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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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An increase in co-morbid conditions with increase in the subject’s age and resultant increase in the number of medications, toxicity, drug interactions, development of resistance and high economic costs results in additional complexities to therapeutic strategies. With the high genetic barrier and highly potent antiretroviral activity associated with boosted protease inhibitors, there is an increasing attention on the simplification of antiretroviral treatment regimens, to 2DR. The aim of this analysis is to describe the use of 2DR in the EuroSIDA study and compare the characteristics of subjects starting 2DR to those starting standard three drug antiretroviral regimens (3DR) followed during the same time period in the EuroSIDA study. EuroSIDA is a prospective observational cohort study that was initiated in 1994, and consists of data from over 22,000 HIV positive subjects in 35 European countries, Israel and Argentina. The observation period for the subjects initiating a 2DR or 3DR will be from June 30, 2010 until December 31, 2016, allowing a maximum of 6.5 years for identification and follow-up.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"An assessment of two-drug regimens (2DR) with respect to regimen durability among HIV Positive Patients in the EuroSIDA cohort","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 21:26:46","criteria":"Inclusion Criteria:\n - Subjects initiating either 2DR or 3DR during prospective follow-up after 30 June 2010 will be eligible for inclusion. Subjects exposed to darunavir (DRV), dolutegravir (DTG), lopinavir (LPV), raltegravir (RTG) and etravirine (ETV) will be included.\n - Subjects will be aged more than 16 years at Baseline, which will be defined as the date of starting one of the regimens of interest. \n - Subjects will be required to have a viral load and CD4 count measured in the 12 months prior to Baseline and some follow-up after Baseline.\n - Subjects will only be included in each treatment group once and only the first treatment regimen within each group will be included in analyses. For example, a subject who starts a 2DR and switches to a 3DR will only contribute data to the 2DR group, and a subject who starts a 2DR and swaps to a different 2DR will only contribute data once, with the first eligible 2DR used during the study period. \n\nExclusion Criteria:\n - Subjects receiving antiretroviral therapies requiring ritonavir or cobicistat as boosting agents will not be included.","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":"b2316f44-d5c9-5059-a333-1ae286637979","internal":{"content":null,"contentDigest":"ddb6ef3864c03a86bee91f94338bc1e0","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria:\n - Subjects initiating either 2DR or 3DR during prospective follow-up after 30 June 2010 will be eligible for inclusion. Subjects exposed to darunavir (DRV), dolutegravir (DTG), lopinavir (LPV), raltegravir (RTG) and etravirine (ETV) will be included.\n - Subjects will be aged more than 16 years at Baseline, which will be defined as the date of starting one of the regimens of interest. \n - Subjects will be required to have a viral load and CD4 count measured in the 12 months prior to Baseline and some follow-up after Baseline.\n - Subjects will only be included in each treatment group once and only the first treatment regimen within each group will be included in analyses. For example, a subject who starts a 2DR and switches to a 3DR will only contribute data to the 2DR group, and a subject who starts a 2DR and swaps to a different 2DR will only contribute data once, with the first eligible 2DR used during the study period. \n\nExclusion Criteria:\n - Subjects receiving antiretroviral therapies requiring ritonavir or cobicistat as boosting agents will not be included.","interventions":[],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["2 DR","Two-drug regimen","Retrospective","Human immunodeficiency virus","EuroSIDA"],"last_follow_up_date":"02/02/2018 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"16","minimum_age_raw":"16 Years","modified_date":"03/04/2020 19:10:12","number_of_arms":"0","observational_design":{"biospecimen_description":"","biospecimen_retention":"None Retained","number_of_groups":"5","observational_study_design":"Cohort","patient_registry":"false","target_duration_quantity":"","target_duration_units":"","timing":"Retrospective"},"official_title":"An assessment of two-drug regimens (2DR) with respect to regimen durability among HIV Positive Patients in the EuroSIDA cohort","org_study_id":"207919","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":"02/02/2018 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Number of subjects utilizing 2DR","outcome_time_frame":"Up to 6.5 years approximately","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with discontinuation of previous regimen","outcome_time_frame":"Up to 6.5 years approximately","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Total time of exposure to antiretrovirals","outcome_time_frame":"Up to 6.5 years approximately","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with Baseline demographic characteristics","outcome_time_frame":"Within 12 months prior to index date","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with Baseline clinical characteristics","outcome_time_frame":"Within 12 months prior to index date","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with immunologic response","outcome_time_frame":"Up to 12 months after initiation","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of virologic responders","outcome_time_frame":"Up to 12 months after initiation","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Number of subjects with incidence of a new clinical event","outcome_time_frame":"Up to 6.5 years approximately","outcome_safety_issue":null}],"product_name":"dolutegravir;dolutegravir/lamivudine;lamivudine","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":"08/07/2017 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[{"citation":"Neesgaard B, Pelchen-Matthews A, Ryom L, Florence E, et al. Uptake and effectiveness of two-drug compared to three-drug antiretroviral regimens among HIV-positive individuals in Europe. AIDS. 2019;33(13):2013-2024","is_results_ref":"","pubmed_id":""}],"is_section_801":null}},"pageContext":{"studyId":"207919"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}