NCT00002101

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 450 (planned)
• Sponsor: Pharmacia · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mycobacterium Avium-Intracellulare Infection
• HIV Infections

Interventions

Type	Name	Description
DRUG	Ethambutol hydrochloride
DRUG	Clarithromycin
DRUG	Rifabutin

Timeline

• First posted: 2001-08-31
• Last updated: 2005-06-24

Locations

44 sites across 1 country: United States