{"componentChunkName":"component---src-templates-study-details-page-js","path":"/en/study/207760","result":{"data":{"studyNotFoundJson":{"title":"Study not found","content":{"childMarkdownRemark":{"html":"<p>If you entered a web address please check it was correct.</p>\n<p>You can also try <a href=\"/en/studies\">Search Page</a> to find the study you are looking for.</p>"}}},"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":"<p>A unique number for a study given by ViiV.</p>"}},"ctGov":{"childMarkdownRemark":{"html":"<p>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.</p>"}},"eudraCT":{"childMarkdownRemark":{"html":"<p>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.</p>"}}}},"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":"Treatment- naïve subjects receiving DTG- regimen","arm_group_description":"Eligible subjects who were never exposed to any ART as PrEP or treatment and who are initiating DTG-containing regimen treatment between 01-Aug-2013 and 31-Dec-2015 will be included.","arm_type":""},{"arm_group_label":"Treatment- naïve subjects receiving other anchor regimen","arm_group_description":"Eligible subjects who were never exposed to any ART as PrEP or treatment and who are receiving other DHHS guideline recommended anchor agents (DRV, RAL, or EVG) between 01-Aug-2013 and 31-Dec-2015 will be included.","arm_type":""},{"arm_group_label":"Treatment-experienced subjects receiving DTG- regimen","arm_group_description":"Eligible subjects who were exposed any previous time to any combination of ART medications and who are initiating DTG-containing regimen treatment between 01-Aug-2013 and 31-Dec-2015 will be included.","arm_type":""}],"assignment":"","brief_summary":"DTG has been recently recommended by The United States (US) Department of Health and Human Services (DHHS) as a preferred regimen-component for treatment of human Immunodeficiency Virus (HIV). This retrospective study aims to understand and characterize the treatment patterns and clinical outcomes of subjects prescribed with DTG which will further help in planning the long-term treatment strategies. The study will include an analysis of a clinical cohort utilizing prospectively-collected electronic medical record (EMR) data obtained from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA) Observational Database. Subjects present in OPERA and initiating DTG or other anchor regimen for HIV treatment from Aug 2013 to Dec 2015 will be included in the study. OPERA is a registered trademark of Epividian, Healthcare Analytics and Software firm.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Clinical Characterization of Therapy-naïve and Therapy-experienced Patients Initiating Dolutegravir in the OPERA® Observational Database","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Acquired Immune Deficiency Syndrome","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 21:26:02","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. - At least 13 years of age at the index date. - At least one HIV-1 VL test and one CD4 lymphocyte test on or up to 90 days prior to index date. - Continuous clinical activity in the year following DTG-based initiation, defined as at least one clinical contact (visit or telephone contact). Exclusion Criteria: - 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 DTG treatment consisting of post exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP). - DTG prescribed as part of a clinical trial. - Initial DRV, RAL or EVG treatment consisting of PEP or PrEP. - DRV, RAL or EVG prescribed as part of a clinical trial.","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"","display_phase_internal":"","display_status":"Finalized","display_status_internal":"RECSTATUS_O_COMPLETED","endpoint":"","enrollment":"1","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"None","id":"c97147c1-509d-5b7d-984d-e9aa8baf1e02","internal":{"content":null,"contentDigest":"a87c69b50646752a7c03499dc5e941ed","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. - At least 13 years of age at the index date. - At least one HIV-1 VL test and one CD4 lymphocyte test on or up to 90 days prior to index date. - Continuous clinical activity in the year following DTG-based initiation, defined as at least one clinical contact (visit or telephone contact). Exclusion Criteria: - 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 DTG treatment consisting of post exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP). - DTG prescribed as part of a clinical trial. - Initial DRV, RAL or EVG treatment consisting of PEP or PrEP. - 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":["Dolutegravir","OPERA","Retrospective","Therapy experienced","HIV","Therapy- naïve"],"last_follow_up_date":"09/22/2017 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"13Years","minimum_age_raw":"13Years","modified_date":"10/01/2018 22:46:43","number_of_arms":"0","observational_design":{"biospecimen_description":"NA","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":"Clinical Characterization of Therapy-naïve and Therapy-experienced Patients Initiating Dolutegravir in the OPERA® Observational Database","org_study_id":"207760","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":"","primary_compl_date":"09/22/2017 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Demographic and Baseline characteristics in treatment naïve group initiating DTG-based regimen and other anchor-based regimen","outcome_time_frame":"Up to 3.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to virologic failure","outcome_time_frame":"Up to 3.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Demographic and clinical characteristics for treatment experienced subjects","outcome_time_frame":"Up to 3.5 years","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Number of pills of DTG used by subjects","outcome_time_frame":"Up to 3.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of pills used by subjects with co-morbid conditions","outcome_time_frame":"Up to 3.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Assessment of durability of the DTG-based regimen","outcome_time_frame":"Up to 3.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Assessment of HIV viral load","outcome_time_frame":"Up to 3.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Change from Baseline in HIV viral load","outcome_time_frame":"Baseline and Up to 3.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time required for viral suppression","outcome_time_frame":"Up to 3.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of incidences of treatment failure","outcome_time_frame":"Up to 3.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to treatment failure","outcome_time_frame":"Up to 3.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Assessment of continuous and categorical cluster of differentiation (CD4) count","outcome_time_frame":"Up to 3.5 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Change from Baseline in CD4 count","outcome_time_frame":"Baseline and Up to 3.5 years","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["N/A"]},"start_date":"05/10/2017 00:00:00","study_type":"Observational","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"207760"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}