Comparative Randomized Study of the Efficacy, Safety, and Toleration of Fluconazole Oral Suspension or Nystatin Oral Suspension in the Treatment of Patients With Oropharyngeal Candidiasis in Association With the Acquired Immunodeficiency Syndrome
NCT ID: NCT00002112
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
Interventions
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Nystatin
Fluconazole
Eligibility Criteria
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Inclusion Criteria
Allowed:
* Phenytoin.
* Oral hypoglycemics.
* Coumarin-type anticoagulants.
* Cyclosporine.
Patients must have:
* ARC or AIDS.
* Signs of oropharyngeal candidiasis (i.e., typical white plaques) with some associated symptoms.
* Confirmation of diagnosis by microscopic exam and culture of organism.
* Life expectancy of at least 4 weeks.
NOTE:
* Patients with signs or symptoms of esophagitis (e.g., odynophagia) are not eligible unless esophagoscopy is performed and results are negative.
Exclusion Criteria
Patients with the following conditions are excluded:
* Unable to tolerate oral medication.
* Concurrent enrollment on another experimental trial of approved or non-approved drugs or systemic compounds (without approval of Pfizer clinical monitor).
Concurrent Medication:
Excluded:
* Antifungal agents other than study drugs.
* Other experimental medications.
Patients with the following prior conditions are excluded:
Known history of intolerance or allergy to imidazoles or triazoles or the polyene components of nystatin.
Prior Medication:
Excluded:
* Other antifungal agents within the past 3 days.
13 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Locations
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California Med Research Group
Fresno, California, United States
UCSF Hosp
San Francisco, California, United States
Johns Hopkins School of Medicine
Baltimore, Maryland, United States
Med College of Pennsylvania
Philadelphia, Pennsylvania, United States
Hampton Roads Med Specialists
Hampton, Virginia, United States
Countries
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Other Identifiers
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R-0223
Identifier Type: -
Identifier Source: secondary_id
012Q
Identifier Type: -
Identifier Source: org_study_id