Completed

Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS

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What is being tested

Ethambutol hydrochloride

+ Clarithromycin
+ Clofazimine
Drug
Who is being recruted

Mycobacterium Avium-intracellulare Infection

+ HIV Infections
Over 13 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3
Interventional

See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
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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) disease in AIDS patients. 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. 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.

Official TitleAn Open-Label, Randomized Trial of Four Treatment Regimens for Patients With Disseminated Mycobacterium Avium Complex Disease and Acquired Immunodeficiency Syndrome (AIDS) 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: November 4, 2021
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
400 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 13 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Mycobacterium Avium-intracellulare Infection
HIV Infections
Criteria
No eligibility criteria are available at this time.Please check with the study contact for more details. 
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Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 16 locations
Suspended
Community Consortium of San FranciscoSan Francisco, United StatesSee the location
Suspended
Denver CPCRA / Denver Public HlthDenver, United States
Suspended
Veterans Administration Med Ctr / Regional AIDS ProgramWashington, United States
Suspended
AIDS Research Consortium of AtlantaAtlanta, United States
Completed16 Study Centers