Nctid:
NCT00002229
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"=>"D019258", "term"=>"Saquinavir"}], "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"}], "browseLeaves"=>[{"id"=>"M20935", "name"=>"Reverse Transcriptase Inhibitors", "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"=>"M21242", "name"=>"Saquinavir", "asFound"=>"SRS", "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"=>["PHASE4"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>80}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"1999-12", "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"=>["Drug Therapy, Combination", "HIV Protease Inhibitors", "Dosage Forms", "Saquinavir", "Reverse Transcriptase Inhibitors", "Anti-HIV Agents"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to see if it is safe and effective to give saquinavir (as a soft gel capsule taken by mouth) along with 2 other anti-HIV drugs to HIV-infected patients.", "detailedDescription"=>"Prior to initiation of study treatment all patients are screened and baseline lab values are taken. Patients then receive the study treatment, FORTOVASE, two times a day plus 2 new NRTI's. Assessments will be performed at specified intervals throughout the duration of treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"64 years", "minimumAge"=>"16 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nYou may be eligible for this study if you:\n\n* Are HIV-positive.\n* Have an HIV count of 5,000 copies/ml or more.\n* Have a CD4 count of 100 cells/mm3 or more.\n* Meet specific requirements if you have ever taken NRTIs.\n* Are 16 - 64 years old (need consent if under 18).\n* Agree to use effective methods of birth control during the study.\n\nExclusion Criteria\n\nYou will not be eligible for this study if you:\n\n* Have taken non-nucleoside reverse transcriptase inhibitors (NNRTIs) or protease inhibitors (PIs) for more than 2 weeks.\n* Have taken all the available NRTIs.\n* Have certain serious medical conditions, including severe liver disease or active opportunistic (AIDS-related) infection.\n* Have a history of weight loss, muscle pain, and loss of appetite.\n* Have taken certain medications, including anti-HIV drugs other than those required by this study.\n* Are pregnant or breast-feeding.\n* Abuse alcohol or drugs.\n* Are unable to complete the study for any reason."}, "identificationModule"=>{"nctId"=>"NCT00002229", "briefTitle"=>"Safety and Effectiveness of Adding Saquinavir (FORTOVASE) in Soft Gel Capsule Form to an Anti-HIV Drug Combination in HIV-Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"NIH AIDS Clinical Trials Information Service"}, "officialTitle"=>"A Phase IV, Non-Comparative Study to Evaluate FORTOVASE (Saquinavir) Soft Gel Capsule (SGC) TID Regimen in Combination With Two NRTI's in HIV-1 Infected Women and Men", "orgStudyIdInfo"=>{"id"=>"229Q"}, "secondaryIdInfos"=>[{"id"=>"NR15750"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Saquinavir", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"36201", "city"=>"Hobson City", "state"=>"Alabama", "country"=>"United States", "facility"=>"ASC Inc", "geoPoint"=>{"lat"=>33.62149, "lon"=>-85.84413}}, {"zip"=>"85006", "city"=>"Phoenix", "state"=>"Arizona", "country"=>"United States", "facility"=>"Dean Martin", "geoPoint"=>{"lat"=>33.44838, "lon"=>-112.07404}}, {"zip"=>"90723", "city"=>"Paramount", "state"=>"California", "country"=>"United States", "facility"=>"Wilbert Jordan", "geoPoint"=>{"lat"=>33.88946, "lon"=>-118.15979}}, {"zip"=>"20009", "city"=>"Washington", "state"=>"District of Columbia", "country"=>"United States", "facility"=>"Whitman Walker Clinic", "geoPoint"=>{"lat"=>38.89511, "lon"=>-77.03637}}, {"zip"=>"32206", "city"=>"Jacksonville", "state"=>"Florida", "country"=>"United States", "facility"=>"Duval County Health Department", "geoPoint"=>{"lat"=>30.33218, "lon"=>-81.65565}}, {"zip"=>"33609", "city"=>"Tampa", "state"=>"Florida", "country"=>"United States", "facility"=>"Ctr for Quality Care", "geoPoint"=>{"lat"=>27.94752, "lon"=>-82.45843}}, {"zip"=>"30033", "city"=>"Decatur", "state"=>"Georgia", "country"=>"United States", "facility"=>"NTouch Research Corp", "geoPoint"=>{"lat"=>33.77483, "lon"=>-84.29631}}, {"zip"=>"60612", "city"=>"Chicago", "state"=>"Illinois", "country"=>"United States", "facility"=>"Univ of Illinois Hosp at Chicago", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"40536", "city"=>"Lexington", "state"=>"Kentucky", "country"=>"United States", "facility"=>"Univ of Kentucky", "geoPoint"=>{"lat"=>37.98869, "lon"=>-84.47772}}, {"zip"=>"70112", "city"=>"New Orleans", "state"=>"Louisiana", "country"=>"United States", "facility"=>"C100 HIV Outpatient Program", "geoPoint"=>{"lat"=>29.95465, "lon"=>-90.07507}}, {"zip"=>"07103", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"NJ CRI", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"07103", "city"=>"Newark", "state"=>"New Jersey", "country"=>"United States", "facility"=>"UMDNJ / Dept of Ob/Gyn", "geoPoint"=>{"lat"=>40.73566, "lon"=>-74.17237}}, {"zip"=>"11203", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"SUNY Health Sciences Ctr", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"11212", "city"=>"Brooklyn", "state"=>"New York", "country"=>"United States", "facility"=>"Brookdale Univ Med Ctr", "geoPoint"=>{"lat"=>40.6501, "lon"=>-73.94958}}, {"zip"=>"10550", "city"=>"Mt. Vernon", "state"=>"New York", "country"=>"United States", "facility"=>"Mt Vernon Hosp", "geoPoint"=>{"lat"=>40.9126, "lon"=>-73.83708}}, {"zip"=>"100296574", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mount Sinai Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"10037", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Harlem Hosp Infectious Disease", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"02860", "city"=>"Pawtucket", "state"=>"Rhode Island", "country"=>"United States", "facility"=>"Mem Hosp of Rhode Island", "geoPoint"=>{"lat"=>41.87871, "lon"=>-71.38256}}, {"zip"=>"77027", "city"=>"Houston", "state"=>"Texas", "country"=>"United States", "facility"=>"Diversified Med Practices, PA", "geoPoint"=>{"lat"=>29.76328, "lon"=>-95.36327}}, {"zip"=>"22908", "city"=>"Charlottesville", "state"=>"Virginia", "country"=>"United States", "facility"=>"Univ of Virginia Health Sciences Ctr", "geoPoint"=>{"lat"=>38.02931, "lon"=>-78.47668}}, {"city"=>"Vancouver", "state"=>"British Columbia", "country"=>"Canada", "facility"=>"Univ of British Columbia Oak Tree Clinic", "geoPoint"=>{"lat"=>49.24966, "lon"=>-123.11934}}, {"zip"=>"00908", "city"=>"San Turce", "country"=>"Puerto Rico", "facility"=>"Programe DeSIDA De San Juan"}], "overallOfficials"=>[{"name"=>"S Palleja", "role"=>"STUDY_CHAIR"}, {"name"=>"C Karol", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hoffmann-La Roche", "class"=>"INDUSTRY"}}}}
