A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
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A Multicenter, Randomized, Double-Blind, Phase II Study to Evaluate the Safety, Tolerance and Efficacy of Multiple Doses of SCH 56592 Versus Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
Patients with any of the following symptoms and conditions are excluded:
Medical condition requiring use of prohibited drugs.
Primary HIV seroconversion-related mucosal 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.
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: