If you entered a web address please check it was correct.
\nYou can also try Search Page to find the study you are looking for.
"}}},"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":"OPERA","allocation":"","arm_groups":[{"arm_group_label":"Subjects receiving Juluca","arm_group_description":"HIV-1 positive/HIV-2 negative adults/adolescents subjects initiating Juluca between 01-January-18 and 30-June-19, and who have not previously participated in any Juluca clinical trial will be included in the study.","arm_type":""}],"assignment":"","brief_summary":"Juluca, the dolutegravir/rilpivirine (DTG/RPV) 50 mg / 25 mg fixed dose combination (FDC), has been approved for the treatment of human immunodeficiency virus (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 c/ml) without known or suspected resistance to either antiretroviral component. While clinical studies have established the efficacy, safety and tolerability of Juluca, this study will assess the effectiveness and durability of Juluca during post approval period, demonstrating the continued effectiveness of Juluca during real world usage. Analyses will be conducted on all Juluca users at 3 different time points; 6-months post launch, 12-months post launch and 18-months post launch. This observational study will utilize prospectively collected electronic medical record (EMR) data obtained from the OPERA® Observational Database. Juluca is the registered trademark of ViiV Healthcare and GlaxoSmithKline (GSK) group of companies. OPERA is the registered trademark of Epividian.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Patient Characteristics, Treatment Patterns and Clinical Outcomes of HIV+ Patients Initiating Juluca®","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus I","LookupValue_OneLinkTx":""}],"created_date":"05/20/2020 14:11:43","criteria":"Inclusion Criteria:\n\n - HIV-1 positive.\n - HIV-2 negative.\n - ART experienced.\n - Initiating a guideline recommended three-drug regimen (3-DR), defined as any regimen containing three drugs including one of the following core agents (dolutegravir [DTG], elvitegravir [EVG], raltegravir [RAL], darunavir/ritonavir [DRV/r] or darunavir/cobicistat [DRV/c], atazanavir [ATV], rilpivirine [RPV], bictegravir [BIC]) and two nucleoside reverse transcriptase inhibitors (NRTI’s) in any combination between 01-January-2018 and 31-December-2018 (to allow for at least six months of follow up).\n - Virally suppressed (<50 copies/mL) at 3-DR initiation.\n - Age 13 or higher at 3-DR initiation.\n\nExclusion Criteria:\n\n - Subjects who were prescribed Juluca prior to 3-DR initiation.\n - Subjects prescribed two- or three-core agent regimens.","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":"0","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"","id":"1365c59b-ab26-53b5-ab2d-bf2e5f399e6f","internal":{"content":null,"contentDigest":"d9e2073102c6ad9df471b170b6001381","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n\n - HIV-1 positive.\n - HIV-2 negative.\n - ART experienced.\n - Initiating a guideline recommended three-drug regimen (3-DR), defined as any regimen containing three drugs including one of the following core agents (dolutegravir [DTG], elvitegravir [EVG], raltegravir [RAL], darunavir/ritonavir [DRV/r] or darunavir/cobicistat [DRV/c], atazanavir [ATV], rilpivirine [RPV], bictegravir [BIC]) and two nucleoside reverse transcriptase inhibitors (NRTI’s) in any combination between 01-January-2018 and 31-December-2018 (to allow for at least six months of follow up).\n - Virally suppressed (<50 copies/mL) at 3-DR initiation.\n - Age 13 or higher at 3-DR initiation.\n\nExclusion Criteria:\n\n - Subjects who were prescribed Juluca prior to 3-DR initiation.\n - Subjects prescribed two- or three-core agent regimens.","interventions":[{"arm_group_label":"Subjects receiving Juluca","intervention_description":"Juluca is a dolutegravir/rilpivirine (DTG/RPV) 50 mg/25 mg fixed dose combination. DTV is an integrase strand transfer inhibitor (INSTI) and RPV is a non-nucleoside reverse transcriptase inhibitor (NNRTI).","intervention_name":"Juluca","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["Human immunodeficiency virus","Rilpivirine","Dolutegravir","Juluca"],"last_follow_up_date":"10/03/2019 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 14:11:43","number_of_arms":"0","observational_design":{"biospecimen_description":"","biospecimen_retention":"None Retained","number_of_groups":"1","observational_study_design":"Cohort","patient_registry":"false","target_duration_quantity":"","target_duration_units":"","timing":"Retrospective"},"official_title":"Patient Characteristics, Treatment Patterns and Clinical Outcomes of HIV+ Patients Initiating Juluca®","org_study_id":"209026","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":"Phase 4","primary_compl_date":"10/03/2019 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Number of subjects with different demographic characteristics at the time of initiating Juluca","outcome_time_frame":"Day 0","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects sustaining virologic suppression","outcome_time_frame":"Up to 18 months post launch","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects discontinuing Juluca","outcome_time_frame":"Up to 18 months post launch","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"HIV viral load at Baseline","outcome_time_frame":"Day 0","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"CD4 cell count at Baseline","outcome_time_frame":"Day 0","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"AIDS defining illnesses at Baseline","outcome_time_frame":"Day 0","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Co-morbidities at Baseline","outcome_time_frame":"Day 0","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to loss of viral suppression","outcome_time_frame":"Up to 18 months post launch","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to discontinuation","outcome_time_frame":"Up to 18 months post launch","outcome_safety_issue":null}],"product_name":"GSK3365791;dolutegravir;rilpivirine","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Number of subjects modifying/discontinuing Juluca or triple drug regimen (3-DR)","outcome_time_frame":"Up to 18 months post launch","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with HIV viral load <50 copies/mL","outcome_time_frame":"Up to 18 months post launch","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with HIV viral load >200 copies/mL","outcome_time_frame":"Up to 18 months post launch","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to virologic loss (HIV-1 RNA >50 copies/mL)","outcome_time_frame":"Up to 18 months post launch","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to virologic loss (HIV-1 RNA >200 copies/mL)","outcome_time_frame":"Up to 18 months post launch","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["N/A"]},"start_date":"09/04/2018 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"209026"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}