Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS
- Conditions
- Mycobacterium Avium-intracellulare InfectionHIV Infections
- Registration Number
- NCT00001047
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Southern New Jersey AIDS Cln Trials / Dept of Med
🇺🇸Camden, New Jersey, United States
Richmond AIDS Consortium
🇺🇸Richmond, Virginia, United States
Baltimore Trials
🇺🇸Baltimore, Maryland, United States
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Philadelphia FIGHT
🇺🇸Philadelphia, Pennsylvania, United States
Community Consortium of San Francisco
🇺🇸San Francisco, California, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Veterans Administration Med Ctr / Regional AIDS Program
🇺🇸Washington, District of Columbia, United States
Denver CPCRA / Denver Public Hlth
🇺🇸Denver, Colorado, United States
Harlem AIDS Treatment Group / Harlem Hosp Ctr
🇺🇸New York, New York, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
🇺🇸New Orleans, Louisiana, United States
Partners Research
🇺🇸Albuquerque, New Mexico, United States
Portland Veterans Adm Med Ctr / Rsch & Education Grp
🇺🇸Portland, Oregon, United States
Comprehensive AIDS Alliance of Detroit
🇺🇸Detroit, Michigan, United States