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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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Integrase strand transfer inhibitors, such as dolutegravir (DTG), are the newest tool for prolonging survival and improving quality of life for HIV subjects especially those with complexities of co-morbid conditions such as hepatitis C virus (HCV) infection. DTG is available as a fixed-dose combination single tablet regimen (STR). It does not require a boosting agent and has a minimal drug-drug interaction (DDI) profile. This study will evaluate the effectiveness and safety of DTG-based regimen in subjects with HCV co-infection in a real-world setting which will provide evidence for the development of treatment strategies for subjects in a more precarious state of health. This is an observational study where the electronic medical record (EMR) data obtained from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) Database will be used for analysis. The observation period of subjects initiating a core interest based regimen will begin on August 12, 2013 and proceed until the data is frozen for aggregation into the database. Study subjects will only be included into the analysis population until June 30, 2016 and followed through June 30, 2017 to allow all subjects at least 12 months of follow up after index date (the first date when the subject is prescribed the first core agent based regimen). OPERA is a registered trademark of Epividian, Healthcare Analytics and Software firm. OPERA is a registered trademark of Epividian, Healthcare Analytics and Software firm.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Comparison of Dolutegravir Effectiveness vs. Other Core Agent Effectiveness among Hepatitis C Virus Co-infected patients in the OPERA® Observational Database","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 21:26:20","criteria":"Inclusion Criteria: - 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. - A diagnosis of HCV and polymerase chain reaction (PCR) or serology positive. - At least 13 years of age at the index date. - At least one HIV-1 viral load test on or up to 120 days prior to index date. - Continuous clinical activity in the year following core agent based regimen initiation, defined as at least one clinical contact (visit or telephone contact). Exclusion Criteria: - HIV negative. - HCV negative. - 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. - Initial core agent based regimen treatment identified as a component of post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP).","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Planned","display_status_internal":"RECSTATUS_O_PLANNED","endpoint":"","enrollment":"1","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"None","id":"81596428-318e-5d94-bb60-d97cd49dd71c","internal":{"content":null,"contentDigest":"fd9a2df828f5bce8da73c21cf1e088b9","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - 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. - A diagnosis of HCV and polymerase chain reaction (PCR) or serology positive. - At least 13 years of age at the index date. - At least one HIV-1 viral load test on or up to 120 days prior to index date. - Continuous clinical activity in the year following core agent based regimen initiation, defined as at least one clinical contact (visit or telephone contact). Exclusion Criteria: - HIV negative. - HCV negative. - 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. - Initial core agent based regimen treatment identified as a component of post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP).","interventions":[],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["OPERA","Human immunodeficiency virus","Core agent","Hepatitis C virus","Dolutegravir"],"last_follow_up_date":"09/27/2017 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"13Years","minimum_age_raw":"13Years","modified_date":"10/01/2018 22:46:57","number_of_arms":"0","observational_design":{"biospecimen_description":"","biospecimen_retention":"None retained","number_of_groups":"0","observational_study_design":"Cohort","patient_registry":"false","target_duration_quantity":"","target_duration_units":"","timing":"Retrospective"},"official_title":"Comparison of Dolutegravir Effectiveness vs. Other Core Agent Effectiveness among Hepatitis C Virus Co-infected patients in the OPERA® Observational Database","org_study_id":"207833","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Not yet recruiting - 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":"Phase 4","primary_compl_date":"09/27/2017 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Analysis of baseline demographic characteristics","outcome_time_frame":"Up to 12 months of Baseline period","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Analysis of baseline clinical characteristics","outcome_time_frame":"Up to 12 months of Baseline period","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of incidences of viral suppression on a core agent based regimen","outcome_time_frame":"Up to 12 months after initiation","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to achieve viral suppression","outcome_time_frame":"Up to 12 months after initiation","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of incidences of liver enzyme elevations on a core agent regimen after initiation","outcome_time_frame":"Up to 4 years after initiation","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to liver enzyme elevations on a core agent based regimen after initiation","outcome_time_frame":"Up to 4 years after initiation","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of incidences of discontinuation/switching of treatment due to hepatotoxicities","outcome_time_frame":"Up to 4 years after initiation","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":null,"outcome_measure":null,"outcome_time_frame":null,"outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["N/A"]},"start_date":"07/21/2017 00:00:00","study_type":"Observational","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"207833"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}