NCT00002112CompletedNot Applicable
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
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pfizer
- Locations
- 5
Study Overview
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.
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
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 13 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Concurrent Medication:
- •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.
- •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:
- •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:
- •Other antifungal agents within the past 3 days.
Investigators
Study Sites (5)
Loading locations...
Similar Trials
Completed
Not Applicable
A Comparison of the Safety and Effectiveness of Fluconazole or Clotrimazole in the Treatment of Fungal Infections of the Mouth and Throat in Patients With AIDSCandidiasis, OralHIV InfectionsNCT00002282Pfizer
Completed
Phase 3
Randomized Comparative Study of Fluconazole Versus Clotrimazole Troches in the Prevention of Serious Fungal Infection in Patients With AIDS or Advanced AIDS-Related Complex. (A Nested Study of ACTG 081)CandidiasisMycosesHIV InfectionsNCT00000676National Institute of Allergy and Infectious Diseases (NIAID)500
Completed
Not Applicable
A Comparison of Fluconazole and Ketoconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune SystemsCandidiasis, EsophagealHIV InfectionsNCT00002304Pfizer
Completed
Phase 3
A Study of Fluconazole in the Treatment of Fungal Infections of the Throat in Patients With Weakened Immune SystemsCandidiasis, EsophagealHIV InfectionsNCT00002339Pfizer100
Completed
Not Applicable
A Study of Fluconazole in the Treatment of Cryptococcal Meningitis in Patients With AIDSMeningitis, CryptococcalHIV InfectionsNCT00002294Pfizer