A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo
- Conditions
- Mycobacterium Avium-Intracellulare InfectionHIV Infections
- Registration Number
- NCT00002101
- Lead Sponsor
- Pharmacia
- Brief Summary
To compare the efficacy of clarithromycin/ethambutol with placebo or with rifabutin at two different doses in reducing colony-forming units (CFUs) by 2 or more logarithms in patients with Mycobacterium avium Complex bacteremia and maintaining this response until 16 weeks post-randomization. To assess survival and comparative tolerability among the three treatment regimens.
- Detailed Description
Patients are randomized to receive clarithromycin and ethambutol plus either placebo or rifabutin at one of two doses. Treatment continues indefinitely. AS PER AMENDMENT 04/19/94: Doses of rifabutin have been lowered.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
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 (43)
TheraFirst Med Ctrs Inc
🇺🇸Fort Lauderdale, Florida, United States
Dr Frank Tornaka
🇺🇸Fort Lauderdale, Florida, United States
Gary Richmond MD
🇺🇸Fort Lauderdale, Florida, United States
Dr Barry Rodwick
🇺🇸Safety Harbor, Florida, United States
Infectious Disease Research Consortium of Georgia
🇺🇸Atlanta, Georgia, United States
Dr Alfred F Burnside Jr
🇺🇸Columbia, South Carolina, United States
Infectious Disease Consultants
🇺🇸Altamonte Springs, Florida, United States
Ctr for Special Immunology
🇺🇸Miami Beach, Florida, United States
Tulane Univ Med School
🇺🇸New Orleans, Louisiana, United States
Combat Group
🇺🇸Los Angeles, California, United States
Cedars Sinai Med Ctr
🇺🇸Los Angeles, California, United States
Dr Daniel Berger
🇺🇸Chicago, Illinois, United States
George Washington Univ Med Ctr
🇺🇸Washington, District of Columbia, United States
Buckley Braffman Stern Med Associates
🇺🇸Philadelphia, Pennsylvania, United States
Community Health Network
🇺🇸Rochester, New York, United States
Polyclinic Med Ctr
🇺🇸Harrisburg, Pennsylvania, United States
Central Texas Med Foundation
🇺🇸Austin, Texas, United States
HIV Research Group
🇺🇸San Diego, California, United States
San Francisco Veterans Administration Med Ctr
🇺🇸San Francisco, California, United States
UCSD / Ctr for Special Immunology
🇺🇸San Diego, California, United States
Saint Francis Mem Hosp
🇺🇸San Francisco, California, United States
Houston Veterans Administration Med Ctr
🇺🇸Houston, Texas, United States
Univ TX San Antonio Health Science Ctr
🇺🇸San Antonio, Texas, United States
Univ of Nebraska Med Ctr / HIV Clinic
🇺🇸Omaha, Nebraska, United States
McDowell Clinic
🇺🇸Phoenix, Arizona, United States
Maricopa Med Research Foundation
🇺🇸Phoenix, Arizona, United States
Bay Area AIDS Consortium
🇺🇸Tampa, Florida, United States
Milwaukee County Med Complex
🇺🇸Milwaukee, Wisconsin, United States
Univ of Kansas School of Medicine
🇺🇸Wichita, Kansas, United States
Infectious Disease Physicians Inc
🇺🇸Annandale, Virginia, United States
Sunnyvale Med Clinic
🇺🇸Sunnyvale, California, United States
Dr Nelson Zide
🇺🇸Hollywood, Florida, United States
East Orange Veterans Administration Med Ctr
🇺🇸East Orange, New Jersey, United States
Long Island Jewish Med Ctr
🇺🇸New Hyde Park, New York, United States
Highland Gen Hosp / San Francisco Gen Hosp
🇺🇸Oakland, California, United States
Bay Harbor Hosp
🇺🇸Harbor City, California, United States
Veterans Administration Med Ctr
🇺🇸Washington, District of Columbia, United States
Dr Arnold Markowitz
🇺🇸Keego Harbor, Michigan, United States
North Jersey Community Research Initiative
🇺🇸Newark, New Jersey, United States
Nalle Clinic
🇺🇸Charlotte, North Carolina, United States
Chelsea Village Med Ctr / Saint Vincent's Hosp
🇺🇸New York, New York, United States
Univ of Wisconsin School of Medicine
🇺🇸Madison, Wisconsin, United States
Charleston Veterans Administration Med Ctr
🇺🇸Charleston, South Carolina, United States