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

Phase 3

Completed

• Conditions: Mycobacterium Avium-intracellulare Infection; HIV Infections

• Registration Number: NCT00001047
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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) 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.

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 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.

Study Timeline

• Study Completion: 1996-08
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-28
• Last Update Posted: 2021-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (16)

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, 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

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