Nctid:
NCT00002220
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"=>"C098320", "term"=>"Efavirenz"}, {"id"=>"C053001", "term"=>"Adefovir"}, {"id"=>"C106812", "term"=>"Adefovir dipivoxil"}, {"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"=>"D065688", "term"=>"Cytochrome P-450 CYP2C9 Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D065689", "term"=>"Cytochrome P-450 CYP2C19 Inhibitors"}, {"id"=>"D065695", "term"=>"Cytochrome P-450 CYP2B6 Inducers"}, {"id"=>"D065693", "term"=>"Cytochrome P-450 Enzyme Inducers"}, {"id"=>"D065701", "term"=>"Cytochrome P-450 CYP3A Inducers"}, {"id"=>"D017320", "term"=>"HIV Protease Inhibitors"}, {"id"=>"D000084762", "term"=>"Viral Protease Inhibitors"}, {"id"=>"D011480", "term"=>"Protease Inhibitors"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}], "browseLeaves"=>[{"id"=>"M340137", "name"=>"Efavirenz", "asFound"=>"Transfusion", "relevance"=>"HIGH"}, {"id"=>"M4314", "name"=>"Antiviral Agents", "relevance"=>"LOW"}, {"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21770", "name"=>"Nelfinavir", "relevance"=>"LOW"}, {"id"=>"M219518", "name"=>"Adefovir", "asFound"=>"Tracer", "relevance"=>"HIGH"}, {"id"=>"M341402", "name"=>"Adefovir dipivoxil", "asFound"=>"Diamine", "relevance"=>"HIGH"}, {"id"=>"M21424", "name"=>"Indinavir", "asFound"=>"Discontinue", "relevance"=>"HIGH"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4214", "name"=>"Anti-Infective Agents", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral 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"}, "enrollmentInfo"=>{"count"=>120}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-06", "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 Resistance", "Drug Therapy, Combination", "Antiviral Agents", "HIV Protease Inhibitors", "Indinavir", "RNA, Viral", "Adenine", "efavirenz"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to compare the effectiveness of giving indinavir plus efavirenz plus adefovir dipivoxil to patients who have failed treatment with nelfinavir and patients who have never taken a protease inhibitor (PI). Effectiveness is measured by the number of patients who have a viral load (level of HIV in the blood) below 400 copies/ml after 48 weeks of treatment.", "detailedDescription"=>"In this open-label, nonrandomized study, 120 HIV-infected patients are stratified into two groups: failed nelfinavir vs protease inhibitor-naive. All patients receive indinavir plus efavirenz plus adefovir dipivoxil plus and L-carnitine, orally. Plasma vRNA is measured every 4 weeks until Week 16, then every 8 weeks for the remainder of the 48-week study."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* Serologically documented HIV infection.\n* Baseline CD4 count greater than or equal to 50 cells and vRNA greater than or equal to 10,000 copies/ml.\n* Parental consent for patients under 18.\n\nNelfinavir-Failure Group:\n\n* Must have protease inhibitor experience solely with nelfinavir and be considered drug-adherent.\n* Must be candidate for changing therapy because of virologic failure and be receiving nelfinavir at entry (at least 16 weeks of nelfinavir plus NRTI therapy with at least a 10-fold decline in vRNA due to nelfinavir therapy and a subsequent increase toward the patient's baseline vRNA of at least 10-fold).\n\nControl Group:\n\n* Must have received any combination of currently licensed nucleoside reverse transcriptase inhibitors for at least 16 weeks.\n* Must be naive to efavirenz, adefovir dipivoxil, and other NRTI's.\n\nExclusion Criteria\n\nPrior Medication:\n\nExcluded:\n\nControl group:\n\n* Prior efavirenz, adefovir dipivoxil, or other non-nucleoside reverse transcriptase inhibitors.\n\nRequired:\n\nNelfinavir-failure patients:\n\n* At least 16 weeks of nelfinavir.\n\nControl group:\n\n* At least 16 weeks of any combination of currently licensed nucleoside reverse transcriptase inhibitors."}, "identificationModule"=>{"nctId"=>"NCT00002220", "briefTitle"=>"Indinavir Plus Efavirenz Plus Adefovir Dipivoxil in HIV-Infected Patients Who Have Not Had Success With Nelfinavir", "nctIdAliases"=>["NCT00002242"], "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"Multi-Center, Open-Label Study of the Effect of Indinavir, Efavirenz, and Adefovir Dipivoxil Combination Therapy in Patients Who Have Failed Nelfinavir", "orgStudyIdInfo"=>{"id"=>"246N"}, "secondaryIdInfos"=>[{"id"=>"075-00"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Indinavir sulfate", "type"=>"DRUG"}, {"name"=>"Efavirenz", "type"=>"DRUG"}, {"name"=>"Levocarnitine", "type"=>"DRUG"}, {"name"=>"Adefovir dipivoxil", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90033", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"LAC / USC Med Ctr / Infectious Diseases", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"06510", "city"=>"New Haven", "state"=>"Connecticut", "country"=>"United States", "facility"=>"Yale Univ / AIDS Clinical Trials Unit", "geoPoint"=>{"lat"=>41.30815, "lon"=>-72.92816}}, {"zip"=>"19899", "city"=>"Wilmington", "state"=>"Delaware", "country"=>"United States", "facility"=>"Med Ctr of Delaware", "geoPoint"=>{"lat"=>39.74595, "lon"=>-75.54659}}, {"zip"=>"96816", "city"=>"Honolulu", "state"=>"Hawaii", "country"=>"United States", "facility"=>"Hawaii AIDS Clinical Trial Unit", "geoPoint"=>{"lat"=>21.30694, "lon"=>-157.85833}}, {"zip"=>"606123832", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Rush Presbyterian Saint Lukes Med Ctr", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"212876220", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins Hosp", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}, {"zip"=>"02114", "city"=>"Boston", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Massachusetts Gen Hosp", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}, {"zip"=>"10032", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Columbia Presbyterian Hosp", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"117948153", "city"=>"Stonybrook", "state"=>"New York", "country"=>"United States", "facility"=>"AIDS TMT Unit / Univ Hosp", "geoPoint"=>{"lat"=>40.92565, "lon"=>-73.14094}}, {"zip"=>"37212", "city"=>"Nashville", "state"=>"Tennessee", "country"=>"United States", "facility"=>"Vanderbilt Clinic", "geoPoint"=>{"lat"=>36.16589, "lon"=>-86.78444}}, {"zip"=>"75219", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Oaklawn Physicians Group", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Merck Sharp & Dohme LLC", "class"=>"INDUSTRY"}}}}
