Nctid:
NCT00002199
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"=>"C106538", "term"=>"Abacavir"}, {"id"=>"C109078", "term"=>"Lamivudine, zidovudine drug combination"}, {"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"=>"M350770", "name"=>"Abacavir", "asFound"=>"Stylet", "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"=>"M21424", "name"=>"Indinavir", "asFound"=>"Discontinue", "relevance"=>"HIGH"}, {"id"=>"M184350", "name"=>"Lamivudine, zidovudine drug combination", "asFound"=>"Annually", "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"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"count"=>550}}, "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"=>["HIV-1", "Drug Therapy, Combination", "Zidovudine", "Drug Resistance, Microbial", "HIV Protease Inhibitors", "Lamivudine", "Indinavir", "Genotype", "Phenotype", "Reverse Transcriptase Inhibitors", "Anti-HIV Agents", "abacavir"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"11231744", "type"=>"BACKGROUND", "citation"=>"Staszewski S, Keiser P, Montaner J, Raffi F, Gathe J, Brotas V, Hicks C, Hammer SM, Cooper D, Johnson M, Tortell S, Cutrell A, Thorborn D, Isaacs R, Hetherington S, Steel H, Spreen W; CNAAB3005 International Study Team. Abacavir-lamivudine-zidovudine vs indinavir-lamivudine-zidovudine in antiretroviral-naive HIV-infected adults: A randomized equivalence trial. JAMA. 2001 Mar 7;285(9):1155-63. doi: 10.1001/jama.285.9.1155. Erratum In: JAMA 2001 Jun 13;285(22):2858."}]}, "descriptionModule"=>{"briefSummary"=>"To compare the safety, tolerance, early antiviral activity, and durability of antiviral response of the lamivudine (3TC)/zidovudine (ZDV)/1592U89 arm versus the 3TC/ZDV/indinavir (IDV) arm. To determine the effect of the two arms on clinical efficacy as determined by the occurrence of new CDC, defined class B/C events, survival, medical resource utilization, and the development of plasma viral genotypic and phenotypic resistance.", "detailedDescription"=>"In this international study, 550 patients are randomized (225 per arm) to receive Combivir in combination with 1592U89 or indinavir. If after 16 weeks (and every 8 weeks thereafter until week 48) a patient has HIV-1 RNA \\>= 400 copies/ml (by PCR on two occasions \\>= 1 week and \\< 4 weeks apart), the patient has the option to switch to open-label therapy consisting of indinavir, 1592U89, and Combivir."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nConcurrent Medication:\n\nAllowed:\n\nGM-CSF, G-CSF, and erythropoietin.\n\nConcurrent Treatment:\n\nAllowed:\n\nLocal treatment for Kaposi's sarcoma.\n\nPatients must have:\n\n* HIV-1 infection documented by a licensed HIV-1 antibody ELISA and confirmed by Western blot detection of HIV-1 antibody or positive HIV-1 blood culture.\n* CD4+ cell count \\>= 100 cells/mm3 within 14 days prior to study drug administration.\n* HIV-1 RNA \\>= 10,000 copies/ml within 14 days prior to study drug administration.\n* No active diagnosis of AIDS according to the 1993 Centers for Disease Control (CDC) AIDS surveillance definition (excluding CD4+ cell counts \\< 200 cells/mm3).\n* Signed, informed consent from parent or legal guardian for patients under 18 years of age.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with the following conditions or symptoms are excluded:\n\n* Malabsorption syndrome or other gastrointestinal dysfunction that may interfere with drug absorption.\n* Serious medical conditions such as diabetes, congestive heart failure, cardiomyopathy, or other cardiac dysfunction that would compromise the safety of the patient.\n\nConcurrent Medication:\n\nExcluded:\n\n* Cytotoxic chemotherapeutic agents.\n* Agents with documented anti-HIV-1 activity in vitro.\n* Foscarnet.\n* Immunomodulating agents such as systemic corticosteroids, interleukins, thalidomide, or interferons.\n* Terfenadine, astemizole, cisapride, triazolam, midazolam, and ergotamine/dihydroergotamine.\n\nConcurrent Treatment:\n\nExcluded:\n\n* Radiation therapy.\n* Other investigational treatments. NOTE:\n* Treatments available through treatment IND or other expanded access programs are the exception and evaluated individually.\n\nPatients with the following prior conditions are excluded:\n\nHistory of relevant pancreatitis or hepatitis in the last 6 months.\n\nPrior Medication:\n\nExcluded:\n\n* Cytotoxic chemotherapeutic agents within 30 days of study drug administration.\n* Prior antiretroviral therapy.\n* HIV vaccine dose within 90 days of study drug administration.\n* Immunomodulating agents such as systemic corticosteroids, interleukins, or interferons within 30 days of study entry.\n\nPrior Treatment:\n\nExcluded:\n\nRadiation therapy within 30 days of study drug administration.\n\nCurrent alcohol or illicit drug use that may interfere with patient compliance."}, "identificationModule"=>{"nctId"=>"NCT00002199", "briefTitle"=>"A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Phase III Randomized Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of 3TC/ZDV/1592U89 and 3TC/ZDV/IDV in HIV-1 Infected Antiretroviral Therapy-Naive Subjects.", "orgStudyIdInfo"=>{"id"=>"238K"}, "secondaryIdInfos"=>[{"id"=>"CNAA/B3005"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Indinavir sulfate", "type"=>"DRUG"}, {"name"=>"Lamivudine/Zidovudine", "type"=>"DRUG"}, {"name"=>"Abacavir sulfate", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"02215", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Beth Israel Deaconess Med Ctr", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}}}}