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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00002112

Collaborator

(none)

Locations

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Candidiasis, Oral HIV Infections	Drug: Nystatin Drug: Fluconazole	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	California Med Research Group	Fresno	California	United States	93726
2	UCSF Hosp	San Francisco	California	United States	94143
3	Johns Hopkins School of Medicine	Baltimore	Maryland	United States	21205
4	Med College of Pennsylvania	Philadelphia	Pennsylvania	United States	19129
5	Hampton Roads Med Specialists	Hampton	Virginia	United States	23666