TenofovirTEAKNCT07812571
Tenofovir Exposures in Advanced Kidney Disease Study
An observational study of Tenofovir and Tenofovir Alafenamide Fumarate, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tenofovir, Tenofovir Alafenamide Fumarate, Chronic Kidney Diease
- What is being tested?
- Plasma sampling for tenofovir and emtricitabine and Descovy
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
King's College Hospital
London
Frank A Post, MBChB PhD
About this study
Official title: Tenofovir Exposures in People With HIV Who Have Advanced Chronic Kidney Disease and Are Receiving Tenofovir Alafenamide-containing Antiretroviral Therapy
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).
Read the detailed description
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.
- Conditions
- Tenofovir, Tenofovir Alafenamide Fumarate, Chronic Kidney Diease, Kidney Failure, Pharmacokinetics
- Being tested
- Plasma sampling for tenofovir and emtricitabine, Descovy
- Keywords
- tenofovir, TAF, chronic kidney disease, kidney failure, pharmacokinetics
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma sampling for tenofovir and emtricitabineDiagnostic test
Samples will be used to measure tenofovir and emtricitabine concentrations
DescovyDrug
Participants will be taking Descovy together with other antiretroviral agents as part of their routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| eGFR<30 | Participants living with HIV and chronic kidney disease, establised on tenofovir alafenamide treatment and eGFR<30 for >3 months Receives: Diagnostic Test: Plasma sampling for tenofovir and emtricitabine; Drug: Descovy | |
| eGFR 30-44 | Participants living with HIV and chronic kidney disease, establised on tenofovir alafenamide treatment and eGFR 30-44 for >3 months Receives: Diagnostic Test: Plasma sampling for tenofovir and emtricitabine; Drug: Descovy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma tenofovir area under the concentration time curve (AUC0-24h)
Measured: Days 1 and 2 (24 hours after an observed dose of tenofovir alafenamide)
Peak plasma tenofovir concentrations (Cmax)
Measured: Day 1
Plasma tenofovir through (Cmin) concentration
Measured: Day 2 (24 hours post-dose)
Secondary outcomes (6)
Intracellular tenofovir-diphosphate concentrations
Intracellular TFV-DP (tenofovir diphosphate) concentrations in peripheral blood mononuclear cells (in a subset of participants) and dried blood spots
Measured: 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)
Measured: On Day 1
Plasma tenofovir alafenamide concentrations
Measured: Day 1
Plasma emtricitabine area under the concentration time curve (AUC0-24h)
Measured: Day 1/2
Peak plasma emtricitabine concentration (Cmax)
Measured: Day 1
Plasma emtricitabine through (Cmin) concentration
Measured: Day 2 (24h post dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TenofovirStudies of the same condition, open and under way.
- More trials run by King's College Hospital NHS TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812571
- Sponsor's protocol ID
- 371700
- Other IDs
- CO-UK-380-7897
- Acronym
- TEAK
- Status last verified
- Aug 2026
- First submitted
- 1 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: To protect participant confidentiality, IPD will not be shared. Aggregate data may be shared as part of approved collaborations.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenofovir Exposures in People With HIV Who Have Advanced Chronic Kidney Disease and Are Receiving Tenofovir Alafenamide-containing Antiretroviral Therapy
- ClinicalTrials.gov ID
- NCT07812571
- Acronym / sponsor ID
- TEAK / 371700
- Conditions
- Tenofovir, Tenofovir Alafenamide Fumarate, Chronic Kidney Diease, Kidney Failure, Pharmacokinetics
- Keywords
- tenofovir, TAF, chronic kidney disease, kidney failure, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eGFR<30 | – | Diagnostic Test: Plasma sampling for tenofovir and emtricitabine, Drug: DescovyParticipants living with HIV and chronic kidney disease, establised on tenofovir alafenamide treatment and eGFR<30 for >3 months |
| eGFR 30-44 | – | Diagnostic Test: Plasma sampling for tenofovir and emtricitabine, Drug: DescovyParticipants living with HIV and chronic kidney disease, establised on tenofovir alafenamide treatment and eGFR 30-44 for >3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma sampling for tenofovir and emtricitabineSamples will be used to measure tenofovir and emtricitabine concentrations | Diagnostic test | eGFR 30-44, eGFR<30 |
| DescovyParticipants will be taking Descovy together with other antiretroviral agents as part of their routine clinical care. | Drug | eGFR 30-44, eGFR<30 |
Primary outcome
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)
6 secondary outcomes
Intracellular tenofovir-diphosphate concentrations
Time frame: Day 1
Intracellular emtricitabine-triphosphate concentrations
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. To protect participant confidentiality, IPD will not be shared. Aggregate data may be shared as part of approved collaborations.
Related trials for Tenofovir
Not yet recruitingPhase 4
Starting HIV Prevention Medicine (PrEP) During an Emergency Department Visit With a Peer Navigator
HIV Prevention, Pre-Exposure Prophylaxis (PrEP)
RecruitingPhase 2
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066)
Human Immunodeficiency Virus (HIV) Infection
Active, not recruitingPhase 3
Pre-Exposure Prophylaxis Study of Lenacapavir and Emtricitabine/Tenofovir Alafenamide in Adolescent Girls and Young Women at Risk of HIV Infection
Pre-Exposure Prophylaxis of HIV Infection
RecruitingPhase 2
A Study of GS-3242 in Combination With Lenacapavir Versus Biktarvy in Virologically Suppressed People With HIV-1
HIV-1-infection
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy
HIV, HIV Infections
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tenofovir and Tenofovir Alafenamide Fumarate, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frank A Post, MBChB, MMed(med), PhD (02078485779, frank.post@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.