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Tenofovir exposures in people with HIV who have advanced chronic kidney disease and are receiving tenofovir alafenamide-containing antiretroviral therapy

NCT ID NCT07812571

NEW Sponsor: King's College Hospital NHS Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 10, 2026 · Last updated Sep 10, 2026

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).

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

chronic kidney disease chronic renal failure syndrome kidney failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic kidney diease Kidney failure Pharmacokinetics Tenofovir Tenofovir alafenamide fumarate

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • King's College Hospital

    London, United Kingdom

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