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).
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]
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
The target population comprises people with HIV and 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). The population will include kidney transplant recipients but exclude those on haemodialysis or peritoneal dialysis.
Cohort
Prospective
Plasma sampling for tenofovir and emtricitabine
Diagnostic testSamples will be used to measure tenofovir and emtricitabine concentrations
Descovy
DrugParticipants will be taking Descovy together with other antiretroviral agents as part of their routine clinical care.
Plasma tenofovir area under the concentration time curve (AUC0-24h)
Peak plasma tenofovir concentrations (Cmax)
Plasma tenofovir through (Cmin) concentration
Intracellular tenofovir-diphosphate concentrations
Intracellular TFV-DP (tenofovir diphosphate) concentrations in peripheral blood mononuclear cells (in a subset of participants) and dried blood spots
Intracellular emtricitabine-triphosphate concentrations
Intracellular emtricitabine-triphosphate concentrations in peripheral blood mononuclear cells (in a subset of patients) and dried blood spots (DBS)
Plasma tenofovir alafenamide concentrations
Plasma emtricitabine area under the concentration time curve (AUC0-24h)
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King's College Hospital NHS Trust
Lead sponsor
Gilead Sciences
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
