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    Summary
    EudraCT Number:2021-002008-11
    Sponsor's Protocol Code Number:IMC-M113V-103
    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:2021-12-10
    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 number2021-002008-11
    A.3Full title of the trial
    An open-label dose-escalation study evaluating the safety, pharmacokinetics and antiviral activity of IMC-M113V in
    HLA-A*02:01 positive subjects with chronic HIV infection who are virologically suppressed
    Estudio abierto de aumento gradual de la dosis para evaluar la seguridad, la farmacocinética y la actividad antivírica de IMC-M113V en sujetos con HLA-A*02:01 positivo con una infección crónica por el virus de la inmunodeficiencia humana (VIH) con supresión vírica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 1/2 study of IMC-M113V in virologically suppressed chronic HIV infection
    Estudio en fase I/II de IMC-M113V sobre la infección crónica por el VIH con supresión vírica
    A.4.1Sponsor's protocol code numberIMC-M113V-103
    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 SponsorImmunocore Limited
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportImmunocore Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationImmunocore, Ltd.
    B.5.2Functional name of contact pointEric Phillips
    B.5.3 Address:
    B.5.3.1Street AddressSix Tower Bridge, 181, Washington Street, Suite 540
    B.5.3.2Town/ cityConshohocken, PA
    B.5.3.3Post code19428
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34676142408
    B.5.6E-maileric.phillips@immunocore.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 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 nameIMC-M113V
    D.3.2Product code IMC-M113V
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNIMC-M113V
    D.3.9.2Current sponsor codeIMC-M113V
    D.3.9.3Other descriptive nameBispecific protein with a high-affinity T cell receptor domain fused to an antibody single-chain variable fragment against CD3
    D.3.9.4EV Substance CodeSUB234644
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.2
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Chronic HIV infection
    Infección crónica por el (VIH)
    E.1.1.1Medical condition in easily understood language
    HIV infection
    Infección (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 PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Part 1: Single Ascending Dose (SAD) Study
    To evaluate the safety and tolerability of M113V when administered as a single dose during ART
    Part 2: Multiple Ascending Dose (MAD) Study
    To evaluate the safety and tolerability of IMC-M113V when administered in a multiple dose schedule, up to at least week 12, in participants receiving ART
    Parte 1: Estudio de dosis única ascendente (DUA)
    Evaluar la seguridad y la tolerabilidad de IMC‐M113V cuando se administra como dosis única durante el TAR
    Parte 2: Estudio de dosis múltiples ascendentes (DMA)
    Evaluar la seguridad y la tolerabilidad del IMC-M113V cuando se administra en una pauta posológica múltiple, hasta al menos la semana 12, en participantes que reciben TAR
    E.2.2Secondary objectives of the trial
    •To characterise the pharmacokinetic (PK) profile of IMC-M113V in single dose and multiple dose schedules
    •To evaluate incidence of anti-IMC-M113V antibody formation following single and multiple infusions.
    •To determine pharmacodynamic changes in the systemic immune response in relation to treatment with IMC-M113V, including but not limited to changes in peripheral cytokines and lymphocyte counts
    •To determine the incidence and duration of post-treatment control during analytical therapy interruption in participants completing multiple dose schedules
    •To determine the recommended Phase 2 dosing regimen
    •Caracterizar el perfil farmacocinético (FC) de IMC-M113V en pautas posológicas monodosis y multidosis
    •Evaluar la incidencia de la formación de anticuerpos anti-IMC-M113V después de infusiones únicas y múltiples
    •Determinar los cambios farmacodinámicos en la respuesta inmunitaria sistémica en relación con el tratamiento con IMC-M113V, incluidos, entre otros, los cambios en las citocinas periféricas y los recuentos de linfocitos
    •Determinar la incidencia y la duración del control posterior al tratamiento durante la interrupción analítica del tratamiento en participantes que completen múltiples pautas posológicas
    •Determinar la pauta posológica recomendada para la fase II
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants are eligible to be included in the study only if all of the following criteria apply:
    Age
    1. 18-65 years inclusive, at time of informed consent HLA
    2. HLA-A*02:01 positive (central laboratory testing) Weight
    3. ≥ 50 kg
    Condition Under Study and Prior Therapy
    4. Documented evidence of HIV-1 infection
    5. On continuous ART for a minimum of 12 months and maximum of 7 years at the time of planned first dose
    6. Plasma HIV RNA < 50 copies/mL at screening and at all available determinations in the 12-month period preceding screening
    7. Current CD4+ T cell count > 500 cells/μL
    8. CD4+ T cell nadir > 200 cells/μL
    Contraception
    9. Participants who engage in sexual activity which could result in pregnancy for themselves or their partner(s) must agree to use highly effective methods of contraception from the trial screening date until 3 months after the final dose of the study intervention or longer if required by local regulations; cessation of contraception after this point should be discussed with a responsible physician. Highly effective methods of contraception are described in Section 10.4.
    a. Participants are not allowed to donate sperm from the time of enrolment until 3 months post-administration of study interventions or longer if required by local regulations.
    b. Participants must refrain from egg donation during the study.
    Informed Consent
    10. Capable of giving signed informed consent as described in Section 10.1, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
    5.1. Criterios de inclusión
    Solo son aptos para inscribirse en el estudio aquellos participantes que cumplan todos y cada uno de los siguientes criterios:
    Edad
    1. Entre 18 y 65 años, ambos inclusive, en el momento de la firma del consentimiento informado
    HLA
    2. HLA-A*02:01 positivo (pruebas de laboratorio central)
    Peso
    3. ≥50 kg
    Afección en estudio y tratamiento anterior
    4. Indicios documentados de infección por el VIH-1.
    5. TAR continuo durante un mínimo de 12 meses y un máximo de 7 años en el momento de la primera dosis planificada
    NOTA: Debe estar tomando una pauta estable sin que se prevea modificar la TAR durante el periodo del estudio.
    6. ARN plasmático del VIH <50 copias/ml en la selección y en todas las determinaciones disponibles en el periodo de 12 meses anteriores a la selección
    NOTA: Se permitirán valores únicos aislados ≥50 y <200 copias/ml si la determinación posterior está por debajo de 50 copias/ml.
    7. Recuento de linfocitos T CD4+ actual >500 células/μl
    8. Nivel más bajo de linfocitos T CD4+ >200 células/μl
    Anticoncepción
    9. Los participantes que tengan una actividad sexual que pueda provocar un embarazo para ellas o sus parejas deben aceptar usar métodos anticonceptivos muy eficaces desde la fecha de selección del ensayo hasta 3 meses después de la última dosis de la intervención del estudio, o durante más tiempo si lo exige la normativa local; el cese de la anticoncepción después de este momento debe consultarse con un médico responsable. Los métodos anticonceptivos muy eficaces se describen en el apartado 10.4.
    a. No se permite que los participantes donen esperma desde el momento de la inscripción hasta 3 meses después de la administración de las intervenciones del estudio o durante más tiempo si así lo exigen las normativas locales.
    b. Las participantes deben abstenerse de donar óvulos durante el estudio.
    Consentimiento informado
    10. Ser capaces de otorgar su consentimiento informado firmado según lo establecido en el apartado 10.1, lo que incluye el cumplimiento de los requisitos y restricciones enumerados en el formulario de consentimiento informado (FCI) y en este protocolo.
    E.4Principal exclusion criteria
    Participants are excluded from the study if any of the following criteria apply:
    Condition Under Study and Prior/Current Antiretroviral Therapy
    1. Known HIV controller: pVL < 2000 copies/mL in absence of ART for at least 12 months and on ≥ 2 determinations.
    2. Initiated ART within 12 weeks of a diagnosis of primary HIV infection, confirmed by any of the following:
    a. Positive HIV-1 serology ≤ 12 weeks after a documented negative HIV-1 antibody (Ab) test,
    b. Negative HIV Ab test plus either positive p24 antigen (Ag) test or detectable HIV RNA,
    c. HIV-1 Ab avidity test consistent with recent infection, or
    d. Weakly reactive or equivocal 4th generation HIV Ab/Ag test.
    3. Prior AIDS-defining condition will preclude participation in Part 1 if diagnosed within 90 days prior to screening. A prior AIDS-defining condition at any time will preclude participation in Part 2.
    4. Individuals receiving an ART regimen containing a non-nucleoside reverse transcriptase inhibitor may not enrol in Part 2 unless willing and able to switch to a short-acting alternative prior to receiving their first dose of study drug.
    Medical Conditions
    5. Co-infection with HBV (defined as positive HBsAg test or detectable HBV DNA) or HCV infection (defined as detectable HCV RNA).
    6. Current active Mycobacterium tuberculosis infection or known untreated latent infection.
    7. History of clinically significant cardiovascular disease or impaired cardiac function, including any of the following:
    a. Congestive heart failure (New York Heart Association Class ≥3).
    b. Uncontrolled hypertension (consistent findings of systolic blood pressure [BP] >160 mmHg or diastolic BP >110 mmHg, as defined in Section 8.5.2).
    c. History of ventricular arrhythmia currently requiring medical treatment or uncontrolled atrial fibrillation.
    d. QTcF > 470 msec on screening electrocardiograms (ECGs) or known history of congenital prolonged QT syndrome.
    e. Acute myocardial infarction or unstable angina pectoris ≤ 6 months prior to screening.
    8. Active autoimmune disease requiring immunosuppressive treatment, including inflammatory bowel disease (ulcerative colitis or Crohn’s disease), within 5 years of screening.
    9. Participants with prior solid organ or bone marrow transplant.
    10. History of malignant disease will preclude participation if diagnosed in the preceding 2 years from the planned first dose of IMC-M113V; in addition, history of systemic virus-associated cancer, including Kaposi’s sarcoma and lymphoma, will preclude participation in Part 2 if diagnosed at any time.
    Prior/Concomitant Therapy
    11. Use of blood products, cytokine therapy or other immunotherapy or immunosuppressive medication in the preceding 3 months from screening.
    12. Current or recent systemic steroid therapy (in the preceding 3 months from screening) or anticipated need for systemic steroids during the study with the following
    exceptions:
    a. Treatment for well-controlled and asymptomatic adrenal insufficiency is permitted, but replacement dosing is limited to prednisone ≤ 12 mg daily or the equivalent.
    b. Local steroid therapies (eg, optic, ophthalmic, intra-articular, or inhaled medications) are acceptable.
    c. Premedication for allergy to contrast reagent.
    Prior/Concurrent Clinical Study Experience
    13. History of any investigational HIV immunotherapy or vaccine within 6 months of screening.
    14. Planned receipt of vaccines: live vaccines are not permitted within 28 days, and nonlive vaccines within 14 days of planned first administration of IMC-M113V.
    Diagnostic Assessments
    15. If any of the following laboratory exclusion criteria are met, then the site may have the participant retested. If a single value is within ±10% of the listed laboratory exclusion criterion value upon retest, and the value is considered not clinically significant by the physician investigator, the participant may be considered for enrolment:
    a. Hemoglobin < 120 g/L for participants assigned male at birth; < 110 g/L for participants assigned female at birth
    b. Platelet count < 150 × 109/L
    c. Alanine aminotransferase (ALT) > 3 × ULN (upper limit of normal)
    d. eGFR41 < 60 mL/min/1.73 m2(calculated using CKD-EPI equation, 2009; or measured)
    Other Exclusions
    16. For subjects enrolling in Part 2, inability or unwillingness to adhere to safer sex practices during ART interruption.
    17. Any medical condition that would, in the investigator’s judgement, interfere with the patient’s participation in the study due to safety concerns, compliance with study procedures or interpretation of study results.
    Se excluirán del estudio aquellos participantes que cumplan cualquiera de los siguientes criterios:
    Afección en estudio y tratamiento antirretrovírico anterior/actual
    1. Controlador del VIH conocido: pVL <2000 copias/ml en ausencia de TAR durante al menos 12 meses y en ≥2 determinaciones.
    2. TAR iniciado antes de 12 semanas tras el diagnóstico de la primoinfección por VIH, confirmada por cualquiera de los siguientes datos:
    a. Seropositividad al VIH-1 ≤12 semanas después de una prueba documentada de anticuerpos (Ac) negativa para el VIH-1.
    b. Prueba negativa de Ac para el VIH más prueba positiva del antígeno p24 (Ag) o ARN del VIH detectable.
    c. Prueba de avidez del Ac para el VIH-1 compatible con una infección reciente.
    d. Prueba de Ac/Ag para el VIH de 4.ª generación débilmente reactiva o equívoca.
    3. Una afección definitoria del SIDA anterior impedirá la participación en la parte 1 si se diagnostica en los 90 días anteriores a la selección. Una afección definitoria del SIDA anterior en cualquier momento impedirá la participación en la parte 2.
    4. Aquellas personas que tomen una pauta de TAR que contenga un inhibidor no nucleosídico de la retrotranscriptasa no pueden inscribirse en la parte 2 a menos que estén dispuestos a, y puedan, cambiar a una alternativa de acción corta antes de recibir la primera dosis del fármaco del estudio. NOTA: Aquellas personas que tomen un agente de acción prolongada que pueda mantenerse activo tras la interrupción de la TAR no pueden inscribirse en la parte 2.
    Enfermedades
    5. Infección concurrente por el VHB (definida como prueba de HBsAg positiva o ADN del VHB detectable) o infección por el VHC (definida como ARN del VHC detectable).
    NOTA: No se excluirá a aquellas personas que hayan experimentado una eliminación espontánea del VHC o que se hayan sometido a un tratamiento curativo del VHC.
    6. Infección actual activa por Mycobacterium tuberculosis o infección latente no tratada conocida.
    7. Antecedentes de enfermedad cardiovascular clínicamente significativa o deterioro de la función cardíaca, incluido cualquiera de los siguientes casos:
    a. Insuficiencia cardíaca congestiva (clase ≥3 según la Asociación de Cardiología de Nueva York (New York Heart Association, NYHA).
    b. Hipertensión no controlada (hallazgos coherentes de tensión arterial [TA] sistólica >160 mmHg o TA diastólica >110 mmHg, como se define en el apartado 8.5.2).
    c. Antecedentes de arritmia ventricular que actualmente requiera tratamiento médico o fibrilación auricular no controlada.
    d. QTcF >470 ms en los electrocardiogramas (ECG) de la selección o antecedentes conocidos de síndrome congénito del QT prolongado.
    e. Infarto agudo de miocardio o angina de pecho inestable ≤6 meses antes de la la selección.
    8. Enfermedad autoinmunitaria activa que requiera tratamiento inmunodepresor, incluida la enteropatía inflamatoria (colitis ulcerosa o enfermedad de Crohn) en los 5 años anteriores a la selección.
    NOTA: No se excluye a participantes con vitíligo, alopecia, hipotiroidismo controlado (con dosis de reemplazo estables), insuficiencia suprarrenal asintomática (con dosis de reemplazo estables), psoriasis, asma/atopía de la infancia resuelta, asma bien controlada y diabetes mellitus de tipo I (HbA1c <7 %).
    9. Participantes con trasplante previo de vísceras macizas o de médula ósea.
    10. Los antecedentes de neoplasia maligna impedirán la participación si se diagnostica en los 2 años anteriores a la primera dosis prevista del IMC-M113V; además, los antecedentes de cáncer asociado a un virus sistémico, incluido sarcoma y linfoma de Kaposi, impedirán la participación en la parte 2 si se diagnostica en cualquier momento.
    Tratamiento previo/concomitante
    11. Uso de hemoderivados, tratamiento con citocinas u otra inmunoterapia o medicación inmunodepresora en los 3 meses anteriores a la selección.
    12. Tratamiento sistémico actual o reciente con esteroides (en los 3 meses anteriores a la selección) o necesidad prevista de esteroides sistémicos durante el estudio, con las siguientes excepciones:
    a. Se permite el tratamiento para la insuficiencia suprarrenal bien controlada y asintomática, pero la administración de la dosis de reemplazo se limita a ≤12 mg de prednisona diarios o su equivalente.
    b. Son aceptables los tratamientos locales con esteroides (p. ej., medicamentos oculares, oftálmicos, intraarticulares o inhalados).
    c. Premedicación por alergia al reactivo de contraste.
    Participación previa/concurrente en estudios clínicos
    13. Antecedentes de cualquier inmunoterapia en fase de investigación para el VIH o vacuna en los 6 meses previos a la selección.
    14. Planificación de vacunación: no se permiten vacunas vivas en los 28 días previos a la primera administración prevista del IMC-M113V, ni vacunas atenuadas en los 14 días previos.

    Ver protocolo para ver mas criterios de exclusion
    E.5 End points
    E.5.1Primary end point(s)
    • Incidence and severity of treatment-emergent adverse events (TEAEs)
    • Incidence of dose-limiting toxicities (DLTs)
    • Changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF)
    • Incidence of serious adverse events (SAEs) and AEs leading to treatment interruption, dose reduction, or discontinuation through 28 days after the last infusion of study treatment
    •Incidencia e intensidad de los acontecimientos adversos surgidos durante el tratamiento (AAST)
    • Incidencia de toxicidades limitantes de la dosis (TLD)
    • Cambios en los parámetros analíticos de seguridad, las constantes vitales y el electrocardiograma (QTcF)
    • Incidencia de acontecimientos adversos graves (AAG) y AA que provoquen la interrupción del tratamiento, la reducción de la dosis o la interrupción del tratamiento hasta 28 días después de la última infusión del tratamiento del estudio
    E.5.1.1Timepoint(s) of evaluation of this end point
    Incidence rates will be used to summarise primary endpoints relating to the incidence of AEs. The denominators for incidence rate calculations will be the Safety Analysis Set (SAF) for participants in the respective part of the study (Part 1, Part 2, ATI) except for summaries of DLTs, which will be based on the SAD DLT evaluable set and MAD DLT evaluable set.
    Numerators will generally be based on TEAEs, which are defined as an AE that occurs after the first dose of investigational product and within 28 days of the last dose of investigational product.
    Las tasas de incidencia se utilizarán para resumir los criterios de valoración primarios relacionados con la incidencia de EA. Los denominadores para los cálculos de la tasa de incidencia serán el conjunto de análisis de seguridad (SAF) para los participantes en la parte respectiva del estudio (Parte 1, Parte 2, ATI) excepto para los resúmenes de DLT, que se basarán en el conjunto evaluable de DLT de SAD y Conjunto evaluable MAD DLT.
    Los numeradores generalmente se basarán en los TEAE, que se definen como un EA que ocurre después de la primera dosis del producto en investigación y dentro de los 28 días posteriores a la última dosis del producto en investigación.
    E.5.2Secondary end point(s)
    •IMC-M113V pharmacokinetics (PK) parameters (eg, AUC, Cmax, Tmax, t1/2) at multiple time points from baseline up to 72 hours post-dose in SAD and MAD (first dose) and after each subsequent dose in MAD studies
    •Incidence of anti-IMC-M113V antibody formation following administration of one or more doses of study drug.
    •Change in serum cytokines/chemokines and peripheral blood lymphocyte counts (absolute values and fold-change) from baseline through 72 hours post-dosing with IMC-M113V in SAD and MAD schedules and during follow-up
    •Proportion of participants with pVL < 200 copies/mL 12 weeks after interruption of ART (W24)
    •Proportion of participants resuming ART before W24
    •Duration of post-treatment control (pVL < 200 copies/mL) after interruption of ART
    •Identification of at least 1 tolerable dosing regimen for further evaluation in subsequent development
    •Parámetros de farmacocinética (FC) de IMC-M113V (p. ej., ABC, Cmáx, Tmáx, t1/2) en diferentes momentos desde el inicio hasta 72 horas después de la dosis con la DUA y las DMA (primera dosis) y después de cada dosis posterior en los estudios de DMA
    •Incidencia de la formación de anticuerpos anti-IMC-M113V después de la administración de una o más dosis del fármaco del estudio
    •Cambio en las citocinas y quimiocinas séricas y en los recuentos de linfocitos en sangre periférica (valores absolutos y factor de cambio) desde el inicio hasta 72 horas después de la administración de la dosis con IMC-M113V en las pautas de DUA y DMA y durante el seguimiento
    •Proporción de participantes con CVp <200 copias/ml 12 semanas después de la interrupción del TAR (S24)
    • Proporción de participantes que reanudan el TAR antes de la S24
    • Duración del control posterior al tratamiento (CVp <200 copias/ml) después de la interrupción del TAR
    •Identificación de al menos 1 pauta posológica tolerable para una evaluación posterior en el desarrollo posterior
    E.5.2.1Timepoint(s) of evaluation of this end point
    •Proportion of participants with pVL < 200 copies/mL 12 weeks after interruption of ART (W24)
    • Proportion of participants resuming ART before W24
    • Duration of post-treatment control (pVL < 200 copies/mL) after interruption of ART
    • Proporción de participantes con CVp <200 copias/ml 12 semanas después de la interrupción del TAR (S24)
    • Proporción de participantes que reanudan el TAR antes de la S24
    • Duración del control posterior al tratamiento (CVp <200 copias/ml) después de la interrupción del TAR
    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 No
    E.6.6Pharmacokinetic Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Antiviral Activity
    Actividad Antiviral
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans Yes
    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 No
    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 No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Spain
    United Kingdom
    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 último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days14
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 53
    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 Decision2022-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-21
    P. End of Trial
    P.End of Trial StatusOngoing
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