NCT00002140

A Randomized, Double-Blind, Comparative Study of Azithromycin Versus Clarithromycin in Combination With Ethambutol for the Treatment of Disseminated Mycobacterium Avium Complex (MAC) Infection in AIDs Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the efficacy and safety of two different doses of azithromycin in combination with ethambutol for the treatment of patients with Mycobacterium avium complex (MAC) infection, and to determine whether an azithromycin-containing regimen is at least as safe and effective as the same regimen containing clarithromycin..

Detailed description

Patients are randomized to receive azithromycin at one of two doses in combination with ethambutol or clarithromycin in combination with ethambutol for 24 weeks, after which they are evaluated for entry into a maintenance phase of treatment. Clinical, microbiologic, and safety assessments are performed every 3 weeks for the first 12 weeks, then monthly for the remaining 12 weeks.

Conditions

• Mycobacterium Avium-intracellulare Infection
• HIV Infections

Interventions

Type	Name	Description
DRUG	Ethambutol hydrochloride
DRUG	Clarithromycin
DRUG	Azithromycin

Timeline

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

Locations

24 sites across 1 country: United States