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":"","allocation":"","arm_groups":[{"arm_group_label":"Comparator group","arm_group_description":"Subects not receiving DTG in 3 Phase III studies in ART-naive adults with HIV","arm_type":""},{"arm_group_label":"DTG Treatment group","arm_group_description":"Patients receiving DTG in 3 Phase III studies of DTG in antiretroviral therapy (ART)-naive adults with HIV","arm_type":""}],"assignment":"","brief_summary":"The objective of this exploratory analysis is to use the data from the three Phase III treatment-naive studies of dolutegravir to investigate whether the efficacy of dolutegravir is consistent across subgroups. This analysis will explore which, if any, baseline factors are prognostic of treatment outcome, whether the treatment differences observed in Phase III studies are consistent across these factors. Of these potential prognostic factors, particular attention will be paid to the nucleoside backbone that subjects receive. The primary endpoint for this analysis will be the same as the primary endpoints for the individual studies: the proportion of subjects with plasma HIV-1 RNA <50 copies/mL at Week 48 according to the US Food and Drug Administration (FDA) snapshot algorithm [FDA, 2013].","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"An Exploratory Meta-Analysis of the Efficacy of Dolutegravir across Subgroups","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV (Human Immunodeficiency Virus)-infected adults","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 20:52:36","criteria":"Inclusion Criteria: - NA Exclusion Criteria: - NA","detailed_description":"Dolutegravir (DTG) has been studied for the treatment of HIV-1 infection in therapy naive subjects in three pivotal clinical studies: ING113086 (SPRING-2), ING114467 (SINGLE) and ING114915 (FLAMINGO). In SPRING-2, dolutegravir demonstrated non-inferiority to raltegravir when each was prescribed with an investigator-selected dual-nucleoside backbone. In SINGLE, dolutegravir with abacavir/lamivudine (ABC/3TC) demonstrated superiority to tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV). In FLAMINGO, dolutegravir demonstrated superior efficacy to darunavir/ritonavir (DRV/r) when each were prescribed with an investigator-selected dual nucleoside backbone. In SPRING-2 and FLAMINGO, investigators could choose a nucleoside backbone of either TDF/FTC or ABC/3TC. The safety data from these studies have been evaluated in the integrated summaries of safety conducted for regulatory review. Regulatory summaries of efficacy presented data separately for each study. The objective of this exploratory analysis is to use the data from the three Phase III treatment-naive studies of dolutegravir to investigate whether the efficacy of dolutegravir is consistent across subgroups. In this meta-analysis, the secondary efficacy endpoints will be the time to treatment-related discontinuation or failure and the time to efficacy-related discontinuation or failure, as defined in each study’s reporting and analysis plan. These endpoints were derived as part of the planned Week 48 analyses.","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":"2139","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"none","id":"14be8bb8-dd88-508b-bb17-5e7be21fc941","internal":{"content":null,"contentDigest":"28549088b62dad89078a41defc763bd5","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - NA Exclusion Criteria: - NA","interventions":[{"arm_group_label":"DTG Treatment group","intervention_description":"DTG 50 mg once daily for 48 weeks","intervention_name":"DTG","intervention_type":"drug"},{"arm_group_label":"Comparator group","intervention_description":"Multiple","intervention_name":"Comparator","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":true,"is_high_value":false,"is_ind_study":true,"keywords":[],"last_follow_up_date":"03/01/2014 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"18","minimum_age_raw":"18 Year","modified_date":"10/01/2018 22:34:44","number_of_arms":"","observational_design":{"biospecimen_description":"NA","biospecimen_retention":"None retained","number_of_groups":"","observational_study_design":"Other","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":"Other"},"official_title":"An Exploratory Meta-Analysis of the Efficacy of Dolutegravir across Subgroups","org_study_id":"201398","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":null,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"N/A","primary_compl_date":"03/01/2014 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"HIV-1 RNA","outcome_time_frame":"48 weeks","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Proportion of subjects with efficacy related discontinuation or failure","outcome_time_frame":"48 weeks","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Proportion of subjects with treatment related discontinuation or failure","outcome_time_frame":"48 weeks","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["N/A","GSK"]},"start_date":"03/01/2014 00:00:00","study_type":"Observational","therapeutic_area":"","citations":[],"is_section_801":true}},"pageContext":{"studyId":"201398"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}