An observational study in Tenofovir, Tenofovir Alafenamide Fumarate and Chronic Kidney Diease, sponsored by King's College Hospital NHS Trust. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by King's College Hospital NHS Trust · 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/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.
1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.
This study's planned enrollment of 50 is below the median of 178 across 292 observational studies indexed under Renal Insufficiency.
Browse Renal Insufficiency studies →King's College Hospital NHS Trust is the lead sponsor of 171 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants living with HIV and chronic kidney disease, establised on tenofovir alafenamide treatment and eGFR\<30 for \>3 months
Diagnostic Test: Plasma sampling for tenofovir and emtricitabine · Drug: Descovy
Participants living with HIV and chronic kidney disease, establised on tenofovir alafenamide treatment and eGFR 30-44 for \>3 months
Diagnostic Test: Plasma sampling for tenofovir and emtricitabine · Drug: Descovy
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.
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)
Plan to share: No — To protect participant confidentiality, IPD will not be shared. Aggregate data may be shared as part of approved collaborations.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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