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
1 country
33
Brief Summary
The primary objectives of this trial are: To compare the safety of oral rifabutin versus placebo in the treatment of Mycobacterium avium complex (MAC) bacteremia in AIDS patients with CD4 counts less than or equal to 200 cells/mm3. To investigate the incidence of MAC in these patients. A secondary objective is to compare clinical response, quality of life (Karnofsky), and survival between these two groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
33 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
January 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.
- Females of childbearing potential must also sign a special informed consent.
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 (33)
Ctr for Special Immunology
Irvine, California, 92718, United States
Olive View Med Ctr
Sylmar, California, 91342, United States
Denver Public Health Dept
Denver, Colorado, 80204, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422, United States
Ctr for Special Immunology
Fort Lauderdale, Florida, 33308, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308, United States
Mem Hosp Hollywood
Hollywood, Florida, 33021, United States
VP Med Services / HHCS Research Institute Inc
Orlando, Florida, 32806, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Grady Memorial Hosp / Hughs Spalding Med Ctr
Atlanta, Georgia, 30335, United States
Dr Winkler Weinberg
Roswell, Georgia, 30076, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205, United States
CRI of New England
Brookline, Massachusetts, 02445, United States
Univ of Missouri at Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
Research Med Ctr
Kansas City, Missouri, 64132, United States
Brooklyn Veterans Administration
Brooklyn, New York, 11209, United States
Maimonides Med Ctr
Brooklyn, New York, 11219, United States
Nassau County Med Ctr
East Meadow, New York, 11554, United States
Long Island Jewish Med Ctr
New Hyde Park, New York, 11042, United States
Community Research Initiative
New York, New York, 10011, United States
Chelsea Village Med Ctr
New York, New York, 10014, United States
Mem Sloan - Kettering Cancer Ctr
New York, New York, 10021, United States
Univ Hosp of Cleveland / Case Western Reserve Univ
Cleveland, Ohio, 44106, United States
Ohio State Univ Med Ctr
Columbus, Ohio, 43210, United States
Central Texas Med Foundation
Austin, Texas, 78751, United States
Nelson Tebedo Community Clinic
Dallas, Texas, 75219, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 75235, United States
Texas Tech Health Sciences Ctr
El Paso, Texas, 79905, United States
Baylor College of Medicine
Houston, Texas, 77005, United States
Houston Clinical Research Network
Houston, Texas, 77266, United States
Univ TX San Antonio Health Science Ctr
San Antonio, Texas, 78284, United States
Scott and White Hosp
Temple, Texas, 76508, United States
Dr Scott Lea
Waco, Texas, 76708, United States
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- 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: 1992-01