[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655520":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":40,"studyPopulation":41,"armGroups":42,"interventions":53,"overallOfficials":11,"centralContacts":64,"locations":70,"responsibleParty":85,"collaborators":87,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":11,"enrollmentInfo":101,"targetDuration":11,"studyType":104,"phases":11,"briefSummary":105,"conditions":106,"keywords":112,"overallStatus":118,"whyStopped":11,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"King's College Hospital NHS Trust","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":11},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Plasma tenofovir area under the concentration time curve (AUC0-24h)",null,"Days 1 and 2 (24 hours after an observed dose of tenofovir alafenamide)",{"measure":14,"description":11,"timeFrame":15},"Peak plasma tenofovir concentrations (Cmax)","Day 1",{"measure":17,"description":11,"timeFrame":18},"Plasma tenofovir through (Cmin) concentration","Day 2 (24 hours post-dose)",[20,23,27,29,32,34],{"measure":21,"description":22,"timeFrame":15},"Intracellular tenofovir-diphosphate concentrations","Intracellular TFV-DP (tenofovir diphosphate) concentrations in peripheral blood mononuclear cells (in a subset of participants) and dried blood spots",{"measure":24,"description":25,"timeFrame":26},"Intracellular emtricitabine-triphosphate concentrations","Intracellular emtricitabine-triphosphate concentrations in peripheral blood mononuclear cells (in a subset of patients) and dried blood spots (DBS)","On Day 1",{"measure":28,"description":11,"timeFrame":15},"Plasma tenofovir alafenamide concentrations",{"measure":30,"description":11,"timeFrame":31},"Plasma emtricitabine area under the concentration time curve (AUC0-24h)","Day 1\u002F2",{"measure":33,"description":11,"timeFrame":15},"Peak plasma emtricitabine concentration (Cmax)",{"measure":35,"description":11,"timeFrame":36},"Plasma emtricitabine through (Cmin) concentration","Day 2 (24h post dose)",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":38,"timePerspective":39,"maskingInfo":11},"COHORT","PROSPECTIVE","Participants with chronic kidney disease who are currently being treated with standard doses of tenofovir alafenamide\u002Femtricitabine (25\u002F200 mg as part of unboosted antiretroviral regimens; 10\u002F200 mg on standard as part of boosted antiretroviral regimens) with suppressed HIV RNA will undergo repeated blood sampling over 24 hours to evaluate tenofovir, emtricitabine, tenofovir di-phosphate and emtricitabine tri-phosphate exposures.","The target population comprises people with HIV and chronic kidney disease stage 4 (estimated glomerular filtration rate \\[eGFR\\] 15-29 mL\u002Fmin\u002F1.73m2) or stage 3 b (eGFR 30-44 mL\u002Fmin\u002F1.73m). The population will include kidney transplant recipients but exclude those on haemodialysis or peritoneal dialysis.",[43,49],{"label":44,"type":11,"description":45,"interventionNames":46},"eGFR\u003C30","Participants living with HIV and chronic kidney disease, establised on tenofovir alafenamide treatment and eGFR\\\u003C30 for \\>3 months",[47,48],"Diagnostic Test: Plasma sampling for tenofovir and emtricitabine","Drug: Descovy",{"label":50,"type":11,"description":51,"interventionNames":52},"eGFR 30-44","Participants living with HIV and chronic kidney disease, establised on tenofovir alafenamide treatment and eGFR 30-44 for \\>3 months",[47,48],[54,59],{"type":55,"name":56,"description":57,"armGroupLabels":58,"otherNames":11},"DIAGNOSTIC_TEST","Plasma sampling for tenofovir and emtricitabine","Samples will be used to measure tenofovir and emtricitabine concentrations",[50,44],{"type":60,"name":61,"description":62,"armGroupLabels":63,"otherNames":11},"DRUG","Descovy","Participants will be taking Descovy together with other antiretroviral agents as part of their routine clinical care.",[50,44],[65],{"name":66,"role":67,"phone":68,"phoneExt":11,"email":69},"Frank A Post, MBChB, MMed(med), PhD","CONTACT","02078485779","frank.post@kcl.ac.uk",[71],{"facility":72,"status":11,"city":73,"state":11,"zip":11,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"King's College Hospital","London","United Kingdom","UK",{"type":77,"coordinates":78},"Point",[79,80],-0.12574,51.50853,{"lat":80,"lon":79},[83],{"name":84,"role":67,"phone":11,"phoneExt":11,"email":11},"Frank A Post, MBChB PhD",{"type":86,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[88],{"name":89,"class":90},"Gilead Sciences","INDUSTRY","100655520","tenofovir-exposures-in-advanced-kidney-disease-study-100655520",false,"NCT07812571","Tenofovir Exposures in Advanced Kidney Disease Study","Tenofovir Exposures in People With HIV Who Have Advanced Chronic Kidney Disease and Are Receiving Tenofovir Alafenamide-containing Antiretroviral Therapy","TEAK","Inclusion Criteria:\n\n* Capable of giving informed consent\n* Male or female aged 18 years or older\n* A history of chronic kidney disease (eGFR \\\u003C45 for at least 3 months) currently not requiring haemodialysis or peritoneal dialysis\n* Current eGFR \\\u003C30 based on serum creatinine measurement and calculated with the CKD-EPI (2021) formula \\[6\\]\n* Up to 20 individuals with eGFR 30-44 will be included; such participants require prior CI approval to ensure at least 30 participants with eGFR \\\u003C30 can be enrolled\n* Stable ART regimen (consistent use for at least 3 months)\n* ART regimens must contain TAF (administered at standard dose \\[25mg once daily as part of unboosted regimens; 10 mg once daily as part of ritonavir- or cobicistat-boosted regimens\\]) and FTC, with any additional retrovirals allowed\n* Agreeable to accommodate morning TAF\u002FFTC dosing schedule for one week prior to undergoing the pharmacokinetic assessments\n* Well controlled HIV for \\>6 months\n* All available HIV RNA measurements \\\u003C200 copies\u002FmL\n* Stable clinical condition\n\nExclusion Criteria:\n\n* Dialysis at screening, Day 1, or in the past 90 days prior to Day 1\n* ART switch in the past 3 months\n* Individuals on ART regimens not containing TAF\u002FFTC, or non-standard doses of TAF\u002FFTC are excluded\n* Uncontrolled HIV (HIV RNA \\>200 copies\u002FmL) or active hepatitis C (HCV RNA positive) in the past 6 months\n* Hb \\\u003C80 g\u002FL or eGFR \\>45 or HIV RNA \\>200 copies\u002FmL at screening\n* Medications that induce TAF or FTC metabolism, e.g. rifamycins, phenytoin, St Johns Wort\n* Current or recent use of entecavir (past 30 days)\n* Current or recent (past 30 days) acute clinical complications (e.g. hospitalizations, severe infections or acute graft rejection)\n* Pregnancy or lactation (female participants only)","ALL","18 Years",{"count":102,"type":103},50,"ESTIMATED","OBSERVATIONAL","Phamacokinetic study to evaluate tenofovir, emtricitabine and tenofovir alafenamide exposures in people with HIV who have chronic kidney disease stage 4 (estimated glomerular filtration rate \\[eGFR\\] 15-29 mL\u002Fmin\u002F1.73m2) or stage 3 b (eGFR 30-44 mL\u002Fmin\u002F1.73m).",[107,108,109,110,111],"Tenofovir","Tenofovir Alafenamide Fumarate","Chronic Kidney Diease","Kidney Failure","Pharmacokinetics",[113,114,115,116,117],"tenofovir","TAF","chronic kidney disease","kidney failure","pharmacokinetics","NOT_YET_RECRUITING","2026-09-04",{"date":121,"type":122},"2026-09-10","ACTUAL",{"date":124,"type":103},"2026-11-01",{"date":126,"type":103},"2027-12-31",{"name":5,"class":6},1]