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Tenofovir Levels in People With HIV and Advanced Chronic Kidney Disease

Measures tenofovir and emtricitabine levels in adults with HIV and kidney disease.

Key facts

Who runs it
King's College Hospital NHS Trust
Where
London, United KingdomSee the site
Trial code
Registry title
Tenofovir Exposures in Advanced Kidney Disease Study
Status
Not yet recruiting
People taking part
50 people, planned
Started
1 Nov 2026
Expected to end
31 Dec 2027
Type of study
Observational, 2 groups
Treatments tested
  • Plasma sampling for tenofovir and emtricitabine
  • Descovy
Record updated
10 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults living with HIV who have advanced chronic kidney disease and take a stable HIV treatment containing TAF and FTC.

Age
18 years or older
Sex
Men and women
Disease stage
Chronic kidney disease with eGFR <45 for at least 3 months, not on dialysis. Current eGFR <30. Up to 20 people with eGFR 30-44 can join.
Earlier treatment
Stable HIV treatment for at least 3 months. It must contain TAF at the standard dose (25mg once daily, or 10 mg once daily with ritonavir or cobicistat) and FTC.
Biomarker or test result
HIV well controlled for more than 6 months. All HIV RNA results below 200 copies/mL.

Main reasons for not taking part

  • Dialysis at screening, on Day 1, or in the 90 days before Day 1
  • HIV treatment changed in the past 3 months
  • HIV RNA above 200 copies/mL or active hepatitis C in the past 6 months
  • Medicines that speed up TAF or FTC breakdown, such as rifamycins, phenytoin, St Johns Wort
  • Pregnancy or breastfeeding

This trial only enrols participants living with HIV. The registry sentence this rests on: Well controlled HIV for >6 months

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Dialysis at screening, Day 1, or in the past 90 days prior to Day 1
  • Medications that induce TAF or FTC metabolism, e.g. rifamycins, phenytoin, St Johns Wort
  • Uncontrolled HIV (HIV RNA >200 copies/mL) or active hepatitis C (HCV RNA positive) in the past 6 months
  • Current or recent (past 30 days) acute clinical complications (e.g. hospitalizations, severe infections or acute graft rejection)
  • Hb <80 g/L or eGFR >45 or HIV RNA >200 copies/mL at screening
  • ART switch in the past 3 months
  • Individuals on ART regimens not containing TAF/FTC, or non-standard doses of TAF/FTC are excluded
  • Current or recent use of entecavir (past 30 days)
  • Pregnancy or lactation (female participants only)

Where in United Kingdom

  • King's College HospitalLondon, United KingdomContact: Frank A Post, MBChB PhDNot yet recruiting

About the trial

What the trial wants to find out

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).

The 2 groups in the trial

  • eGFR<30

    Participants living with HIV and chronic kidney disease, establised on tenofovir alafenamide treatment and eGFR\<30 for \>3 months

    Treatment: Plasma sampling for tenofovir and emtricitabine and Descovy

  • eGFR 30-44

    Participants living with HIV and chronic kidney disease, establised on tenofovir alafenamide treatment and eGFR 30-44 for \>3 months

    Treatment: Plasma sampling for tenofovir and emtricitabine and Descovy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Tenofovir Exposures in People With HIV Who Have Advanced Chronic Kidney Disease and Are Receiving Tenofovir Alafenamide-containing Antiretroviral Therapy
Plain-language title
Tenofovir Levels in People With HIV and Advanced Chronic Kidney DiseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 September 2026