Nctid:
NCT00002374
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007239", "term"=>"Infections"}], "browseLeaves"=>[{"id"=>"M16355", "name"=>"Syndrome", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "asFound"=>"Infection", "relevance"=>"HIGH"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M18250", "name"=>"HIV Infections", "relevance"=>"LOW"}, {"id"=>"M10199", "name"=>"Immunologic Deficiency Syndromes", "relevance"=>"LOW"}, {"id"=>"M3522", "name"=>"Acquired Immunodeficiency Syndrome", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "abbrev"=>"BXS"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D019438", "term"=>"Ritonavir"}, {"id"=>"D019888", "term"=>"Nelfinavir"}, {"id"=>"D019258", "term"=>"Saquinavir"}, {"id"=>"D018119", "term"=>"Stavudine"}], "ancestors"=>[{"id"=>"D017320", "term"=>"HIV Protease Inhibitors"}, {"id"=>"D000084762", "term"=>"Viral Protease Inhibitors"}, {"id"=>"D011480", "term"=>"Protease Inhibitors"}, {"id"=>"D004791", "term"=>"Enzyme Inhibitors"}, {"id"=>"D045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D019380", "term"=>"Anti-HIV Agents"}, {"id"=>"D044966", "term"=>"Anti-Retroviral Agents"}, {"id"=>"D000998", "term"=>"Antiviral Agents"}, {"id"=>"D000890", "term"=>"Anti-Infective Agents"}, {"id"=>"D065692", "term"=>"Cytochrome P-450 CYP3A Inhibitors"}, {"id"=>"D065607", "term"=>"Cytochrome P-450 Enzyme Inhibitors"}, {"id"=>"D000963", "term"=>"Antimetabolites"}, {"id"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}], "browseLeaves"=>[{"id"=>"M21394", "name"=>"Ritonavir", "asFound"=>"Associated", "relevance"=>"HIGH"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "relevance"=>"LOW"}, {"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"=>"M20272", "name"=>"Stavudine", "asFound"=>"Native", "relevance"=>"HIGH"}, {"id"=>"M21242", "name"=>"Saquinavir", "asFound"=>"Nursing care", "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"=>"M30564", "name"=>"Cytochrome P-450 CYP3A Inhibitors", "relevance"=>"LOW"}, {"id"=>"M30537", "name"=>"Cytochrome P-450 Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M4281", "name"=>"Antimetabolites", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase 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"}, "enrollmentInfo"=>{"count"=>120}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1997-08", "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"=>["HIV-1", "Drug Therapy, Combination", "Acquired Immunodeficiency Syndrome", "HIV Protease Inhibitors", "RNA, Viral", "Saquinavir", "Anti-HIV Agents", "Viral Load"], "conditions"=>["HIV Infections"]}, "referencesModule"=>{"references"=>[{"pmid"=>"11364377", "type"=>"BACKGROUND", "citation"=>"Cadman J. Roche brings new formulation of saquinavir to FDA. Food and Drug Administration. GMHC Treat Issues. 1997 Apr-May;11(4/5):8."}]}, "descriptionModule"=>{"briefSummary"=>"To examine the efficacy of saquinavir SGC (soft gel capsules) in combination with other antiretrovirals in HIV-1 infected patients currently treated with saquinavir HGC (hard gel capsules) measured by the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment.", "detailedDescription"=>"Eligible patients will be stratified by HIV-1 RNA level into 2 populations: 1) \\>= 5,000-30,000 HIV-1 RNA, 2) \\> 30,000 HIV-1 RNA. All patients will be randomized to 1 of 3 treatment arms: Arm A - Saquinavir soft gel capsules (SQV SGC) + 2 new nucleoside analogs (reverse transcriptase inhibitors \\[RTIs\\]), Arm B - SQV SGC + nelfinavir + stavudine (d4T) or a new RTI, or Arm C - SQV SGC + ritonavir + d4T or a new RTI. All patients will undergo plasma HIV-1 RNA determinations, CD4 lymphocyte counts, hematology and chemistry blood work at baseline, weeks 4, 8, 12, 16 and 24."}, "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 \\> 100 cells/mm3.\n* Saquinavir HGC-experienced patients (\\>= 3 months cumulative therapy).\n\nRequired:\n\n\\>= 3 months cumulative saquinavir HGC therapy."}, "identificationModule"=>{"nctId"=>"NCT00002374", "briefTitle"=>"A Study of Saquinavir Soft Gelatin Capsules Combined With Other Anti-HIV Drugs in HIV-1 Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Phase IIIB Open-Label Trial Replacing Saquinavir HGC (Ro 31-8959) With Saquinavir SGC (Ro 31-8959) in Combination With Other Antiretroviral Drugs in Patients With HIV-1 Infection", "orgStudyIdInfo"=>{"id"=>"229G"}, "secondaryIdInfos"=>[{"id"=>"NR15521"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ritonavir", "type"=>"DRUG"}, {"name"=>"Nelfinavir mesylate", "type"=>"DRUG"}, {"name"=>"Saquinavir", "type"=>"DRUG"}, {"name"=>"Stavudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"90211", "city"=>"Beverly Hills", "state"=>"California", "country"=>"United States", "facility"=>"Pacific Oaks Med Ctr", "geoPoint"=>{"lat"=>34.07362, "lon"=>-118.40036}}, {"zip"=>"90048", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Tower Infectious Diseases / Med Associates Inc", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"33146", "city"=>"Coral Gables", "state"=>"Florida", "country"=>"United States", "facility"=>"Community Research Initiative of South Florida", "geoPoint"=>{"lat"=>25.72149, "lon"=>-80.26838}}, {"zip"=>"33609", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"Ctr for Quality Care", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"02445", "city"=>"Brookline", "state"=>"Massachusetts", "country"=>"United States", "facility"=>"Community Research Initiative of New England", "geoPoint"=>{"lat"=>42.33176, "lon"=>-71.12116}}, {"zip"=>"10011", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"AIDS Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"15213", "city"=>"Pittsburgh", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Anderson Clinical Research / Inc", "geoPoint"=>{"lat"=>40.44062, "lon"=>-79.99589}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hoffmann-La Roche", "class"=>"INDUSTRY"}}}}
