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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00002112
• Date of registration: 02/11/1999
• Primary sponsor: Pfizer
• Public 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
• Scientific 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
• Date of first enrolment: January 1976
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00002112
• Study type: Interventional
• Study design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Countries of recruitment

United States

Key inclusion & exclusion 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.



Age minimum: 13 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Candidiasis, Oral

HIV Infections

Intervention(s)

Drug: Fluconazole

Drug: Nystatin

Secondary ID(s)

012Q

R-0223

Source(s) of Monetary Support

Please refer to primary and secondary sponsors