A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS
NCT ID: NCT00001995
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
NA
200 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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Rifabutin
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Zidovudine (AZT).
* Didanosine (ddI).
Patients must have the following:
* Diagnosis of AIDS as defined by the CDC.
* Blood cultures positive for Mycobacterium avium complex or for acid-fast bacilli (AFB).
* Provide written informed consent.
Prior Medication:
Allowed:
* If receiving zidovudine (AZT) or ddI must be taking the medication for at least 4 weeks prior to study entry.
* Required:
* Antipneumocystis prophylactic therapy for at least 4 weeks prior to study entry.
Exclusion Criteria
Patients with the following conditions or symptoms are excluded:
* Known hypersensitivity to any of the study drugs.
Concurrent Medication:
Excluded:
* Other therapy for mycobacterial disease.
Patients with the following are excluded:
* Known hypersensitivity to any of the study drugs.
Prior Medication:
Excluded within 4 weeks:
* Therapy for mycobacterial disease.
* Antiretroviral drugs, other than zidovudine (AZT) or ddI.
* Investigational drugs, other than ddI.
18 Years
ALL
No
Sponsors
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Pharmacia
INDUSTRY
Locations
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Maricopa County Med Ctr
Phoenix, Arizona, United States
Bay Harbor Hosp
Harbor City, California, United States
Ctr for Special Immunology
Irvine, California, United States
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
HIV Research Group
San Diego, California, United States
Davies Med Ctr
San Francisco, California, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, United States
Ctr for Special Immunology
Fort Lauderdale, Florida, United States
Mem Hosp Hollywood
Hollywood, Florida, United States
Miami Veterans Administration Med Ctr
Miami, Florida, United States
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, United States
Dr Frank Rhame
Minneapolis, Minnesota, United States
Research Med Ctr
Kansas City, Missouri, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Nassau County Med Ctr
East Meadow, New York, United States
Chelsea Village Med Ctr / Saint Vincent's Hosp
New York, New York, United States
Dr Alfred F Burnside Jr
Columbia, South Carolina, United States
Infectious Disease Physicians Inc
Annandale, Virginia, United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, United States
Countries
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References
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Dautzenberg B, Castellani P, Pellegrin JL, Vittecoq D, Truffot-Pernot C, Pirotta N, Sassella D. Early bactericidal activity of rifabutin versus that of placebo in treatment of disseminated Mycobacterium avium complex bacteremia in AIDS patients. Antimicrob Agents Chemother. 1996 Jul;40(7):1722-5. doi: 10.1128/AAC.40.7.1722.
Other Identifiers
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CS 087065
Identifier Type: -
Identifier Source: secondary_id
048C
Identifier Type: -
Identifier Source: org_study_id