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    Summary
    EudraCT Number:2018-003880-79
    Sponsor's Protocol Code Number:EBONY
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-003880-79
    A.3Full title of the trial
    Efficacy and safety of the switch from Efavirenz / emtricitabine / tenofovir difumarate taken once daily or alternate days to Bictegravir / emtricitabine / tenofovir alafenamide in HIV + virologically suppressed patients
    Efficacia e sicurezza dello switch da Efavirenz/emtricitabina/tenofovir difumarato assunto una volta al giorno o a giorni alterni a Bictegravir/emtricitabina/tenofovir alafenamide in pazienti HIV+ virologicamente soppressi
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Switch from Efavirenz / emtricitabine / tenofovir difumarate taken once a day or alternate day to Bictegravir / emtricitabine / tenofovir alafenamide in HIV+ patients with suppressed viral load.
    Passaggio da Efavirenz/emtricitabina/tenofovir difumarato assunto una volta al giorno o a giorni alterni a Bictegravir/emtricitabina/tenofovir alafenamide in pazienti HIV+ con carica virale soppressa.
    A.3.2Name or abbreviated title of the trial where available
    EBONY
    EBONY
    A.4.1Sponsor's protocol code numberEBONY
    A.5.4Other Identifiers
    Name:-Number:-
    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 SponsorISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    B.1.3.4CountryItaly
    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 Inc.
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIstituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
    B.5.2Functional name of contact pointUOC Immunodeficienze Virali
    B.5.3 Address:
    B.5.3.1Street AddressVia Portuense 292
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00149
    B.5.3.4CountryItaly
    B.5.4Telephone number0655170546
    B.5.5Fax number0655170477
    B.5.6E-mailimmunodeficienzevirali@inmi.it
    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 Biktarvy
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.1Product nameBiktarvy
    D.3.2Product code [-]
    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.3.8INN - Proposed INNBictegravir
    D.3.9.1CAS number 1611493-60-7
    D.3.9.2Current sponsor code-
    D.3.9.3Other descriptive nameBictegravir
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINA
    D.3.9.1CAS number 143491-57-0
    D.3.9.2Current sponsor code-
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTenofovir alafenamide fumarato
    D.3.9.1CAS number 379270-37-8
    D.3.9.2Current sponsor code-
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Infezione da HIV
    E.1.1.1Medical condition in easily understood language
    HIV infection
    infezione da HIV
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020441
    E.1.2Term Human immunodeficiency virus infection, unspecified
    E.1.2System Organ Class 100000004862
    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 efficacy of switching from EFV/TDF/FTC either QD and on alternate days (ATAD) to BIC/TAF/FTC 48 weeks after switch in total population and comparing patients switching from EFV/TDF/FTC QD vs ATAD.
    Valutare l’efficacia dello switch da EFV/TDF/FTC sia somministrato QD che a gg alterni (ATAD) a BIC/FTC/TAF 48 settimane dopo lo switch nella popolazione totale e confrontando i pazienti che passano da EFV/FTC/TDF QD vs ATAD.
    E.2.2Secondary objectives of the trial
    To evaluate, in total population, the following parameters:
    •safety
    •change in immunological recovery compared to baseline (BL)
    •change in lipid profile compared to BL
    •change in neurocognitive performance compared to BL
    Comparing patients switching from EFV/TDF/FTC QD vs ATAD.

    To evaluate in 3 subgroups (80 patients each) the following substudies:
    • 1st subgroup: to evaluate adherence and quality of life (self-reported questionnaires) (80 patients:40 patients switching from EFV/TDF/FTC QD and 40 switching from EFV/TDF/FTC ATAD)
    • 2nd subgroup: to evaluate bictegravir pharmakocinetic (80 patients)
    • 3rd subgroup: to evaluate the change of renal function, bone mineral density and bone turn-over markers from baseline (80 patients:40 patients switching from EFV/TDF/FTC QD and 40 switching from EFV/TDF/FTC ATAD).
    Valutare, nella popolazione totale, i seguenti parametri:
    • sicurezza
    • modifica dell’assetto immunologico rispetto al baseline (BL)
    • modifica del profilo lipidico rispetto al BL
    • modifica della performance neurocognitiva rispetto al BL confrontando pazienti che effettuano lo switch da EVF/TDF/FTC QD vs ATAD.

    Valutare in 3 sottogruppi, ciascuno di 80 pazienti, i seguenti parametri:
    • 1° sottogruppo: valutazione dell’aderenza e della qualità della vita qualità della vita (autoriportate dal paziente) (80 pazienti: 40 switch da EFV/TDF/FTC QD e 40 switch da EFV/TDF/FTC ATAD)
    • 2° sottogruppo: valutazione della farmacocinetica di Bictegravir (80 pazienti)
    • 3° sottogruppo: variazione della funzionalità renale rispetto al BL e della bone mineral density (BMD) rispetto al BL (80 pazienti: 40 switch da EFV/TDF/FTC QD e 40 switch da EFV/TDF/FTC ATAD).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age > 18 years
    - Stable treatment with EFV/TDF/FTC either QD or ATAD for at least 24 weeks before the screening
    -Virological suppression (HVRNA < 50 cp/mL) for at least 24 weeks before the screening.
    -Historical Genotyping Resistance Test (GRT) without known resistance mutations to any antiretroviral drug class
    - No previous virological failures on INI-based regimens
    - eGFR>50 ml/min
    - Women of childbearing potential must accept the use of one of the following contraceptive methods, from the screening for the duration of the study: Combined hormonal contraceptives associated with ovulation inhibitors (oral, intravaginal, transdermal); progestagogenic hormonal contraceptives associated with an ovulation inhibitor (oral, injectable, implantable); intrauterine devices
    d; intrauterine devices with hormonal release system; bilateral tubal ligation; partner's vasectomy; sexual abstinence (hetero).
    -Men must agree to specified highly effective method of contraception during heterosexual intercourse or practice sexual abstinence from first dose throughout the study period
    - Written informed consent
    -Età> 18 anni
    -Trattamento stabile con EFV / TDF / FTC QD o ATAD per almeno 24 settimane prima dello screening
    - Soppressione virologica (HVRNA <50 cp/mL) per almeno 24 settimane prima dello screening.
    -Test genotipico di resistenza con assenza di mutazioni per qualsiasi classe di farmaci antiretrovirali
    -Assenza di precedenti fallimenti virologici a regimi contenenti INI
    -CrCl=50 mL/min
    -Le donne in età fertile debbono accettare l’utilizzo di uno dei seguenti metodi contraccettivi, a partire dallo screening e per tutta la durata dello studio: Contraccettivi ormonali combinati associati ad inibitori dell’ovulazione (orali, intravaginali, transdermici); contraccettivi ormonali progestinici associati ad un inibitore dell’ovulazione (orale, iniettabile, impiantabile); dispositivi intrauterini
    d; dispositivi intrauterini con sistema di rilascio ormonale; legatura tubarica bilaterale; vasectomia del partner; astinenza (etero) sessuale.
    -gli uomini debbono accettare un metodo contraccettivo altamente efficace specificato durante il rapporto eterosessuale o praticare l'astinenza sessuale dalla prima dose per tutto il periodo di studio
    - Consenso informato scritto
    E.4Principal exclusion criteria
    - Women who are pregnant or breastfeeding
    - HCV co-infection
    - Severe hepatic impairment
    - Known hypersensitivity to the study drug, the metabolites or formulation excipients
    - Presence of an opportunistic infection or an AIDS-defining illness, unless they are directly attributable to the acute seroconversion illness
    - Ongoing malignancy (including untreated carcinoma in-situ) other than basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma.
    - Active, serious infections (other than HIV 1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior the screening.
    - Receipt of immunosuppressive medications or immune-modulators within the past 6 months.
    - Use of pshycoactive substances which can interfere with patients adherence to the prescribed regimen
    - Subjects who do not guarantee an appropriate adherence to the study procedures, according to the investigator’s opinion
    - Enrollement in other clinical trials or pharmacological treatment with sperimental drug within the past 30 days.
    - Inability to express informed consent
    - Donne in gravidanza o in allattamento
    - funzionalità renale con CrCl inferiore a 50 ml / min
    - co-infezione da HCV
    - Precedente fallimento virologico a regimi INI-based
    - Grave insufficienza epatica
    - Ipersensibilità nota al farmaco in studio, ai metaboliti o agli eccipienti presenti nella formulazione
    - Presenza di un'infezione opportunistica o di una malattia AIDS definente, a meno che non siano direttamente attribuibili ad una sieroconversione acuta
    - Neoplasia in atto (incluso carcinoma non trattato in situ) che non sia carcinoma a cellule basali o carcinoma squamoso cutaneo non invasivo asportato.
    -Malattie infettive in atto (diverse dall'infezione da HIV- 1) che richiedono terapia antibiotica o antimicotica per via parenterale entro 30 giorni prima dello screening.
    -Assunzione di farmaci immunosoppressivi o immunomodulatori negli ultimi 6 mesi.
    - Uso di sostanze psicoattive che possano in qualsivoglia maniera interferire con l’aderenza del paziente al regime terapeutico prescritto;
    - Soggetti che, secondo il parere dello sperimentatore, non garantiscano adeguata aderenza allo studio;
    - Partecipazione ad altri trial clinici o trattamento farmacologico con farmaci sperimentali nei 30 giorni precedenti l’ingresso nel protocollo;
    - incapacità a sottoscrivere il consenso informato.
    E.5 End points
    E.5.1Primary end point(s)
    • Number of patients with HIV RNA <50 copies / mL at week 24 (FDA snapshot analysis)
    • Numero di pazienti con HIV-RNA<50 cp/mL alla settimana 24 (FDA snapshot analysis)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    settimana 24
    E.5.2Secondary end point(s)
    • Number of patients with viral rebound (HIV-RNA> 50 cp / mL in two consecutive samples);
    • Number of patients who discontinue treatment for any cause;
    • Number of patients discontinuing toxicity treatment;
    • WHO 3-4 degree of toxicity at any time;
    • Changes from baseline in the number of CD4 T-cells in peripheral blood (absolute number and%) at each visit;
    • Changes to the eGFR baseline (at any time);
    • Changes to the baseline of the lipid profile (total cholesterol, HDL and LDL, triglycerides, total cholesterol / HDL and LDL / HDL ratio) at each visit;
    • Changes to the baseline of neurocognitive functions (neurocognitive assessment NPZ-12) at week 48 and in patients with neuropsychiatric symptoms (self-reported neuropsychiatric symptom questionnaire, Pittsburg Sleep Quality Index, Beck Depression Inventory, Beck Anxiety Inventory) at week 48.
    • Numero di pazienti che presentano rebound virale (HIV-RNA>50 cp/mL in due prelievi consecutivi);
    • Numero di pazienti che discontinuano il trattamento per qualsiasi causa;
    • Numero di pazienti che discontinuano il trattamento per tossicità;
    • WHO grado 3-4 di tossicità a qualsiasi tempo;
    • Modifiche rispetto al baseline del numero di linfociti CD4 T-cells nel sangue periferico (numero assoluto e %) ad ogni visita;
    • Modifiche rispetto al baseline dell’eGFR (a qualsiasi tempo);
    • Modifiche rispetto al baseline del profilo lipidico (colesterolo totale, HDL e LDL, trigliceridi, rapporto colesterolo totale /HDL e LDL/HDL) ad ogni visita;
    • Modifiche rispetto al baseline delle funzioni neurocognitive (neurocognitive assessment NPZ-12) alla settimana 48 ed in pazienti con sintomi neuropsichiatrici (questionario di sintomi neuropsichiatrici autoriportato, Pittsburg Sleep Quality Index, Beck Depression Inventory, Beck Anxiety Inventory) alle settimana 48.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • At each visit -> Number of patients presenting with viral rebound;
    • At each visit -> Number of patients who discontinue treatment for any reason;
    • At each visit -> Number of patients discontinuing toxicity treatment;
    • At each visit -> WHO 3-4 degree of toxicity at any time;
    • At each visit -> Changes from baseline in the number of CD4 T-cells in peripheral blood;
    • At any time -> Changes to the eGFR baseline;
    • At each visit -> Changes to the baseline of the lipid profile at each visit;
    • Week 48 -> Changes to the baseline of neurocognitive functions and in patients with neuropsychiatric symptoms.
    • Ad ogni visita --> Numero di pazienti che presentano rebound virale ;
    • Ad ogni visita --> Numero di pazienti che discontinuano il trattamento per qualsiasi causa;
    • Ad ogni visita --> Numero di pazienti che discontinuano il trattamento per tossicità;
    • Ad ogni visita --> WHO grado 3-4 di tossicità a qualsiasi tempo;
    • Ad ogni visita --> Modifiche rispetto al baseline del numero di linfociti CD4 T-cells nel sangue periferico (numero assoluto e %) ;
    • Ad ogni visita --> Modifiche rispetto al baseline dell’eGFR;
    • Ad ogni visita --> Modifiche rispetto al baseline del profilo lipidico;
    • Alla settimana 48 --> Modifiche rispetto al baseline delle funzioni neurocognitive ed in pazienti con sintomi neuropsichiatrici.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    pilota
    pilot
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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 Information not present in EudraCT
    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
    The trial will end to the clinical center formal closure.
    La sperimentazione si concluderà con la chiusura formale del centro clinico.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 220
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state240
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 240
    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)
    At the end of the clinical trial the patients will be followed at the Institute and will continue the treatment in the form required by the normal clinical practice.
    I pazienti al termine del trattamento sperimentale saranno seguiti presso l' istituto e continueranno il trattamento secondo gli schemi previsti dalla normale pratica clinica.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-17
    P. End of Trial
    P.End of Trial StatusOngoing
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