Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS
An Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS)
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
This PHASE3 trial investigates HIV Infections and Mycobacterium Avium-intracellulare Infection and is currently completed. National Institute of Allergy and Infectious Diseases (NIAID) leads this study, which shows 7 recorded versions since 2026 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.
Study Description(click to expand)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.
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.
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.
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.
Status Flow
Change History
7 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Dec 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Dec 2021 [monthly]
Completed PHASE3
▶ Show 2 earlier versions
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Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
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Jan 2017 — Jun 2018 [monthly]
Completed PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- National Institute of Allergy and Infectious Diseases (NIAID)
For direct contact, visit the study record on ClinicalTrials.gov .