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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.
"}}}},"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":"Patients who have virologic failure without resistance","arm_group_description":"Virologic failure without resistance, will be defined as one of the following: Following initial viral load suppression, two consecutive plasma viral load measurements of ≥ 200 copies/mL without a corresponding resistance test or with a corresponding negative resistance test, Following initial viral load suppression, one plasma viral load measurement of > 1,000 copies/mL with a corresponding negative resistance test, Two viral load measurements of ≥ 200 copies/mL after 24 weeks following treatment initiation, without a corresponding resistance test or with a corresponding negative resistance test","arm_type":""},{"arm_group_label":"Patients who have virologic failure with resistance","arm_group_description":"Virologic failure with resistance will be defined as one of the following: Following initial viral load suppression, one plasma viral load measurement of > 500 copies/mL with a corresponding positive resistance test, Two viral load measurements of ≥ 200 copies/mL after 24 weeks following treatment initiation, with a corresponding positive resistance test","arm_type":""},{"arm_group_label":"Patients who switch for tolerability/safety reasons","arm_group_description":"Switch to a different drug regimen for tolerability or safety concerns. Tolerability concern is defined as the presence of related symptoms among those who initiate and/or discontinue each of the regimens of interest. Safety concerns are defined using information from the electronic medical record or from laboratory values as the presence of one of severe adverse reactions or other health event within 1 month prior to treatment switch","arm_type":""},{"arm_group_label":"Patients who switch for simplification/reduced pill burden","arm_group_description":"Switch to a different drug regimen to simplify the drug regimen or reduce number of pills to be taken","arm_type":""}],"assignment":"","brief_summary":"Due to its higher barrier to resistance and easier dosing schedule, it is thought that dolutegravir (DTG)-based regimens will result in lower drug resistance, leading to fewer treatment switches. This study will investigate durability of human immunodeficiency virus (HIV)-1 integrase strand inhibitor (INSTI) treatment regimens, reasons for switching among treatment-naïve and treatment-experienced patients, and virologic failure comparing dolutegravir-based regimens to regimens using INSTI drugs other than dolutegravir. Additionally, levels of resistance (i.e., specific viral genetic mutations that allow the virus to continue to replicate in the presence of the drug) will be compared for each INSTI-based therapy regimen. This will be an observational cohort study of patients with HIV who are treatment-naïve and treatment-experienced at baseline and initiate an antiviral INSTI treatment regimen during the study period. Eligible patients will be classified into three exposure groups based on their index treatment regimen identified at study cohort entry. Follow-up will begin after treatment regimen is assigned. A 2 week window after the first prescription is noted will be used to classify all treatments into a specific regimen. Patients will be followed for up to 1 year until they experience a treatment regimen switch, discontinuation of the initial INSTI regimen without starting a new regimen, death, loss to follow-up, or the end of study period. Secondary analyses will also include individuals who initiate darunavir (DRV)/ritonavir (RIT)/ tenofovir disoproxil fumarate (TDF)/ emtricitabine (FTC) regimens. This analysis will use Centers for acquired immune deficiency syndrome (AIDS) Research (CFAR) Network of Integrated Clinical Systems (CNICS) data available at the start of the study.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"PRJ2568: Comparing durability, treatment failure and emergence of resistance of integrase strand transfer inhibitor treatment regimens among treatment-naïve and treatment-experienced patients with HIV","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 21:13:48","criteria":"- Treatment-naïve patients with HIV that reside in the united states (US) who start on an antiretroviral drug regimen during the study period will be eligible for inclusion into the cohort. - Also, treatment-experienced patients with HIV that switch to an INSTI drug regimen during the study period will be eligible. - Treatment naïve or experienced individuals who initiate DAR/RIT/TDF/FTC will be eligible for secondary analyses. - Additional inclusion criteria are that patients must be 18 years of age or older and have at least one viral load measurement prior to or on the day of treatment initiation. - Patients who were initially enrolled in dolutegravir clinical trials before entering a CNICS cohort will be flagged. - If complete data are available for their clinical trial experience, they may be included in the study cohort, if not, they will be excluded. - Treatment-experienced patients with a documented history of virologic failure or INSTI drug resistance will be 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DAR/RIT/TDF/FTC will be eligible for secondary analyses. - Additional inclusion criteria are that patients must be 18 years of age or older and have at least one viral load measurement prior to or on the day of treatment initiation. - Patients who were initially enrolled in dolutegravir clinical trials before entering a CNICS cohort will be flagged. - If complete data are available for their clinical trial experience, they may be included in the study cohort, if not, they will be excluded. - Treatment-experienced patients with a documented history of virologic failure or INSTI drug resistance will be excluded.","interventions":[{"arm_group_label":"Patients who have virologic failure without resistance","intervention_description":"Raltegravir 400 mg twice daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Elvitegravir 150 mg/cobicistat 150 mg/tenofovir 300 mg/emtricitabine 200 mg once daily in patients with estimated creatinine clearance ≥ 70 mL/min","intervention_name":"DHHS-preferred non–DTG-based INSTI regimens","intervention_type":"drug"},{"arm_group_label":"Patients who have virologic failure with resistance","intervention_description":"Raltegravir 400 mg twice daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Elvitegravir 150 mg/cobicistat 150 mg/tenofovir 300 mg/emtricitabine 200 mg once daily in patients with estimated creatinine clearance ≥ 70 mL/min","intervention_name":"DHHS-preferred non–DTG-based INSTI regimens","intervention_type":"drug"},{"arm_group_label":"Patients who switch for tolerability/safety reasons","intervention_description":"Raltegravir 400 mg twice daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Elvitegravir 150 mg/cobicistat 150 mg/tenofovir 300 mg/emtricitabine 200 mg once daily in patients with estimated creatinine clearance ≥ 70 mL/min","intervention_name":"DHHS-preferred non–DTG-based INSTI regimens","intervention_type":"drug"},{"arm_group_label":"Patients who switch for simplification/reduced pill burden","intervention_description":"Raltegravir 400 mg twice daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Elvitegravir 150 mg/cobicistat 150 mg/tenofovir 300 mg/emtricitabine 200 mg once daily in patients with estimated creatinine clearance ≥ 70 mL/min","intervention_name":"DHHS-preferred non–DTG-based INSTI regimens","intervention_type":"drug"},{"arm_group_label":"Patients who have virologic failure without resistance","intervention_description":"All INSTI regimens other than: Dolutegravir 50 mg once daily plus abacavir 600 mg/lamivudine 300 mg once daily in patients who are HLA B*5701 negative, Dolutegravir 50 mg once daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Raltegravir 400 mg twice daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Elvitegravir 150 mg/cobicistat 150 mg/tenofovir 300 mg/emtricitabine 200 mg once daily in patients with estimated creatinine clearance ≥ 70 mL/min","intervention_name":"All other INSTI regimens","intervention_type":"drug"},{"arm_group_label":"Patients who have virologic failure with resistance","intervention_description":"All INSTI regimens other than: Dolutegravir 50 mg once daily plus abacavir 600 mg/lamivudine 300 mg once daily in patients who are HLA B*5701 negative, Dolutegravir 50 mg once daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Raltegravir 400 mg twice daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Elvitegravir 150 mg/cobicistat 150 mg/tenofovir 300 mg/emtricitabine 200 mg once daily in patients with estimated creatinine clearance ≥ 70 mL/min","intervention_name":"All other INSTI regimens","intervention_type":"drug"},{"arm_group_label":"Patients who switch for tolerability/safety reasons","intervention_description":"All INSTI regimens other than: Dolutegravir 50 mg once daily plus abacavir 600 mg/lamivudine 300 mg once daily in patients who are HLA B*5701 negative, Dolutegravir 50 mg once daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Raltegravir 400 mg twice daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Elvitegravir 150 mg/cobicistat 150 mg/tenofovir 300 mg/emtricitabine 200 mg once daily in patients with estimated creatinine clearance ≥ 70 mL/min","intervention_name":"All other INSTI regimens","intervention_type":"drug"},{"arm_group_label":"Patients who switch for simplification/reduced pill burden","intervention_description":"All INSTI regimens other than: Dolutegravir 50 mg once daily plus abacavir 600 mg/lamivudine 300 mg once daily in patients who are HLA B*5701 negative, Dolutegravir 50 mg once daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Raltegravir 400 mg twice daily plus tenofovir 300 mg/emtricitabine 200 mg once daily, Elvitegravir 150 mg/cobicistat 150 mg/tenofovir 300 mg/emtricitabine 200 mg once daily in patients with estimated creatinine clearance ≥ 70 mL/min","intervention_name":"All other INSTI 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mg/emtricitabine 200 mg once daily","intervention_name":"DHHS-preferred DTG-based regimens","intervention_type":"drug"},{"arm_group_label":"Patients who switch for simplification/reduced pill burden","intervention_description":"Dolutegravir 50 mg once daily plus abacavir 600 mg/lamivudine 300 mg once daily in patients who are HLA B*5701 negative , Dolutegravir 50 mg once daily plus tenofovir 300 mg/emtricitabine 200 mg once daily","intervention_name":"DHHS-preferred DTG-based regimens","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["Dolutegravir","HIV","INSTI","CNICS","treatment failure","safety","tolerability","treatment switching"],"last_follow_up_date":"07/11/2017 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"18Years","minimum_age_raw":"18Years","modified_date":"10/01/2018 22:39:26","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":"PRJ2568: Comparing durability, treatment failure and emergence of resistance of integrase strand transfer inhibitor treatment regimens among treatment-naïve and treatment-experienced patients with HIV","org_study_id":"204943","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":["United States: No Health Authority"]},"phase":"","primary_compl_date":"07/11/2017 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Switch to a different treatment regimen","outcome_time_frame":"Up to 1 year after starting dolutegravir or the alternate INSTI regimen","outcome_safety_issue":null}],"product_name":"","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","GSK"]},"start_date":"06/01/2016 00:00:00","study_type":"Observational","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"204943"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}