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    Summary
    EudraCT Number:2019-002733-10
    Sponsor's Protocol Code Number:Dual-Triple-ART
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-26
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-002733-10
    A.3Full title of the trial
    Exploratory, open-label, randomized clinical trial to assess the efficacy of first-line dual vs. triple antiretroviral therapy (art) in hiv-1 reservoir and in peripheral compartments in hiv-infected patients.
    Ensayo clínico abierto, aleatorizado para evaluar el efecto del tratamiento antirretroviral inicial doble vs.triple en el reservorio del VIH-1 y en tejidos periféricos en pacientes infectados por el VIH-1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Exploratory, open-label, randomized clinical trial to assess the efficacy of first-line dual vs. triple antiretroviral therapy (art) in hiv-1 reservoir and in peripheral compartments in hiv-infected patients.
    Ensayo clínico abierto, aleatorizado para evaluar el efecto del tratamiento antirretroviral inicial doble vs.triple en el reservorio del VIH-1 y en tejidos periféricos en pacientes infectados por el VIH-1.
    A.3.2Name or abbreviated title of the trial where available
    Dual-Triple-ART
    Dual-Triple-ART
    A.4.1Sponsor's protocol code numberDual-Triple-ART
    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 SponsorFUNDACIÓ LLUITA CONTRA LA SIDA
    B.1.3.4CountrySpain
    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 supportViiv Healthcare
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Lluita contra la SIDA
    B.5.2Functional name of contact pointClinical Research Associate
    B.5.3 Address:
    B.5.3.1Street AddressCrta. de Canyet, sn
    B.5.3.2Town/ cityBadalona (Barcelona)
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493497 8414
    B.5.5Fax number+3493465 7602
    B.5.6E-mailafiguerola@fls-rs.com
    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 Tivicay
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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.3.9.3Other descriptive nameDolutegravir Sodium
    D.3.9.4EV Substance CodeSUB35122
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Ireland U
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 INNTENOFOVIR ALAFENAMIDE
    D.3.9.1CAS number 379270-37-8
    D.3.9.4EV Substance CodeSUB121761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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: 3
    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 Lamivudine
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Intl Ltd
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 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 INNLAMIVUDINE
    D.3.9.1CAS number 134678-17-4
    D.3.9.4EV Substance CodeSUB08392MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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 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
    Infección por VIH
    E.1.1.1Medical condition in easily understood language
    HIV infection
    Infección por VIH
    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 LLT
    E.1.2Classification code 10008919
    E.1.2Term Chronic HIV 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
    To compare changes in the HIV-1 reservoir (proviral HIV-1 DNA in CD4+ T cells) from baseline to week 48 between first-line treatment with DTG+3TC versus DTG +FTC/TAF.
    Evaluar el cambio en el reservorio de VIH-1 (VIH ADN proviral en linfocitos CD4+) desde la visita basal hasta la semana 48 de tratamiento comparando tratamiento doble (DTG+3TC) versus triple (DTG +FTC/TAF).
    E.2.2Secondary objectives of the trial
    •To compare the following variables during the study period between the two study arms: Plasma viremia decay.
    - Proportion of participants with HIV-1 RNA in plasma < 50 copies/mL and < 1 copy/mL.
    - Changes in CD4/CD8.
    - Changes in cell-associated HIV-1 RNA in CD4+ T cells.
    - Changes in plasma and cell-associated p24 .
    - Changes in activation (HLA-DR/CD38) and exhaustion (PD-1/TIGIT) markers in different lymphocyte subsets defined by CD3/CD4/CD8/CDR7/CD45RA and CD27 surface markers by multiparametric Flow cytometry.
    - Change in Inflammatory markers (sCD14, CRP, IL-6, IL-10, d-dimer, IP-10, sCD163, LFABP and TRAIL) in plasma.
    •To evaluate DTG, TFV, FTC and 3TC penetration and distribution in peripheral lymph node.
    •To evaluate the longitudinal and spatial association between drug distribution and cell-associated HIV- 1 RNA and DNA expression within peripheral lymph node.
    •To evaluate the resistance-associated mutations in those patients who develop virologic failure.
    •Comparar la evolución temporal de las siguientes variables entre ambos grupos de estudio:
    -Descenso en la carga viral en plasma
    -Proporción de participantes con ARN del HIV en plasma < 50 copias/ml y < 1 copia/ml
    -Cambios en CD4/CD8
    -Cambios en niveles de p24 asociada a células
    -Cambios en los marcadores de activación (HLA-DR/CD38) y de agotamiento (PD-1/TIGIT) en diferentes subconjuntos de linfocitos definidos por los marcadores de superficie CD3/CD4/CD8/CDR7/CD45RA y CD27 por citometría multiparamétrica de flujo
    -Cambios en marcadores inflamatorios (sCD14, CRP, IL-6, IL-10, d-dimer, IP-10, sCD163, LFABP and TRAIL) en plasma
    •Evaluar penetración y distribución de DTG, TFV, FTC y 3TC en el ganglio linfático periférico
    •Evaluar la asociación longitudinal y espacial entre la distribución de los antirretrovirales y la expresión de RNA-HIV y DNA-VIH dentro del ganglio linfático
    •Evaluar las mutaciones de resistencia asociadas a los pacientes que desarrollen fallo virológico
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years.
    2. Documented HIV-1 infection (confirmed by a NAT/PCR test).
    3. Naïve to cART (Pre-exposure prophylaxis with FTC/TDF or TAF/FTC or post-exposure prophylaxis will be allowed if more than 4 weeks before the screening visit).
    4. Willing and able to be adherent to antiretroviral therapy for the duration of the study.
    5. Willing to comply with the requirements of the protocol and available for follow-up for the planned duration of the study.
    6. In the opinion of the principal investigator or designee, the participant has understood the information provided and capable of giving written informed consent.
    7. If female in fertile age and heterosexually active; using an effective method of contraception (hormonal contraception, intra-uterine device (IUD), or anatomical sterility in self or partner*) from 14 days prior to the first study product administration until at least 12 weeks after the last study product administration; all female participants must be willing to undergo urine pregnancy tests at time points specified in the Schedule of Procedures.
    1. Edad ≥18 años.
    2. Infección VIH documentada y confirmada por una prueba PCR.
    3. Sin TAR previo (Se permitirá la profilaxis pre-exposición con FTC/TDF o la profilaxis post-exposición en el caso de que hayan tenido lugar más de 4 semanas antes de la visita de Screening)
    4. Estar dispuesto y ser capaz de tomar el TAR durante toda la duración del estudio.
    5. Estar dispuesto a cumplir con los requisitos del protocolo y acudir a todas las visitas durante el estudio.
    6. En opinión del equipo investigador, el participante ha comprendido la información proporcionada y es capaz de dar su consentimiento informado por escrito
    7. Si mujer en edad fértil y heterosexualmente activa; utilizar un método anticonceptivo eficaz (anticoncepción hormonal, dispositivo intrauterino (DIU) o esterilidad anatómica en sí misma o en la pareja *) desde 14 días antes de su inclusión en el estudio y al menos hasta 12 semanas después del final del estudio; todas las participantes deben estar dispuestas a someterse a pruebas de embarazo en orina en los momentos especificados en el calendario de Procedimientos.
    E.4Principal exclusion criteria
    1. Exposure to any antiretroviral drug within the 4 weeks prior to the screening visit.
    2. HIV-1 RNA in plasma >500,000 copies/mL.
    3. Active AIDS-defining illness within the prior 4 weeks.
    4. Chronic hepatitis B (positive HBsAg).
    5. Chronic hepatitis C (positive IgG HCV confirmed by positive HCV RNA in plasma).
    6. Estimated glomerular filtration rate (eGFR) <50 mL/min.
    7. Advance liver function impairment (Child-Pugh C).
    8. Use of systemic chemotherapy within the 12 months before the screening visit.
    9. Use of systemic corticosteroids during more than 7 consecutive days within the 3 months before the screening visit.
    10. Concomitant treatment with co-medications with known drug-drug interactions with study drugs.
    11. History or clinical manifestations of any physical or psychiatric disorder which could impair the subject’s ability to complete the study.
    12. Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study.
    13. In women, pregnancy or breastfeeding.
    1.Exposición a cualquier medicamento antirretroviral dentro de las 4 semanas previas a la visita de selección.
    2.ARN del VIH-1 en plasma> 500,000 copias / ml.
    3.Enfermedad activa definitoria de SIDA en las 4 semanas previas.
    4.Hepatitis B crónica (HBsAg positivo).
    5.Hepatitis C crónica (IgG HCV positivo confirmado por ARN de HCV positivo en plasma).
    6.Tasa de filtración glomerular estimada (eGFR) <50 ml / min.
    7.Deterioro de la función hepática avanzada (Child-Pugh C).
    8.Uso de quimioterapia sistémica durante los 12 meses previos a la visita de selección.
    9.Uso de corticosteroides sistémicos durante más de 7 días consecutivos durante los 3 meses previos a la visita de selección.
    10.Tratamiento concomitante con fármacos que tengan interacciones relevantes con los medicamentos del estudio.
    11.Historia o manifestaciones clínicas de cualquier trastorno físico o psiquiátrico que pueda afectar la capacidad del participante para completar el estudio.
    12.Cualquier otra tratamiento actual o previo que, en opinión de los investigadores, haga que el individuo no sea adecuado para el estudio o influya en los resultados del mismo.
    13.En mujeres, embarazo o lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    Change in proviral HIV-1 DNA in CD4+ Tcells from baseline to week 48.
    Evaluar cambio en el ADN proviral del VIH en células CD4+ desde la visita basal hasta la semana 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Semana 48
    E.5.2Secondary end point(s)
    1. Comparative dynamics of plasma viremia decay during the study period.
    2. Proportion of participants with HIV-1 RNA in plasma below 50 copies/mL and below 1 copy/mL at 48 weeks.
    3. Changes in the ratio CD4/CD8.
    4. Change in cell-associated HIV-1 RNA in CD4+ T cells from baseline to week 48.
    5. Change in plasma and cell-associated p24 (single molecule assay) from baseline to week 48.
    6. Change in activation (HLA-DR/CD38) and exhaustion (PD-1/TIGIT) markers from baseline to week 48 indifferent lymphocyte subsets defined by CD3/CD4/CD8/CDR7/CD45RA and CD27 surface markers by multiparametric Flow cytometry.
    7. Change in inflammatory markers (sCD14, CRP, IL-6, IL-10, d-dimer, IP-10, sCD163, LFABP and TRAIL) from baseline to week 48.
    8. DTG, TFV, FTC and 3TC penetration and distribution in peripheral lymph node.
    9. Longitudinal and spatial association between drug distribution and cell-associated HIV-1 RNA and DNA expression within peripheral lymph node from baseline to week 48.
    10. Resistance-associated mutations in those patients who develop virologic failure during the study.
    1.Comparación de la dinámica de la carga viral en plasma durante el período de estudio.
    2.Proporción de participantes con ARN del HIV en plasma <50 copias/ml y < 1 copia/ml
    3.Cambios en CD4/CD8
    4.Cambios en el ARN del VIH en células CD4 desde la visita basal a la semana 48
    5.Cambios desde la visita basal hasta la semana 48 en los niveles de p24 asociada a células
    6.Cambios en los marcadores de activación (HLA-DR/CD38) y de agotamiento (PD-1/TIGIT) desde la visita basal hasta la semana 48 en diferentes subconjuntos de linfocitos definidos por los marcadores de superficie CD3/CD4/CD8/CDR7/CD45RA y CD27 por citometría multiparamétrica de flujo.
    7.Cambios en marcadores inflamatorios (sCD14, CRP, IL-6, IL-10, d-dimer, IP-10, sCD163, LFABP and TRAIL) en plasma
    8.Evaluar penetración y distribución de DTG, TFV, FTC y 3TC en el nódulo linfático periférico.
    9.Evaluar la asociación longitudinal y espacial entre la distribución de los antirretrovirales y la expresión de RNA-HIV y DNA-VIH dentro del ganglio linfático desde la visita basal hasta la semana 48.
    10.Evaluar las mutaciones de resistencia asociadas a los pacientes que desarrollen fallo virológico
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48
    Semana 48
    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 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 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) 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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 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
    última visita del último paciente
    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 months20
    E.8.9.1In the Member State concerned days
    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: 44
    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 state44
    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
    Ninguno
    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 Decision2019-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-26
    P. End of Trial
    P.End of Trial StatusOngoing
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