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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fluconazole; Nystatin

Criteria

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.