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.
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.
Hosp Fernandez, Buenos Aires, Argentina
Centro de Micologia / Facultad de Medicina UBA, Buenos Aires, Argentina
CHU Saint Pierre, Brussels, Belgium
Fundacion Arriaran, Santiago, Chile
Avenida Lope de Vega Avenue esq/Calle Jose Amado Soler, Ensanche NACO/ Santo Domingo, Dominican Republic
Faculty of Medicine / Dept of Internal Medicine, Addis Ababa, Ethiopia
Service des Maladies Infectieuses, Villejuif Cedex, France
Hopital de l Institut Pasteur, Paris cedex, France
Service des Maladies Infectieuses, Tours Cedex, France
Hopital Guy de Chauliac Service des Maladies Infectieuses, Montpellier, France
Service des Maladies Infectieuses Hopital de l Archet, Nice, France
Hopital Raymond Poincare, Garches, France
Hopital Rothchild, Paris, France
Hopital de La Conception, Maseille, France
Universitat Munchen / Medizinische Poliklinik, Munich 2, Germany
Universitaet Klinik Koln, Koln, Germany
Allgemeines Krankenhaus St Georg, Hamburg, Germany
Heinrich Heine Universitat, Dusseldorf, Germany
Rheinische Friedrich Wilhelms Universitaet Medizinische, Bonn, Germany
Universitaets Krankenhaus Eppendorf Medizinische Kernklinik, Hamburg, Germany
Staedtisches Krankenhaus Kiel, Kiel, Germany
Hosp Roosevelt Chief Infectious Diseases Unit, Guatemala, Guatemala
Hosp Regional del Seguro Social, San Pedro Sula, Honduras
Sheba Med Ctr, Tel Hashomer, Israel
Hosp de Especialidades Centro Medico La Raza, Mexico, Mexico
Royal Ctr, Panama, Panama
Univ of Stellenbosch Med School Depart Med Phys, Tygerberg, South Africa
Daniel Rudolph Malan, Port Elizabeth, South Africa
The Studio, Rosebank, South Africa
Hosp Valle D Hebron, Barcelona, Spain
Hosp Clinic, Barcelona, Spain
Program on AIDS / Thai Red Cross Society, Bangkok, Thailand
Policlinica Metropolitana, Caracas, Venezuela
Tucson Veterans Administration Med Ctr, Tucson, Arizona 85723, United States
Northeast Arkansas Clinic, Jonesboro, Arkansas 72401, United States
St Paul's Hosp, Vancouver, British Columbia, Canada
Miami Veterans Administration Med Ctr, Miami, Florida 33125, United States
Mercy Hosp, Miami, Florida 33133, United States
Ponce de Leon Med Ctr, Atlanta, Georgia 30308, United States
Med College of Georgia, Augusta, Georgia 30912, United States
Rush Med College / Rush Presbyterian - St Luke's Med Cen, Chicago, Illinois 60612, United States
Wishard Hosp, Indianapolis, Indiana 46202, United States
Wayne State Univ / Harper Hosp, Detroit, Michigan 48201, United States
St Michaels Med Ctr, Newark, New Jersey 07102, United States
Duke Univ Med Ctr, Durham, North Carolina 27710, United States
Victoria Gen Hosp, Halifax, Nova Scotia, Canada
Thomas Jefferson Univ / Division of Infectious Disease, Philadelphia, Pennsylvania 19107, United States
Montreal Gen Hosp, Montreal, Quebec, Canada
Vanderbilt Univ Med Ctr, Nashville, Tennessee 372321302, United States
Univ of Texas Health Sciences Ctr, San Antonio, Texas 78284, United States
Univ of Texas / Med School at Houston, Houston, Texas 77030, United States
Univ of Texas Southwestern Med Ctr, Dallas, Texas 75390, United States
Infections Ltd / Physicians Med Ctr, Tacoma, Washington 98405, United States
