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    Summary
    EudraCT Number:2020-006102-23
    Sponsor's Protocol Code Number:ImmuneRaRe_RF-2019-12369708
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-07
    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 number2020-006102-23
    A.3Full title of the trial
    Study of a novel combination of immunovirologic and genetic parameters in early-treated HIV-1 patients undergone to antiretroviral therapy interruption (ATI) aimed at defining an algorithm predictive of post-treatment control (PCT)
    Studio di una nuova combinazione di parametri immunovirologici e genetici in pazienti affetti da HIV 1 trattati precocemente e sottoposti ad interruzione della terapia antiretrovirale (ATI) per definire un algoritmo predittivo del controllo post-trattamento (PCT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the genetic, viral and immune response characteristics of a group of patients infected with the AIDS virus treated early and then subjected to suspension of antiretroviral therapy to define biological markers predicting the control of virus replication after pharmacological treatment
    Studio delle caratteristiche genetiche, virali e della risposta immune di un gruppo di pazienti infettati dal virus dell'AIDS trattati precocemente e poi sottoposti a sospensione della terapia antiretrovirale per definire i marcatori biologici predittori del controllo della replicazione del virus dopo trattamento farmacologico
    A.3.2Name or abbreviated title of the trial where available
    ImmuneRaRe_RF-2019-12369708
    ImmuneRaRe_RF-2019-12369708
    A.4.1Sponsor's protocol code numberImmuneRaRe_RF-2019-12369708
    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 SponsorOSPEDALE SAN RAFFAELE
    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 supportMinistero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale San Raffaele
    B.5.2Functional name of contact pointOspedale San Raffaele
    B.5.3 Address:
    B.5.3.1Street AddressVia Olgettina 60
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20132
    B.5.3.4CountryItaly
    B.5.4Telephone number0226433473
    B.5.5Fax number02264337909
    B.5.6E-mailcastagna.antonella1@hsr.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 JULUCA
    D.2.1.1.2Name of the Marketing Authorisation holderVIIV HEALTHCARE BV AIC: 046638019
    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 nameART
    D.3.2Product code [ART]
    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 INNDOLUTEGRAVIR
    D.3.9.2Current sponsor codeART
    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 INNRILPIVIRINA
    D.3.9.2Current sponsor codeART
    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-1 positive subjects treated with effective antiretroviral therapy during the acute phase of HIV-1 infection
    Soggetti sieropositivi a HIV-1 trattati con terapia antiretrovirale efficace durante la fase acuta dell'infezione da HIV-1
    E.1.1.1Medical condition in easily understood language
    People infected with the AIDS virus who have been successfully treated with antiretroviral drugs during the early stage of infection
    Soggeti infettati con il virus dell'AIDS che sono stati trattati con successo coni farmaci antiretrovirali durante la fase precoce dell'infezione
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    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
    Step 1: Investigate a set of immune-genetic and viroimmunologic biomarkers that might be useful to individuate PTC

    Step 2: Validate the Predictive Algorithms of PTC
    Step 1: Indagare una serie di biomarcatori immunogenetici e viro-immunologici che potrebbero essere utili per individuare i pazienti capaci di controllo viremico post-trattamento (PTC)

    Step 2: Convalidare gli algoritmi predittivi della PTC
    E.2.2Secondary objectives of the trial
    Step1: Validation of the immune-genetics platform for the genotyping of KIRs/TRIM22/SNPs regulating HLA-C expression and HLA A-B-C supratyping in a clinical setting

    Step 2: Evaluate the time of HIV-1 plasma load relapse and/or loss of a stable CD4 T-cell count = 350 cells/mm3 occurring in patients subjected to MAP
    Step 1: Validazione della piattaforma di immunogenetica per la genotipizzazione di KIRs/TRIM22/SNPs che regolano l'espressione HLA-C e la sovratipizzazione HLA A-B-C nella gestione dei pazienti nella pratica clinica

    Step 2: Valutare il tempo di rimbalzo del carico plasmatico di HIV-1 e/o la perdita di una conta stabile di cellule T CD4 = 350 cellule/mm3 che si verifica nei pazienti sottoposti alla pausa monitorata di terapia (MAP)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male or female, aged 18-60 years
    Confirmed HIV-1 seropositive documented
    ART commenced during primary HIV infection, as defined by Fiebig stage
    Plasma HIV-RNA < 50 copies/ml for at least 24 months
    CD4+ T cell count > 350 cells/mm3 at the last routine follow-up visit
    No new AIDS-defining diagnosis or progression of HIV-related disease
    Able to adhere to an effective ART regimen for the duration of the study
    Willing and able to give written informed consent for participation in the study
    Maschio o femmina, di età compresa tra i 18 e i 60 anni
    Documentazione di sieropositività confermata di HIV-1
    ART iniziata durante l'infezione primaria da HIV, come definito dalla stadiazione di Fiebig
    Plasma HIV-RNA <50 copie/ml per almeno 24 mesi
    Conteggio delle cellule CD4+ T > 350 cellule/mm3 all'ultima visita di controllo di routine
    Nessuna nuova diagnosi che definisca l'AIDS o la progressione della malattia legata all'HIV
    In grado di aderire ad un efficace regime ART per tutta la durata dello studio
    Disponibilità e capacità di dare il consenso informato scritto per la partecipazione allo studio
    E.4Principal exclusion criteria
    Confirmed HIV-2 seropositive
    Women who are pregnant
    History of systemic cancer, such as Kaposi’s sarcoma and lymphoma, or other virus-associated malignancies and/or history of AIDS-defining illness according to Centers for Disease Control and Prevention criteria
    Active or chronic hepatitis B virus infection, with detectable hepatitis B surface antigen, hepatitis B virus DNA, or both active and chronic hepatitis C virus infection, with detectable virus RNA, and syphilis

    Only Step 2
    Naso-pharyngeal swab positive for SARS-CoV-2
    Sieropositivo confermato HIV-2
    Donne gravide
    Storia di tumori sistemici, come il sarcoma di Kaposi, il linfoma o altri tumori maligni associati al virus e/o
    storia di malattie che definiscono l'AIDS secondo i criteri del CDC.
    Infezione attiva o cronica da virus dell'epatite B, con antigene di superficie rilevabile dell'epatite B, DNA del virus dell'epatite B o infezione sia attiva che cronica da virus dell'epatite C, con RNA del virus rilevabile, e sifilide

    Solo Step 2
    Tampone naso-faringeo positivo per SARS-CoV-2
    E.5 End points
    E.5.1Primary end point(s)
    Step 1: To complete the immune-virologic and immune-genetic profiling of volunteers enrolled in the study and perform all the statistical analysis within the time frame proposed (21 months) before the beginning of the MAP cohort recruitment

    Step 2: Proportion of participants who controlled viremia counts (<50%) and maintained a stable CD4 T-cell count = 350 cells/µl for all the follow-up (6 months) (no CD4 significant drop)
    Step 1: Completare il profilo immuno-virologico e immuno-genetico dei volontari arruolati nello studio ed eseguire tutte le analisi statistiche entro il periodo di tempo proposto (21 mesi) prima dell'inizio del reclutamento della coorte MAP

    Step 2: Percentuale dei partecipanti che hanno controllato il carico viremico (<50%) e mantenuto un conteggio stabile delle cellule T CD4 = 350 cellule/mm3 per tutto il follow-up (6 mesi) (nessun calo significativo di CD4)
    E.5.1.1Timepoint(s) of evaluation of this end point
    STEP 1 - 21 months

    STEP 2 - 6 months
    STEP 1 - 21 mesi

    STEP 2 - 6 mesi
    E.5.2Secondary end point(s)
    Step 2: Proportion of participants who controlled viremia without a significant drop of CD4 T-cell counts (<50%) for = 3 months but <6 months; Step 2: Proportion of individuals in whom ART is reinitiated due to viral rebound (pVL =100000 copies/ml or 2 consecutive pVL =10000 copies/ml 7 days apart), >50% drop in CD4 cell counts, <350 cells/mm3 and/or symptomatic acute retroviral syndrome; Step 2: Proportion of participants who maintained a CD4 T cell count =350 cells but experienced viral rebound; Step 2: Time to viral rebound during MAP; Step 1: To complete the immune-genetics platform set-up and validation on reference samples
    Step 2: Percentuale dei partecipanti che hanno controllato la viremia senza un calo significativo della conta delle cellule T CD4 (<50%) per =3 mesi ma <6 mesi; Step 2: Percentuale di individui in cui la terapia antiretrovirale (ART) viene reintrodotta a causa del rimbalzo virale (carico virale plasmatico = pVL =100000 copie/ml o 2 pVL consecutivi =10000 copie/ml a 7 giorni di distanza l'uno dall'altro), >50% di calo della conta delle cellule CD4, <350 cellule/mm3 e/o sindrome retrovirale acuta sintomatica; Step 2: Percentuale dei partecipanti che hanno mantenuto un numero di cellule T CD4 =350 ma hanno sperimentato un rimbalzo virale; Step 2: Tempo al rimbalzo virale durante la MAP; Step 1: completamento e validazione con campioni di riferimento della piattaforma delle analisi immunogenetiche
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 months; 6 months; 6 months; 10 months; 1 years
    10 mesi; 6 mesi; 6 mesi; 10 mesi; 1 anno
    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 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 Yes
    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 No
    E.8.1.2Open Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Non esiste un comparatore
    There is no comparator
    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 No
    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
    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 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: 100
    F.1.3Elderly (>=65 years) No
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 100
    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)
    will be followed for 6 months with more stringent monitoring than normal clinical practice (every three months) and then as per clinical practice
    verranno seguiti per 6 mesi con un monitoraggio più stringente rispetto alla normale pratica clinica (ogni tre mesi) e poi come da 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 Decision2021-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-10-13
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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