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: NCT00002267
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 obtained, which must include a statement that treatment may involve risks to the embryo or fetus, which are currently unforeseeable, if the subject becomes pregnant.
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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Maricopa County Med Ctr
Phoenix, Arizona, United States
East Bay AIDS Ctr
Berkeley, California, United States
Pacific Oaks Med Group
Beverly Hills, California, United States
AIDS Community Research Consortium
Redwood City, California, United States
HIV Research Group
San Diego, California, United States
Dr Larry A Waites
San Francisco, California, United States
Saint Francis Mem Hosp / HIV Care
San Francisco, California, United States
Dr Marcus Conant
San Francisco, California, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, United States
Dr Marshall Kubota
Santa Rosa, California, United States
Dr Jeffrey Galpin
Tarzana, California, United States
Miami Veterans Administration Med Ctr
Miami, Florida, United States
Community Research Initiative of South Florida
Miami, Florida, United States
Northwestern Univ Med School
Chicago, Illinois, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, United States
Comprehensive AIDS Alliance of Detroit / Harper Hosp
Detroit, Michigan, United States
Univ of Minnesota
Minneapolis, Minnesota, United States
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, United States
Univ of Nevada / Veterans Administration Med Ctr
Reno, Nevada, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, United States
Dr Donald Romig
Sante Fe, New Mexico, United States
Albany Veterans Administration
Albany, New York, United States
AIDS Services Erie County Med Ctr
Buffalo, New York, United States
Community Health Network
Rochester, New York, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, United States
Thomas Jefferson Med College
Philadelphia, Pennsylvania, 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
Univ of Calgary Health Science Ctr
Calgary, Alberta, Canada
Univ of Alberta/Division of Inf Dis/Dept of Med
Edmonton, Alberta, Canada
Saint Paul's Hosp
Vancouver, British Columbia, Canada
Victoria Gen Hosp
Halifax, Nova Scotia, Canada
McMaster Univ Med Ctr
Hamilton, Ontario, Canada
Ottawa Gen Hosp
Ottawa, Ontario, Canada
Mount Sinai Hosp
Toronto, Ontario, Canada
Saint Michael's Hosp
Toronto, Ontario, Canada
Sunnybrook Health Science Ctr
Toronto, Ontario, Canada
Dr Emil Toma / Hotel Dieu de Montreal
Montreal, Quebec, Canada
Montreal Chest Institute
Montreal, Quebec, Canada
Montreal Gen Hosp
Montreal, Quebec, Canada
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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087027-999
Identifier Type: -
Identifier Source: secondary_id
048B
Identifier Type: -
Identifier Source: org_study_id