Nctid:
NCT00002429
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-06"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D015658", "term"=>"HIV Infections"}], "ancestors"=>[{"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D003141", "term"=>"Communicable Diseases"}, {"id"=>"D007239", "term"=>"Infections"}, {"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"}], "browseLeaves"=>[{"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", "asFound"=>"HIV Infections", "relevance"=>"HIGH"}, {"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"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System 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"=>"D016049", "term"=>"Didanosine"}, {"id"=>"D018119", "term"=>"Stavudine"}, {"id"=>"C109078", "term"=>"Lamivudine, zidovudine drug combination"}, {"id"=>"D019888", "term"=>"Nelfinavir"}], "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"=>"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"=>"Group A", "relevance"=>"HIGH"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M21770", "name"=>"Nelfinavir", "asFound"=>"Lymphedema", "relevance"=>"HIGH"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Underwent", "relevance"=>"HIGH"}, {"id"=>"M20272", "name"=>"Stavudine", "asFound"=>"Lithium", "relevance"=>"HIGH"}, {"id"=>"M18548", "name"=>"Didanosine", "asFound"=>"IV bolus", "relevance"=>"HIGH"}, {"id"=>"M184350", "name"=>"Lamivudine, zidovudine drug combination", "asFound"=>"Gynecology", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "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"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "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"=>500}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1999-07"}, "statusVerifiedDate"=>"2011-04", "dispFirstSubmitDate"=>"2011-04-13", "completionDateStruct"=>{"date"=>"2001-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2011-04-28", "studyFirstSubmitDate"=>"1999-11-02", "dispFirstSubmitQcDate"=>"2011-04-13", "studyFirstSubmitQcDate"=>"2001-08-30", "dispFirstPostDateStruct"=>{"date"=>"2011-04-25", "type"=>"ESTIMATED"}, "lastUpdatePostDateStruct"=>{"date"=>"2011-05-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}, "primaryCompletionDateStruct"=>{"date"=>"2001-01", "type"=>"ACTUAL"}}, "conditionsModule"=>{"keywords"=>["Didanosine", "Drug Therapy, Combination", "Stavudine", "RNA, Viral", "Nelfinavir", "Reverse Transcriptase Inhibitors", "Anti-HIV Agents"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"type"=>"BACKGROUND", "citation"=>"Gathe J, Badero R, Grimwood A, Abrams L, Klesczewski K, Mclaren C. AI454152: Comparison of a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine Administered Once-Daily Versus a Regimen of Combivir Plus Nelfinavir. 8th Conference on Retroviruses and Opportunistic Infections, 2001 Feb 4-8. (abstract no 319)"}]}, "descriptionModule"=>{"briefSummary"=>"This study tests a new form of didanosine, ddI EC, a coated pill that passes through the stomach before dissolving. The purpose of this study is to compare the effectiveness of an anti-HIV drug combination that includes ddI EC versus another anti-HIV drug combination.", "detailedDescription"=>"Patients are randomized to 1 of 2 groups for 48 weeks of open-label treatment. Group 1 receives ddI EC plus d4T plus NFV. Group 2 receives Combivir plus NFV. Antiviral activity is determined by the proportion of patients with HIV RNA levels of less than 400 copies/ml at Week 48."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients may be eligible for this study if they:\n\n* Are HIV-positive.\n* Have a viral load of at least 2,000 copies/ml and a CD4 count of at least 200 cells/mm3.\n* Are at least 18 years old.\n* Agree to practice sexual abstinence or to use effective barrier methods of birth control (such as condoms).\n\nExclusion Criteria\n\nPatients will not be eligible for this study if they:\n\n* Have had severe diarrhea within 30 days of study entry.\n* Have a history of pancreatic disease or any other serious condition.\n* Have hepatitis within 30 days of study entry.\n* Are diagnosed with an opportunistic (AIDS-related) infection at the time of enrollment.\n* Are unable to take medications by mouth.\n* Have received certain medications.\n* Are pregnant or breast-feeding."}, "identificationModule"=>{"nctId"=>"NCT00002429", "briefTitle"=>"Evaluation of an Anti-HIV Drug Combination That Includes a Coated Form of Didanosine (ddI EC) Compared to a Typical Anti-HIV Drug Regimen", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Bristol-Myers Squibb"}, "officialTitle"=>"Evaluation of HIV RNA Suppression Produced by a Triple Combination Regimen Containing an Enteric Coated Formulation of Didanosine (ddI EC) Administered Once Daily Compared to a Reference Combination Regimen", "orgStudyIdInfo"=>{"id"=>"039F"}, "secondaryIdInfos"=>[{"id"=>"AI454-152"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Lamivudine/Zidovudine", "type"=>"DRUG"}, {"name"=>"Nelfinavir mesylate", "type"=>"DRUG"}, {"name"=>"Stavudine", "type"=>"DRUG"}, {"name"=>"Didanosine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35203", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Sorra Research Ctr / Med Forum", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"85016", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "facility"=>"Body Positive", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"900276069", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"AIDS Healthcare Foundation", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94115", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"33308", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"Med Alternatives", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"33023", "city"=>"Pembrook", "state"=>"Florida", "country"=>"United States", "facility"=>"County Line Med CtrInc", "geoPoint"=>{"lat"=>26.00315, "lon"=>-80.22394}}, {"zip"=>"32960", "city"=>"Vero Beach", "state"=>"Florida", "country"=>"United States", "facility"=>"Dr Gerald Pierone Jr", "geoPoint"=>{"lat"=>27.63864, "lon"=>-80.39727}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"The CORE Ctr", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"462025250", "city"=>"Indianapolis", "state"=>"Indiana", "country"=>"United States", "facility"=>"Indiana Univ Med Ctr", "geoPoint"=>{"lat"=>39.76838, "lon"=>-86.15804}}, {"zip"=>"672143124", "city"=>"Wichita", "state"=>"Kansas", "country"=>"United States", "facility"=>"Univ of Kansas School of Medicine", "geoPoint"=>{"lat"=>37.69224, "lon"=>-97.33754}}, {"zip"=>"48202", "city"=>"Detroit", "state"=>"Michigan", "country"=>"United States", "facility"=>"Henry Ford Hosp", "geoPoint"=>{"lat"=>42.33143, "lon"=>-83.04575}}, {"zip"=>"03756", "city"=>"Lebanon", "state"=>"New Hampshire", "country"=>"United States", "facility"=>"Dartmouth-Hitchcock Med Ctr", "geoPoint"=>{"lat"=>43.64229, "lon"=>-72.25176}}, {"zip"=>"07103", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"NJCRI", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"08876", "city"=>"Somerville", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Infectious Disease Assoc of Central Jersey", "geoPoint"=>{"lat"=>40.57427, "lon"=>-74.60988}}, {"zip"=>"432101228", "city"=>"Columbus", "state"=>"Ohio", "country"=>"United States", "facility"=>"Ohio State Univ Hosp Clinic", "geoPoint"=>{"lat"=>39.96118, "lon"=>-82.99879}}, {"zip"=>"15213", "city"=>"Pittsburgh", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Anderson Clinical Research", "geoPoint"=>{"lat"=>40.44062, "lon"=>-79.99589}}, {"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"=>"77004", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Gathe, Joseph, M.D.", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"77006", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Montrose Clinic", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"23666", "city"=>"Hampton", "state"=>"Virginia", "country"=>"United States", "facility"=>"Hampton Roads Med Specialists", "geoPoint"=>{"lat"=>37.02987, "lon"=>-76.34522}}, {"city"=>"Montreal", "state"=>"Quebec", "country"=>"Canada", "facility"=>"Clinique Medicale du Quartier Latin", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}, {"city"=>"Montreal", "state"=>"Quebec", "country"=>"Canada", "facility"=>"Clinique Medicale L'Actuele", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}, {"city"=>"Montreal", "state"=>"Quebec", "country"=>"Canada", "facility"=>"Dr Roger P Leblanc", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}], "overallOfficials"=>[{"name"=>"Bristol-Myers Squibb", "role"=>"STUDY_DIRECTOR", "affiliation"=>"Bristol-Myers Squibb"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}}}}
