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    EudraCT Number:2019-003614-14
    Sponsor's Protocol Code Number:RAINBOW
    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:2020-10-07
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2019-003614-14
    A.3Full title of the trial
    Feasibility, efficacy and safety of rapid (within 7 days from HIV diagnosis) antiretroviral initiation strategy based on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in HIV-infected naïve individuals presenting with advanced HIV disease
    Fattibilità, efficacia e sicurezza di una strategia di terapia antiretrovirale basata su un inizio rapido (entro 7 giorni dalla diagnosi di HIV) di bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) in una popolazione di persone affette da infezione da HIV, naïve, che si presentano alla diagnosi con uno stadio clinico di malattia avanzata
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rapid ART Initiation with B/F/TAF in HIV people presenting with advanced HIV disease
    Rapido inizio di terapia ART con B/F/TAF nelle persone con HIV che si presentano con uno stadio di malattia da HIV avanzato
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberRAINBOW
    A.5.4Other Identifiers
    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.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 Sicences Inc.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINMI Lazzaro Spallanzani IRCCS
    B.5.2Functional name of contact pointImmunodeficienze Virali
    B.5.3 Address:
    B.5.3.1Street AddressVia Portuense 292
    B.5.3.2Town/ cityRoma
    B.5.3.3Post code00149
    B.5.4Telephone number0655170546
    B.5.5Fax number0655170477
    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. name Biktarvy
    D. of the Marketing Authorisation holderGilead Sicences Inc.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.10 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.3.9.1CAS 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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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 the efficacy and feasibility of a rapid ART starting strategy (within 7 days from HIV diagnosis) based on B/F/TAF as initial regimen in HIV-infected naïve individuals presentating with an advanced HIV disease
    Valutare l’efficacia e la fattibilità di una ART ad inizio rapido (entro 7 giorni dalla diagnosi di infezione da HIV) basata su B/F/TAF come regime iniziale in una popolazione di individui naïve che si presentano alla diagnosi con infezione da HIV in stato avanzato.
    E.2.2Secondary objectives of the trial
    • pure virologic response
    • virologic response determined by ultrasensitive HIV-1 RNA method
    • evolution of HIV-DNA in PBMC
    • emergent drug resistance-associated mutations in participants with protocol-defined virological failure
    • determination of viral co-recettorial tropism at screening
    • change in immunological competence from baseline
    • change in immune activation and inflammation from baseline
    • change in renal function from baseline
    • change in neurocognitive performance and neuropsychiatric status from baseline, excluding patients with neurological involvement from HIV infection or CNS opportunistic infections
    • safety and drug-drug interactions
    • changes of Self- reported adherence and level of therapy satisfaction
    • changes in PROs at BL, week 24 and week 48 (quaily of life assessment), Columbia-suicide severity rating scale, Pittsburgh sleep quality index
    • TDM of Bictegravir
    • risposta virologica
    • risposta virologica determinata mediante la metodica dell’HIV-RNA ultrasensibile
    • evoluzione dell’HIV-DNA in PBMC
    • emergenza di mutazioni nei pazienti che presentano fallimento virologico secondo protocollo
    • determinazione del tropismo co-recettoriale allo screening
    • cambiamento della competenza immunologica rispetto al BL
    • cambiamento nei marcatori di immunoattivazione e infiammazione rispetto al BL
    • cambiamento della funzione renale rispetto al BL
    • Cambiamento delle funzioni neurocognitive e delle condizioni neuropsichiatriche rispetto al BL, con l’esclusione dei pazienti con infezioni opportunistiche che coinvolgono il SNC o con CNS
    • Sicurezza del farmaco ed interazioni farmacologiche
    • Cambiamento nei parametri di aderenza auto-riportata e di soddisfazione della terapia
    • Cambiamento nei PROs al BL, settimana 24 e settimana 48: Columbia-suicide severity rating scale , Pittsburgh sleep quality index e qualità della vita
    • TDM del Bictegravir
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age > 18 years;
    2. Newly diagnosed with HIV-1 infection within 7 days before the enrolment with either:
    a) Confirmed or suspected AIDS defining event at screening (see appendix xx for AIDS defining conditions) or;
    b) Patients with CD4 cell count < 200 µl at the determination closest to the study entry.
    3. Naïve to antiretroviral therapy
    4. Women of childbearing age must accept the use of one of the following contraceptive methods, starting from screening to the end of the study:
    - Combined hormonal contraceptives associated with ovulation inhibitors (oral, intravaginal, transdermal);
    - Progestin hormonal contraceptives associated with an ovulation inhibitor (oral, injectable, implantable);
    - Intrauterine devices;
    - Intrauterine devices with hormonal release system;
    - Bilateral tubal ligation;
    - Vasectomy of the partner;
    - Sexual abstinence (for heterosexual intercourse);
    • Men must accept a highly effective contraceptive method specified during heterosexual intercourse or practice sexual abstinence from the first dose throughout the study period.
    5. Be able to understand and sign a written informed consent;
    1. Età > 18 anni;
    2. Soggetti con neo-diagnosi di HIV che presentino una delle due seguenti caratteristiche, entro 7 giorni dal BL dello studio:
    a) Sospetto o confermato evento AIDS definente alla visita di screening (vedi appendice K per le condizioni AIDS definenti) oppure;
    b) Soggetti con conta di cellule CD4 < 200 µl alla determinazione più vicina all’arruolamento nello studio.
    3. Naïve alla terapia antiretrovirale
    4. Donne fertili devono accettare l’uso ai uno dei seguenti metodi anticoncezionali a partire dallo screening per tutta la durata dello studio:
    - Combinazione di pillola anticoncezionale contenente estrogeni associata ad inibitori dell’ovulazione (via orale, via endovaginale, via transdermica);
    -Combinazione di pillola anticoncezionale contenente progestinici associata ad un inibitore dell’ovulazione (via orale, via endovaginale, via transdermica)
    - dispositivo intrauterino con meccanismo di barriera;
    - dispositivo intrauterino a rilascio ormonale;
    - legatura bilaterale delle tube;
    - vasectomia del partner;
    - astinenza sessuale (for rapporti eterosessuali);
    • Gli uomini devono accettare un metodo anticoncezionale ad alta efficacia (per I rapporti eterosessuali) o praticare l’astinenza sessuale durante il periodo dello studio
    5. Essere in gradi di comprendere e firmare il consenso informato;
    E.4Principal exclusion criteria
    • Pregnant/breastfeeding women, or women who are willing to become pregnant or to breastfeed during study;
    • Impaired renal function defined as CrCl below 30 mL/min according to the CKD-EPI formula;
    • Severe hepatic impairment defined as Child-Pugh Class C;
    • Pulmonary or extrapulmonary active tuberculosis or expected treatment requiring Rifampicin or Rifabutin
    • Meningeal or disseminated cryptococcosis;
    • Known hypersensitivity to the study drug, the metabolites or formulation excipients;
    • Patients not able to subscribe informed consent;
    • Using any concomitant therapy disallowed as per product labelling for the study drugs.
    • Systemic cancer chemotherapy within 30 days prior to the study entry with the exclusion of Kaposi’s sarcoma and lymphomas
    • Donne in gravidanza / allattamento, o donne che sono disposte a rimanere incinta o ad allattare durante lo studio;
    • Funzione renale compromessa definita come CrCl inferiore a 30 ml / min secondo la formula CKD-EPI;
    • Grave compromissione epatica definita come classe C di Child-Pugh;
    • Tubercolosi attiva polmonare o extrapolmonare o trattamento atteso che richiede rifampicina o rifabutina
    • criptococcosi meningea o disseminata;
    • Ipersensibilità nota al farmaco in studio, ai metaboliti o agli eccipienti di formulazione;
    • Pazienti non in grado di sottoscrivere il consenso informato;
    • L'uso di qualsiasi terapia concomitante non è consentito secondo l'etichettatura del prodotto per i farmaci in studio.
    • Chemioterapia per il cancro sistemico entro 30 giorni prima dell'ingresso nello studio con l'esclusione del sarcoma e dei linfomi di Kaposi.
    E.5 End points
    E.5.1Primary end point(s)
    Time-to-clinical or virologic failure, as the first occurrence of any of the following components:
    Virological reasons
    A) failure to achieve virologic response defined as either:
    1. HIV-1 RNA reduction < 1 log10 copies/ml by W12 (confirmed within 2 weeks)
    2. HIV-1 RNA >= 200 copies/mL at or after 24 weeks (confirmed within 2 weeks)
    3. HIV-1 RNA >= 50 copies /ml at W48 (confirmed within 2 weeks)
    B) viral rebound, which is subsequently defined as either:
    1. rebound of HIV-1 RNA to >200 copies/mL after having achieved HIV-1 RNA <50 copies/mL (confirmed within 2 weeks)
    2. rebound of HIV RNA by >1 log 10 copies/mL from nadir value, for patients whose viral load has never been suppressed below 50 copies/mL (confirmed within 2 weeks)
    Clinical reasons
    A) Change of any component of the initial randomized regimen before week 48 because of toxicity or unmanageable drug-drug interactions or IRIS
    B) Death due to any cause
    C) Any new or recurrent AIDS defining event (CDC definition)
    D) Any new serious non-AIDS defining event
    Tempo al fallimento clinico o virologico, definito come il primo tra i seguenti eventi:
    Motivi Virologici
    A) mancato raggiungimento della risposta virologica definita come segue:
    1. riduzione dell’HIV-1 RNA < 1 log10 copie/ml entro la settimana 12 (confermato entro due settimane)
    2. HIV-1 RNA >=200 copie/mL alla settimana 24 o successivamente (confermato entro due settimane)
    3. HIV-1 RNA >= 50 copie /ml alla settimana 48 (confermato entro due settimane)
    B) rebound virale, definito come segue:
    1. incremento HIV-1 RNA >200 copie/mL dopo aver raggiunto HIV-1 RNA <50 copie/mL (confermato entro due settimane) oppure
    2. rebound of HIV RNA di >1 log 10 copies/mL rispetto al nadir di viremia, per un paziente la cui viremia non è mai stata inferiore alle 50 copie/mL (confermato entro due settimane)
    Motivi Clinici
    A) Modifica di almeno un componente della terapia somministrata prima della settimana 48 per la comparsa di tossicità o di interazioni farmacologiche di incompatibilità o IRIS
    B) Morte per qualsiasi motivo
    C) Nuova comparsa o ricorrenza di un evento AIDS
    D) Comparsa di un nuovo evento serio non-AIDS definente
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. by W12 (confirmed within 2 weeks)
    2. a or after 24 weeks (confirmed within 2 weeks)
    3. at W48 (confirmed within 2 weeks)
    1. at any time (confirmed within 2 weeks)
    2. at any time
    Clinical reasons
    A) before week 48
    B) at any time
    C) at any time
    D) at any time
    1. entro W12 (confermata entro 2 settimane)
    2. a o dopo 24 settimane (confermato entro 2 settimane)
    3. alla W48 (confermato entro 2 settimane)
    1. in qualsiasi momento (confermato entro 2 settimane)
    2. in qualsiasi momento
    Ragioni cliniche
    A) prima della settimana 48
    B) in qualsiasi momento
    C) in qualsiasi momento
    D) in qualsiasi momento
    E.5.2Secondary end point(s)
    • Time-to-pure virologic failure, as the first occurrence of any of the following components:
    1. failure to achieve virologic response defined as either:
    - HIV-1 RNA reduction < 1 log10 copies/ml by W12 (confirmed within 2 weeks)
    - HIV-1 RNA > =200 copies/mL at or after 24 weeks (confirmed within 2 weeks)
    - HIV-1 RNA > = 50 copies /ml at any time after W48 (confirmed within 2 weeks)
    • Percentage of subjects with HIV-1 RNA 5 copies/mL at week 48 by ultrasensitive assay
    • Change in total viral HIV-1 DNA in peripheral blood mononuclear cells (PBMCs) at baseline and at w48
    • Assessment of viral co-receptor tropism at screening. If not performed at screening, will be performed at baseline.
    • Proportion of participants developing resistance-conferring mutations (integrase and reverse transcriptase) by genotypic resistance test (GRT) by standard SS technique at screening and ai PDVF.
    • Proportion of viral minority variants (>1% prevalence) harboring resistance associated mutations in reverse transcriptase and integrase by NGS will be at the time of PDVF .
    • Change from baseline in CD4+ T-cells count (absolute and %) and CD4/CD8 ratio in the peripheral blood at any visit
    • Percentage of activated T-cell lymphocyte subset (%CD38+DR+) and monocyte subset (%CD14+CD16+ and %CD14(dim)CD16+), at baseline, week 24 and 48
    • Absolute and percentage values of inflammation and pro-coagulation markers (soluble CD14, soluble CD163, IL-6, D-Dimer, high-sensitivity C-Reactive Protein) at baseline and at week 24 and 48
    • Change in urinary tubular damage markers (alpha-1-microglobulin, beta-2-microglobulin) and albumin-creatinine ratio (ACR), at baseline, 24 and 48 weeks.
    • Change in neurocognitive performance
    • Proportion of patients discontinuing
    • WHO grade 3-4 toxicity at any time
    • Changes of Self- reported adherence and level of therapy satisfaction (HIVTSQ) at week 12, week 24 and week 48
    • Changes in PROs at BL, week 24 and week 48 (quaily of life assessment (SF-12; EQ5D) [Appendix F1, F2], Columbia-suicide severity rating scale (C-SSRS) [Appendix G1-G2], Pittsburgh sleep quality index (PSQI) [Appendix J].
    , Self-reported symptoms (MSAS-SF) [Appendix O].
    • TDM of Bictegravir at week 4, 24, 48.
    • Insufficienza virologica time-to-pure, come prima occorrenza di uno dei seguenti componenti:
    1. mancato raggiungimento della risposta virologica definita come:
    - Riduzione dell'RNA dell'HIV-1 <1 log10 copie / ml dopo W12 (confermata entro 2 settimane)
    - HIV-1 RNA > =200 copie / ml a o dopo 24 settimane (confermato entro 2 settimane)
    - HIV-1 RNA > = 50 copie / ml in qualsiasi momento dopo W48 (confermato entro 2 settimane
    • Percentuale di soggetti con HIV-1 RNA 5 copie / mL alla settimana 48 mediante saggio ultrasensibile
    • Variazione del HIV-1 DNA virale totale nelle cellule mononucleate del sangue periferico (PBMC) al basale e al w48
    • Valutazione del tropismo virale del co-recettore allo screening. Se non eseguito allo screening, verrà eseguito al basale.
    • Proporzione di partecipanti che sviluppano mutazioni che conferiscono resistenza (integrasi e trascrittasi inversa) mediante test di resistenza genotipica (GRT) mediante tecnica SS standard al PDVF.
    • La proporzione di varianti di minoranza virale (> 1% di prevalenza) che ospita mutazioni associate alla resistenza nella trascrittasi inversa e nell'integrasi da parte di NGS sarà al momento della PDVF.
    • Variazione rispetto al basale della conta delle cellule T CD4 + (assolute e%) e del rapporto CD4 / CD8 nel sangue periferico ad ogni visita
    • Percentuale di sottoinsieme di linfociti a cellule T attivati ¿¿(% CD38 + DR +) e sottoinsieme di monociti (% CD14 + CD16 + e% CD14 (dim) CD16 +), al basale, settimana 24 e 48
    • Valori assoluti e percentuali dei marker di infiammazione e pro-coagulazione (CD14 solubile, CD163 solubile, IL-6, D-Dimer, proteina C reattiva ad alta sensibilità) al basale e alla settimana 24 e 48
    • Modifica dei marker di danno tubulare urinario (alfa-1-microglobulina, beta-2-microglobulina) e rapporto albumina-creatinina (ACR), al basale, 24 e 48 settimane.
    • Variazione delle prestazioni neurocognitive
    E.5.2.1Timepoint(s) of evaluation of this end point
    • To See E.2.
    • % of subjects with HIV-1 RNA 5 copies / mL -> at week 48
    • HIV-1 total DNA in mononuclear cells -> at baseline and at w48
    • viral co-receptor tropism -> screening
    • develop. mutations etc. -> at any time of the study
    • viral minority variants etc. -> screening and PDVF
    • T cells and CD4 / CD8 ratio -> at each visit
    • activated T-cell and subset of monocytes -> at baseline, weeks 24 and 48
    • infiamm. and pro-coagulation -> at baseline and at week 24 and 48
    • tubular damage nd rapp. alb-creat -> at baseline, 24 and 48 weeks.
    • neurocognitive perf. -> from baseline to week 48
    • patients discontinuing ->at any time
    • 3-4 toxicity ->at any time
    • Self- rep. adherence ecc. ->at week 12, week 24 and week 48
    • PROs ecc. -> at BL, week 24 and week 48
    • TDM -> week 4, 24, 48.; • V
    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. 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. trial design description
    Pilota, proof of concept, in aperto , braccio singolo
    Pilot, proof of concept, open-label,single-arm
    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 be declared concluded with the closure visit of the clinical center by the CTQT.
    La sperimentazione sarà dichiarata conclusa con la visita di chiusura del centro clinico da parte del CTQT.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    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: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 trial the patients will be followed at the INMI and they will continue the treatment according to the normal clinical practice.
    I pazienti al termine del trial saranno seguiti presso l'INMI 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 Decision2019-11-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-16
    P. End of Trial
    P.End of Trial StatusOngoing
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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