Status:
COMPLETED
Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Mycobacterium Avium-intracellulare Infection
HIV Infections
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief Summary
To compare the safety and efficacy of two doses of clarithromycin in combination with ethambutol and either rifabutin or clofazimine for the treatment of disseminated Mycobacterium avium Complex (MAC)...
Detailed Description
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 azithr...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication:
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
Co-existing Condition:
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).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
August 1 1996
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00001047
End Date
August 1 1996
Last Update
November 4 2021
Active Locations (16)
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1
Community Consortium of San Francisco
San Francisco, California, United States, 94110
2
Denver CPCRA / Denver Public Hlth
Denver, Colorado, United States, 802044507
3
Veterans Administration Med Ctr / Regional AIDS Program
Washington D.C., District of Columbia, United States, 20422
4
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308