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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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It is in development for the treatment and prevention of human immunodeficiency virus (HIV) infection. In vitro data indicated that the metabolism of CAB primarily involves UGT1A1, with a minor contribution from UGT1A9. UGT1A1 and UGT1A9 are responsible for the glucuronidation of multiple medicines. Carriage of the UGT1A1*28, *37 and *6 alleles results in decreased UGT1A1 enzyme activity compared to wild-type enzyme activity (UGT1A1*1/*1). UGT1A1*28 is a common genetic variant among all populations, *37 is found in populations of African ancestry, and *6 is commonly observed in East Asian populations. The clinical impact of reduced UGT1A1 enzyme activity varies between medicines. Reduced UGT1A1enzyme activity is associated with significant changes in disposition of irinotecan and its metabolites and, consequently, increased risk of treatment-induced toxicities. In contrast, carriage of UGT1A1 polymorphisms that reduce enzyme activity have a modest effect on dolutegravir exposure and safety. ViiV Healthcare, GlaxoSmithKline (GSK) Genetics and PAREXEL Genomic Medicine previously evaluated the effect of UGT1A1 genotypes on oral CAB PK parameters (study 205162). Genetically predicted UGT1A1 activity was significantly associated with steady-state oral (30 milligrams [mg]) CAB PK parameters, with mean values of trough concentration (Ctau), area under the plasma-concentration time curve for a dosing interval (AUCtau), and peak concentration (Cmax) being approximately 1.5, 1.4 and 1.3-fold, respectively, higher in subjects with low versus normal predicted UGT1A1 enzyme activity. Based on the cumulative CAB PK and safety data collected to date, this magnitude of increase in CAB exposure is not anticipated to have a clinically relevant impact and does not change the understood benefit-risk profile of 30 mg oral CAB. This PGx study has been undertaken primarily to evaluate the effects of UGT1A1 genotypes on CAB long-acting (LA) PK parameters. Furthermore, a descriptive comparison of the effects of UGT1A1 genotypes on CAB LA and oral CAB PK parameters has also been conducted.","brief_summary_OneLinkTx":"","brief_title_OneLinkTx":"","brief_title":"PGx7696: Exploratory evaluation of relationships between UGT1A1 genotypes and injection cabotegravir pharmacokinetics in Study 200056","conditions":[{"DisplayValue":"Human Immunodeficiency Virus (HIV)","DisplayValue_OneLinkTx":"","InternalValue":"CON_HIV","LookupValue":"HIV infections","LookupValue_OneLinkTx":""}],"created_date":"09/15/2018 21:32:08","criteria":"Inclusion Criteria: - Subjects who provided written informed consent and a DNA sample for PGx research, and had clinical phenotypes and genotyping data available. Exclusion Criteria: - Subject may be removed from analysis if potential DNA sample contamination is detected.","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":"3c7f7a22-8254-577e-90a7-5656ec73d577","internal":{"content":null,"contentDigest":"a3647263d84b80028b331541a5f2c83f","description":null,"fieldOwners":null,"mediaType":null,"ignoreType":null,"owner":"default-site-plugin","type":"studyDetails"},"inclusion":"Inclusion Criteria: - Subjects who provided written informed consent and a DNA sample for PGx research, and had clinical phenotypes and genotyping data available. Exclusion Criteria: - Subject may be removed from analysis if potential DNA sample contamination is detected.","interventions":[{"arm_group_label":"PGx LA PK population","intervention_description":"Subjects were treated with GSK1265744 via both oral dosing (in the induction period) and intramuscular injection administered every 4 or 8 weeks.","intervention_name":"GSK1265744","intervention_type":"drug"},{"arm_group_label":"PGx oral and LA population","intervention_description":"Subjects were treated with GSK1265744 via both oral dosing (in the induction period) and intramuscular injection administered every 4 or 8 weeks.","intervention_name":"GSK1265744","intervention_type":"drug"}],"interventional_subtype":"","is_fda_regulated":false,"is_high_value":false,"is_ind_study":false,"keywords":["CAB LA","injection","long-acting (LA)","pharmacogenetic (PGx)","200056 (LATTE2)","pharmacokinetic (PK) parameters","UGT1A1","oral","cabotegravir (CAB)"],"last_follow_up_date":"04/30/2018 00:00:00","links":[],"locations":[],"masking":"","maximum_age_raw":"","maximum_age":null,"minimum_age":null,"minimum_age_raw":"","modified_date":"10/01/2018 22:48:22","number_of_arms":"0","observational_design":{"biospecimen_description":"","biospecimen_retention":"None retained","number_of_groups":"0","observational_study_design":"Cohort","patient_registry":"","target_duration_quantity":"","target_duration_units":"","timing":"Retrospective"},"official_title":"PGx7696: Exploratory evaluation of relationships between UGT1A1 genotypes and injection cabotegravir pharmacokinetics in Study 200056","org_study_id":"209374","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":"04/30/2018 00:00:00","primary_outcomes":[{"outcome_description":"","outcome_measure":"Evaluate the effect of UGT1A1 genotypes on cabotegravir PK parameters following intramuscular injection administered every 4 weeks (Q4W) or every 8 weeks (Q8W) at Study Weeks 32 and 48","outcome_time_frame":"Week 48","outcome_safety_issue":null}],"product_name":"","product_name_OneLinkTx":"","secondary_ids":[],"secondary_outcomes":[{"outcome_description":"","outcome_measure":"Perform a descriptive comparison of pre-dose concentration (Cpre-dose) at Day 1 (which represents Ctau following the end of oral dosing) and Cpre-dose at Study Weeks 32 and 48 for each of the dosing regimen, Q4W or Q8W","outcome_time_frame":"Week 48","outcome_safety_issue":null}],"sponsors":{"investigator_affiliation":"","investigator_username":"","lead_sponsor":"ViiV Healthcare","collaborators":["N/A"]},"start_date":"04/16/2018 00:00:00","study_type":"Observational","therapeutic_area":"","citations":[],"is_section_801":null}},"pageContext":{"studyId":"209374"}},"staticQueryHashes":["162689979","3332233851","3729204765","3769354840","399703114"]}