Safety of tenofovir alafenamide (TAF) in patients with a history of tubulopathy on tenofovir disoproxil fumarate (TDF) - FANCONI-TAF (FANTA) study

Kings College Hospital NHS Foundation Trust0 个研究点目标入组 40 人开始时间: 2016年11月15日最近更新: 2024年9月9日

适应症

试验速览

暂无简介。

•Subjects must meet all the following inclusion criteria to be eligible for participation in this study
•Age = 16 years
•Documented HIV-1 antibody test
•Able to give informed consent
•Documented history of TDF-induced acute tubular injury on renal biopsy which was not explained by other factors, or TDF-induced treatment-limiting tubulopathy, defined by at least 2 of the following:
•oProteinuria of =1+ on urinary dipstick (or protein/creatinine ratio >30 mg/mmol)
•oGlycosuria of =1+ on urinary dipstick
•oSerum phosphate <0.64 mmol/L
•oRapid eGFR decline (>5 mL/min/1.73m2/year with >25% reduction from baseline)
•On stable antiretroviral therapy for preceding 6 months
•HIV RNA <200 copies/ml at the most recent visit
•Female patients of child-bearing potential (non-child-bearing potential is defined as 12 months of spontaneous amenorrhea in women = 45 years of age, documented tubal ligation, hysterectomy or bilateral oophorectomy) must agree to use contraception to avoid pregnancy.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•Subjects who meet any of the exclusion criteria must not be enrolled in the study
•Diabetes mellitus
•Dipstick glucose =1+ at screening or baseline
•Dipstick proteinuria >2+ or urine protein-creatinine ratio =100 mg/mmol at screening or baseline
•Estimated glomerular filtration rate (eGFR) <30 mL/min, according to the Cockcroft Gault formula for creatinine clearance (CLcr) mL/min
•Male=((140-age in years)×(weight in kg)×1.23)/(Serum creatinine (in µmol/L)
•Female=((140-age in years)×(weight in kg)×1.04)/(Serum creatinine (in µmol/L)
•Current use of tenofovir (TDF or TAF)
•Screening laboratory parameters > grade 3 (ACTG criteria)
•Current alcohol use (>3 units daily for the past month) or drug dependence which would make the participant unable to comply with the protocol (investigator opinion)
•Significant co-morbidities (investigator opinion)
•Current use of rifamycins (rifampicin or rifabutin)
•Individuals unable or unwilling to comply with the requirements of the study (investigator opinion)

发起方

Kings College Hospital NHS Foundation Trust