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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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Subjects receiving either ABC/3TC, DTG, ABC/DTG/3TC or CAB, were either randomized to ABC vs. other ARTs, or ABC was administered as a background medication by investigator as part of these randomized clinical trials.","arm_type":""}],"assignment":"","brief_summary":"With demonstration of the clinical utility of screening for the human leukocyte antigen (HLA)-B*5701 allele to reduce patient risk from abacavir (ABC) hypersensitivity reaction (HSR), it became standard practice for Marketing Authorisation Holder (MAH)- Sponsored Clinical Trials to require study participants to have tested negative for this allele, prior to initiating an ABC- containing study medication. This practice subsequently entered clinical use in 2008, following the update of treatment guidelines. The last MAH clinical trial meta-analysis on ABC HSR in 2006 involved studies conducted before the era of routine screening for HLA-B*5701, which demonstrated an incidence rate of between 5% to 7% for clinically suspected ABC HSR. The current analysis will assess the use of HLA-B*5701 testing in clinical trials along with the clinical trial reporting rates of suspected ABC HSR in the post-testing era, as part of the MAH’s continued pharmacovigilance efforts to monitor this risk. This meta-analysis will include previously collected data from 12 MAH- Sponsored randomized clinical trials in HIV- infected, HLA-B*5701 negative adult subjects, from Phase IIb–IV of drug development for either ABC/lamivudine (3TC), dolutegravir (DTG), ABC/DTG/3TC or cabotegravir (CAB), conducted since January 2007.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Rates of Suspected Hypersensitivity Reaction in HIV infected Adult treatment populations screened HLA-B*5701 negative prior to commencing Abacavir therapy: Meta-analysis of Data from GlaxoSmithKline and ViiV Healthcare Sponsored Clinical Trials","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 18:11:12","criteria":"Inclusion criteria: - Clinical trials conducted since the 2006 meta-analysis with at least 20 weeks of ABC exposure in HLA-B*5701 negative, HIV-infected adult subjects will be included. Only studies that were completed or for which the primary objective was completed, will be included. - Subjects who received at least one dose of an ABC- containing product (i.e., ABC/3TC or ABC/DTG/3TC) as either randomized investigational medicinal product or background medication (i.e., randomization was not based on ABC).","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"Phase 4","display_phase_internal":"PHASE_4","display_status":"Planned","display_status_internal":"RECSTATUS_O_PLANNED","endpoint":"","enrollment":"1","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"none","id":"8ebf9d30-90c5-5dc4-a31e-2c6afd3f8eb0","internal":{"content":null,"contentDigest":"4b8069113107a566741a9fcfd5e6b8c8","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion criteria: - Clinical trials conducted since the 2006 meta-analysis with at least 20 weeks of ABC exposure in HLA-B*5701 negative, HIV-infected adult subjects will be included. Only studies that were completed or for which the primary objective was completed, will be included. - Subjects who received at least one dose of an ABC- containing product (i.e., ABC/3TC or ABC/DTG/3TC) as either randomized investigational medicinal product or background medication (i.e., randomization was not based on ABC).","interventions":[{"arm_group_label":"HLA-B*5701 negative subjects treated with ABC-containing ARTs","intervention_description":"Abacavir sulfate is a carbocyclic 2’-deoxyguanosine nucleoside analogue. Subjects were either randomized to abacavir versus other ARTs, or abacavir was received as a background medication by investigator.","intervention_name":"Abacavir","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["Meta-analysis","HLA-B*5701 screening","HIV","abacavir","hypersensitivity reaction"],"last_follow_up_date":"06/26/2017 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"18","minimum_age_raw":"18 Years","modified_date":"10/01/2018 22:46:48","number_of_arms":"","observational_design":{"biospecimen_description":"","biospecimen_retention":"None retained","number_of_groups":"","observational_study_design":"Cohort","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":"Retrospective"},"official_title":"Rates of Suspected Hypersensitivity Reaction in HIV infected Adult treatment populations screened HLA-B*5701 negative prior to commencing Abacavir therapy: Meta-analysis of Data from GlaxoSmithKline and ViiV Healthcare Sponsored Clinical Trials","org_study_id":"207831","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":[""]},"phase":"phase 4","primary_compl_date":"06/26/2017 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Incidence rate of investigator diagnosed clinically suspected abacavir hypersensitivity reaction cases","outcome_time_frame":"Up to 144 weeks","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Incidence rate of clinically suspected, marketing authorization holder (MAH) adjudicated abacavir hypersensitivity reaction cases","outcome_time_frame":"Up to 144 weeks","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":["GlaxoSmithKline"]},"start_date":"04/10/2017 00:00:00","study_type":"Observational","therapeutic_area":"Infectious Diseases","citations":[],"is_section_801":null}},"pageContext":{"studyId":"207831"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}