NCT07812571Not yet recruiting
Tenofovir Exposures in Advanced Kidney Disease Study
Tenofovir Exposures in People With HIV Who Have Advanced Chronic Kidney Disease and Are Receiving Tenofovir Alafenamide-containing Antiretroviral Therapy
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 1 Sept 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- King's College Hospital NHS Trust
- Diseases
- Chronic kidney disease, HIV
- NCT number
- NCT07812571
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Nov 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Lab values
- Hb \<80 g/L or eGFR \>45 or HIV RNA \>200 copies/mL at screening
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.