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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.
"}},"ctGov":{"childMarkdownRemark":{"html":"This number identifies the study on the US clinicaltrials.gov register. Click this link to go to the entry for this study on Clinicaltrials.gov where you will be able to see protocol and results summaries where available.
"}},"eudraCT":{"childMarkdownRemark":{"html":"This number identifies the study on the EU clinicaltrials.eu register. Click this link to go to the entry for this study on clinicaltrials.eu where you will be able to see protocol and results summaries where available.
"}}}},"site":{"siteMetadata":{"siteUrl":"https://www.viiv-studyregister.com"}},"studyDetails":{"nct_number":"","ctis_id":"","HasResults":"false","IpdAccessCriteria":"","IpdDescription":"","IpdInfoTypeAnalyticCode":"","IpdInfoTypeIcf":"","IpdInfoTypeCsr":"","IpdInfoTypeProtocol":"","IpdInfoTypeSap":"","IpdTimeFrame":"","IpdUrl":"","IsFlexibleTrial":false,"IsReleasedToCtGov":"false","MaskingInfo":{"masked_assessor":"false","masked_caregiver":"false","masked_investigator":"false","masked_subject":"false","masking_description":"","no_masking":""},"PatientLevelData":"false","SharingIpd":"","acronym":"","allocation":"","arm_groups":[{"arm_group_label":"Subjects switched to TRIUMEQ","arm_group_description":"Subjects information will be provided by the healthcare provider through completion of an electronic survey. Healthcare provider will require to complete 18 questions survey maximum","arm_type":""},{"arm_group_label":"Subjects switched off TRIUMEQ","arm_group_description":"Subjects information will be provided by the healthcare provider through completion of an electronic survey. Healthcare provider will require to complete 18 plus 9 (more) questions survey maximum.","arm_type":""}],"assignment":"","brief_summary":"Combination therapy of Abacavir sulfate, Dolutegravir Sodium and Lamivudine (TRIUMEQ) was licensed for use in Australia (14 Jan 2015) and has been reimbursed through the Pharmaceutical Benefits Scheme (PBS) since (01 Apr 2015). The STRIIVING study demonstrated the non-inferiority of switching from a variety of ARVs onto TRIUMEQ (DTG/ABC/3TC) therapy in comparison to staying on baseline (current) antiretroviral therapy (CAR). The STRIIVING study was conducted in the US, Canada and Puerto Rico and as such no Australian subjects participated in this study. Results of the study have been presented by Trottier et al. Switching to Abacavir/Dolutegravir/Lamivudine fixed dose combination (ABC/DTG/3TC FDC) from a protease inhibitor (PI), integrase inhibitor (INI) or non-nucleoside reverse transcriptase inhibitors (NNRTI) based regimen maintains HIV suppression. 66th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), September 17th-21st, 2015, San Diego, California and, Kotteff et al. Measuring safety and satisfaction of ABC/DTG/3TC in a Switch Trial: Secondary Endpoints from the STRIIVING Study. 15th Conference by European AIDS Clinical Society (EACS), October 21st-24th, 2015, Barcelona, Spain. Understanding the clinical cascade of treatment is an important part of government submissions, and describing current practice may disseminate best practice amongst clinicians treating human immunodeficiency virus (HIV). Real World Data describing the reason for subjects switching onto TRIUMEQ therapy, as well as the reasoning and outcomes of subjects switching off TRIUMEQ therapy will provide quantitative descriptions of the treatment cascade for subjects in Australia. Therefore, a descriptive retrospective analysis of subjects switched onto TRIUMEQ in high case load General Practice (GP) clinics in Australia is conducted. TRIUMEQ is a registered trade mark of the ViiV Healthcare group of companies.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"A retrospective clinical audit of high case load General Practices in Australia with patients switched to Triumeq to determine the motivation for switch and clinical outcomes after the switch","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 21:18:24","criteria":"Inclusion Criteria: - Subjects with HIV identified by General Practice database as having switched to TRIUMEQ from a prior regimen that had achieved viral suppression (<50 copies/mL) Exclusion Criteria: - No exclusion criteria","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Finalized","display_status_internal":"RECSTATUS_O_COMPLETED","endpoint":"","enrollment":"1","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"none","id":"f48059fa-1b18-5d5d-a4c6-3848dd52e629","internal":{"content":null,"contentDigest":"aa00aff9a93bc18bea1cc4ea4b168793","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Subjects with HIV identified by General Practice database as having switched to TRIUMEQ from a prior regimen that had achieved viral suppression (<50 copies/mL) Exclusion Criteria: - No exclusion criteria","interventions":[{"arm_group_label":"Subjects switched to TRIUMEQ","intervention_description":"It is the combination of Abacavir sulfate, Dolutegravir Sodium and Lamivudine used in the treatment of HIV","intervention_name":"TRIUMEQ","intervention_type":"drug"},{"arm_group_label":"Subjects switched off TRIUMEQ","intervention_description":"Any other anti-retroviral other than TRIUMEQ used in the treatment of HIV","intervention_name":"Other antiretroviral therapy","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["Audit","Triumeq"],"last_follow_up_date":"05/01/2016 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":null,"minimum_age_raw":"","modified_date":"10/01/2018 22:40:42","number_of_arms":"","observational_design":{"biospecimen_description":"","biospecimen_retention":"None retained","number_of_groups":"","observational_study_design":"Case-Only","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":"Retrospective"},"official_title":"A retrospective clinical audit of high case load General Practices in Australia with patients switched to Triumeq to determine the motivation for switch and clinical outcomes after the switch","org_study_id":"205824","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Completed - Observational","oversight_info":{"exported_from_us":"","fda_regulated_device":"","fda_regulated_drug":"","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":["US: No Health Authority"]},"phase":"Phase 4","primary_compl_date":"05/01/2016 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Percentage of subjects remaining on TRIUMEQ therapy over time with HIV-1 ribose nucleic acid (RNA) <50 copies/milliliter (mL)","outcome_time_frame":"Up to 30 Days","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Number of subjects with specific reasons for switching to TRIUMEQ therapy","outcome_time_frame":"Up to 30 Days","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with specific reasons for the discontinuation of TRIUMEQ therapy","outcome_time_frame":"Up to 30 Days","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects who started anti-retroviral therapy after discontinuation of TRIUMEQ","outcome_time_frame":"Up to 30 Days","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["N/A","GSK"]},"start_date":"04/01/2016 00:00:00","study_type":"Observational","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"205824"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}