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
Completed · Phase 3
Conditions studied: Mycobacterium Avium-Intracellulare Infection, HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002101
- Run by
- Pharmacia
- People needed
- 450
- Last updated by the study team
- 2005-06-24
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Concurrent Medication:
- Allowed:
- Isoniazid for TB prophylaxis ONLY.
- Patients must have:
- HIV infection.
- MAC infection.
- Life expectancy of at least 16 weeks.
You may not qualify if…
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Perceived unreliability or unavailability for frequent monitoring.
- Concurrent Medication:
- Excluded:
- Antimycobacterial drugs other than the study drugs.
- Carbamazepine.
- Terfenadine.
- Theophylline.
- Patients with the following prior condition are excluded:
- History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol.
- Prior Medication:
- Excluded within 7 days prior to study entry:
- Rifabutin.
- Rifampin.
- Ethionamide.
- Cycloserine.
- Clofazimine.
- Ethambutol.
- Amikacin.
- Ciprofloxacin.
- Ofloxacin.
- Sparfloxacin.
- Azithromycin.
- Clarithromycin.
Where it is running
- McDowell Clinic — Phoenix, Arizona, United States
- Maricopa Med Research Foundation — Phoenix, Arizona, United States
- Bay Harbor Hosp — Harbor City, California, United States
- Ctr for Special Immunology — Irvine, California, United States
- Combat Group — Los Angeles, California, United States
- Cedars Sinai Med Ctr — Los Angeles, California, United States
- Highland Gen Hosp / San Francisco Gen Hosp — Oakland, California, United States
- HIV Research Group — San Diego, California, United States
- UCSD / Ctr for Special Immunology — San Diego, California, United States
- Saint Francis Mem Hosp — San Francisco, California, United States
- San Francisco Veterans Administration Med Ctr — San Francisco, California, United States
- Sunnyvale Med Clinic — Sunnyvale, California, United States
- George Washington Univ Med Ctr — Washington D.C., District of Columbia, United States
- Veterans Administration Med Ctr — Washington D.C., District of Columbia, United States
- Infectious Disease Consultants — Altamonte Springs, Florida, United States
- 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 Nelson Zide — Hollywood, Florida, United States
- Ctr for Special Immunology — Miami Beach, Florida, United States
- Dr Barry Rodwick — Safety Harbor, Florida, United States
- Bay Area AIDS Consortium — Tampa, Florida, United States
- Infectious Disease Research Consortium of Georgia — Atlanta, Georgia, United States
- Dr Daniel Berger — Chicago, Illinois, United States
- Univ of Kansas School of Medicine — Wichita, Kansas, United States
Full record on ClinicalTrials.gov
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