Nctid:
NCT00002223
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"=>"D019469", "term"=>"Indinavir"}], "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"=>"M21394", "name"=>"Ritonavir", "asFound"=>"Associated", "relevance"=>"HIGH"}, {"id"=>"M19609", "name"=>"HIV Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M14343", "name"=>"Protease Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21424", "name"=>"Indinavir", "asFound"=>"Discontinue", "relevance"=>"HIGH"}, {"id"=>"M7951", "name"=>"Enzyme Inhibitors", "relevance"=>"LOW"}, {"id"=>"M21350", "name"=>"Anti-HIV Agents", "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"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2009-02", "lastUpdateSubmitDate"=>"2009-02-19", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"2001-08-30", "lastUpdatePostDateStruct"=>{"date"=>"2009-02-20", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2001-08-31", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Drug Therapy, Combination", "Adolescent Behavior", "HIV Protease Inhibitors", "Ritonavir", "Indinavir"], "conditions"=>["HIV Infections"]}, "descriptionModule"=>{"briefSummary"=>"The purpose of this study is to determine how many HIV-infected patients continue taking ritonavir/indinavir combination after having taken indinavir three times a day as part of their anti-HIV drug therapy. This study also examines the safety and effectiveness of the ritonavir/indinavir combination."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "minimumAge"=>"12 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria\n\nPatients must have:\n\n* HIV infection.\n* CD4 cell count greater than 100 cells/microliter.\n* HIV RNA levels greater than 400 copies/microliter using the Roche Ultrasensitive assay.\n* No acute illness.\n* Consent of parent or guardian if less than legal age.\n* No prior enrollment in this study.\n* All entry criteria for this study met within 15 days prior to enrollment.\n\nExclusion Criteria\n\nCo-existing Condition:\n\nPatients with any of the following symptoms or conditions are excluded:\n\nAny condition that in the opinion of the investigator may obscure proper observation of the safety or activity of the treatment regimens used in this study.\n\nConcurrent Medication:\n\nExcluded:\n\n* Concurrent non-nucleoside reverse transcriptase inhibitors as part of the antiretroviral regimen.\n* Any of the following medications with ritonavir:\n* midazolam, clorazepate, diazepam, estazolam, flurazepam, triazolam, zolpidem, quinidine, amiodarone, encainide, flecainide, propafenone, bepridil, terfenadine, astemizole, cisapride, bupropion, clozapine, rifabutin, meperidine, propoxyphene, piroxicam, pimozide, dihydroergotamine, and ergotamine.\n* Any of the following medications with indinavir:\n* terfenadine, astemizole, cisapride, triazolam, midazolam. No requirement for rifampin or ketoconazole.\n* Any concurrent treatment with other protease inhibitors.\n* Other concurrent medication (including over-the-counter medicine or alcohol) without the knowledge and permission of the primary investigator.\n\nPatients with the following prior conditions are excluded:\n\n* History of significant drug hypersensitivity.\n* Psychiatric illness that precludes compliance with the protocol.\n* Receipt of investigational drug within 30 days prior to administration of study drug.\n* History of acute or chronic pancreatitis.\n* Anticipation of poor patient compliance with protocol.\n\nPrior Medication:\n\nExcluded:\n\nPrior treatment with ritonavir.\n\nRisk Behavior:\n\nExcluded:\n\nHistory of active substance abuse (i.e., recreational drugs or alcohol).\n\nIncluded:\n\n- Indinavir 800 mg three times a day plus unspecified nucleosides for at least 3 months."}, "identificationModule"=>{"nctId"=>"NCT00002223", "briefTitle"=>"A Study of Ritonavir/Indinavir Combination in HIV-Infected Patients", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Abbott"}, "officialTitle"=>"Ritonavir (ABT-538)/Indinavir Combination Treatment in HIV-Infected Patients Previously Receiving Indinavir 800 mg TID", "orgStudyIdInfo"=>{"id"=>"245E"}, "secondaryIdInfos"=>[{"id"=>"M98-823"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Indinavir sulfate", "type"=>"DRUG"}, {"name"=>"Ritonavir", "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"=>"90048", "city"=>"Los Angeles", "state"=>"California", "country"=>"United States", "facility"=>"Tower Infectious Diseases", "geoPoint"=>{"lat"=>34.05223, "lon"=>-118.24368}}, {"zip"=>"33316", "city"=>"Fort Lauderdale", "state"=>"Florida", "country"=>"United States", "facility"=>"Urgent Care Ctr / North Broward Hosp District", "geoPoint"=>{"lat"=>26.12231, "lon"=>-80.14338}}, {"zip"=>"32751", "city"=>"Maitland", "state"=>"Florida", "country"=>"United States", "facility"=>"Goodgame Med Ctr / Central Florida Research Initiati", "geoPoint"=>{"lat"=>28.62778, "lon"=>-81.36312}}, {"zip"=>"10029", "city"=>"New York", "state"=>"New York", "country"=>"United States", "facility"=>"Mount Sinai Med Ctr", "geoPoint"=>{"lat"=>40.71427, "lon"=>-74.00597}}, {"zip"=>"19107", "city"=>"Philadelphia", "state"=>"Pennsylvania", "country"=>"United States", "facility"=>"Stephen Hauptman", "geoPoint"=>{"lat"=>39.95233, "lon"=>-75.16379}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Abbott", "class"=>"INDUSTRY"}}}}
