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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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The primary objective of the analysis is to evaluate the effect of UGT1A1 genotypes on DTG pharmacokinetics (PK) exposure in subjects receiving DTG 50mg once daily (QD) tablet. 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Subjects who did not receive at least one 50mg dose of DTG - Subjects who did not consent to genotyping - Subjects who did not provide a blood sample - Subjects who were not successfully genotyped for at least one of the genetic markers under study - Subjects who did not have sufficient PK sampling data to provide estimates of oral clearance","detailed_description":"","display_gender":"Both","display_gender_internal":"GENDER_ALL","display_phase":"N/A","display_phase_internal":"PHASE_NA","display_status":"Ongoing","display_status_internal":"RECSTATUS_O_ONGOING","endpoint":"","enrollment":"1","exclusion":"","gender":"Both","gender_based":"","gender_description":"","healthy_volunteers":"yes","id":"2919465a-683c-51e8-97ea-aa0d694d9847","internal":{"content":null,"contentDigest":"fbdafe65247b13a5fa26cdf9c981c250","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Subjects received at least one 50mg dose of DTG - Subjects who consented to genotyping, provided a blood sample for genotyping and were successfully genotyped for at least one of the genetic markers under study, and had sufficient PK sampling data to provide estimates of oral clearance Exclusion Criteria: - Subjects who did not receive at least one 50mg dose of DTG - Subjects who did not consent to genotyping - Subjects who did not provide a blood sample - Subjects who were not successfully genotyped for at least one of the genetic markers under study - Subjects who did not have sufficient PK sampling data to provide estimates of oral clearance","interventions":[{"arm_group_label":"Subjects enrolled in Phase I clinical studies evaluating DTG","intervention_description":"Dolutegravir (DTG, GSK1349572) is a next-generation integrase inhibitor (INI) currently in Phase 3 clinical development","intervention_name":"dolutegravir","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["Dolutegravir","GSK1349572","HIV","integrase inhibitor","pharmacogenetics","PK","UGT1A1"],"last_follow_up_date":"04/01/2012 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":null,"minimum_age_raw":"","modified_date":"10/01/2018 22:30:12","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":"PGx432 evaluation of the effect of UGT1A1 polymorphisms on dolutegravir pharmacokinetics: meta-analysis of Phase 1 studies ING111521, ING111603, ING111604, ING112934, ING113068, ING113096, ING114005, ING114819, ING113099","org_study_id":"116265","overall_contact":{"email":"GSKClinicalSupportHD@gsk.com","last_name":"Call Center","phone":"877-379-3718"},"overall_status":"Active, not recruiting - 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