drugset / Trial / 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

NCT00002101

Phase 3 Completed 450 enrolled Pharmacia
Double-blindTreatment

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.

Timeline

Start
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Rifabutin Small molecule 300 mg
Subject Rifabutin Small molecule 450 mg
Background Clarithromycin Small molecule
Background Ethambutol Small molecule