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    Summary
    EudraCT Number:2016-002724-83
    Sponsor's Protocol Code Number:iHIVARNA-01
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-10-18
    Trial results View 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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2016-002724-83
    A.3Full title of the trial
    A phase IIa randomized, placebo controlled, double blinded study to evaluate the safety and immunogenicity of iHIVARNA-01 in chronically HIV-infected patients under stable combined antiretroviral therapy.
    Een fase II gerandomiseerde, placebo gecontroleerde, dubbelblinde studie naar de veiligheid en immunogeniciteit van intranodale vaccinatie met TriMix/mRNA in chronisch HIV geïnfecteerde patiënten tijdens cART
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II vaccination trial in HIV-1 infected subjects
    Fase II vaccinatie studie in HIV-1 geïnfecteerde patiënten
    A.3.2Name or abbreviated title of the trial where available
    iHIVARNA phase II
    iHIVARNA fase II
    A.4.1Sponsor's protocol code numberiHIVARNA-01
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02888756
    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 SponsorErasmus MC
    B.1.3.4CountryNetherlands
    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 supportEuropean Union
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIDIBAPS
    B.5.2Functional name of contact pointHospital Clínic
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number349322754002884
    B.5.6E-mailfgarcia@clinic.cat
    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 No
    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 nameiHIVARNA-01
    D.3.2Product code iHIVARNA-01.3
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTriMix
    D.3.9.3Other descriptive nameMixture of mRNAs of human CD40L, TLR4ca and human CD70
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHIVACAT
    D.3.9.3Other descriptive namemRNA encoding different HIV antigens
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number900
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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 RoleComparator
    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 No
    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 nameTriMix
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralymphatic use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTriMix
    D.3.9.3Other descriptive nameMixture of mRNAs of human CD40L, TLR4ca and human CD70
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntralymphatic use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic HIV-1 infection
    Chronische HIV-1 infectie
    E.1.1.1Medical condition in easily understood language
    Vaccine against HIV-1 infection
    Vaccin tegen HIV-1 infectie
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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
    • safety and tolerability, as measured by the total number of adverse events.
    • immunogenicity of an immunization schedule with HIV-TriMix-mRNA as measured by the increase in frequency of the HIV-specific T-cell responses between baseline and 2 weeks after the last injection as compared to both control groups, immunized with TriMix-mRNA only or WFI only
    veiligheid en verdraagbaarheid gemeten door het totale aantal bijwerkingen
    • immunogeniciteit van een immunisatie schema met HIV-TriMix-mRNA (iHIVARNA-01) om de frequentie van HIV-specifieke T-cel responsen te verhogen tussen baseline en 2 weken na de laatste injectie in vergelijking met de controle groepen, geïmmuniseerd met alleen TriMix-mRNA of alleen WFI.
    E.2.2Secondary objectives of the trial
    • magnitude and kinetics of the HIV-specific CD4+ and CD8+ T cell responses after immunization (ELISPOT, ICS).
    • time until plasma viral rebound after cART interruption at week 6.
    • plasma viral load suppression in vivo after interruption of cART
    • functional cure: proportion of patients with pVL below the lower level of detectability level after cART interruption.
    • primary immune response against vaccine.
    • CD8+ T-cell HIV suppressive capacity.
    • effect on reservoir as measured by proviral DNA and the intracellular viral RNA.
    • viral immune escape
    • host protein mRNA expression profiles in whole blood
    • omvang en kinetiek van de HIV-specifieke CD4+ and CD8+ T cel responsen opgewekt immunisatie s(ELISPOT, ICS).
    • tijd tot virale rebound, na therapie onderbreking (ATI) op week 6,
    • Bepaling van het deel van de patiënten met controle van viral load (ondetecteerbaar) na cART onderbreking.
    • primaire immuunrespons tegen het vaccin.
    • CD8+ T-cel HIV suppressive capaciteit.
    • effect op het reservoir gemeten door proviraal DNA en intracellulair viraal RNA
    • virale immuun escape
    • mRNA expressie profielen van gastheer eiwitten in volbloed
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥ 18 years of age;
    2. Voluntarily signed informed consent;
    3. Proven HIV-1 infection (with documented antibodies against HIV-1 and a detectable plasma HIV-1 RNA before initiation of therapy);
    4. On stable treatment with cART regimen (antiretroviral therapy consisting of at least three registered antiretroviral agents) for at least 3 years;
    5. Nadir CD4+ ≥ 350 cells/μl (up to 2 occasional determinations ≤ 350 cells/μl are allowed);
    6. Current CD4+ cell count ≥ 450 cells/μl;
    7. HIV-RNA below 50 copies/mL in the last 6 months prior to randomization, during at least two measurements (occasional so called ‘blips’ ≤ 500 copies/mL are permitted);
    8. If sexually active, willing to use a reliable method of reducing the risk of transmission to their sexual partners during treatment interruption (including PrEP).
    a. For heterosexually active female, using an effective method of contraception with partner (combined oral contraceptive pill; injectable or implanted contraceptive; IUD/IUS; consistent record with condoms; physiological or anatomical sterility (in self or partner) from 14 days prior to the first vaccination until 4 months after the last vaccination.
    b. For heterosexually active male, using an effective method of contraception with their partner from the first day of vaccination until 4 months after the last vaccination.
    1. ≥ 18 jaar oud;
    2. Vrijwillig ondertekend toestemmingsformulier;
    3. Bewezen HIV-1 infectie (met gedocumenteerde antilichamen tegen HIV-1 en detecteerbaar plasma HIV-1 RNA voor begin van therapie);
    4. Op stabiele behandeling met een cART regime (antiretrovirale therapie bestaande uit ten minste drie geregistreerde antiretrovirale middelen) voor ten minste drie jaar;
    5. Nadir CD4+ ≥ 350 cellen/μl (tot 2 occasionele uitslagen ≤ 350 cellen/μl zijn toegestaan);
    6. Huidig CD4+ cel aantal ≥ 450 cellen/μl;
    7 HIV-RNA onder 50 kopieën/mL in de laatste 6 maanden voorafgaand aan randomisatie, tijdens ten minste twee bepalingen (occasionele zogenaamde ‘blips’ ≤ 500 kopieën/mL zijn toegestaan)
    8. Indien seksueel actief, bereidheid tot het gebruik van een betrouwbare methode voor het reduceren van het risico van transmissie naar de seksuele partner tijdens de onderbreking van de cART behandeling (inclusief PrEP)
    a. Voor heteroseksueel actieve vrouwen, het gebruik van een effectieve methode van contraceptie met de partner (gecombineerde orale contraceptie pil, geïnjecteerde of geïmplementeerde contraceptie, consistent gebruik van condooms, fysiologische of anatomische steriliteit (zelf of van partner) vanaf 14 dagen voor de eerste vaccinatie tot vier maanden na de laatste vaccinatie.
    b. Voor heteroseksueel actieve mannen, gebruik van een effectieve voor contraceptie met hun partner vanaf de eerste dag van vaccinatie tot vier maanden na de laatste vaccinatie.
    E.4Principal exclusion criteria
    1. Treatment with non-cART regimen prior to cART regimen;
    2. Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy;
    3. Non-subtype B HIV infection;
    4. Active Hepatitis B virus and/or Hepatitis C virus co-infection;
    5. History of a CDC class C event (see appendix A);
    6. Pregnant female (screened with a positive pregnancy test), lactating or intending to become pregnant during the study;
    7. Active malignancy ≤ 30 days (extended period on the clinical assessment of the investigator) prior to screening;
    8. Active infection with fever (38°C or above) ≤ 10 days of screening and/or first vaccination;
    9. Therapy with immunomodulatory agents (e.g. systemic corticosteroids), including cytokines (e.g. IL-2), immunoglobulins and/or cytostatic chemotherapy ≤ 90 days prior to screening. This does not include seasonal influenza, hepatitis B and/or other travel related vaccines;
    10. Congenital, acquired or induced coagulation disorders, such as thrombocytopenia (thrombocytes < 150x109/L) and/or current use of anti-coagulant medication (e.g. coumarins, inhibitors of Xa); Usage of NSAIDs (including acetylsalicylic acid) is allowed, however it is advised to interrupt therapy 10 days ahead of vaccination;
    11. Usage of any investigational drug ≤ 90 days prior to study entry;
    12. An employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, or is a family member of an employee or the investigator
    13. Any other condition, which, in the opinion of the investigator, may interfere with the evaluation of the study objectives
    1. Behandeling met niet-cART regime voorafgaand aan cART regime;
    2. Eerder falen op antiretrovirale therapie en/of mutaties die resistentie tegen antiretroviral therapie geven;
    3. Niet-subtype B HIV infectie;
    4. Eerdere HIV vaccinatie behandeling;
    5. Actieve Hepatitis B virus en/of Hepatitis C virus co-infectie;
    6. Geschiedenis van een CDC class C voorval;
    7. Zwangere vrouw (bewezen met een positieve zwangerschapstest), borstvoeding gevend of de intentie om zwanger te worden tijdens de studie;
    8. Actieve infectie (38°C of hoger) ≤ 10 dagen voorafgaand aan de screening visite en/of eerste vaccinatie;
    9. Therapie met immunomodulatoire agentia (bijv. systemische corticosteroïden), inclusief cytokinen (bijv. IL-2), immunoglobulinen en/of cytostatische chemotherapie ≤ 90 dagen voor screening. Dit omvat niet de seizoensgriep, hepatitis B en/of andere reis gerelateerde vaccins;
    10. Congenitale, verworven of geïnduceerde stollingsafwijkingen, zoals thrombocytopenie (thrombocyten < 150x109/L) en/of huidig gebruik van anti-coagulant medicatie (bijv. coumarinen, remmers van Xa); Gebruik van NSAID (inclusief acetylsalicylzuur) is toegestaan, maar het wordt geadviseerd deze behandeling 10 dagen voor vaccinatie te onderbreken;
    11. Gebruik van enig ander onderzoeksgeneesmiddel ≤ 90 days voorafgaand aan studie entree;
    12. Een werknemer van de onderzoeker of onderzoeksplek, met directe betrokkenheid bij de voorgestelde studie of andere studies onder leiding van de onderzoeker of studieplek of een familielid van een werknemer van de onderzoeker
    13. Enige andere gesteldheid die naar mening van de onderzoeker de evaluatie van de studiedoelen kan beïnvloeden.
    E.5 End points
    E.5.1Primary end point(s)
    • safety and tolerability, as measured by the total number of adverse
    events.
    • immunogenicity of an immunization schedule with HIV-TriMix-mRNA
    as measured by the increase in frequency of the HIV-specific T-cell
    responses between baseline and 2 weeks after the last injection as
    compared to both control groups, immunized with TriMix-mRNA only or WFI only
    • veiligheid en verdraagbaarheid gericht op de aard, frequentie en ernst van lokale adverse voorvallen en systemische bijwerkingen
    • immunogeniciteit van een immunisatie schema met HIV-TriMix-mRNA (iHIVARNA-01) om de frequentie van HIV-specifieke T-cel responsen te verhogen tussen baseline en 2 weken na de laatste injectie in vergelijking met de controle groepen, geïmmuniseerd met alleen TriMix-mRNA of alleen WFI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Safety will be reported 6 weeks after the first vaccination.

    Immunogenicity will be determined by an Elipsot assay at week 6, two
    week after the last vaccination
    Veiligheid wordt gemeten 6 weken na de eerste vaccinatie

    Immunogeniciteit wordt gemeten op 6 weken, twee weken na de laatste vaccinatie
    E.5.2Secondary end point(s)
    • magnitude and kinetics of the HIV-specific CD4+ and CD8+ T cell responses after immunization (ELISPOT, ICS).
    • time until plasma viral rebound after cART interruption at week 6.
    • plasma viral load suppression in vivo after interruption of cART
    • functional cure: proportion of patients with pVL below the lower level of detectability level after cART interruption.
    • primary immune response against vaccine.
    • CD8+ T-cell HIV suppressive capacity.
    • effect on reservoir as measured by proviral DNA and the intracellular viral RNA.
    • viral immune escape
    • host protein mRNA expression profiles in whole blood
    storage of samples for future determining gut microbiota composition
    and diversity in relation to HIV immune status
    • Evaluatie van de omvang en kinetiek van de HIV-specifieke CD4+ and CD8+ T cel responsen opgewekt door het immunisatie schema in de 3 groepen, m.b.v. twee methodes (ELISPOT, intra-cellulaire cytokine kleuring - ICS).
    • Evaluatie van het vermogen van het immunisatie schema om de tijd tot virale rebound, na therapie onderbreking (ATI) op week 6, te verlengen.
    • Evaluatie van het suppressieve effect op plasma viral load in vivo na ATI van W6 tot W18 in vergelijking met twee controle groepen, die alleen TriMix of alleen WFI krijgen toegediend.
    • Bepaling van het deel van de patiënten met controle van virale load below (ondetecteerbaar) 12 and 24 weken nar start ATI (functional cure).
    • Evaluatie van het percentage patiënten die een primaire immuun respons heeft ontwikkeld tegen eerder niet herkende HIV peptiden.
    • Analyze van de inductie of versterking van de CD8+ T-cel HIV suppressive capaciteit.
    • Evaluatie van het effect op het reservoir gemeten door proviraal DNA en intracellulair viraal RNA (niet gespliced en multiple spliced viraal RNA).
    • Detectie van virale immuun escape d.m.v. sequencing van HIV en het uitvoering van zeef effect analyses op virus dat terugkomt na cART onderbreking.
    • Evaluatie van de gastheer eiwit mRNA expressie profielen in volledig bloed bij baseline en W6 en W18.
    • Opslag van samples voor toekomstige bepaling van darm microbiota samenstelling en diversiteit in relatie tot HIV immuun status.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary end point will be determined after the analytical treatment
    interruption 18 and 30 weeks after the first vaccination.
    De secundaire endpoints worden gemeten na de analytical treatment interruption (ATI), 18 en 30 weken na de eerste vaccinatie
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    TriMix combinación (adjuvante)
    TriMix stimulatory mix (cf adjuvants alone)
    E.8.2.4Number of treatment arms in the trial3
    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 concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    Laatste visite van laatste patiënt
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days23
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days23
    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: 70
    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 state14
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    Not different from normal HIV cART treatment
    Niet anders dan normale HIV behandeling met cART
    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 Decision2016-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-02
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