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Tenofovir Exposures in Advanced Kidney Disease Study

Not Yet RecruitingN/A

Sponsor: King's College Hospital NHS Trust

Conditions: Tenofovir, Tenofovir Alafenamide Fumarate, Chronic Kidney Diease, Kidney Failure, Pharmacokinetics

Interventions: Plasma sampling for tenofovir and emtricitabine, Descovy

Countries: United Kingdom

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/min/1.73m2) or stage 3 b (eGFR 30-44 mL/min/1.73m).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Capable of giving informed consent
* Male or female aged 18 years or older
* A history of chronic kidney disease (eGFR \<45 for at least 3 months) currently not requiring haemodialysis or peritoneal dialysis
* Current eGFR \<30 based on serum creatinine measurement and calculated with the CKD-EPI (2021) formula \[6\]
* 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 \<30 can be enrolled
* Stable ART regimen (consistent use for at least 3 months)
* 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
* Agreeable to accommodate morning TAF/FTC dosing schedule for one week prior to undergoing the pharmacokinetic assessments
* Well controlled HIV for \>6 months
* All available HIV RNA measurements \<200 copies/mL
* Stable clinical condition

Exclusion Criteria:

* Dialysis at screening, Day 1, or in the past 90 days prior to Day 1
* ART switch in the past 3 months
* Individuals on ART regimens not containing TAF/FTC, or non-standard doses of TAF/FTC are excluded
* Uncontrolled HIV (HIV RNA \>200 copies/mL) or active hepatitis C (HCV RNA positive) in the past 6 months
* Hb \<80 g/L or eGFR \>45 or HIV RNA \>200 copies/mL at screening
* Medications that induce TAF or FTC metabolism, e.g. rifamycins, phenytoin, St Johns Wort
* Current or recent use of entecavir (past 30 days)
* Current or recent (past 30 days) acute clinical complications (e.g. hospitalizations, severe infections or acute graft rejection)
* Pregnancy or lactation (female participants only)

Locations (1)

London, United Kingdom