Nctid:
NCT00002195
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}, {"id"=>"D015658", "term"=>"HIV Infections"}, {"id"=>"D000163", "term"=>"Acquired Immunodeficiency Syndrome"}], "ancestors"=>[{"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"=>"D007153", "term"=>"Immunologic Deficiency Syndromes"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D012897", "term"=>"Slow Virus Diseases"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M18250", "name"=>"HIV Infections", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "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"=>"M17522", "name"=>"Virus Diseases", "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"}], "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"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D019259", "term"=>"Lamivudine"}, {"id"=>"D015215", "term"=>"Zidovudine"}, {"id"=>"C095108", "term"=>"Amprenavir"}], "ancestors"=>[{"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D000904", "term"=>"Antibiotics, Antitubercular"}, {"id"=>"D000995", "term"=>"Antitubercular Agents"}, {"id"=>"D000900", "term"=>"Anti-Bacterial Agents"}, {"id"=>"D017320", "term"=>"HIV Protease Inhibitors"}, {"id"=>"D000084762", "term"=>"Viral Protease Inhibitors"}, {"id"=>"D011480", "term"=>"Protease Inhibitors"}], "browseLeaves"=>[{"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21243", "name"=>"Lamivudine", "asFound"=>"Next", "relevance"=>"HIGH"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Corticosteroid", "relevance"=>"HIGH"}, {"id"=>"M339956", "name"=>"Amprenavir", "asFound"=>"10^6 cells/kg", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M4311", "name"=>"Antitubercular Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>290}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1998-11", "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"=>["Drug Therapy, Combination", "Zidovudine", "HIV Protease Inhibitors", "Lamivudine", "VX 478", "Reverse Transcriptase Inhibitors", "Anti-HIV Agents", "Viral Load"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to see if it is safe and effective to add 141W94 to an anti-HIV regimen that includes retrovir plus epivir.", "detailedDescription"=>"This is a double-blind, placebo-controlled, two-arm study comparing treatment with a triple regimen consisting of 141W94, retrovir, and epivir and a double regimen consisting of retrovir and epivir."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* HIV-positive status.\n* Screening viral load \\>= 10,000 copies/mm3 14 days prior to entry.\n* CD4+ cell counts \\>= 200 cells/mm3 14 days prior to entry.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nClinical diagnosis of AIDS (CDC 1993 Classification C).\n\nConcurrent Medication:\n\nExcluded:\n\nTerfenadine, astemizole, cisapride, triazolam, medazolam, and ergotamine/dihydroergotamine-containing regimens.\n\nPatients with the following prior conditions are excluded:\n\nClinically relevant hepatitis in the previous 6 months.\n\nPrior Medication:\n\nExcluded:\n\n* Greater than 4 weeks of any nucleoside antiretroviral therapy.\n* Previous therapy with an HIV protease inhibitor.\n* Cytotoxic chemotherapeutic agents within 4 weeks prior to entry.\n* Immunomodulating agents within 3 months prior to entry.\n\nPrior Treatment:\n\nExcluded:\n\nRadiotherapy within 4 weeks prior to entry.\n\nRisk Behavior:\n\nExcluded:\n\nCurrent alcohol or illicit drug use that may interfere with the patient's ability to comply with the dosing schedule or protocol evaluations."}, "identificationModule"=>{"nctId"=>"NCT00002195", "briefTitle"=>"A Study of Retrovir and Epivir Alone or in Combination With 141W94 in HIV-Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Phase III Trial to Evaluate the Safety and Antiviral Efficacy of 141W94 in Combination With Retrovir and Epivir Compared to Retrovir and Epivir Alone in Patients With HIV Infection.", "orgStudyIdInfo"=>{"id"=>"264D"}, "secondaryIdInfos"=>[{"id"=>"PROA3001"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Amprenavir", "type"=>"DRUG"}, {"name"=>"Lamivudine", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90211", "city"=>"Beverly Hills", "state"=>"California", "country"=>"United States", "facility"=>"Pacific Oaks Research", "geoPoint"=>{"lat"=>34.07362, "lon"=>-118.40036}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Dr Bruce Rashbaum", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33146", "city"=>"Coral Gables", "state"=>"Florida", "country"=>"United States", "facility"=>"Community Research Initiative of South Florida", "geoPoint"=>{"lat"=>25.72149, "lon"=>-80.26838}}, {"zip"=>"32751", "city"=>"Maitland", "state"=>"Florida", "country"=>"United States", "facility"=>"Community Research Initiative of Central Florida", "geoPoint"=>{"lat"=>28.62778, "lon"=>-81.36312}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami School of Medicine", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"60610", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Ctr for Clinical Research", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"02445", "city"=>"Brookline", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Community Research Initiative of New England", "geoPoint"=>{"lat"=>42.33176, "lon"=>-71.12116}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Saint Vincent's AIDS Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"38104", "city"=>"Memphis", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Methodist Hosp", "geoPoint"=>{"lat"=>35.14953, "lon"=>-90.04898}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}}}}
