Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial
NCT ID: NCT00002032
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
750 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
* Diagnosis of AIDS with a case defining infection other than Mycobacterium avium complex (MAC).
* Written informed consent.
* Females of childbearing potential must also sign a special informed consent.
Exclusion Criteria
Patients with the following conditions or symptoms are excluded:
* Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddI).
* Previous or current infection due to Mycobacterium avium complex (MAC) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation.
Concurrent Medication:
Excluded:
* Antiretroviral agents other than zidovudine (AZT).
* Didanosine (ddI).
* Antimycobacterial therapy.
* Rifampin.
* Isoniazid.
* Clofazimine.
* Ethambutol.
* Cycloserine.
* Ethionamide.
* Amikacin.
* Ciprofloxacin.
* Streptomycin.
* Other investigational drugs.
* If antimicrobial therapy is required to treat bacterial infections (= or \< 14 days), Adria Laboratories must be contacted prior to initiation of therapy.
Patients with the following are excluded:
* Known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (AZT), or didanosine (ddI).
* Previous or current Mycobacterium avium complex (MAC) infection.
* Perceived patient unreliability or unavailability for frequent monitoring.
Prior Medication:
Excluded within 4 weeks of study entry:
* Antiretroviral agents other than zidovudine (AZT) or didanosine (ddI).
* Antimycobacterial therapy.
* Rifampin.
* Isoniazid.
* Clofazimine.
* Ethambutol.
* Cycloserine.
* Ethionamide.
* Amikacin.
* Ciprofloxacin.
Required:
* Zidovudine (AZT).
* Antipneumocystis prophylactic therapy.
Required for at least 4 weeks prior to study entry:
* Zidovudine (AZT) or didanosine (ddI).
* Antipneumocystis prophylaxis.
18 Years
ALL
No
Sponsors
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Pharmacia
INDUSTRY
Locations
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Ctr for Special Immunology
Irvine, California, United States
Olive View Med Ctr
Sylmar, California, United States
Denver Public Health Dept
Denver, Colorado, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, United States
Ctr for Special Immunology
Fort Lauderdale, Florida, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, United States
Mem Hosp Hollywood
Hollywood, Florida, United States
VP Med Services / HHCS Research Institute Inc
Orlando, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Grady Memorial Hosp / Hughs Spalding Med Ctr
Atlanta, Georgia, United States
Dr Winkler Weinberg
Roswell, Georgia, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
CRI of New England
Brookline, Massachusetts, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, United States
Research Med Ctr
Kansas City, Missouri, United States
Brooklyn Veterans Administration
Brooklyn, New York, United States
Maimonides Med Ctr
Brooklyn, New York, United States
Nassau County Med Ctr
East Meadow, New York, United States
Long Island Jewish Med Ctr
New Hyde Park, New York, United States
Community Research Initiative
New York, New York, United States
Chelsea Village Med Ctr
New York, New York, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, United States
Ohio State Univ Med Ctr
Columbus, Ohio, United States
Central Texas Med Foundation
Austin, Texas, United States
Nelson Tebedo Community Clinic
Dallas, Texas, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, United States
Texas Tech Health Sciences Ctr
El Paso, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Clinical Research Network
Houston, Texas, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, United States
Scott and White Hosp
Temple, Texas, United States
Dr Scott Lea
Waco, Texas, 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.
Moore RD, Chaisson RE. Survival analysis of two controlled trials of rifabutin prophylaxis against Mycobacterium avium complex in AIDS. AIDS. 1995 Dec;9(12):1337-42. doi: 10.1097/00002030-199512000-00006.
Other Identifiers
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087023-999
Identifier Type: -
Identifier Source: secondary_id
048A
Identifier Type: -
Identifier Source: org_study_id