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
2 other identifiers
interventional
750
2 countries
43
Brief Summary
The primary objective of this trial is to assess the safety and the relative benefit of rifabutin monotherapy in preventing or delaying the incidence of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200, as compared to placebo, and to assess if survival is prolonged in patients who receive rifabutin prophylaxis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
43 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
March 1, 1992
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have the following:
- 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.
You may not qualify if:
- Co-existing Condition:
- 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.
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmacialead
Study Sites (43)
Maricopa County Med Ctr
Phoenix, Arizona, 85010, United States
East Bay AIDS Ctr
Berkeley, California, 94704, United States
Pacific Oaks Med Group
Beverly Hills, California, 90211, United States
AIDS Community Research Consortium
Redwood City, California, 94063, United States
HIV Research Group
San Diego, California, 92102, United States
Dr Larry A Waites
San Francisco, California, 94108, United States
Saint Francis Mem Hosp / HIV Care
San Francisco, California, 94109, United States
Dr Marcus Conant
San Francisco, California, 94115, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
Dr Marshall Kubota
Santa Rosa, California, 95404, United States
Dr Jeffrey Galpin
Tarzana, California, 91356, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
Community Research Initiative of South Florida
Miami, Florida, 33137, United States
Northwestern Univ Med School
Chicago, Illinois, 60611, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, 60657, United States
Tulane Univ School of Medicine
New Orleans, Louisiana, 70112, United States
Comprehensive AIDS Alliance of Detroit / Harper Hosp
Detroit, Michigan, 48201, United States
Univ of Minnesota
Minneapolis, Minnesota, 55455, United States
St Paul Ramsey Med Ctr
Saint Paul, Minnesota, 55101, United States
Univ of Nevada / Veterans Administration Med Ctr
Reno, Nevada, 89520, United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842, United States
Univ of New Mexico Hlth Sciences Ctr / Dept of Med
Albuquerque, New Mexico, 87131, United States
Dr Donald Romig
Sante Fe, New Mexico, 87501, United States
Albany Veterans Administration
Albany, New York, 12208, United States
AIDS Services Erie County Med Ctr
Buffalo, New York, 14215, United States
Community Health Network
Rochester, New York, 14620, United States
Buckley Braffman Stern Med Associates
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson Med College
Philadelphia, Pennsylvania, 19107, United States
Dr Alfred F Burnside Jr
Columbia, South Carolina, 29204, United States
Infectious Disease Physicians Inc
Annandale, Virginia, 22203, United States
Milwaukee County Med Complex
Milwaukee, Wisconsin, 53226, 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
Related Publications (2)
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.
PMID: 8807071BACKGROUNDMoore 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.
PMID: 8605053BACKGROUND