Nctid:
NCT00002447
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-11-01"}, "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"=>"D019438", "term"=>"Ritonavir"}, {"id"=>"D019258", "term"=>"Saquinavir"}, {"id"=>"C098320", "term"=>"Efavirenz"}], "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"=>"D018894", "term"=>"Reverse Transcriptase Inhibitors"}, {"id"=>"D019384", "term"=>"Nucleic Acid Synthesis Inhibitors"}, {"id"=>"D065688", "term"=>"Cytochrome P-450 CYP2C9 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"}], "browseLeaves"=>[{"id"=>"M21394", "name"=>"Ritonavir", "asFound"=>"Antibody", "relevance"=>"HIGH"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "relevance"=>"LOW"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M340137", "name"=>"Efavirenz", "asFound"=>"Multicenter Study", "relevance"=>"HIGH"}, {"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21242", "name"=>"Saquinavir", "asFound"=>"Prematurity", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M25428", "name"=>"Anti-Retroviral Agents", "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"}], "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"=>146}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1999-10"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2001-01", "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", "Saquinavir", "HIV Protease Inhibitors", "Ritonavir", "Dosage Forms", "Reverse Transcriptase Inhibitors", "Anti-HIV Agents", "efavirenz"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to compare 2 anti-HIV drug combinations.", "detailedDescription"=>"Patients are stratified by HIV RNA: 5,000-75,000 vs greater than 75,000 copies/ml by Amplicor assay. Patients are randomized to two arms. Arm A receives SQV plus RTV plus two NRTIs. Arm B receives EFV plus two NRTIs. Patients must take their dose at approximately the same time every day. Patients have the option of taking daily dose in AM or PM. Patients are evaluated for changes in plasma HIV RNA levels and CD4/CD8 counts and for adverse experiences and laboratory determinations. Evaluations are made every 4-8 weeks until Week 48. Patients continuing beyond Week 48 who reach Weeks 60, 72, 84, and common study closure, will be seen at those weeks."}, "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* Have a viral load of at least 5,000 copies/ml and a CD4 cell count of at least 75 cells/mm3.\n* Are at least 18.\n* Are able to complete the study.\n\nExclusion Criteria\n\nPatients will not be eligible for this study if they:\n\n* Have taken any anti-HIV medications for more than 2 weeks.\n* Are pregnant or breast-feeding."}, "identificationModule"=>{"nctId"=>"NCT00002447", "briefTitle"=>"A Study to Compare Two Anti-HIV Drug Combinations", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"An Open Label, Randomized, Multicenter Study to Evaluate Fortovase (Saquinavir) SGC QD, Norvir (Ritonavir) QD Plus Two NRTIs Vs Sustiva (Efavirenz) QD Plus Two NRTIs in HIV Infected Patients", "orgStudyIdInfo"=>{"id"=>"229R"}, "secondaryIdInfos"=>[{"id"=>"NR15720C/M61027"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ritonavir", "type"=>"DRUG"}, {"name"=>"Efavirenz", "type"=>"DRUG"}, {"name"=>"Saquinavir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"35294", "city"=>"Birmingham", "state"=>"Alabama", "country"=>"United States", "facility"=>"Univ of Alabama at Birmingham / AIDS Outpatient Clinic", "geoPoint"=>{"lat"=>33.52066, "lon"=>-86.80249}}, {"zip"=>"90813", "city"=>"Long Beach", "state"=>"California", "country"=>"United States", "facility"=>"St Mary's Med Ctr", "geoPoint"=>{"lat"=>33.76696, "lon"=>-118.18923}}, {"zip"=>"94110", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"UCSF - San Francisco Gen Hosp", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"94118", "city"=>"San Francisco", "state"=>"California", "country"=>"United States", "facility"=>"Kaiser Foundation Hospital", "geoPoint"=>{"lat"=>37.77493, "lon"=>-122.41942}}, {"zip"=>"20007", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Georgetown Univ Med Ctr", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"20037", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Physicans Home Service", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"33901", "city"=>"Fort Myers", "state"=>"Florida", "country"=>"United States", "facility"=>"Associates in Research", "geoPoint"=>{"lat"=>26.62168, "lon"=>-81.84059}}, {"zip"=>"33136", "city"=>"Miami", "state"=>"Florida", "country"=>"United States", "facility"=>"Univ of Miami / Jackson Memorial Hosp", "geoPoint"=>{"lat"=>25.77427, "lon"=>-80.19366}}, {"zip"=>"606575147", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Illinois Masonic Med Ctr", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"07102", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Saint Michael's Med Ctr / Dept of Infectious Diseases", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"07083", "city"=>"Union", "state"=>"New Jersey", "country"=>"United States", "facility"=>"Infectious Disease Specialists of NJ", "geoPoint"=>{"lat"=>40.6976, "lon"=>-74.2632}}, {"zip"=>"11373", "city"=>"Elmhurst", "state"=>"New York", "country"=>"United States", "facility"=>"Elmhurst Hosp", "geoPoint"=>{"lat"=>40.73649, "lon"=>-73.87791}}, {"zip"=>"11432", "city"=>"Jamaica", "state"=>"New York", "country"=>"United States", "facility"=>"Queens Hospital Center", "geoPoint"=>{"lat"=>40.69149, "lon"=>-73.80569}}, {"zip"=>"11040", "city"=>"New Hyde Park", "state"=>"New York", "country"=>"United States", "facility"=>"LIJMC", "geoPoint"=>{"lat"=>40.7351, "lon"=>-73.68791}}, {"zip"=>"27858", "city"=>"Greenville", "state"=>"North Carolina", "country"=>"United States", "facility"=>"East Carolina Univ School of Medicine", "geoPoint"=>{"lat"=>35.61266, "lon"=>-77.36635}}, {"zip"=>"18105", "city"=>"Allentown", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Lehigh Valley Hosp", "geoPoint"=>{"lat"=>40.60843, "lon"=>-75.49018}}, {"zip"=>"29206", "city"=>"Columbia", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Burnside Clinic", "geoPoint"=>{"lat"=>34.00071, "lon"=>-81.03481}}, {"zip"=>"29605", "city"=>"Greenville", "state"=>"South Carolina", "country"=>"United States", "facility"=>"Greenville Hospital System", "geoPoint"=>{"lat"=>34.85262, "lon"=>-82.39401}}, {"zip"=>"75246", "city"=>"Dallas", "state"=>"Texas", "country"=>"United States", "facility"=>"Nicholas Bellos", "geoPoint"=>{"lat"=>32.78306, "lon"=>-96.80667}}, {"zip"=>"77004", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Joseph Gathe", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"84132", "city"=>"Salt Lake City", "state"=>"Utah", "country"=>"United States", "facility"=>"Univ of Utah", "geoPoint"=>{"lat"=>40.76078, "lon"=>-111.89105}}, {"zip"=>"98104", "city"=>"Seattle", "state"=>"Washington", "country"=>"United States", "facility"=>"Univ of Washington / AIDS Clinical Trial Unit", "geoPoint"=>{"lat"=>47.60621, "lon"=>-122.33207}}, {"city"=>"Vancouver", "state"=>"British Columbia", "country"=>"Canada", "facility"=>"Saint Paul's Hosp", "geoPoint"=>{"lat"=>49.24966, "lon"=>-123.11934}}, {"city"=>"Toronto", "state"=>"Ontario", "country"=>"Canada", "facility"=>"Toronto Gen Hosp", "geoPoint"=>{"lat"=>43.70011, "lon"=>-79.4163}}, {"city"=>"Montreal", "state"=>"Quebec", "country"=>"Canada", "facility"=>"Centre Hospitalier de la Universite de Montreal (CHUM)", "geoPoint"=>{"lat"=>45.50884, "lon"=>-73.58781}}, {"zip"=>"00731", "city"=>"Ponce", "country"=>"Puerto Rico", "facility"=>"Ponce Univ Hosp", "geoPoint"=>{"lat"=>18.01108, "lon"=>-66.61406}}], "overallOfficials"=>[{"name"=>"JSG Montaner", "role"=>"PRINCIPAL_INVESTIGATOR"}, {"name"=>"Ann Collier", "role"=>"STUDY_CHAIR"}, {"name"=>"Danielle Rouleau", "role"=>"STUDY_CHAIR"}, {"name"=>"Michael Saag", "role"=>"STUDY_CHAIR"}, {"name"=>"Paul Volberding", "role"=>"STUDY_CHAIR"}, {"name"=>"Sharon Walmsley", "role"=>"STUDY_CHAIR"}, {"name"=>"Nicholas Bellos", "role"=>"STUDY_CHAIR"}, {"name"=>"Alfred Burnside", "role"=>"STUDY_CHAIR"}, {"name"=>"Stephen Follansbee", "role"=>"STUDY_CHAIR"}, {"name"=>"Joseph Gathe", "role"=>"STUDY_CHAIR"}, {"name"=>"Bruce Hathaway", "role"=>"STUDY_CHAIR"}, {"name"=>"Margaret Hoffman-Terry", "role"=>"STUDY_CHAIR"}, {"name"=>"Jazila Mantis", "role"=>"STUDY_CHAIR"}, {"name"=>"Joseph Masci", "role"=>"STUDY_CHAIR"}, {"name"=>"Mahmoud Mustafa", "role"=>"STUDY_CHAIR"}, {"name"=>"John Schrank", "role"=>"STUDY_CHAIR"}, {"name"=>"Malte Schutz", "role"=>"STUDY_CHAIR"}, {"name"=>"Leon Smith", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hoffmann-La Roche", "class"=>"INDUSTRY"}}}}