Nctid:
NCT00002446
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002177", "term"=>"Candidiasis"}, {"id"=>"D002180", "term"=>"Candidiasis, Oral"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D009181", "term"=>"Mycoses"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D009059", "term"=>"Mouth Diseases"}, {"id"=>"D009057", "term"=>"Stomatognathic Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M9742", "name"=>"HIV Seropositivity", "relevance"=>"LOW"}, {"id"=>"M5437", "name"=>"Candidiasis", "asFound"=>"Candidiasis", "relevance"=>"HIGH"}, {"id"=>"M13515", "name"=>"Pharyngeal Diseases", "relevance"=>"LOW"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M5440", "name"=>"Candidiasis, Oral", "asFound"=>"Candidiasis, Oral", "relevance"=>"HIGH"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M12019", "name"=>"Mouth Diseases", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D015725", "term"=>"Fluconazole"}, {"id"=>"C101425", "term"=>"Posaconazole"}], "ancestors"=>[{"id"=>"D000935", "term"=>"Antifungal Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D058888", "term"=>"14-alpha Demethylase Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D065088", "term"=>"Steroid Synthesis Inhibitors"}, {"id"=>"D006727", "term"=>"Hormone Antagonists"}, {"id"=>"D006730", "term"=>"Hormones, Hormone Substitutes, and Hormone Antagonists"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}, {"id"=>"D065688", "term"=>"Cytochrome P-450 CYP2C9 Inhibitors"}, {"id"=>"D065689", "term"=>"Cytochrome P-450 CYP2C19 Inhibitors"}, {"id"=>"D014344", "term"=>"Trypanocidal Agents"}, {"id"=>"D000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000977", "term"=>"Antiparasitic Agents"}], "browseLeaves"=>[{"id"=>"M18296", "name"=>"Fluconazole", "asFound"=>"Elements", "relevance"=>"HIGH"}, {"id"=>"M219015", "name"=>"Posaconazole", "asFound"=>"Now", "relevance"=>"HIGH"}, {"id"=>"M4254", "name"=>"Antifungal Agents", "relevance"=>"LOW"}, {"id"=>"M6252", "name"=>"Clotrimazole", "relevance"=>"LOW"}, {"id"=>"M11796", "name"=>"Miconazole", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M9788", "name"=>"Hormone Antagonists", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>300}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1998-08"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-02", "lastUpdateSubmitDate"=>"2005-06-23", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2005-06-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["AIDS-Related Opportunistic Infections", "Fluconazole", "Administration, Oral", "Antifungal Agents", "Candidiasis, Oral", "Pharyngeal Diseases", "posaconazole"], "conditions"=>["Candidiasis, Oral", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to compare the safety and effectiveness of 2 treatments for thrush (a fungal infection of the mouth and throat) in HIV-positive patients. Fluconazole is a drug that is commonly used to treat thrush. SCH 56592 is a new drug that will be compared to fluconazole.", "detailedDescription"=>"Patients receive SCH 56592 oral suspension or fluconazole suspension for 14 days. Patients remain on study for 44 days total and are monitored for safety and efficacy of study treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nYou may be eligible for this study if you:\n\n* Are at least 18 years old.\n* Are HIV-positive.\n* Have thrush (oropharyngeal candidiasis).\n* Agree to practice sexual abstinence or use effective barrier methods of birth control (e.g., condoms).\n* Are able to take study medication and return for clinic visits during the study.\n* Are expected to live for at least 2 months.\n\nExclusion Criteria\n\nYou will not be eligible for this study if you:\n\n* Have received protease inhibitors for the first time within 30 days prior to study entry.\n* Have received certain medications.\n* Have certain other types of fungal infections.\n* Have certain types of cancer.\n* Have received SCH 56592 within 3 months prior to study entry.\n* Are pregnant or breast-feeding.\n* Cannot take medications by mouth.\n* Are allergic to azole drugs.\n* Have certain medical conditions.\n* Have been in this study before."}, "identificationModule"=>{"nctId"=>"NCT00002446", "briefTitle"=>"Safety and Effectiveness of Fluconazole Versus SCH 56592 to Treat Thrush in HIV-Positive Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Randomized, Controlled Trial of SCH 56592 Oral Suspension Versus Fluconazole Suspension in the Treatment of Oropharyngeal Candidiasis (OPC) in HIV-Positive Patients", "orgStudyIdInfo"=>{"id"=>"305A"}, "secondaryIdInfos"=>[{"id"=>"C97-331"}, {"id"=>"I97-331"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Posaconazole", "type"=>"DRUG"}, {"name"=>"Fluconazole", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"94705", "city"=>"Berkeley", "state"=>"California", "country"=>"United States", "facility"=>"East Bay AIDS Ctr", "geoPoint"=>{"lat"=>37.87159, "lon"=>-122.27275}}, {"zip"=>"94109", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"ViRx Inc", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94118", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Kaiser Foundation Hospital", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"80204", "city"=>"Denver", "state"=>"Colorado", "country"=>"United States", "facility"=>"Infectious Disease and AIDS Clinic", "geoPoint"=>{"lat"=>39.73915, "lon"=>-104.9847}}, {"zip"=>"200091104", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Dupont Circle Physicians Group", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"32209", "city"=>"Jacksonville", "state"=>"Florida", "country"=>"United States", "facility"=>"Boulevard Comprehensive Care Ctr", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}, {"zip"=>"33125", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Miami Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"60657", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"TRIAD Health Practice", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"46219", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Community Hosp Indianapolis", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"48201", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Wayne State Univ / Harper Hosp", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"08103", "city"=>"Camden", "state"=>"New Jersey", "country"=>"United States", "facility"=>"UMDNJ - New Jersey Med School / Cooper Hosp", "geoPoint"=>{"lat"=>39.92595, "lon"=>-75.11962}}, {"zip"=>"07304", "city"=>"Jersey City", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Jersey City Med Ctr", "geoPoint"=>{"lat"=>40.72816, "lon"=>-74.07764}}, {"zip"=>"11203", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Health Science Ctr at Brooklyn", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Univ of Pennsylvania School of Dental Medicine", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"29425", "city"=>"Charleston", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Med Univ of South Carolina", "geoPoint"=>{"lat"=>32.77657, "lon"=>-79.93092}}, {"zip"=>"75235", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Amelia Ct Clinic", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"78284", "city"=>"San Antonio", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ of Texas Health Sciences Ctr", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}, {"city"=>"St Michael", "country"=>"Barbados", "facility"=>"Queen Elizabeth Hosp Respiratory Unit"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Schering-Plough", "class"=>"INDUSTRY"}}}}
