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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.
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The observation period will begin on 12-Aug-2013 with follow-up through 31-Jul-2018.","arm_type":""},{"arm_group_label":"ART naïve subjects","arm_group_description":"Subjects initiating DTG-based regimens and other core agent-based regimens (DRV, EVG, RAL) will be identified from the OPERA observational database. The observation period will begin on 12-Aug-2013 with follow-up through 31-Jul-2018.","arm_type":""}],"assignment":"","brief_summary":"Dolutegravir has demonstrated favorable resistance profile, absence of pharmaco-enhancement requirements, once daily dosing, and single tablet regimen formulation it is likely that many clinicians will consider substituting DTG for other core agents to improve adherence and durability and lessen the likelihood of drug-drug interactions. As the therapeutic options for human immunodeficiency virus (HIV) is changing rapidly, an ongoing assessment of the patterns of DTG use within the first few years following market approval will provide a foundational understanding for future comparative effectiveness and pharmaco-economic modeling. This is an observational clinical cohort analysis that will utilize electronic medical record (EMR) data obtained from the OPERA® Observational Database to address the study objectives like comparison of clinical outcomes, clinical effectiveness and clinical characteristics of DTG regimen with core agent based regimens (darunavir [DRV], efavirenz [EVG], raltegravir [RAL]). The observation period will begin on 12-Aug-2013 with study subjects identified through 31-Jul-2017 with follow-up through 31-Jul-2018. OPERA is a registered trademark of Epividian, Healthcare Analytics and Software firm.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Clinical Characterization of Therapy-naive and Therapy-experienced Patients Initiating Dolutegravir","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Acquired Immune Deficiency Syndrome","LookupValue_OneLinkTx":""}],"created_date":"05/20/2020 14:10:23","criteria":"Inclusion Criteria:\n - ART naïve subjects: a diagnosis of HIV-1, a positive HIV-1 Western Blot, or a positive HIV-1 enzyme-linked immunosorbent assay (ELISA); and a detectable HIV-1 viral load test.\n - Subjects who have initiated any of the following core agents in a first-line regimen containing at least 3 agents: a) dolutegravir based regimen (DBR). b) any raltegravir based regimen. c) any elvitegravir based regimen. d) any darunavir based regimen.\n - At least one HIV-1 viral load test result >=1000 copies/mL and one cluster of differentiation 4 (CD4) lymphocyte test on or up to 90 days prior to the date of ART initiation (index). \n - Subjects with at least 13 years of age at the index date. \n - Subjects with continuous clinical activity in the first-year post-index, defined as at least one clinical contact (visit or telephone contact). \n - ART-experienced subjects: a diagnosis of HIV-1, a positive HIV-1 Western Blot, or a positive HIV-1 ELISA; and a detectable HIV-1viral load test.\n - Exposure to a DBR in the second or later line of ART. \n - At least one HIV-1 viral load test and one CD4 lymphocyte test on or up to 90 days prior to the start date of the qualifying DBR regimen (index).\n - At least 13 years of age at the index date.\n - Continuous clinical activity in the first-year post index, defined as at least one clinical contact (visit or telephone contact). \n\nExclusion Criteria:\n - ART experienced subjects: A diagnosis of HIV-2, a positive HIV-1/HIV-2 Multispot, a positive HIV-2 specific ELISA, a positive HIV-2 Western Blot or a detectable HIV-2 viral load test.\n - Initial DTG treatment consisting of post exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP).\n - DTG prescribed as part of a clinical trial.\n - ART naïve subjects: A diagnosis of HIV-2, a positive HIV-1/HIV-2 Multispot, a positive HIV-2 specific\nELISA, a positive HIV-2 Western Blot or a detectable HIV-2 viral load test.\n - Initial DTG, DRV, RAL or EVG treatment consisting of PEP or PrEP.\n - DTG, DRV, RAL or EVG prescribed as part of a clinical trial.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"N/A","display_phase_internal":"PHASE_NA","display_status":"Finalized","display_status_internal":"RECSTATUS_O_COMPLETED","endpoint":"","enrollment":"0","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"","id":"9e2c73ce-915f-5a43-89bd-158652ad1747","internal":{"content":null,"contentDigest":"c0797758a7074be09d053457bcc6be2c","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n - ART naïve subjects: a diagnosis of HIV-1, a positive HIV-1 Western Blot, or a positive HIV-1 enzyme-linked immunosorbent assay (ELISA); and a detectable HIV-1 viral load test.\n - Subjects who have initiated any of the following core agents in a first-line regimen containing at least 3 agents: a) dolutegravir based regimen (DBR). b) any raltegravir based regimen. c) any elvitegravir based regimen. d) any darunavir based regimen.\n - At least one HIV-1 viral load test result >=1000 copies/mL and one cluster of differentiation 4 (CD4) lymphocyte test on or up to 90 days prior to the date of ART initiation (index). \n - Subjects with at least 13 years of age at the index date. \n - Subjects with continuous clinical activity in the first-year post-index, defined as at least one clinical contact (visit or telephone contact). \n - ART-experienced subjects: a diagnosis of HIV-1, a positive HIV-1 Western Blot, or a positive HIV-1 ELISA; and a detectable HIV-1viral load test.\n - Exposure to a DBR in the second or later line of ART. \n - At least one HIV-1 viral load test and one CD4 lymphocyte test on or up to 90 days prior to the start date of the qualifying DBR regimen (index).\n - At least 13 years of age at the index date.\n - Continuous clinical activity in the first-year post index, defined as at least one clinical contact (visit or telephone contact). \n\nExclusion Criteria:\n - ART experienced subjects: A diagnosis of HIV-2, a positive HIV-1/HIV-2 Multispot, a positive HIV-2 specific ELISA, a positive HIV-2 Western Blot or a detectable HIV-2 viral load test.\n - Initial DTG treatment consisting of post exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP).\n - DTG prescribed as part of a clinical trial.\n - ART naïve subjects: A diagnosis of HIV-2, a positive HIV-1/HIV-2 Multispot, a positive HIV-2 specific\nELISA, a positive HIV-2 Western Blot or a detectable HIV-2 viral load test.\n - Initial DTG, DRV, RAL or EVG treatment consisting of PEP or PrEP.\n - DTG, DRV, RAL or EVG prescribed as part of a clinical trial.","interventions":[],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["Human immunodeficiency virus","OPERA","raltegravir","Dolutegravir","Antiretroviral therapy","efavirenz"],"last_follow_up_date":"05/30/2019 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"13","minimum_age_raw":"13 Years","modified_date":"05/20/2020 14:10:23","number_of_arms":"0","observational_design":{"biospecimen_description":"","biospecimen_retention":"None Retained","number_of_groups":"2","observational_study_design":"Cohort","patient_registry":"false","target_duration_quantity":"","target_duration_units":"","timing":"Retrospective"},"official_title":"Clinical Characterization of Therapy-naive and Therapy-experienced Patients Initiating Dolutegravir","org_study_id":"209405","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":[""]},"phase":"N/A","primary_compl_date":"05/30/2019 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Number of anti-retroviral therapy (ART) naïve subjects with treatment failure","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null}],"product_name":"abacavir;darunavir;dolutegravir;dolutegravir/abacavir/lamivudine;elvitegravir;lamivudine;raltegravir","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Number of ART naïve subjects with ART pill burden","outcome_time_frame":"Day 1","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time between prescriptions for ART naïve subjects","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to discontinuation for ART naïve subjects","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of ART naïve subjects with discontinuation","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of ART naïve subjects with subsequent ART regimen","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of ART experienced subjects with ART pill burden","outcome_time_frame":"Day 1","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time between prescriptions for ART-experienced subjects","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to discontinuation for ART-experienced subjects","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of ART-experienced subjects with discontinuation","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of ART experienced subjects with subsequent ART regimen","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"HIV viral load-ART naïve subjects","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"HIV viral load-ART experienced subjects","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Change from Baseline in HIV viral load for ART naïve subjects","outcome_time_frame":"Baseline and up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Change from Baseline in HIV viral load for ART experienced subjects","outcome_time_frame":"Baseline and up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to viral suppression for ART naïve subjects","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to viral suppression for ART experienced subjects","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of ART experienced subjects with treatment failure","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of ART naïve subjects with CD4 count","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of ART experienced subjects with CD4 count","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Absolute cluster of differentiation 4 (CD4) count in ART naïve subjects","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Absolute CD4 count in ART experienced subjects","outcome_time_frame":"Up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Change from Baseline in CD4 count for ART naïve subjects","outcome_time_frame":"Baseline and up to 5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Change from Baseline in CD4 count for ART experienced subjects","outcome_time_frame":"Baseline and up to 5 years","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["Epividian"]},"start_date":"09/25/2018 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"209405"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}