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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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Information on each subject will be provided by the investigator through a complete systematic electronic survey comprising multiple choice or open text fields with limited characters.","arm_type":""}],"assignment":"","brief_summary":"The 2 Drug Regimen (2DR) approach explores how HIV treatment can improve and evolve to reduce the number of antiretrovirals (ARVs) whilst maintaining the efficacy of a traditional three or four drug regimens (3- or 4DR) containing 3 active ARV with or without a pharmacokinetic (PK) booster . The absence of treatment-emergent mutations to DTG or background agents in Antiretroviral Therapy (ART)-naive individuals and rapid virologic response demonstrated for DTG-based regimens, and the in-vitro potency and well-tolerated safety profile of both DTG, Rilpivirine (RPV) and Lamivudine (3TC) all provide a strong rationale for the development of a DTG/ RPV or DTG/ 3TC single tablet regimen (STR) as a treatment option for subjects with HIV. The objective of this retrospective study is to describe from a treating physician perspective their reasons for selecting a DTG-based 2DR for their patients with HIV, and to evaluate time on the regimen, reasons for discontinuation, and selection of subsequent therapy.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Prior Experience with Dolutegravir-based Two-drug Regimen and Outcomes (PEDTRO): Motivation behind the use of DTG-based 2DRs for Treatment of HIV in the United States","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 21:27:33","criteria":"Sites will complete a survey for each of their patients meeting the following inclusion/exclusion criteria: Inclusion Criteria - History of ARV therapy consisting of 2DR with one of the antiretroviral drugs being DTG (PK-boosting agents such as ritonavir and cobisistat do not count as antiretroviral drugs) - At least 6 months of clinical follow-up after initiation of DTG-based 2 DR; clinical follow up can include time post-discontinuation of DTG-based 2DR. If history of multiple DTG-based 2DRs, the most recent DTG-based 2DRs with at least 6 months of clinical follow up should be included. - Patients started on or switched to a DTG-based 2DR regimen that contain antiretroviral drugs present in the following list only: • DTG • In combination with one of the following ARVs and additional PK boosters when appropriate: darunavir (DRV), atazanavir (ATV), lopinavir (LPV), efavirenz (EFV), nevirapine (NVP), etravirine (ETR), rilpivirine (RPV), maraviroc (MVC), abacavir (ABC), lamivudine (3TC), tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), zidovudine (AZT), ritonavir (RTV), and cobicistat (COBI). Exclusion Criteria - Patients on ARVs without an approved HIV indication. - Patients in the clinical trial studies SWORD and GEMINI will be excluded.","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":"c6f80230-c362-5fa2-b996-6e6a87ce7fdd","internal":{"content":null,"contentDigest":"47c7396320140571f9bea5e7a4125e2d","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Sites will complete a survey for each of their patients meeting the following inclusion/exclusion criteria: Inclusion Criteria - History of ARV therapy consisting of 2DR with one of the antiretroviral drugs being DTG (PK-boosting agents such as ritonavir and cobisistat do not count as antiretroviral drugs) - At least 6 months of clinical follow-up after initiation of DTG-based 2 DR; clinical follow up can include time post-discontinuation of DTG-based 2DR. If history of multiple DTG-based 2DRs, the most recent DTG-based 2DRs with at least 6 months of clinical follow up should be included. - Patients started on or switched to a DTG-based 2DR regimen that contain antiretroviral drugs present in the following list only: • DTG • In combination with one of the following ARVs and additional PK boosters when appropriate: darunavir (DRV), atazanavir (ATV), lopinavir (LPV), efavirenz (EFV), nevirapine (NVP), etravirine (ETR), rilpivirine (RPV), maraviroc (MVC), abacavir (ABC), lamivudine (3TC), tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), zidovudine (AZT), ritonavir (RTV), and cobicistat (COBI). Exclusion Criteria - Patients on ARVs without an approved HIV indication. - Patients in the clinical trial studies SWORD and GEMINI will be excluded.","interventions":[],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["GSK3515864","GSK336571","anti-retrovirals","Dolutegravir","HIV","two-drug regimen","Retrospective"],"last_follow_up_date":"06/29/2018 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"18Years","minimum_age_raw":"18Years","modified_date":"10/01/2018 22:47:05","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":"Prior Experience with Dolutegravir-based Two-drug Regimen and Outcomes (PEDTRO): Motivation behind the use of DTG-based 2DRs for Treatment of HIV in the United States","org_study_id":"207951","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":"06/29/2018 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Type of reason(s) for initiating the most recent DTG-based 2DR","outcome_time_frame":"Up to 31 days","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Time to discontinuation of DTG-based 2DR regimen","outcome_time_frame":"Up to 31 days","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Rate of discontinuation of DTG-based 2DR regimen","outcome_time_frame":"Up to 31 days","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Type of reason(s) for discontinuing DTG-based 2DR therapy","outcome_time_frame":"Up to 31 days","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Therapy switched to if discontinued DTG-based 2DR therapy","outcome_time_frame":"Up to 31 days","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["NA"]},"start_date":"04/16/2018 00:00:00","study_type":"Observational","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"207951"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}