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).
Participants with chronic kidney disease who are currently being treated with standard doses of tenofovir alafenamide/emtricitabine (25/200 mg as part of unboosted antiretroviral regimens; 10/200 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.
Study Type
OBSERVATIONAL
Enrollment
50
Samples will be used to measure tenofovir and emtricitabine concentrations
Participants will be taking Descovy together with other antiretroviral agents as part of their routine clinical care.
King's College Hospital
London, United Kingdom
Plasma tenofovir area under the concentration time curve (AUC0-24h)
Time frame: Days 1 and 2 (24 hours after an observed dose of tenofovir alafenamide)
Peak plasma tenofovir concentrations (Cmax)
Time frame: Day 1
Plasma tenofovir through (Cmin) concentration
Time frame: Day 2 (24 hours post-dose)
Intracellular tenofovir-diphosphate concentrations
Intracellular TFV-DP (tenofovir diphosphate) concentrations in peripheral blood mononuclear cells (in a subset of participants) and dried blood spots
Time frame: Day 1
Intracellular emtricitabine-triphosphate concentrations
Intracellular emtricitabine-triphosphate concentrations in peripheral blood mononuclear cells (in a subset of patients) and dried blood spots (DBS)
Time frame: On Day 1
Plasma tenofovir alafenamide concentrations
Time frame: Day 1
Plasma emtricitabine area under the concentration time curve (AUC0-24h)
Time frame: Day 1/2
Peak plasma emtricitabine concentration (Cmax)
Time frame: Day 1
Plasma emtricitabine through (Cmin) concentration
Time frame: Day 2 (24h post dose)
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