A Comparison of SCH 56592 and Fluconazole in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients
NCT ID: NCT00002399
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
500 participants
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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TREATMENT
DOUBLE
Interventions
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Posaconazole
Fluconazole
Eligibility Criteria
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Inclusion Criteria
* 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
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.
18 Years
65 Years
ALL
No
Sponsors
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Schering-Plough
INDUSTRY
Locations
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Tucson Veterans Administration Med Ctr
Tucson, Arizona, United States
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
Faculty of Medicine / Dept of Internal Medicine
Addis Ababa, , Ethiopia
Hopital Raymond Poincare
Garches, , France
Hopital de La Conception
Maseille, , France
Hopital Guy de Chauliac Service des Maladies Infectieuses
Montpellier, , France
Service des Maladies Infectieuses Hopital de l Archet
Nice, , France
Hopital de l Institut Pasteur
Paris, , France
Hopital Rothchild
Paris, , France
Service des Maladies Infectieuses
Tours, , France
Service des Maladies Infectieuses
Villejuif, , France
Rheinische Friedrich Wilhelms Universitaet Medizinische
Bonn, , Germany
Universitaet Klinik Koln
Cologne, , Germany
Heinrich Heine Universitat
Düsseldorf, , Germany
Allgemeines Krankenhaus St Georg
Hamburg, , Germany
Universitaets Krankenhaus Eppendorf Medizinische Kernklinik
Hamburg, , Germany
Staedtisches Krankenhaus Kiel
Kiel, , Germany
Universitat Munchen / Medizinische Poliklinik
Munich, , Germany
Hosp Roosevelt Chief Infectious Diseases Unit
Guatemala City, , Guatemala
Hosp Regional del Seguro Social
San Pedro Sula, , Honduras
Sheba Med Ctr
Tel Litwinsky, , Israel
Hosp de Especialidades Centro Medico La Raza
México, , Mexico
Royal Ctr
Panama City, , Panama
Daniel Rudolph Malan
Port Elizabeth, , South Africa
The Studio
Rosebank, , South Africa
Univ of Stellenbosch Med School Depart Med Phys
Tygerberg, , South Africa
Hosp Clinic
Barcelona, , Spain
Hosp Valle D Hebron
Barcelona, , Spain
Program on AIDS / Thai Red Cross Society
Bangkok, , Thailand
Policlinica Metropolitana
Caracas, , Venezuela
Countries
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Other Identifiers
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C96-209
Identifier Type: -
Identifier Source: secondary_id
I96-209
Identifier Type: -
Identifier Source: secondary_id
288A
Identifier Type: -
Identifier Source: org_study_id