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

Completed · Phase 2

Conditions studied: Candidiasis, Oral, HIV Infections

In brief

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.

Key facts

Study ID

NCT00002399

Run by

Schering-Plough

People needed

500

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Northeast Arkansas Clinic — Jonesboro, Arkansas, United States
• Miami Veterans Administration Med Ctr — Miami, Florida, United States
• Mercy Hosp — Miami, Florida, United States
• Ponce de Leon Med Ctr — Atlanta, Georgia, United States
• Med College of Georgia — Augusta, Georgia, United States
• Rush Med College / Rush Presbyterian - St Luke's Med Cen — Chicago, Illinois, United States
• Wishard Hosp — Indianapolis, Indiana, United States
• Wayne State Univ / Harper Hosp — Detroit, Michigan, United States
• St Michaels Med Ctr — Newark, New Jersey, United States
• Duke Univ Med Ctr — Durham, North Carolina, United States
• Thomas Jefferson Univ / Division of Infectious Disease — Philadelphia, Pennsylvania, United States
• Vanderbilt Univ Med Ctr — Nashville, Tennessee, United States
• Univ of Texas Southwestern Med Ctr — Dallas, Texas, United States
• Univ of Texas / Med School at Houston — Houston, Texas, United States
• Univ of Texas Health Sciences Ctr — San Antonio, Texas, United States
• Infections Ltd / Physicians Med Ctr — Tacoma, Washington, United States
• Centro de Micologia / Facultad de Medicina UBA — Buenos Aires, Argentina
• Hosp Fernandez — Buenos Aires, Argentina
• CHU Saint Pierre — Brussels, Belgium
• St Paul's Hosp — Vancouver, British Columbia, Canada
• Victoria Gen Hosp — Halifax, Nova Scotia, Canada
• Montreal Gen Hosp — Montreal, Quebec, Canada
• Fundacion Arriaran — Santiago, Chile
• Avenida Lope de Vega Avenue esq/Calle Jose Amado Soler — Ensanche Naco/ Santo Domingo, Dominican Republic
• Tucson Veterans Administration Med Ctr — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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