A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients

Launched by SCHERING-PLOUGH · Aug 30, 2001

Keywords

ClinConnect Summary

This is a randomized, multicenter, double-blind study consisting of 5 arms (4 dose levels of SCH 56592 vs fluconazole) in the treatment of oropharyngeal candidiasis (OPC) in HIV-positive patients.

Gender

ALL

Eligibility criteria

• • 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, starting for the first time, 30 days prior to study enrollment.
• • Cytotoxic therapy for cancer.
• • Oral or intravenous corticosteroids at supraphysiologic doses (prednisone 10 mg/day or greater; hydrocortisone 40 mg/day or greater; dexamethasone 2 mg/day or greater.
• Patients with any of the following prior conditions are excluded:
• • Prior enrollment in this study.
• • Less than 3 months life expectancy.
• • History of hypersensitivity to azole antifungals.
• • History of failed therapy with fluconazole 100 mg/day for 2 weeks in the last 3 months.
• Prior Medication:
• Excluded (wash-outs for medications):
• • Systemic antifungals (IV, oral) within 14 days prior to enrollment.
• • Topical oral antifungals within 1 day prior to enrollment.
• • Oral or intravenous corticosteroids at supraphysiologic doses within 10 days prior to enrollment.
• • Astemizole within 10 days prior to enrollment.
• • Drugs known to lower the serum concentration/efficacy of azole antifungals within 30 days prior to enrollment.
• • Investigational drug (unlicensed new chemical entity) use within 30 days prior to enrollment.
• • Current known drug abuse, in the opinion of the lead investigator, that would interfere with the subject's participation in the study.