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"}}},"trialDetailsJson":{"title":"Details Page","returnSearch":"Back to search results","description":"Study Description","identifier":"ViiV Study ID","clinicalID":"Clinicaltrials.gov Identifier","EudraCtID":"EudraCT Number","resultsAvailable":"Has Results Available Below","docAvailable":"Has Results Document Available","studyOverview":"Study Overview","overviewSection":{"conditionsDisplay":"Medical Conditions","product":"Product","collaborators":"Collaborators","dates":"Date","studyType":"Type","phase":"Phase","gender":"Gender","age":"Age","acceptVolunteers":"Accepts Healthy Volunteers"},"studyDocuments":"Study Documents","noDocuments":"No documents available","studyDocumentsAdditionalText":"If you wish to request for Full Study Report, please contact - ","studyDocumentsAdditionalEmail":"GSKClinicalSupportHD@gsk.com","isReleased":{"firstPart":"This study has Protocol and Result summary on ClinicalTrial.gov. Click","secondPart":"to learn more.","linkText":"here"},"mapLocations":"Locations","centralContact":"Central Contact","centralPhone":"Central Contact Phone","centralEmail":"Central Contact Email","mapSection":{"site":"GSK Investigational Site","condition":"Condition","id":"Study ID","city":"City","state":"State","zip":"Zip","country":"Country"},"studyDesign":"Study Design","designSection":{"purpose":"Primary Purpose","allocation":"Allocation","study_design":"Study Design","study_classification":"Study Classification","masking":"Masking","masked_subject":"Masked Subject","masked_caregiver":"Masked Caregiver","masked_investigator":"Masked Investigator","masked_assessor":"Masked Assessor","primary_outcomes":"Primary Outcomes","secondary_outcomes":"Secondary Outcomes","arms":"Arms","interventions":"Interventions","keyword":"Keyword","inclusionTitle":"Inclusion Criteria","exclusionTitle":"Exclusion Criteria","criteriaText":"Inclusion/Exclusion Criteria","criteria_button":"Click to view inclusion/exclusion criteria","enrollment":"Enrollment","clinicalPublications":"Clinical Publications"},"popoversText":{"studyId":{"childMarkdownRemark":{"html":"A unique number for a study given by ViiV.
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We aimed to conduct PMS to monitor the safety and effectiveness based on the data collected in a real world clinical practice according to PMS regulation. Primary objective is to monitor overall adverse events (AEs) including serious adverse events (SAEs)/adverse drug reactions (ADRs) and unexpected AEs/adverse drug reactions, after administrating Tivicay for at least one dose. 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Subjects co-administering Tivicay with dofetilide, pilsicainide","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Ongoing","display_status_internal":"RECSTATUS_O_ONGOING","endpoint":"","enrollment":"3000","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"None","id":"4f2edb7e-9988-5acf-afe3-92ee3a16d94d","internal":{"content":null,"contentDigest":"5a3bf611d394d5b0be332feb4c427fad","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Adults and adolescent subjects (12 years and above) on Tivicay for treatment of HIV-1 infection in combination with other antiretroviral medications - Subjects who will administer (new users) or are administering (current users) Tivicay according to locally approved prescribing information Exclusion Criteria: - Subjects who have a history of anaphylaxis for ingredients of this medicine - Subjects co-administering Tivicay with dofetilide, pilsicainide","interventions":[{"arm_group_label":"Tivicay (dolutegravir)","intervention_description":"The usual recommended dose of dolutegravir is 50 milligrams (mg) (one tablet) once daily for subjects infected with HIV-1 without resistance to the integrase strand transfer inhibitor, and 50 mg twice daily in patients infected with HIV-1 that has resistance to the integrase strand transfer inhibitor.","intervention_name":"Dolutegravir","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["human immunodeficiency virus (HIV)","dolutegravir","post marketing surveillance (PMS)","Tivicay"],"last_follow_up_date":"09/28/2020 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"12Years","minimum_age_raw":"12Years","modified_date":"10/01/2018 22:38:04","number_of_arms":"0","observational_design":{"biospecimen_description":"","biospecimen_retention":"None retained","number_of_groups":"0","observational_study_design":"Cohort","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":"Prospective"},"official_title":"An open label, multi-centre, post marketing surveillance (PMS) to monitor the safety and effectiveness of Tivicay administered in Korean subjects for treatment of HIV-1 infection in real life practice","org_study_id":"204666","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Recruiting - 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