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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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While there have been improvements in HIV morbidity and mortality, these gains have not been the same for all groups. The shifting demographics of the United States (US) population, and that of people living with HIV, makes it imperative to determine if there are therapeutic interventions can lessen the racial disparities in viral suppression. This study will be a post-hoc and retrospective subgroup analysis of efficacy and safety endpoints in ART-naïve and ART-experienced HIV-1 positive subjects. Subject level data from ViiV Healthcare sponsored randomized controlled trials (RCTs) that have completed to 48 Weeks in adult Phase III/IIIb drug development for Dolutegravir (DTG) 50 milligram (mg) daily dose with a non-DTG comparator will be used. This pooled meta-analysis of RCTs aims to assess differences in virologic efficacy dependency on subject factors such as sex (female versus male), race (Black versus non-Black) and geography (US versus non-US).","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Meta-Analysis Plan for the integrated subgroup analysis of efficacy and safety endpoints in antiretroviral (ART)-naïve and ART-experienced Human Immunodeficiency Virus-1 subjects using ViiV Healthcare sponsored Phase III/IIIb clinical trials","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"02/01/2022 12:40:05","criteria":"Inclusion Criteria\n - HIV-1 positive subjects from RCTs evaluating DTG treatment regimens with non-DTG treatment regimens will be included.\n - Subjects from four phase III adult ART-naïve studies (Spring-2, Single, Flamingo and Aria) and four phase III adult ART-experienced studies (Dawning, Sailing, Sword-1 and Sword-2) will be included.\n\nExclusion Criteria\n - Not Applicable","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 3","display_phase_internal":"PHASE_3","display_status":"Finalized","display_status_internal":"RECSTATUS_O_COMPLETED","endpoint":"","enrollment":"0","exclusion":"","gender":"All","gender_based":"No","gender_description":"","healthy_volunteers":"No","id":"ba1dc256-07f9-5f3d-9a2a-7020eab482ee","internal":{"content":null,"contentDigest":"7264ca2d17b22d964e4339592de0db22","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria\n - HIV-1 positive subjects from RCTs evaluating DTG treatment regimens with non-DTG treatment regimens will be included.\n - Subjects from four phase III adult ART-naïve studies (Spring-2, Single, Flamingo and Aria) and four phase III adult ART-experienced studies (Dawning, Sailing, Sword-1 and Sword-2) will be included.\n\nExclusion Criteria\n - Not Applicable","interventions":[],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["human immunodeficiency virus type-1,","antiretroviral therapy-naïve,","antiretroviral therapy-experienced,","Dolutegravir,","GSK1349572"],"last_follow_up_date":"05/22/2020 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"N/A","maximum_age":"N/A","minimum_age":"18","minimum_age_raw":"18 Years","modified_date":"07/04/2022 14:20:06","number_of_arms":"","observational_design":{"biospecimen_description":"","biospecimen_retention":"None Retained","number_of_groups":"2","observational_study_design":"Other","patient_registry":"false","target_duration_quantity":"","target_duration_units":"","timing":"Retrospective"},"official_title":"ING212285: Meta-Analysis Plan for the integrated subgroup analysis of efficacy and safety endpoints in antiretroviral (ART)-naïve and ART-experienced human immunodeficiency virus type 1 positive subjects using subject level data from ViiV Healthcare sponsored randomized clinical trials in adult Phase III/IIIb where dolutegravir treatment regimens were compared with non-dolutegravir treatment regimens","org_study_id":"212285","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":"No","fda_regulated_drug":"No","ped_postmarket_surv":"","has_dmc":false,"post_prior_to_approval":"","regulatory_authorities":[""]},"phase":"Phase 3","primary_compl_date":"05/22/2020 00:00:00","primary_outcomes":[{"outcome_description":"Virologic suppression (VS) is defined as subjects with plasma HIV-1 Ribonucleic Acid <50 copies/milliliter (mL) at Week 48 using the Food and Drug administration (FDA) Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Impact of subject factors e.g. race and sex on antiviral activity of DTG to comparator treatment regimen will be assessed.","outcome_measure":"Number of subjects with virologic suppression at Week 48","outcome_time_frame":"Week 48","outcome_safety_issue":null}],"product_name":"dolutegravir","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"Impact of subject factors e.g. race and sex on change from Baseline to Week 48 in CD4+ cell count of DTG to comparator treatment will be assessed.","outcome_measure":"Change from Baseline in cluster of differentiation 4 (CD4)+ cell count at Week 48","outcome_time_frame":"Baseline and up to Week 48","outcome_safety_issue":null},{"outcome_description":"Subjects withdrawing from DTG or comparator treatment regimen by Week 48 will be assessed within subgroups of interest e.g. male and female subjects.","outcome_measure":"Number of subjects withdrawing from treatment by Week 48","outcome_time_frame":"Week 48","outcome_safety_issue":null},{"outcome_description":"Number of DTG and comparator treatment regimen subjects with AEs by Week 48 will be assessed within subgroups of interest e.g. male and female subjects","outcome_measure":"Number of subjects with adverse events (AEs) by Week 48","outcome_time_frame":"Week 48","outcome_safety_issue":null},{"outcome_description":"Number of DTG and comparator treatment regimen subjects with AEs leading to withdrawal by Week 48 will be assessed within subgroups of interest e.g. male and female subjects","outcome_measure":"Number of subjects with AEs leading to withdrawal by Week 48","outcome_time_frame":"Week 48","outcome_safety_issue":null},{"outcome_description":"Number of DTG and comparator treatment regimen subjects with ADRs by Week 48 will be assessed within subgroups of interest e.g. male and female subjects","outcome_measure":"Number of subjects with adverse drug reactions (ADRs) by Week 48","outcome_time_frame":"Week 48","outcome_safety_issue":null},{"outcome_description":"Number of DTG and comparator treatment regimen subjects with grade 3 or 4 AEs according to DAIDs by Week 48 will be assessed within subgroups of interest e.g. male and female subjects","outcome_measure":"Number of subjects with grade 3 or 4 AEs according to Division of acquired immune deficiency syndrome (DAIDs","outcome_time_frame":"Week 48","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["NA"]},"start_date":"12/11/2018 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"212285"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}