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
Information source: NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Candidiasis, Oral; HIV Infections
Intervention: Nystatin (Drug); Fluconazole (Drug)
Phase: N/A
Status: Completed
Sponsored by: Pfizer
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.
Clinical Details
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
Study design: Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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.
Eligibility
Minimum age: 13 Years.
Maximum age: N/A.
Gender(s): 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.
Locations and Contacts
California Med Research Group, Fresno, California 93726, United States
UCSF Hosp, San Francisco, California 94143, United States
Johns Hopkins School of Medicine, Baltimore, Maryland 21205, United States
Med College of Pennsylvania, Philadelphia, Pennsylvania 19129, United States
Hampton Roads Med Specialists, Hampton, Virginia 23666, United States
Additional Information
Last updated: June 23, 2005
|