NCT00002399

A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

A Multicenter, Randomized, Double-Blind, Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Multiple Doses of SCH 56592 Versus Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 500 (planned)
• Sponsor: Schering-Plough · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.

Detailed description

This is a randomized, multicenter, double-blind study consisting of 5 arms (4 dose levels of SCH 56592 vs fluconazole) in the treatment of oropharyngeal candidiasis (OPC) in HIV-positive patients.

Conditions

• Candidiasis, Oral
• HIV Infections

Interventions

Type	Name	Description
DRUG	Posaconazole
DRUG	Fluconazole

Timeline

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

Locations

53 sites across 18 countries: United States, Argentina, Belgium, Canada, Chile, Dominican Republic, Ethiopia, France, Germany, Guatemala, Honduras, Israel, Mexico, Panama, South Africa, Spain, Thailand, Venezuela