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    Summary
    EudraCT Number:2016-003345-29
    Sponsor's Protocol Code Number:3568
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2016-11-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2016-003345-29
    A.3Full title of the trial
    Safety of tenofovir alafenamide (TAF) in patients with a history of tubulopathy on tenofovir disoproxil fumarate (TDF)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety of tenofovir alafenamide (TAF) in patients who developed kidney toxicity while receiving tenofovir disoproxil fumarate (TDF)
    A.3.2Name or abbreviated title of the trial where available
    FANCONI-TAF (FANTA) study
    A.4.1Sponsor's protocol code number3568
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorKings College Hospital NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKings College Hospital NHS Foundation Trust
    B.5.2Functional name of contact pointDr Frank Post
    B.5.3 Address:
    B.5.3.1Street AddressWeston Education Centre (2.53), Cutcombe Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSE5 9RJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number442078485779
    B.5.5Fax number442078485769
    B.5.6E-mailfrank.post@kcl.ac.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Descovy
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Descovy
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HIV infection
    E.1.1.1Medical condition in easily understood language
    HIV infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the renal and bone safety of TAF in patients with a history of tubulopathy/Fanconi syndrome while receiving TDF

    Primary endpoint
    • Between study arm difference in change from baseline to week 12 in retinol-binding protein/creatinine ratio (RBPCR)

    Secondary endpoints

    • Incidence of tubulopathy in the TAF/FTC exposed population (through week 96)
    • Between study arm difference in change from baseline in:
    o Renal function and bone turnover markers (week 4, 12)
    • Change from baseline in the TAF/FTC exposed population:
    o Renal function and bone turnover markers (week 24, 48, 72, 96)
    o Bone mineral density (week 48, 96)
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    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:
    o Proteinuria of ≥1+ on urinary dipstick (or protein/creatinine ratio >30 mg/mmol)
    o Glycosuria of ≥1+ on urinary dipstick
    o Serum phosphate <0.64 mmol/L
    o Rapid 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.
    E.4Principal exclusion criteria
    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)
    E.5 End points
    E.5.1Primary end point(s)
    Between study arm difference in the change from baseline to week 12 in retinol-binding protein/creatinine ratio (RBPCR).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Between baseline and week 12
    E.5.2Secondary end point(s)
    Between study arm differences in changes from baseline in:
    o Estimated glomerular filtration rate (eGFR-CKD-Epi) based on plasma creatinine and cystatin C, fractional excretion of phosphate, fractional excretion of uric acid, fractional excretion of urea, fasting plasma osmolarity, fasting urine osmolarity at weeks 4 and 12
    o Urine albumin/creatinine ratio (ACR), protein/creatinine ratio (PCR), cystatin C/creatinine ratio (CCR), renal phosphate threshold (TmPO4), at weeks 4 and 12 and RBPCR at week 4
    o Alkaline phosphatase (ALP), carboxy-terminal collagen crosslinks (CTx), procollagen type 1 N propeptide (P1NP) and parathyroid hormone (PTH) at week 12
    • Incidence of tubulopathy (Fanconi syndrome) in the TAF/FTC exposed population (through 5 years), and changes from baseline in:
    o eGFR-creatinine and eGFR-cystatin C at weeks 4, 12, 24, 48 and 96, and year 3, 4 and 5
    o ACR, PCR, RBPCR and fractional excretion of phosphate at weeks 4, 12, 24, 48 and 96, and at year 3, 4 and 5
    o ALP, CTx, P1NP, vitamin D (25[OH]D) and PTH at weeks 24, 48 and 96, and at year 3, 4 and 5.
    Bone mineral density (BMD) of the femoral neck, total hip and lumbar spine at weeks 48 and 96, and year 5.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between baseline at weeks 24, 48 and 96, and at year 3, 4 and 5.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned6
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 40
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 40
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 40
    F.4.2.2In the whole clinical trial 40
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None. However, as tenofovir is one of the most important drugs to treat HIV, it is highly likely (costing dependant) that routine NHS care will allow these patients to continue to access TAF/FTC once the study is finished.

    If the drug is not part of routine NHS care attempts should be made to continue to provide TAF/FTC (or similar medications) to participants who wish to stay on this treatment.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-10-14
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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