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

This study has been completed.
Study NCT00002339.   Last updated on June 23, 2005.   Information provided by NIH AIDS Clinical Trials Information Service

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Descriptive Information Fields
Brief Title  A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune Systems
Official Title  An Open Multicenter Trial of Fluconazole Oral Suspension in the Treatment of Esophageal Candidiasis in Immunocompromised Patients
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 Phase Phase III
Study Type  Interventional
Study Design  Treatment, Safety Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Candidiasis, Esophageal
HIV Infections
Intervention  Drug: Fluconazole
MEDLINE PMIDs 7957784
Links
Recruitment Information Fields
Recruitment Status  Completed
Enrollment  100
Start Date 
Completion Date
Eligibility Criteria 

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.

Concurrent Medication:

Excluded:

  • Concomitant oral or topical antifungal agent.
  • Other experimental medications.

Patients with the following prior condition are excluded:

History of allergy to imidazoles or azoles.

Prior Medication:

Excluded:

  • Any oral or topical antifungal therapy within the past 3 days. Active use of illicit or illegal drugs.
Gender Both
Ages 13 Years to 70 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00002339
Organization ID 120
Secondary IDs †† R-0220
Study Sponsor  Pfizer
Collaborators ††
Investigators 
Information Provided By NIH AIDS Clinical Trials Information Service
Verification Date April 1996
First Received Date  November 2, 1999
Last Updated Date June 23, 2005

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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