Official Title: “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”

To compare the efficacy, safety, and toleration of fluconazole as a single daily oral suspension for 14 days versus nystatin oral suspension 4 times daily for 14 days in the treatment of oropharyngeal candidiasis in patients with AIDS or HIV infection.

Study Type: Interventional

Study Design: Treatment, Parallel Assignment, Safety Study

Patients are randomized to receive fluconazole oral suspension once daily (swallowed at approximately the same time every day) for 14 days or nystatin oral suspension used to rinse the mouth four times daily for 14 days. No food or drink is permitted immediately following the administration of the nystatin.

Intervention(s) in this Clinical Trial

• Drug: Nystatin
• Drug: Fluconazole

Inclusion Criteria

Concurrent Medication:

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

Co-existing Condition:

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 13 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Pfizer

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00002112

Study ID Number: 012Q

ClinicalTrials.gov Identifier: NCT00002112

Health Authority: United States: Food and Drug Administration