Pharmacokinetics of antirelease tratment in HIV-1 infected kidney transplant recipients after switch to biktarvy treatment: IMEA 064- KINETIK STUDY

Pharmacokinetics of calcineurin & mTOR inhibitors in HIV-1 infected kidney transplant recipients after switch to BIC/FTC/TAF: a pilot study - KINETIK (KIdNEy Transplant bIKtarvy) IMEA 064 - KINETIK

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-004010-19-FR

Enrollment

Unknown

Registered

2021-08-12

Start date

2021-10-15

Completion date

Unknown

Last updated

2024-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

• HIV-1 infected patients > 18 years • Antiretroviral treatment switch to BIC/FTC/TAF decided in standard care by ID physician • Kidney transplant recipient = 3 months • Receiving calcineurin and/or mTOR inhibitors without change in doses = 4 weeks • Plasma HIV RNA = 50 cpml = 6 months (1 blip permitted 200cp/ml) • eGFR (CKD-EPI) = 30 ml/mn/1.73m2 • Written consent • GSS to BIC/FTC/TAF = 2 • Active contraception in potential child-bearing women

Interventions

Trade Name: BIKTARVY Product Name: BIKTARVY Product Code: TAF/FTC/BIC Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • HIV-1 infected patients > 18 years • Kidney transplant recipient = 3 months • Receiving calcineurin and/or mTOR inhibitors without change in doses = 4 weeks • Plasma HIV RNA = 50 cpml = 6 months (1 blip permitted =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Allergy or intolerance to one of the following drug or to any of excipients: FTC, TDF, INSTI • Current ART containing TAF • HIV-2 or HIV-1/HIV-2 co-infection • Patients with severe hepatic impairment (Child-Pugh Class C) • Patient without health coverage • Pregnancy and breast-feeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Change in calcineurin & mTOR inhibitors’ blood concentrations from BL to W2 after switch to B/F/TAF (ciclosporine, tacrolimus, everolimus);Secondary Objective: • Proportion in calcineurin & mTOR inhibitors’ dose changes from BL to W2 after switch to B/F/TAF • Changes in plasma levels of calcineurin & mTOR inhibitors • B/F/TAF plasma levels • Change in mGFR (iohexol clearance) • Change in bone mineral density and bone markers • Incidence of proximal tubulopathy at W48 • Change in eGFR evaluated with plasma or serum Cystatin C • graft Survival defined as the necessity to return to dialysis, or death • Change in plasma metabolome from BL to W48 • Incidence of Grade =3 adverse events up to Week 48 • Incidence of specific calcineurin inhibitors histological renal damage (if graft biopsy performed for standard care) • Antiretroviral therapy changes during the follow-up through W48 • Calcineurin & mTOR inhibitors’ drug dose changes from BL to W48 • Immuno-virological efficacy • Adherence, HIV Treatment Satisfaction (Satisfactory Questionnaire) up to Week 48 ;Primary end point(s): Change in calcineurin & mTOR inhibitors’ blood concentrations from BL to W2 after switch to BIKTARVY;Timepoint(s) of evaluation of this end point: WEEK 2	—

Measure

Time frame

Main Objective: Change in calcineurin & mTOR inhibitors’ blood concentrations from BL to W2 after switch to B/F/TAF (ciclosporine, tacrolimus, everolimus);Secondary Objective: • Proportion in calcineurin & mTOR inhibitors’ dose changes from BL to W2 after switch to B/F/TAF • Changes in plasma levels of calcineurin & mTOR inhibitors • B/F/TAF plasma levels • Change in mGFR (iohexol clearance) • Change in bone mineral density and bone markers • Incidence of proximal tubulopathy at W48 • Change in eGFR evaluated with plasma or serum Cystatin C • graft Survival defined as the necessity to return to dialysis, or death • Change in plasma metabolome from BL to W48 • Incidence of Grade =3 adverse events up to Week 48 • Incidence of specific calcineurin inhibitors histological renal damage (if graft biopsy performed for standard care) • Antiretroviral therapy changes during the follow-up through W48 • Calcineurin & mTOR inhibitors’ drug dose changes from BL to W48 • Immuno-virological efficacy • Adherence, HIV Treatment Satisfaction (Satisfactory Questionnaire) up to Week 48 ;Primary end point(s): Change in calcineurin & mTOR inhibitors’ blood concentrations from BL to W2 after switch to BIKTARVY;Timepoint(s) of evaluation of this end point: WEEK 2

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Secondary

Measure	Time frame
Secondary end point(s): • Proportion in calcineurin & mTOR inhibitors’ dose changes from BL to W2 after switch to B/F/TAF PK: • Changes in plasma levels of calcineurin & mTOR inhibitors from baseline to week 2, 12, 24 and 48 • B/F/TAF plasma levels at week 4 Safety • Change in mGFR (iohexol clearance) from BL to W48 • Change in bone mineral density and bone markers from BL to W48 • Incidence of proximal tubulopathy at W48 (hypouricemia, hypophosphatemia, low molecular weight proteinuria, orthoglycemic glycosuria, • Change in eGFR evaluated with plasma or serum Cystatin C • graft Survival defined as the necessity to return to dialysis, or death • Change in plasma metabolome from BL to W48 • Incidence of Grade =3 adverse events up to Week 48 • Incidence of specific calcineurin inhibitors histological renal damage (if graft biopsy performed for standard care) • Antiretroviral therapy changes during the follow-up through W48 • Calcineurin & mTOR inhibitors’ drug dose changes from BL to W48 • Immuno-virological efficacy: • Proportion of patients with plasma HIV RNA = 50 cpml at W48 • Change from baseline to W48 of plasma HIV RNA, CD4 cell count, ratio CD4/CD8 • Change in GSS* after switch to B/F/TAF (intervention arm) • proportion of participants with virological failure defined as two consecutive HIV RNA VL>50 copies/mL or a HIV RNA >50 copies/mL followed by a study treatment discontinuation” • Genotypic Susceptibility Score (GSS) to B/F/TAF will be calculated as the sum of active (=1), partially active (=0.5) and inactive (=0) drugs according to drug susceptibility using the latest ANRS HIV-1 drug-resistance algorithm from all the resistance genotyping tests available for each patient • Adherence, HIV Treatment Satisfaction (Satisfactory Questionnaire) up to Week 48 ;Timepoint(s) of evaluation of this end point: Baseline, week2, week 12,week 24 and week 48	—

Measure

Time frame

Secondary end point(s): • Proportion in calcineurin & mTOR inhibitors’ dose changes from BL to W2 after switch to B/F/TAF PK: • Changes in plasma levels of calcineurin & mTOR inhibitors from baseline to week 2, 12, 24 and 48 • B/F/TAF plasma levels at week 4 Safety • Change in mGFR (iohexol clearance) from BL to W48 • Change in bone mineral density and bone markers from BL to W48 • Incidence of proximal tubulopathy at W48 (hypouricemia, hypophosphatemia, low molecular weight proteinuria, orthoglycemic glycosuria, • Change in eGFR evaluated with plasma or serum Cystatin C • graft Survival defined as the necessity to return to dialysis, or death • Change in plasma metabolome from BL to W48 • Incidence of Grade =3 adverse events up to Week 48 • Incidence of specific calcineurin inhibitors histological renal damage (if graft biopsy performed for standard care) • Antiretroviral therapy changes during the follow-up through W48 • Calcineurin & mTOR inhibitors’ drug dose changes from BL to W48 • Immuno-virological efficacy: • Proportion of patients with plasma HIV RNA = 50 cpml at W48 • Change from baseline to W48 of plasma HIV RNA, CD4 cell count, ratio CD4/CD8 • Change in GSS* after switch to B/F/TAF (intervention arm) • proportion of participants with virological failure defined as two consecutive HIV RNA VL>50 copies/mL or a HIV RNA >50 copies/mL followed by a study treatment discontinuation” • Genotypic Susceptibility Score (GSS) to B/F/TAF will be calculated as the sum of active (=1), partially active (=0.5) and inactive (=0) drugs according to drug susceptibility using the latest ANRS HIV-1 drug-resistance algorithm from all the resistance genotyping tests available for each patient • Adherence, HIV Treatment Satisfaction (Satisfactory Questionnaire) up to Week 48 ;Timepoint(s) of evaluation of this end point: Baseline, week2, week 12,week 24 and week 48

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Countries

France

Contacts

Public ContactGALLIEN

Creteil Hospital- Infectious Desease

sebastien.gallien@aphp.frFranc14981443333

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026