Tenofovir Exposures in Advanced Kidney Disease Study

NCT07812571 | Not Yet Recruiting FDA Drug

• 2 other identifiers: 371700CO-UK-380-7897
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Tenofovir; Tenofovir Alafenamide Fumarate; Chronic Kidney Diease; Kidney Failure; Pharmacokinetics

Keywords

tenofovir; TAF; chronic kidney disease; kidney failure; pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• Plasma tenofovir area under the concentration time curve (AUC0-24h)

  Days 1 and 2 (24 hours after an observed dose of tenofovir alafenamide)

• Peak plasma tenofovir concentrations (Cmax)

  Day 1

• Plasma tenofovir through (Cmin) concentration

  Day 2 (24 hours post-dose)

Secondary Outcomes (6)

• Intracellular tenofovir-diphosphate concentrations

  Day 1

• Intracellular emtricitabine-triphosphate concentrations

  On Day 1

• Plasma tenofovir alafenamide concentrations

  Day 1

• Plasma emtricitabine area under the concentration time curve (AUC0-24h)

  Day 1/2

• Peak plasma emtricitabine concentration (Cmax)

  Day 1

Study Arms (2)

eGFR<30

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

eGFR 30-44

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

Interventions

Descovy DRUG

Participants will be taking Descovy together with other antiretroviral agents as part of their routine clinical care.

eGFR 30-44; eGFR<30

Plasma sampling for tenofovir and emtricitabine DIAGNOSTIC_TEST

Samples will be used to measure tenofovir and emtricitabine concentrations

eGFR 30-44; eGFR<30

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• Gilead Sciences: collaborator

Study Sites (1)

King's College Hospital

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples and PBMC

MeSH Terms

Conditions

Renal Insufficiency; Renal Insufficiency, Chronic

Interventions

emtricitabine tenofovir alafenamide

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Frank A Post, MBChB, MMed(med), PhD

CONTACT

02078485779; frank.post@kcl.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2026
• First Posted: September 10, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)