Med Ctr
Charleston, South Carolina, 294015799, United States
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204, United States
Central Texas Med Foundation
Austin, Texas, 78751, United States
Houston Veterans Administration Med Ctr
Houston, Texas, 77030, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
Univ of Wisconsin School of Medicine
Madison, Wisconsin, 53792, United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1999-06