Nctid:
NCT00002378
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"=>"D019438", "term"=>"Ritonavir"}, {"id"=>"D019888", "term"=>"Nelfinavir"}, {"id"=>"D019258", "term"=>"Saquinavir"}, {"id"=>"D019259", "term"=>"Lamivudine"}, {"id"=>"D015215", "term"=>"Zidovudine"}, {"id"=>"D018119", "term"=>"Stavudine"}, {"id"=>"D020008", "term"=>"Delavirdine"}], "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"=>"D000963", "term"=>"Antimetabolites"}], "browseLeaves"=>[{"id"=>"M21394", "name"=>"Ritonavir", "asFound"=>"Associated", "relevance"=>"HIGH"}, {"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21243", "name"=>"Lamivudine", "asFound"=>"Next", "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"=>"E-cigarette", "relevance"=>"HIGH"}, {"id"=>"M17920", "name"=>"Zidovudine", "asFound"=>"Corticosteroid", "relevance"=>"HIGH"}, {"id"=>"M20272", "name"=>"Stavudine", "asFound"=>"Twenty", "relevance"=>"HIGH"}, {"id"=>"M21242", "name"=>"Saquinavir", "asFound"=>"SRS", "relevance"=>"HIGH"}, {"id"=>"M21867", "name"=>"Delavirdine", "asFound"=>"Accelerated Partial Breast Irradiation", "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"}, {"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"}, "enrollmentInfo"=>{"count"=>825}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1998-12", "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", "Stavudine", "HIV Protease Inhibitors", "Lamivudine", "RNA, Viral", "Dosage Forms", "Saquinavir", "Reverse Transcriptase Inhibitors", "Anti-HIV Agents", "Viral Load", "Nelfinavir"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"To determine the proportion of patients whose plasma HIV-1 RNA level falls below the level of detection (\\< 400 copies/ml) at week 24 of study therapy. To determine the absolute change in plasma HIV-1 RNA during the 24 weeks of study treatment. To collect safety data on the treatment regimens.\n\nAS PER AMENDMENT 12/12/97: To compare the virologic response of Fortovase (FTV) (Saquinavir) Soft Gel Capsule (SGC) tid plus nucleoside reverse transcriptase inhibitors (NRTIs) versus FTV bid plus NRTIs. Further, to compare the virologic response of FTV tid plus NRTIs versus FTV bid plus Nelfinavir bid plus a NRTI with respect to: the percentage of patients whose plasma HIV-1 RNA level falls below the Amplicor assay level of detection (\\< 400 copies/ml) at week 24 and week 48.", "detailedDescription"=>"Patients will be randomized to receive 1 of 3 study regimens: Group A - Saquinavir (SQV) sgc plus 2 new reverse transcriptase inhibitors (RTIs), Group B - SQV sgc plus delavirdine plus new RTI, and Group C - SQV sgc plus nelfinavir plus new RTI, or SQV sgc plus ritonavir plus 2 new RTIs.\n\nNOTE: \"New RTI\" is defined for this study as any reverse transcriptase inhibitor to which the patient has never been exposed.\n\nAS PER AMENDMENT 12/12/97: In this open-label, multicenter, Phase IIIB, comparative study, 825 patients are randomized to treatment arms. (NOTE: 50% of the patients will be treatment naive and 50% will be NRTI experienced.) Further, patients are randomized with stratification based on HIV-1 RNA level (5,000-30,000 copies/ml vs. greater than 30,000 copies/ml) and prior antiretroviral therapy to one of the three study arms.\n\nThe drug regimens for the three treatment arms are as follows:\n\nARM A: Fortovase (FTV), plus 2 new NRTIs\\*. ARM B: FTV plus 2 new NRTIs\\*. ARM C: FTV plus nelfinavir plus new NRTI\\*\\*.\n\n* Naive patients in Arm A and Arm B will take: d4T (or zidovudine) plus 3TC unless contraindicated.\n\n \\*\\* Naive patients in Arm C will take: d4T, unless contraindicated.\n* NRTI experienced patients in Arms A \\& B should be treated with 2 NRTIs to which he/she has not been previously exposed. If the patient has only 1 NRTI to which he/she has never been exposed, then the second NRTI can be one that the patient has been previously exposed to from the most distant past.\n\nTherapy is administered for an initial 24 weeks and may be extended for an additional 24 weeks."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* HIV-1 infection.\n* HIV RNA \\>= 5000 copies/ml by Amplicor assay.\n* Signed, informed consent from parent or legal guardian for patients less than 18 years old.\n\nPrior Medication:\n\nRequired:\n\n(Note:\n\n* 50% of the patients will be treatment naive).\n* \\> 3 months cumulative therapy with antiretrovirals other than non-nucleoside reverse transcriptase inhibitors and/or protease inhibitors.\n* Stable antiretroviral therapy for at least 4 weeks prior to enrollment.\n\nAllowed:\n\n* \\<= 2 weeks cumulative treatment with protease inhibitors.\n\nAS PER AMENDMENT 12/12/97:\n\nRequired:\n\nNRTI experienced patients:\n\n* \\> 3 months cumulative therapy with antiretrovirals.\n* \\<= 2 weeks cumulative previous treatment with non-nucleoside analogue reverse transcriptase inhibitors (NNRTIs).\n* \\<= 2 weeks cumulative previous treatment with protease inhibitors.\n* Must have at least one NRTI (preferably two) to which he/she has not been previously exposed.\n* Stable antiretroviral therapy defined as within (+/-) 1 log HIV-1 RNA between the 2 most recent values greater than 8 weeks apart (may include screening visit) prior to study enrollment. (NOTE:\n* If patient does not have a previous HIV-1 RNA value, screening will be accepted.)\n\nRequired:\n\n* Note:\n* 50% of the patients will be treatment naive and 50% will be NRTI experienced. AS PER AMENDMENT 12/12/97."}, "identificationModule"=>{"nctId"=>"NCT00002378", "briefTitle"=>"A Comparison of Three Anti-HIV Drug Combinations Containing Saquinavir Soft Gelatin Capsules Used in HIV-1 Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Randomized Phase IIIB Comparative Study to Evaluate Saquinavir Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) BID Regimen in Combination With Two NRTIs Versus Saquinavir Soft Gel Capsule (SGC) BID Plus Nelfinavir BID Plus a NRTI in HIV-1 Infected Patients", "orgStudyIdInfo"=>{"id"=>"229H"}, "secondaryIdInfos"=>[{"id"=>"NR15520"}, {"id"=>"M6101"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Ritonavir", "type"=>"DRUG"}, {"name"=>"Nelfinavir mesylate", "type"=>"DRUG"}, {"name"=>"Saquinavir", "type"=>"DRUG"}, {"name"=>"Delavirdine mesylate", "type"=>"DRUG"}, {"name"=>"Lamivudine", "type"=>"DRUG"}, {"name"=>"Stavudine", "type"=>"DRUG"}, {"name"=>"Zidovudine", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"36201", "city"=>"Aniston", "state"=>"Alabama", "country"=>"United States", "facility"=>"ASC Inc", "geoPoint"=>{"lat"=>33.65983, "lon"=>-85.83163}}, {"zip"=>"85006", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "facility"=>"CIGNA", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"85712", "city"=>"Tucson", "state"=>"Arizona", "country"=>"United States", "facility"=>"Arizona Clinical Research Ctr Inc", "geoPoint"=>{"lat"=>32.22174, "lon"=>-110.92648}}, {"zip"=>"85724", "city"=>"Tucson", "state"=>"Arizona", "country"=>"United States", "facility"=>"Univ of Arizona", "geoPoint"=>{"lat"=>32.22174, "lon"=>-110.92648}}, {"zip"=>"94705", "city"=>"Berkeley", "state"=>"California", "country"=>"United States", "facility"=>"Alta Bates Med Ctr", "geoPoint"=>{"lat"=>37.87159, "lon"=>-122.27275}}, {"zip"=>"92718", "city"=>"Irving", "state"=>"California", "country"=>"United States", "facility"=>"Ctr for Special Immunology", "geoPoint"=>{"lat"=>38.01687, "lon"=>-122.72443}}, {"zip"=>"90027", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"AIDS Healthcare Foundation Labs", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90036", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Beer Med Group", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"90048", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Dr Charles Farthing", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"91607", "city"=>"North Hollywood", "state"=>"California", "country"=>"United States", "facility"=>"Gottlieb Med Group", "geoPoint"=>{"lat"=>34.17223, "lon"=>-118.37897}}, {"zip"=>"90723", "city"=>"Paramount", "state"=>"California", "country"=>"United States", "facility"=>"Dr Wilbert 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