Nctid:
NCT00002336
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D009164", "term"=>"Mycobacterium Infections"}, {"id"=>"D015270", "term"=>"Mycobacterium avium-intracellulare Infection"}], "ancestors"=>[{"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D000193", "term"=>"Actinomycetales Infections"}, {"id"=>"D016908", "term"=>"Gram-Positive Bacterial Infections"}, {"id"=>"D001424", "term"=>"Bacterial Infections"}, {"id"=>"D001423", "term"=>"Bacterial Infections and Mycoses"}, {"id"=>"D009165", "term"=>"Mycobacterium Infections, Nontuberculous"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M12119", "name"=>"Mycobacterium Infections", "asFound"=>"Mycobacterium", "relevance"=>"HIGH"}, {"id"=>"M17970", "name"=>"Mycobacterium avium-intracellulare Infection", "asFound"=>"Mycobacterium Avium", "relevance"=>"HIGH"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M4722", "name"=>"Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M19252", "name"=>"Gram-Positive Bacterial Infections", "relevance"=>"LOW"}, {"id"=>"M12136", "name"=>"Mycoses", "relevance"=>"LOW"}, {"id"=>"M4721", "name"=>"Bacterial Infections and Mycoses", "relevance"=>"LOW"}, {"id"=>"M12120", "name"=>"Mycobacterium Infections, Nontuberculous", "relevance"=>"LOW"}, {"id"=>"T3977", "name"=>"Mycobacterium Avium Complex Infections", "asFound"=>"Mycobacterium Avium", "relevance"=>"HIGH"}], "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"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D017291", "term"=>"Clarithromycin"}], "ancestors"=>[{"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D011500", "term"=>"Protein Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D065692", "term"=>"Cytochrome P-450 CYP3A Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}], "browseLeaves"=>[{"id"=>"M19585", "name"=>"Clarithromycin", "asFound"=>"Pharmacodynamics", "relevance"=>"HIGH"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30564", "name"=>"Cytochrome P-450 CYP3A Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1992-11"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2009-02", "completionDateStruct"=>{"date"=>"1994-11", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2015-01-15", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2015-01-16", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"1994-11", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Mycobacterium avium-intracellular Infection", "Acquired Immunodeficiency Syndrome", "Clarithromycin"], "conditions"=>["Mycobacterium Avium-intracellular Infection", "HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"8663871", "type"=>"BACKGROUND", "citation"=>"Pierce M, Crampton S, Henry D, Heifets L, LaMarca A, Montecalvo M, Wormser GP, Jablonowski H, Jemsek J, Cynamon M, Yangco BG, Notario G, Craft JC. A randomized trial of clarithromycin as prophylaxis against disseminated Mycobacterium avium complex infection in patients with advanced acquired immunodeficiency syndrome. N Engl J Med. 1996 Aug 8;335(6):384-91. doi: 10.1056/NEJM199608083350603."}]}, "descriptionModule"=>{"briefSummary"=>"To determine whether clarithromycin is safe and effective in preventing disseminated Mycobacterium avium Complex in HIV-infected patients with CD4 counts \\<= 100 cells/mm3."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* HIV infection.\n* CD4 count \\<= 100 cells/mm3.\n* No evidence of MAC.\n* Life expectancy of at least 6 months.\n\nExclusion Criteria\n\nConcurrent Medication:\n\nExcluded:\n\n* Certain restricted drugs (details not available).\n\nPatients with the following prior conditions are excluded:\n\nHistory of allergy or hypersensitivity to macrolides. Active substance abuse or other conditions that would affect study compliance."}, "identificationModule"=>{"nctId"=>"NCT00002336", "briefTitle"=>"The Safety and Effectiveness of Clarithromycin in the Prevention of Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Abbott"}, "officialTitle"=>"A Prospective, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Clarithromycin for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) Infection in HIV-Infected Patients With CD4 Counts <= 100 Cells/mm3", "orgStudyIdInfo"=>{"id"=>"124A"}, "secondaryIdInfos"=>[{"id"=>"M91-561"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Clarithromycin", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"85724", "city"=>"Tucson", "state"=>"Arizona", "country"=>"United States", "facility"=>"Univ of Arizona / Health Science Ctr", "geoPoint"=>{"lat"=>32.22174, "lon"=>-110.92648}}, {"zip"=>"93726", "city"=>"Fresno", "state"=>"California", "country"=>"United States", "facility"=>"California Med Research Group", "geoPoint"=>{"lat"=>36.74773, "lon"=>-119.77237}}, {"zip"=>"92102", "city"=>"San Diego", "state"=>"California", "country"=>"United States", "facility"=>"HIV Research Group", "geoPoint"=>{"lat"=>32.71533, "lon"=>-117.15726}}, {"zip"=>"94109", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Saint Francis Mem Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Kaiser Permanente Med Ctr", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"951282699", "city"=>"San Jose", "state"=>"California", "country"=>"United States", "facility"=>"Santa Clara Valley Med Ctr", "geoPoint"=>{"lat"=>37.33939, "lon"=>-121.89496}}, {"zip"=>"33308", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"TheraFirst Med Ctrs Inc", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"33021", "city"=>"Hollywood", "state"=>"Florida", "country"=>"United States", "facility"=>"Dr Nelson Zide", "geoPoint"=>{"lat"=>26.0112, "lon"=>-80.14949}}, {"zip"=>"33614", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"Infectious Disease Research Institute Inc", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"46202", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ Hosp", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"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"=>"13210", "city"=>"Syracuse", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY / Health Sciences Ctr at Syracuse", "geoPoint"=>{"lat"=>43.04812, "lon"=>-76.14742}}, {"zip"=>"10595", "city"=>"Valhalla", "state"=>"New York", "country"=>"United States", "facility"=>"New York Med College / Westchester County Med Ctr", "geoPoint"=>{"lat"=>41.07482, "lon"=>-73.77513}}, {"zip"=>"28207", "city"=>"Charlotte", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Nalle Clinic", "geoPoint"=>{"lat"=>35.22709, "lon"=>-80.84313}}, {"zip"=>"97210", "city"=>"Portland", "state"=>"Oregon", "country"=>"United States", "facility"=>"Westover Heights Clinic", "geoPoint"=>{"lat"=>45.52345, "lon"=>-122.67621}}, {"zip"=>"38163", "city"=>"Memphis", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Univ of Tennessee", "geoPoint"=>{"lat"=>35.14953, "lon"=>-90.04898}}, {"zip"=>"37212", "city"=>"Nashville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Vanderbilt Univ", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}, {"zip"=>"75235", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ of Texas Southwestern Med Ctr of Dallas", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"77030", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Houston Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"78284", "city"=>"San Antonio", "state"=>"Texas", "country"=>"United States", "facility"=>"Audie L Murphy Veterans Administration Hosp", "geoPoint"=>{"lat"=>29.42412, "lon"=>-98.49363}}, {"zip"=>"24153", "city"=>"Salem", "state"=>"Virginia", "country"=>"United States", "facility"=>"Salem Veterans Administration Med Ctr", "geoPoint"=>{"lat"=>37.29347, "lon"=>-80.05476}}, {"zip"=>"98405", "city"=>"Tacoma", "state"=>"Washington", "country"=>"United States", "facility"=>"Dr Alan D Tice / Infections Ltd", "geoPoint"=>{"lat"=>47.25288, "lon"=>-122.44429}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Abbott", "class"=>"INDUSTRY"}}}}
