Nctid:
NCT00002168
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "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"=>"D019469", "term"=>"Indinavir"}], "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"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"id"=>"M21243", "name"=>"Lamivudine", "asFound"=>"Next", "relevance"=>"HIGH"}, {"id"=>"M21350", "name"=>"Anti-HIV 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"=>"M20272", "name"=>"Stavudine", "asFound"=>"Twenty", "relevance"=>"HIGH"}, {"id"=>"M21424", "name"=>"Indinavir", "asFound"=>"Discontinue", "relevance"=>"HIGH"}, {"id"=>"M18548", "name"=>"Didanosine", "asFound"=>"Circulation", "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"=>"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", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>200}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "statusVerifiedDate"=>"2007-10", "lastUpdateSubmitDate"=>"2007-10-01", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2007-10-02", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Didanosine", "Drug Therapy, Combination", "Zidovudine", "Stavudine", "HIV Protease Inhibitors", "CD4 Lymphocyte Count", "Lamivudine", "Indinavir", "Reverse Transcriptase Inhibitors", "Anti-HIV Agents", "Viral Load"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to compare the safety and effectiveness of two anti-HIV drug combinations when given to HIV-infected patients who have never been treated with anti-HIV drugs. One drug combination is stavudine (d4T) plus didanosine (ddI) plus Crixivan. The other combination is Retrovir (AZT) plus Epivir (3TC) plus Crixivan.", "detailedDescription"=>"100 patients will be randomized to receive Zerit (Stavudine) + Videx (Didanosine) + Crixivan (Indinavir) and 100 patients will be randomized to receive Retrovir (Zidovudine) + Epivir (Lamivudine) + Crixivan (Indinavir).\n\nPatients will be treated for 48 weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* Documented HIV infection.\n* CD4 cell count of 200 - 700 cells/mm3.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following symptoms or conditions are excluded:\n\nAIDS defining condition within 1 month of study entry.\n\nPrior Medication:\n\nExcluded:\n\nPatients with any history of antiretroviral therapy treatment."}, "identificationModule"=>{"nctId"=>"NCT00002168", "briefTitle"=>"A Comparison of Two Anti-HIV Triple-Drug Combinations in HIV-Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Bristol-Myers Squibb"}, "officialTitle"=>"An Open Label, Randomized, Comparative Study of Zerit (d4T) + Videx (ddI) + Crixivan Versus Retrovir (AZT) + Epivir (3TC) + Crixivan in HIV-Infected, Antiretroviral Naive Subjects With CD4 Cell Counts of 200 - 700/mm3 and HIV RNA Baseline Copy Number of >= 10,000 Copies/ml", "orgStudyIdInfo"=>{"id"=>"260B"}, "secondaryIdInfos"=>[{"id"=>"BMS 002"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Indinavir sulfate", "type"=>"DRUG"}, {"name"=>"Lamivudine", "type"=>"DRUG"}, {"name"=>"Stavudine", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}, {"name"=>"Didanosine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"94705", "city"=>"Berkeley", "state"=>"California", "country"=>"United States", "facility"=>"East Bay AIDS Clinic", "geoPoint"=>{"lat"=>37.87159, "lon"=>-122.27275}}, {"zip"=>"90509", "city"=>"Torrance", "state"=>"California", "country"=>"United States", "facility"=>"Harbor UCLA Med Ctr / Division of Immunology / N-24", "geoPoint"=>{"lat"=>33.83585, "lon"=>-118.34063}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Anderson Clinical Research", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"George Washington Med Ctr / Clinical Trials Unit", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"60610", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Chicago Ctr for Clinical Research", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern Univ", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"68195", "city"=>"Omaha", "state"=>"Nebraska", "country"=>"United States", "facility"=>"Univ of Nebraska", "geoPoint"=>{"lat"=>41.25626, "lon"=>-95.94043}}, {"zip"=>"27599", "city"=>"Chapel Hill", "state"=>"North Carolina", "country"=>"United States", "facility"=>"Univ of North Carolina / Infectious Disease Division", "geoPoint"=>{"lat"=>35.9132, "lon"=>-79.05584}}, {"zip"=>"28207", "city"=>"Charlotte", "state"=>"North Carolina", "country"=>"United States", "facility"=>"The Nalle Clinic / Clinical Research Dept", "geoPoint"=>{"lat"=>35.22709, "lon"=>-80.84313}}, {"zip"=>"19104", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Univ of Pennsylvania / Infectious Diseases Division", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}, {"zip"=>"75225", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Southwest Infectious Disease Association / PA", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"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"=>"00731", "city"=>"Ponce", "country"=>"Puerto Rico", "facility"=>"Hosp Regional de Ponce - Area Vieja", "geoPoint"=>{"lat"=>18.01108, "lon"=>-66.61406}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Bristol-Myers Squibb", "class"=>"INDUSTRY"}}}}
