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
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
13 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Isoniazid for TB prophylaxis ONLY.
Patients must have:
Life expectancy of at least 16 weeks.
Patients with the following symptoms or conditions are excluded:
Perceived unreliability or unavailability for frequent monitoring.
Antimycobacterial drugs other than the study drugs.
Patients with the following prior condition are excluded:
History of hypersensitivity to rifabutin, rifampin, erythromycin, clarithromycin, azithromycin, or ethambutol.