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

Phase 3

Completed

• Conditions: Candidiasis, Esophageal; HIV Infections

• Registration Number: NCT00002339
• Lead Sponsor: Pfizer

Brief 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.

Study Timeline

• Status Verified: 1996-04
• Study First Submitted: 1999-11-02
• Study First Submitted QC: 2001-08-30
• Study First Posted: 2001-08-31
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Houston Veterans Administration Med Ctr; 🇺🇸 Houston, Texas, United States

Los Angeles County - USC Med Ctr; 🇺🇸 Los Angeles, California, United States