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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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Agents currently available are being tested in new 2DR combinations and new agents are being tested in long-acting 2DR formulations. This will be a retrospective observational clinical cohort analysis utilizing prospectively collected electronic medical record (EMR) data obtained from the Observational Pharmaco-Epidemiology Research & Analysis (OPERA®) Observational Database.","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 OPERA cohort","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 21:25:50","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 viral load test and one cluster of differentiation 4 (CD4) lymphocyte test on or up to 120 days prior to index date - Antiretroviral therapy (ART) naïve or experienced - Continuous clinical activity in the year following 2DR initiation, defined as at least one clinical contact (visit or telephone contact). - Regimen exposure (combination of ritonavir and combination of cobicistat not included in monotherapy single drug regimen (1 DR), two-drug regimens (2DR), three drug regimens (3DR) definitions) • Exposure to 2DR ART regimens including 1 anchor/core agent + 1 NRTI, 2 anchor/core agents • Exposure to 3DR ART regimens including: 1 anchor/core agent + 2 NRTIs with pharmacokinetic (PK) boosting agent, 1 anchor/core agent + 2 NRTIs without PK boosting agent Exclusion Criteria - HIV 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 - Patients prescribed 2DR treatment as part of clinical trial participation - Initial 2DR treatment identified as a component of post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) - Patients prescribed monotherapy regimens (includes 1 anchor agent with or without a PK boosting agent; these patients will be analysed in a secondary analysis)","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":"768717fc-d209-52ea-8bd2-05c2655aace0","internal":{"content":null,"contentDigest":"e497b5717001f934d41d49debe261f17","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 viral load test and one cluster of differentiation 4 (CD4) lymphocyte test on or up to 120 days prior to index date - Antiretroviral therapy (ART) naïve or experienced - Continuous clinical activity in the year following 2DR initiation, defined as at least one clinical contact (visit or telephone contact). - Regimen exposure (combination of ritonavir and combination of cobicistat not included in monotherapy single drug regimen (1 DR), two-drug regimens (2DR), three drug regimens (3DR) definitions) • Exposure to 2DR ART regimens including 1 anchor/core agent + 1 NRTI, 2 anchor/core agents • Exposure to 3DR ART regimens including: 1 anchor/core agent + 2 NRTIs with pharmacokinetic (PK) boosting agent, 1 anchor/core agent + 2 NRTIs without PK boosting agent Exclusion Criteria - HIV 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 - Patients prescribed 2DR treatment as part of clinical trial participation - Initial 2DR treatment identified as a component of post-exposure prophylaxis (PEP) or pre-exposure prophylaxis (PrEP) - Patients prescribed monotherapy regimens (includes 1 anchor agent with or without a PK boosting agent; these patients will be analysed in a secondary analysis)","interventions":[{"arm_group_label":"ART 3DR in OPERA","intervention_description":"Study participants will be identified from the database (OPERA Observational Database) available and updated on most recent available data. The observation period will be from 01 Jan 2010 and until 31 Dec 2016.","intervention_name":"Electronic medical record (EMR) data obtained OPERA","intervention_type":"other"},{"arm_group_label":"ART monotherapy-1DR in OPERA","intervention_description":"Study participants will be identified from the database (OPERA Observational Database) available and updated on most recent available data. The observation period will be from 01 Jan 2010 and until 31 Dec 2016.","intervention_name":"Electronic medical record (EMR) data obtained OPERA","intervention_type":"other"},{"arm_group_label":"ART 2DR in OPERA","intervention_description":"Study participants will be identified from the database (OPERA Observational Database) available and updated on most recent available data. The observation period will be from 01 Jan 2010 and until 31 Dec 2016.","intervention_name":"Electronic medical record (EMR) data obtained OPERA","intervention_type":"other"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["Durability","two-drug regimens (2DR)","virologic outcomes","integrase strand transfer inhibitors"],"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 22:46:38","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":"An assessment of two-drug regimens (2DR) with respect to regimen durability among HIV Positive Patients in OPERA cohort","org_study_id":"207645","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":"09/27/2017 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Percentage of viral suppression in subjects initiating 2DR compared to those initiating 3 drug regimen (DR)","outcome_time_frame":"Up to 7 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to virologic failure in subjects initiating 2DR compared to those initiating 3DR","outcome_time_frame":"Up to 7 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Percentage virologic failure by subjects initiating 2DR compared to those initiating 3DR","outcome_time_frame":"Up to 7 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Percentage discontinuing during follow-up in subjects initiating 2DR compared to those initiating 3DR","outcome_time_frame":"Up to 7 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to discontinuing/switching ART medications in subjects initiating 2DR compared to those initiating 3DR","outcome_time_frame":"Up to 7 years","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Percentage of viral suppression in subjects initiating monotherapy","outcome_time_frame":"Up to 7 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to virologic failure in subjects initiating monotherapy","outcome_time_frame":"Up to 7 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Percentage of virologic failure by subjects initiating monotherapy","outcome_time_frame":"Up to 7 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Percentage discontinuing during follow-up in subjects initiating monotherapy","outcome_time_frame":"Up to 7 years","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Time to discontinuing/switching ART medications in subjects initiating monotherapy","outcome_time_frame":"Up to 7 years","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["GSK"]},"start_date":"04/24/2017 00:00:00","study_type":"Observational","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"207645"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}