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.

Condition	Treatment or Intervention
Candidiasis, Oral HIV Infections	Drug: Nystatin  Drug: Fluconazole

Further Study Details: 

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.

Ages Eligible for Study:  13 Years and above,  Genders Eligible for Study:  Both

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.

California
      California Med Research Group, Fresno,  California,  93726,  United States
      UCSF Hosp, San Francisco,  California,  94143,  United States
Maryland
      Johns Hopkins School of Medicine, Baltimore,  Maryland,  21205,  United States
Pennsylvania
      Med College of Pennsylvania, Philadelphia,  Pennsylvania,  19129,  United States
Virginia
      Hampton Roads Med Specialists, Hampton,  Virginia,  23666,  United States

Study ID Numbers:  012Q; R-0223
Record last reviewed:  April 1996
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002112
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08