Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS
NCT ID: NCT00001047
Last Updated: 2021-11-04
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
PHASE3
400 participants
INTERVENTIONAL
1996-08-31
Brief Summary
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Recommendations have been issued for AIDS patients with disseminated MAC to be treated with at least two antimycobacterial agents and for every regimen to include a macrolide (clarithromycin or azithromycin). However, the optimal treatment for disseminated MAC remains unknown.
Detailed Description
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Patients are randomized to receive clarithromycin at one of two doses plus ethambutol and either rifabutin or clofazimine. Patients are followed at 1, 2, and 4 months and every 4 months thereafter for a minimum of 1.5 years to a common closing date.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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Ethambutol hydrochloride
Clarithromycin
Clofazimine
Rifabutin
Eligibility Criteria
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Inclusion Criteria
Recommended in patients with CD4 count \<= 200 cells/mm3:
* Antiretroviral therapy.
* PCP prophylaxis.
Allowed in all patients:
* Isoniazid preventive therapy.
Patients must have:
* HIV infection.
* Evidence of disseminated MAC infection.
NOTE:
* Pregnant women are permitted to enroll following counseling by their clinician regarding the potential negative side effects of the study medications. These drugs should be used in pregnancy only when the potential benefits outweigh the risks.
Exclusion Criteria
Patients with the following symptoms or conditions are excluded:
* Known hypersensitivity to the study drugs.
* Other concurrent mycobacterial disease requiring therapy, i.e., disseminated nontuberculous mycobacterial infection or active tuberculosis.
Concurrent Medication:
Excluded:
* Additional medications with antimycobacterial activity (unless patient is failing or intolerant of assigned study regimen).
* Drugs with potential additive toxicity or with potential interaction with study drugs (e.g., fluconazole).
13 Years
ALL
No
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Cohn D
Role: STUDY_CHAIR
Fisher E
Role: STUDY_CHAIR
Horsburgh CR
Role: STUDY_CHAIR
Locations
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Community Consortium of San Francisco
San Francisco, California, United States
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
Chicago, Illinois, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
New Orleans, Louisiana, United States
Baltimore Trials
Baltimore, Maryland, United States
Comprehensive AIDS Alliance of Detroit
Detroit, Michigan, United States
Henry Ford Hosp
Detroit, Michigan, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
Camden, New Jersey, United States
North Jersey Community Research Initiative
Newark, New Jersey, United States
Partners Research
Albuquerque, New Mexico, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
New York, New York, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
Portland, Oregon, United States
Philadelphia FIGHT
Philadelphia, Pennsylvania, United States
Richmond AIDS Consortium
Richmond, Virginia, United States
Countries
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References
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Cohn DL, Fisher EJ, Peng GT, Hodges JS, Chesnut J, Child CC, Franchino B, Gibert CL, El-Sadr W, Hafner R, Korvick J, Ropka M, Heifets L, Clotfelter J, Munroe D, Horsburgh CR Jr. A prospective randomized trial of four three-drug regimens in the treatment of disseminated Mycobacterium avium complex disease in AIDS patients: excess mortality associated with high-dose clarithromycin. Terry Beirn Community Programs for Clinical Research on AIDS. Clin Infect Dis. 1999 Jul;29(1):125-33. doi: 10.1086/520141.
Other Identifiers
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11577
Identifier Type: REGISTRY
Identifier Source: secondary_id
CPCRA 027
Identifier Type: -
Identifier Source: org_study_id