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

HIV Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002112
• Other study ID #: 012Q
• Secondary ID: R-0223
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: April 1996
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 13 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Candidiasis
• Candidiasis, Oral
• HIV Infections
• Immunologic Deficiency Syndromes

Intervention

Drug:
• Nystatin

• Fluconazole

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland
United States	California Med Research Group	Fresno	California
United States	Hampton Roads Med Specialists	Hampton	Virginia
United States	Med College of Pennsylvania	Philadelphia	Pennsylvania
United States	UCSF Hosp	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States,