NCT00002339

A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems

An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 100 (planned)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 13 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To determine the safety, toleration, and efficacy of fluconazole oral suspension in the treatment of esophageal candidiasis in immunocompromised patients, including those with AIDS.

Detailed description

Patients receive fluconazole oral suspension for a minimum of 3 weeks and maximum of 8 weeks. Patients are evaluated weekly, and treatment continues for 2 weeks after resolution of symptoms. Endoscopic exams and possibly biopsies are performed at baseline and at the end of treatment. Patients undergo follow-up at 2 weeks post-treatment.

Conditions

• Candidiasis, Esophageal
• HIV Infections

Interventions

Type	Name	Description
DRUG	Fluconazole

Timeline

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

Locations

2 sites across 1 country: United States