Nctid:
NCT00002075
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D016919", "term"=>"Meningitis, Cryptococcal"}, {"id"=>"D008581", "term"=>"Meningitis"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D000090862", "term"=>"Neuroinflammatory Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D016921", "term"=>"Meningitis, Fungal"}, {"id"=>"D020314", "term"=>"Central Nervous System Fungal Infections"}, {"id"=>"D009181", "term"=>"Mycoses"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D003453", "term"=>"Cryptococcosis"}, {"id"=>"D002494", "term"=>"Central Nervous System Infections"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M11564", "name"=>"Meningitis", "asFound"=>"Meningitis", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M19263", "name"=>"Meningitis, Cryptococcal", "asFound"=>"Meningitis, Cryptococcal", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M6664", "name"=>"Cryptococcosis", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M2803", "name"=>"Neuroinflammatory Diseases", "relevance"=>"LOW"}, {"id"=>"M19265", "name"=>"Meningitis, Fungal", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M22126", "name"=>"Central Nervous System Fungal Infections", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M5743", "name"=>"Central Nervous System Infections", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T1668", "name"=>"Cryptococcosis", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D015725", "term"=>"Fluconazole"}, {"id"=>"D000666", "term"=>"Amphotericin B"}, {"id"=>"C068538", "term"=>"Liposomal amphotericin B"}, {"id"=>"D005437", "term"=>"Flucytosine"}], "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"=>"D000563", "term"=>"Amebicides"}, {"id"=>"D000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000963", "term"=>"Antimetabolites"}], "browseLeaves"=>[{"id"=>"M18296", "name"=>"Fluconazole", "asFound"=>"Premature", "relevance"=>"HIGH"}, {"id"=>"M4002", "name"=>"Amphotericin B", "asFound"=>"Serious", "relevance"=>"HIGH"}, {"id"=>"M255436", "name"=>"Liposomal amphotericin B", "asFound"=>"Serious", "relevance"=>"HIGH"}, {"id"=>"M8565", "name"=>"Flucytosine", "asFound"=>"Pleural Mesothelioma", "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"=>"M3904", "name"=>"Amebicides", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1989-09", "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", "Meningitis", "Cryptococcosis", "Drug Therapy, Combination", "Fluconazole", "Flucytosine", "Acquired Immunodeficiency Syndrome", "Amphotericin B"], "conditions"=>["Meningitis, Cryptococcal", "HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To compare the safety and effectiveness of fluconazole and amphotericin B, alone or in combination with flucytosine, as treatment for acute cryptococcal meningitis."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\n* Immunosuppressant therapy.\n* Antiviral such as zidovudine.\n* Radiation therapy for mucocutaneous Kaposi's sarcoma.\n* Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine.\n\nConcurrent Treatment:\n\nAllowed:\n\n* Radiation therapy for mucocutaneous Kaposi's sarcoma.\n\nWritten informed consent must be obtained for each patient, either from the patient himself or from the patient's legal guardian.\n\n* No prior systemic antifungal therapy for cryptococcosis.\n* Relapse after prior therapy.\n* Success of prior therapy must have been documented by negative cerebrospinal fluid (CSF) culture at the end of therapy. Following prior therapy, such patients may not have received more than 1 mg/kg/wk amphotericin B in the 4 weeks before entry into study.\n\nPrior Medication:\n\nAllowed:\n\n* Immunosuppressant therapy.\n* Antivirals such as zidovudine (AZT).\n* Prophylaxis for Pneumocystis carinii pneumonia (PCP) including aerosol pentamidine.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following are excluded:\n\n* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.\n* History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.\n* Moderate or severe liver disease.\n* Comatose.\n* Unlikely to survive more than 2 weeks.\n* Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.\n\nConcurrent Medication:\n\nExcluded:\n\n* Coumadin-type anticoagulants.\n* Oral hypoglycemics.\n* Barbiturates.\n* Phenytoin.\n* Immunostimulants.\n* Investigational drugs or approved (licensed) drugs for investigational indications.\n* Any exceptions to these prohibitions of concomitant medications must be approved by Pfizer Central Research.\n* Excluded within 4 weeks of study entry:\n* Received more than 1 mg/kg/wk amphotericin B.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Lymphocyte replacement.\n\nPatients with the following are excluded:\n\n* Evidence of acute or chronic meningitis based upon any etiology other than cryptococcosis.\n* History of allergy to or intolerance of imidazoles, azoles, or amphotericin B.\n* Moderate or severe liver disease.\n* Comatose.\n* Unlikely to survive more than 2 weeks.\n\nPrior Medication:\n\nExcluded:\n\n* Coumadin-type anticoagulants.\n* Oral hypoglycemics.\n* Barbiturates.\n* Phenytoin.\n* Immunostimulants.\n* Investigational drugs or approved (licensed) drugs for investigational indications.\n* Excluded within 4 weeks of study entry:\n* More than 1 mg/kg/wk amphotericin B.\n\nPrior Treatment:\n\nExcluded:\n\n* Lymphocyte replacement."}, "identificationModule"=>{"nctId"=>"NCT00002075", "briefTitle"=>"Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Multicenter Comparison of Fluconazole (UK-49,858) and Amphotericin B as Treatment for Acute Cryptococcal Meningitis", "orgStudyIdInfo"=>{"id"=>"012G"}, "secondaryIdInfos"=>[{"id"=>"056-159A"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Flucytosine", "type"=>"DRUG"}, {"name"=>"Fluconazole", "type"=>"DRUG"}, {"name"=>"Amphotericin B", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Dr Robert Larsen", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Pfizer", "class"=>"INDUSTRY"}}}}
