Nctid:
NCT00001994
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}, {"id"=>"D014123", "term"=>"Toxoplasmosis"}, {"id"=>"D016781", "term"=>"Toxoplasmosis, Cerebral"}, {"id"=>"D004660", "term"=>"Encephalitis"}, {"id"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}], "ancestors"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D015229", "term"=>"Sexually Transmitted Diseases, Viral"}, {"id"=>"D012749", "term"=>"Sexually Transmitted Diseases"}, {"id"=>"D016180", "term"=>"Lentivirus Infections"}, {"id"=>"D012192", "term"=>"Retroviridae Infections"}, {"id"=>"D012327", "term"=>"RNA Virus Infections"}, {"id"=>"D014777", "term"=>"Virus Diseases"}, {"id"=>"D000091662", "term"=>"Genital Diseases"}, {"id"=>"D000091642", "term"=>"Urogenital Diseases"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}, {"id"=>"D001927", "term"=>"Brain Diseases"}, {"id"=>"D002493", "term"=>"Central Nervous System Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D000090862", "term"=>"Neuroinflammatory Diseases"}, {"id"=>"D003048", "term"=>"Coccidiosis"}, {"id"=>"D011528", "term"=>"Protozoan Infections"}, {"id"=>"D010272", "term"=>"Parasitic Diseases"}, {"id"=>"D001922", "term"=>"Brain Abscess"}, {"id"=>"D002494", "term"=>"Central Nervous System Infections"}, {"id"=>"D020808", "term"=>"Central Nervous System Protozoal Infections"}, {"id"=>"D020807", "term"=>"Central Nervous System Parasitic Infections"}, {"id"=>"D000038", "term"=>"Abscess"}, {"id"=>"D013492", "term"=>"Suppuration"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"Human Immunodeficiency Virus (HIV)", "relevance"=>"HIGH"}, {"id"=>"M7825", "name"=>"Encephalitis", "asFound"=>"Encephalitis", "relevance"=>"HIGH"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "asFound"=>"Immunodeficiency", "relevance"=>"HIGH"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"Human Immunodeficiency Virus (HIV)", "relevance"=>"HIGH"}, {"id"=>"M16877", "name"=>"Toxoplasmosis", "asFound"=>"Toxoplasmosis", "relevance"=>"HIGH"}, {"id"=>"M19136", "name"=>"Toxoplasmosis, Cerebral", "asFound"=>"Toxoplasmosis, Cerebral", "relevance"=>"HIGH"}, {"id"=>"M12825", "name"=>"Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M19410", "name"=>"AIDS-Related Opportunistic Infections", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M15558", "name"=>"Sexually Transmitted Diseases", "relevance"=>"LOW"}, {"id"=>"M17933", "name"=>"Sexually Transmitted Diseases, Viral", "relevance"=>"LOW"}, {"id"=>"M18640", "name"=>"Lentivirus Infections", "relevance"=>"LOW"}, {"id"=>"M15026", "name"=>"Retroviridae Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M2876", "name"=>"Genital Diseases", "relevance"=>"LOW"}, {"id"=>"M2875", "name"=>"Urogenital Diseases", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M15700", "name"=>"Slow Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M5204", "name"=>"Brain Diseases", "relevance"=>"LOW"}, {"id"=>"M5742", "name"=>"Central Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M2803", "name"=>"Neuroinflammatory Diseases", "relevance"=>"LOW"}, {"id"=>"M6276", "name"=>"Coccidioidomycosis", "relevance"=>"LOW"}, {"id"=>"M6277", "name"=>"Coccidiosis", "relevance"=>"LOW"}, {"id"=>"M14388", "name"=>"Protozoan Infections", "relevance"=>"LOW"}, {"id"=>"M13185", "name"=>"Parasitic Diseases", "relevance"=>"LOW"}, {"id"=>"M37", "name"=>"Abscess", "relevance"=>"LOW"}, {"id"=>"M5199", "name"=>"Brain Abscess", "relevance"=>"LOW"}, {"id"=>"M5743", "name"=>"Central Nervous System Infections", "relevance"=>"LOW"}, {"id"=>"M16273", "name"=>"Suppuration", "relevance"=>"LOW"}, {"id"=>"T1374", "name"=>"Coccidioidomycosis", "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"=>"D053626", "term"=>"Atovaquone"}], "ancestors"=>[{"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D000962", "term"=>"Antimalarials"}, {"id"=>"D000981", "term"=>"Antiprotozoal Agents"}, {"id"=>"D000977", "term"=>"Antiparasitic Agents"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}], "browseLeaves"=>[{"id"=>"M17555", "name"=>"Vitamin K", "relevance"=>"LOW"}, {"id"=>"M27378", "name"=>"Atovaquone", "asFound"=>"Aesthetic", "relevance"=>"HIGH"}, {"id"=>"M14591", "name"=>"Pyrimethamine", "relevance"=>"LOW"}, {"id"=>"M16197", "name"=>"Sulfadiazine", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M4280", "name"=>"Antimalarials", "relevance"=>"LOW"}, {"id"=>"M4298", "name"=>"Antiprotozoal Agents", "relevance"=>"LOW"}, {"id"=>"M4294", "name"=>"Antiparasitic Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"T481", "name"=>"Vitamin K", "relevance"=>"LOW"}, {"id"=>"T449", "name"=>"Menadione", "relevance"=>"LOW"}, {"id"=>"T450", "name"=>"Menaquinone", "relevance"=>"LOW"}, {"id"=>"T452", "name"=>"Naphthoquinone", "relevance"=>"LOW"}, {"id"=>"T458", "name"=>"Phylloquinone", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"Coagulants", "abbrev"=>"Coag"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1992-03", "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"=>["Toxoplasmosis", "AIDS-Related Opportunistic Infections", "Naphthoquinones", "Encephalitis", "Acquired Immunodeficiency Syndrome"], "conditions"=>["Toxoplasmosis, Cerebral", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Masur H, et al. 566C80 is effective as salvage treatment for toxoplasma encephalitis. Int Conf AIDS. 1991 Jun 16-21;7(2):30 (abstract no WB31)"}]}, "descriptionModule"=>{"briefSummary"=>"To evaluate the safety and tolerance of atovaquone (566C80) in AIDS patients with central nervous system (CNS) toxoplasmosis. To evaluate the efficacy of 566C80 in the acute treatment and suppression of CNS toxoplasmosis in AIDS patients who fail or who cannot tolerate conventional therapy."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"13 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have the following:\n\n* Presumptive diagnosis of AIDS.\n* Cerebral toxoplasmosis.\n* Expected survival of at least four weeks without therapy.\n* Willing and able to give informed consent.\n\nPrior Medication:\n\nAllowed:\n\n* Pyrimethamine-sulfonamide.\n* Clindamycin-sulfonamide.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Significant emotional disorder or psychosis.\n* Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.\n* Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:\n* Ensure Plus) or pulverized form through a nasogastric tube.\n* Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.\n\nConcurrent Medication:\n\nExcluded:\n\n* Drugs with potential anti-toxoplasmosis activity including sulfone, sulfonamide, trimethoprim, pyrimethamine and clindamycin during the acute therapy phase of the trial.\n* First three weeks of treatment:\n* Retrovir (zidovudine) or any investigational agent including antiretroviral agents (eg:\n* ddI,ddC).\n\nPatients with the following are excluded:\n\n* Significant emotional disorder or psychosis.\n* Evidence of significant malabsorption, ileus or significant emesis at entry which would inhibit drug absorption.\n* Other known central nervous system lesions such as lymphoma, tuberculoma, cryptococcoma, active neurosyphilis. Unwilling or unable to take 566C80 with a meal, enteral supplements (eg:\n* Ensure Plus) or pulverized form through a nasogastric tube.\n* Active drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen.\n\nActive drug or alcohol abuse sufficient in the investigator's opinion to prevent compliance with the study regimen."}, "identificationModule"=>{"nctId"=>"NCT00001994", "briefTitle"=>"A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or Are Intolerant of Pyrimethamine-Sulfadiazine", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Pilot Study of 566C80 for the Salvage Treatment of Toxoplasmic Encephalitis in Patients Infected With the Human Immunodeficiency Virus (HIV) Who Have Failed or Are Intolerant of Pyrimethamine-Sulfadiazine", "orgStudyIdInfo"=>{"id"=>"101A"}, "secondaryIdInfos"=>[{"id"=>"02"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Atovaquone", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Los Angeles County - USC Med Ctr", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94609", "city"=>"Oakland", "state"=>"California", "country"=>"United States", "facility"=>"Infectious Disease Med Group", "geoPoint"=>{"lat"=>37.80437, "lon"=>-122.2708}}, {"zip"=>"941102859", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF - San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94114", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Davies Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"20007", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Georgetown Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"30345", "city"=>"Atlanta", "state"=>"Georgia", "country"=>"United States", "facility"=>"Infectious Disease Research Consortium of Georgia", "geoPoint"=>{"lat"=>33.749, "lon"=>-84.38798}}, {"zip"=>"21205", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"10003", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Beth Israel Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Saint Vincent's Hosp and Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10037", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harlem Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"117948153", "city"=>"Stony Brook", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Health Sciences Ctr at Stony Brook", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"27710", "city"=>"Durham", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Duke Univ Med Ctr", "geoPoint"=>{"lat"=>35.99403, "lon"=>-78.89862}}, {"zip"=>"97210", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Portland Veterans Adm Med Ctr / Rsch & Education Grp", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"38103", "city"=>"Memphis", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Regional Med Ctr at Memphis", "geoPoint"=>{"lat"=>35.14953, "lon"=>-90.04898}}, {"zip"=>"77004", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Gathe, Joseph, M.D.", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Baylor College of Medicine", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"22203", "city"=>"Annandale", "state"=>"Virginia", "country"=>"United States", "facility"=>"Infectious Disease Physicians Inc", "geoPoint"=>{"lat"=>38.83039, "lon"=>-77.19637}}, {"city"=>"Calgary", "state"=>"Alberta", "country"=>"Canada", "facility"=>"Southern Alberta HIV Clinic / Foothills Hosp", "geoPoint"=>{"lat"=>51.05011, "lon"=>-114.08529}}, {"city"=>"Vancouver", "state"=>"British Columbia", "country"=>"Canada", "facility"=>"Dr Julio S G Montaner", "geoPoint"=>{"lat"=>49.24966, "lon"=>-123.11934}}, {"city"=>"Toronto", "state"=>"Ontario", "country"=>"Canada", "facility"=>"Wellesley Hosp", "geoPoint"=>{"lat"=>43.70011, "lon"=>-79.4163}}, {"city"=>"Montreal", "state"=>"Quebec", "country"=>"Canada", "facility"=>"Dr Emil Toma / Hotel Dieu de Montreal", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}}}}
