A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS
2 other identifiers
interventional
200
1 country
22
Brief Summary
To determine if a drug regimen containing rifabutin will eradicate or decrease the numbers of Mycobacterium avium complex (MAC) organisms in blood, improve the symptoms associated with MAC infection, and increase survival in patients with AIDS. To assess the safety of the drug regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
22 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
November 1, 1992
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- 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.
You may not qualify if:
- Co-existing Condition:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pharmacialead
Study Sites (22)
Maricopa County Med Ctr
Phoenix, Arizona, 85010, United States
Bay Harbor Hosp
Harbor City, California, 90710, United States
Ctr for Special Immunology
Irvine, California, 92718, United States
Southwest Community Based AIDS Treatment Group - COMBAT
Los Angeles, California, 90028, United States
AIDS Community Research Consortium
Redwood City, California, 94063, United States
HIV Research Group
San Diego, California, 92102, United States
Davies Med Ctr
San Francisco, California, 94114, United States
San Francisco Veterans Administration Med Ctr
San Francisco, California, 94121, United States
Veterans Administration Med Ctr
Washington D.C., District of Columbia, 20422, United States
TheraFirst Med Ctrs Inc
Fort Lauderdale, Florida, 33308, United States
Ctr for Special Immunology
Fort Lauderdale, Florida, 33316, United States
Mem Hosp Hollywood
Hollywood, Florida, 33021, United States
Miami Veterans Administration Med Ctr
Miami, Florida, 33125, United States
Infectious Disease Research Consortium of Georgia
Atlanta, Georgia, 30076, United States
Dr Frank Rhame
Minneapolis, Minnesota, 55455, United States
Research Med Ctr
Kansas City, Missouri, 64132, United States
North Jersey Community Research Initiative
Newark, New Jersey, 071032842, United States
Nassau County Med Ctr
East Meadow, New York, 11554, United States
Chelsea Village Med Ctr / Saint Vincent's Hosp
New York, New York, 10014, 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
Related Publications (1)
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: 8807071BACKGROUND
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: 1992-11