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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002339

Collaborator

(none)

100

Enrollment

Locations

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis, Esophageal HIV Infections	Drug: Fluconazole	Phase 3

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 Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria

Patients must have:

AIDS or other immunocompromising condition.
Candidal esophagitis.
Life expectancy of at least 2 months.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

Evidence of non-candidal systemic fungal infection.
Abnormalities that may preclude esophagoscopy or endoscopy.
Unable to tolerate fluconazole.
Unable to give informed consent.
Enrollment in other experimental trials of approved or non-approved drugs or systemic compounds (unless approved by the Pfizer Clinical Monitor).
Other condition that would make patient unsuitable for enrollment.