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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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"}},"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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Guidelines subsequently recommended HLA testing for all patients when considering an abacavir containing regimen. This analysis will assess the use of HLA testing in the general Human Immunodeficiency Virus (HIV) practice setting along with the rates of suspected hypersensitivity reaction due to abacavir in the pre-testing era compared to the post-testing era. An observational clinical cohort analysis utilizing prospectively collected electronic medical record (EMR) data obtained from the OPERA (Observational Pharmaco-Epidemiology Research & Analysis) Observational Database will be used to address the study objectives.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"Rates of Suspected Hypersensitivity Reaction to Abacavir and Associated Rates of HLA-B*5701 Testing","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"Infection, Human Immunodeficiency Virus","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 21:19:18","criteria":"Inclusion criteria - At least 13 years of age at the index date. - Continuous clinical activity in the year prior to abacavir initiation, defined as at least one clinic visit. - Continuous clinical activity in the year following abacavir initiation, defined as at least one clinical contact (visit or telephone contact).","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"","display_phase_internal":"","display_status":"Planned","display_status_internal":"RECSTATUS_O_PLANNED","endpoint":"","enrollment":"1","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"None","id":"35578a45-fc5b-5a85-833a-c35385b7ac12","internal":{"content":null,"contentDigest":"24b568667f56aad38cb35f9d34e07bc1","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion criteria - At least 13 years of age at the index date. - Continuous clinical activity in the year prior to abacavir initiation, defined as at least one clinic visit. - Continuous clinical activity in the year following abacavir initiation, defined as at least one clinical contact (visit or telephone contact).","interventions":[{"arm_group_label":"HIV positive patients exposed to abacavir","intervention_description":"Abacavir sulfate, a carbocyclic 2’-deoxyguanosine nucleoside analogue, was approved by United States -Food and Drug Administration, for the treatment of adults and children with HIV infection. Abacavir-based antiretroviral (ART) regimen includes abacavir and abacavir combination with lamivudine, zidovudine and dolutegravir.","intervention_name":"Abacavir-containing regimen","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["HLA-B*5701 testing","hypersensitivity reaction","Abacavir"],"last_follow_up_date":"07/28/2017 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":"13Years","minimum_age_raw":"13Years","modified_date":"10/01/2018 22:43:34","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":"Rates of Suspected Hypersensitivity Reaction to Abacavir and Associated Rates of HLA-B*5701 Testing","org_study_id":"206206","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":"","primary_compl_date":"08/01/2016 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Documentation of HLA-B*5701 testing and timing of the test","outcome_time_frame":"Up to 17 years (01-Jan-1999 to 01-Jan-2016)","outcome_safety_issue":null},{"outcome_description":"","outcome_measure":"Diagnosis of suspected hypersensitivity reaction among abacavir-exposed patients","outcome_time_frame":"Up to 17 years (01-Jan-1999 to 01-Jan-2016)","outcome_safety_issue":"True"},{"outcome_description":"","outcome_measure":"Exposure to abacavir post positive HLA testing","outcome_time_frame":"Up to 7.5 years (15-Jun-2008 to 01-Jan-2016)","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":[]},"start_date":"07/23/2016 00:00:00","study_type":"Observational","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"206206"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}