A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in … (NCT00002399) | Clinical Trial Compass
CompletedPhase 2
A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
United States500 participants
Plain-language summary
The purpose of this study is to compare the safety and effectiveness of SCH 56592 with that of fluconazole in the treatment of OPC (a fungal infection of the throat) in HIV-positive patients.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria
Patients must have:
* Documented HIV seropositivity (by Western blot or other approved confirmatory test) prior to enrollment.
* Pseudomembranous oropharyngeal candidiasis.
* Fungal stain or KOH consistent with Candida species, confirmed by a positive mycologic culture.
* Ability to swallow study medication.
Exclusion Criteria
Co-existing Condition:
Patients with any of the following symptoms and conditions are excluded:
* Medical condition requiring use of prohibited drugs.
* Primary HIV seroconversion-related mucosal candidiasis.
* Systemic candidiasis.
* All forms of OPC other than pseudomembranous (unless accompanied by pseudomembranous OPC).
* Documented or suspected fungal esophagitis in patients with symptoms of esophagitis.
* EKG with prolonged QTc interval or clinically-significant abnormalities.
Concurrent Medication:
Excluded:
* Systemic antifungals (IV or oral).
* Topical oral antifungals, e.g., Nystatin, Mycelex, etc.
* Medications known to interact with azoles and that may lead to life-threatening side effects:
* terfenadine, astemizole, cisapride, ebastine, triazolam, midazolam.
* Medications known to lower the serum concentration/efficacy of azole antifungals:
* rifampin, carbamazepine, phenytoin, rifabutin, barbiturates, isoniazid, H2 blockers.
* Cytokines (except erythropoietin), interferon, or lymphocyte replacement therapy unless patient already taking these agents for at least 30 days prior to enrollment.
* Protease inhibitors,…