Nctid:
NCT00002442
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}], "browseLeaves"=>[{"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "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"=>"D018119", "term"=>"Stavudine"}, {"id"=>"D019888", "term"=>"Nelfinavir"}, {"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"=>"D017320", "term"=>"HIV Protease Inhibitors"}, {"id"=>"D000084762", "term"=>"Viral Protease Inhibitors"}, {"id"=>"D011480", "term"=>"Protease Inhibitors"}, {"id"=>"D000963", "term"=>"Antimetabolites"}], "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"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21770", "name"=>"Nelfinavir", "asFound"=>"105", "relevance"=>"HIGH"}, {"id"=>"M17920", "name"=>"Zidovudine", "relevance"=>"LOW"}, {"id"=>"M20272", "name"=>"Stavudine", "asFound"=>"Native", "relevance"=>"HIGH"}, {"id"=>"M21424", "name"=>"Indinavir", "asFound"=>"Cholangiocarcinoma", "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"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1999-06"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-08", "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", "Drug Administration Schedule", "Stavudine", "HIV Protease Inhibitors", "Lamivudine", "Indinavir", "Dosage Forms", "Nelfinavir", "Reverse Transcriptase Inhibitors", "Anti-HIV Agents"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to compare the safety and effectiveness of 2 dosing schedules (once daily vs twice daily) of lamivudine (3TC) given with stavudine (d4T) and either indinavir (IDV) or nelfinavir (NFV) for 24 weeks.", "detailedDescription"=>"Patients are randomized to 1 of 2 groups. Group 1 receives 3TC qd plus d4T plus either IDV or NFV. Group 2 receives 3TC bid plus d4T plus either IDV or NFV. Patients are evaluated for drug tolerance, medication adherence, and genotypic and phenotypic resistance."}, "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* Are at least 18 years old.\n* Have had an HIV level below 400 copies/ml for at least 3 months prior to study entry.\n* Have a CD4 cell count of at least 50 cells/mm3.\n* Are currently taking an anti-HIV drug regimen that includes 3TC plus d4T plus either IDV or NFV for at least 6 months prior to study entry. (Note: This must be their first anti-HIV drug regimen.)\n* Agree to abstain from sex or use effective methods of birth control during the study.\n\nExclusion Criteria\n\nPatients will not be eligible for this study if they:\n\n* Have a history of an AIDS-defining illness or certain other medical conditions.\n* Are allergic to any of the study drugs.\n* Are unable to take medication by mouth for any reason.\n* Have received certain medications.\n* Will need to receive radiation therapy or chemotherapy (for any cancer other than Kaposi's sarcoma) during the study.\n* Are pregnant or breast-feeding."}, "identificationModule"=>{"nctId"=>"NCT00002442", "briefTitle"=>"A Study to Compare the Safety and Effectiveness of Two Dosing Schedules of Lamivudine in Combination With Two Other Anti-HIV Drugs", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of Epivir 150 Mg BID Versus Epivir 300 Mg Once-Daily When Administered for 24 Weeks in Combination With FDA-Approved Dosage Regimens of Zerit and Either Crixivan or Viracept in Subjects With HIV-1 Infection", "orgStudyIdInfo"=>{"id"=>"225C"}, "secondaryIdInfos"=>[{"id"=>"COLA 4005"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Indinavir sulfate", "type"=>"DRUG"}, {"name"=>"Nelfinavir mesylate", "type"=>"DRUG"}, {"name"=>"Lamivudine", "type"=>"DRUG"}, {"name"=>"Stavudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90027", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"AIDS Healthcare Foundation", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"94304", "city"=>"Palo Alto", "state"=>"California", "country"=>"United States", "facility"=>"Palo Alto Veterans Affairs Health Care System", "geoPoint"=>{"lat"=>37.44188, "lon"=>-122.14302}}, {"zip"=>"200091104", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Dupont Circle Physicians Group", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"32701", "city"=>"Altamonte Springs", "state"=>"Florida", "country"=>"United States", "facility"=>"IDC Research Initiative", "geoPoint"=>{"lat"=>28.66111, "lon"=>-81.36562}}, {"zip"=>"33316", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"North Broward Hosp District", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"33133", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Steinhart Medical Associates", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"60611", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Northwestern Univ Med School", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Saint Vincents Hosp", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10019", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"St Lukes - Roosevelt Hosp Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"19102", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"MCP Hahnemann Univ Hosp", "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"=>"77550", "city"=>"Galveston", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ TX Galveston Med Branch", "geoPoint"=>{"lat"=>29.30135, "lon"=>-94.7977}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Glaxo Wellcome", "class"=>"INDUSTRY"}}}}
