A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS
- Conditions
- Mycobacterium Avium-intracellulare InfectionHIV Infections
- Registration Number
- NCT00001058
- Brief Summary
To compare the efficacy and safety of clarithromycin combined with rifabutin, ethambutol, or both in the treatment of disseminated Mycobacterium avium Complex (MAC) disease in persons with AIDS, including individuals who have or have not received prior MAC prophylaxis.
It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones.
- Detailed Description
It is believed that effective therapy for MAC disease in patients with AIDS requires combinations of two or more antimycobacterial agents in order to overcome drug resistance and the unfavorable influence of the profound immunosuppression associated with AIDS. Data suggest that clarithromycin may have substantial activity in two- or three-drug combination regimens with clofazimine, rifamycin derivatives, ethambutol, or the 4-quinolones.
Patients are randomized to one of three treatment arms containing clarithromycin in combination with ethambutol, rifabutin, or both. Clarithromycin alone is taken on days 1 through 3 to determine tolerance and rifabutin and/or ethambutol is added on day 3. AS PER AMENDMENT 7/2/97: Patients may elect to add ritonavir or indinavir to their treatment regimen. Treatment continues daily for 48 weeks. In the absence of a dose-limiting toxicity, those patients who are determined to be complete or partial responders continue on the regimen to which they were originally assigned. Patients who have failed or relapsed on originally assigned MAC therapy, must have their therapy amended to receive clarithromycin and at least two other drugs not included in their originally assigned regimen. Patients are followed twice in the first week, then every 2 weeks for the first 2 months, then monthly for the next 4 months, and then every 2 months thereafter until the end of 12 months. PER AMENDMENT 10/10/96: NOTE: Any patient who develops a toxicity to rifabutin or ethambutol after week 12 or thereafter will be offered the option of being registered to a salvage regimen of 2 new drugs not previously received, plus clarithromycin to continue for the study duration.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 246
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 (34)
Indiana Univ. School of Medicine, Infectious Disease Research Clinic
🇺🇸Indianapolis, Indiana, United States
Methodist Hosp. of Indiana
🇺🇸Indianapolis, Indiana, United States
Harbor-UCLA Med. Ctr. CRS
🇺🇸Torrance, California, United States
Northwestern University CRS
🇺🇸Chicago, Illinois, United States
UCLA CARE Center CRS
🇺🇸Los Angeles, California, United States
The Ponce de Leon Ctr. CRS
🇺🇸Atlanta, Georgia, United States
Rush Univ. Med. Ctr. ACTG CRS
🇺🇸Chicago, Illinois, United States
Weiss Memorial Hosp.
🇺🇸Chicago, Illinois, United States
USC CRS
🇺🇸Los Angeles, California, United States
Hosp. of the Univ. of Pennsylvania CRS
🇺🇸Philadelphia, Pennsylvania, United States
Cook County Hosp. CORE Ctr.
🇺🇸Chicago, Illinois, United States
Bmc Actg Crs
🇺🇸Boston, Massachusetts, United States
Indiana Univ. School of Medicine, Wishard Memorial
🇺🇸Indianapolis, Indiana, United States
Univ. of Rochester ACTG CRS
🇺🇸Rochester, New York, United States
Johns Hopkins Adult AIDS CRS
🇺🇸Baltimore, Maryland, United States
The Ohio State Univ. AIDS CRS
🇺🇸Columbus, Ohio, United States
Beth Israel Deaconess - East Campus A0102 CRS
🇺🇸Boston, Massachusetts, United States
SUNY - Buffalo, Erie County Medical Ctr.
🇺🇸Buffalo, New York, United States
St. Louis ConnectCare, Infectious Diseases Clinic
🇺🇸Saint Louis, Missouri, United States
Univ. of Cincinnati CRS
🇺🇸Cincinnati, Ohio, United States
Ucsd, Avrc Crs
🇺🇸San Diego, California, United States
University of Minnesota, ACTU
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Med. Ctr., Div. of Infectious Diseases
🇺🇸Minneapolis, Minnesota, United States
Mbeya Med. Research Program, Mbeya Referral Hosp. CRS
🇹🇿Mbeya, Tanzania
Beth Israel Med. Ctr. (Mt. Sinai)
🇺🇸New York, New York, United States
NY Univ. HIV/AIDS CRS
🇺🇸New York, New York, United States
University of Washington AIDS CRS
🇺🇸Seattle, Washington, United States
Washington U CRS
🇺🇸Saint Louis, Missouri, United States
Unc Aids Crs
🇺🇸Chapel Hill, North Carolina, United States
Alabama Therapeutics CRS
🇺🇸Birmingham, Alabama, United States
Ucsf Aids Crs
🇺🇸San Francisco, California, United States
University of Colorado Hospital CRS
🇺🇸Aurora, Colorado, United States
Queens Med. Ctr.
🇺🇸Honolulu, Hawaii, United States
Univ. of Hawaii at Manoa, Leahi Hosp.
🇺🇸Honolulu, Hawaii, United States