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    Summary
    EudraCT Number:2020-001029-30
    Sponsor's Protocol Code Number:PENTA22-Viiv212968
    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:2021-08-11
    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 number2020-001029-30
    A.3Full title of the trial
    A multicenter, open-label, single-arm trial to evaluate the safety, pharmacokinetics and antiviral activity of fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected children and adolescents who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class antiretroviral (ARV) resistance
    Ensayo multicéntrico, abierto y con un solo grupo para evaluar la seguridad, la farmacocinética y la actividad antivírica de fostemsavir en combinación con un tratamiento de base optimizado (TBO) en niños y adolescentes infectados por el VIH-1 cuyo tratamiento antirretrovírico combinado (TARc) actual fracasa y que presentan resistencia a antirretrovíricos (ARV) de doble o triple clase
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Use of Fostemsavir in HIV-1 infected children and adolescents with Multi Drug-Resistant virus
    Uso de fostemsavir en niños y adolescentes infectados por el VIH-1 con virus multirresistente
    A.3.2Name or abbreviated title of the trial where available
    SHIELD
    SHIELD
    A.4.1Sponsor's protocol code numberPENTA22-Viiv212968
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04648280
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/040/2019
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFondazione Penta ONLUS
    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 supportViiV Healthcare
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFondazione Penta ONLUS
    B.5.2Functional name of contact pointTiziana Grossele
    B.5.3 Address:
    B.5.3.1Street AddressCorso Stati Uniti 4
    B.5.3.2Town/ cityPadova
    B.5.3.3Post code35127
    B.5.3.4CountryItaly
    B.5.4Telephone number+39345 10 98 481
    B.5.5Fax number+39049 964 0123
    B.5.6E-mailtiziana.grossele@pentafoundation.org
    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 nameFostemsavir
    D.3.2Product code BMS-663068-03/GSK3684934A
    D.3.4Pharmaceutical form 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 INNFOSTEMSAVIR
    D.3.9.2Current sponsor codeBMS-663068-03/GSK3684934A
    D.3.9.4EV Substance CodeSUB183636
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 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 nameFostemsavir
    D.3.2Product code not applicable
    D.3.4Pharmaceutical form 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 INNFOSTEMSAVIR
    D.3.9.3Other descriptive nameFostemsavir
    D.3.9.4EV Substance CodeSUB183636
    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.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 infection in children and adolescents with Multi Drug-Resistant virus
    Infección por VIH-1 en niños y adolescentes con virus multirresistente
    E.1.1.1Medical condition in easily understood language
    HIV-1 infection in children and adolescents who are failing their current combination antiretroviral therapy and have dual- or triple-class antiretroviral resistance
    Infección por VIH-1 en niños y adolescentes que están fracasando con su terapia antirretroviral combinada actual y tienen resistencia a los antirretrovirales de clase doble o triple.
    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 10020447
    E.1.2Term Human immunodeficiency virus type I infection with other conditions
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To evaluate the safety of 24 weeks of treatment with fostemsavir + OBT in HIV-1 infected children and adolescents aged 6 to < 18 years and weighing at least 20kg who are failing their current antiretroviral treatment and have dual- or triple-class ARV resistance.
    - To evaluate the steady-state pharmacokinetics (PK) of temsavir (the active moiety of fostemsavir) in HIV-1 infected children and adolescents.
    • Evaluar la seguridad de 24 semanas de tratamiento con fostemsavir + TBO en niños y adolescentes infectados por el VIH-1 de 6 a < 18 años de edad y que pesan al menos 20 kg cuyo tratamiento antirretrovírico actual fracasa y presentan resistencia a ARV de doble o triple clase.
    • Evaluar la farmacocinética (FC) en estado estacionario de temsavir (el metabolito activo de fostemsavir) en niños y adolescentes infectados por el VIH-1.
    E.2.2Secondary objectives of the trial
    - To evaluate the antiviral activity of fostemsavir + OBT at 24 and 48 weeks in HIV-1 infected children and adolescents.
    - To evaluate the safety of 48 and 156 weeks of treatment with fostemsavir + OBT in HIV-1
    infected children and adolescents.
    - To evaluate HIV-1 disease progression while on fostemsavir + OBT in HIV-1 infected children and adolescents.
    - To evaluate the emergence of ARV resistance
    among HIV-1 infected children and adolescents
    with confirmed virologic failure.
    - To evaluate the efficacy of fostemsavir plus OBT by examining the changes from baseline in CD4+ T cell counts and the percentage of CD4 + T-cells through week 24, 48 and at end of study.
    - To evaluate the acceptability and swallowability of fostemsavir in HIV-1 infected children and adolescents.
    • Evaluar la actividad antivírica de fostemsavir + TBO a las 24 y 48 semanas en niños y adolescentes infectados por el VIH-1.
    • Evaluar la seguridad de 48 y 156 semanas de tratamiento con fostemsavir + TBO en niños y adolescentes infectados por el VIH-1.
    • Evaluar la progresión de la enfermedad del VIH-1 durante el tratamiento con fostemsavir + TBO en niños y adolescentes infectados por el VIH-1.
    • Evaluar la aparición de resistencia a ARV en niños y adolescentes infectados por el VIH-1 con fracaso virológico confirmado.
    • Evaluar la eficacia de fostemsavir más TBO examinando los cambios con respecto a los valores iniciales en la cifra de linfocitos T CD4+ y el porcentaje de linfocitos T CD4+ hasta la semana 24, 48 y el final del estudio.
    • Evaluar la aceptabilidad y la deglutibilidad de fostemsavir en niños y adolescentes infectados por el VIH-1.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Signed Written informed consent
    - Ability to obtain an understood and signed written informed consent from parents/caregivers of the participant, and assent from the participant, when applicable.
    Target Population:
    - Male and female HIV-1 infected pediatric
    participants from 6 years old and weighing at
    least 20 kg to less than 18 years of age.
    - Antiretroviral-experienced with documented
    historical or baseline resistance to one or more
    agents in at least two classes. All resistance has to be properly documented.
    - Failing current antiretroviral regimen with a
    confirmed plasma HIV-1 RNA ≥ 1000 c/mL (first
    value from Investigator within 6 months of
    screening visit, with the second value obtained
    from Screening labs, without a decline greater
    than 1 log10, and no value <1000 in between).
    - Documented resistance to at least one component of the current failing regimen per screening resistance testing.
    - Must have at least 1 fully active and available
    agent in 2 or more ARV classes, based on current and/or documented historical resistance testing, taking into account tolerability, and other safety concerns. At least two fully active agents must be a part of the initial OBT to be paired with FTR.
    - Girls who have reached menarche must have a negative pregnancy test at screening, not be
    breastfeeding, and be willing to adhere to
    effective methods of contraception if sexually
    active. All participants (male or female) have to
    agree with recommendations in Section 8.7.1 for effective contraception.
    • Capacidad para obtener un consentimiento informado por escrito comprendido y firmado de los padres/cuidadores del participante, y aceptación del participante, cuando proceda.
    Población objetivo:
    • Participantes pediátricos infectados por el VIH-1 de ambos sexos a partir de los 6 años de edad, con un peso mínimo de 20 kg, y hasta menos de los 18 años de edad.
    • Participantes con tratamiento anterior con antirretrovíricos con resistencia previa o inicial documentada a uno o más agentes en al menos dos clases. Todas las resistencias deben documentarse debidamente.
    • Fracaso del tratamiento antirretrovírico actual, con ARN del VIH-1 en plasma confirmado ≥ 1000 c/ml (primer valor del Investigador en los 6 meses anteriores a la visita de selección, obteniéndose el segundo valor de los laboratorios de selección, sin un descenso superior a 1 log10, y sin ningún valor < 1000 entre ambos).
    • Resistencia documentada a al menos un componente del tratamiento con fracaso actual según los análisis de resistencia realizados en la selección.
    • Deben tener al menos 1 fármaco totalmente activo y disponible en 2 o más clases de ARV, basándose en los análisis actuales o documentados de resistencia previa, teniendo en cuenta la tolerabilidad y otros problemas de seguridad. Al menos dos agentes totalmente activos deben formar parte del TBO inicial que se debe combinar con FTR.
    • Las chicas que hayan alcanzado la menarquia deben tener un resultado negativo en la prueba de embarazo realizada en la selección, no estar dando el pecho y estar dispuestas a utilizar métodos anticonceptivos eficaces si son sexualmente activas. Todos los participantes (varones o mujeres) deben aceptar las recomendaciones incluidas en el Apartado 8.7.1 para una anticoncepción eficaz.
    E.4Principal exclusion criteria
    Medical History and Concurrent Diseases:
    - Unable to comply with dosing requirements (to
    swallow solid pharmaceutical form of the
    investigational medicinal product)
    - Unable to comply with study visits
    - Presence of a malabsorption syndrome or other
    gastrointestinal dysfunction which might
    interfere with drug absorption or render the
    participant unable to take oral medication.
    - Any clinical condition (including but not limited to recreational drug use) or prior therapy that, in
    the opinion of the Investigator, would make the
    participant unsuitable for the study
    - Pregnancy and breastfeeding

    Physical and Laboratory Test Findings:
    - Chronic untreated Hepatitis B virus (HBV)
    (however, participants with chronic treated HBV or spontaneously remitted HBV are eligible)
    - HIV-2 infection
    - Alanine aminotransferase (ALT) ≥5 times the
    upper limit of normal (ULN), OR ALT ≥3xULN and bilirubin ≥1.5xULN (with>35% direct bilirubin)
    - History of unstable liver disease, decompensated cirrhosis, or known biliary disorder
    - History of congestive heart failure, or
    congenital/acquired prolonged QT
    syndrome/other cardiac diseases predisposing to prolonged QTc
    - Hemoglobin < 8.0 g/dL
    - Platelets < 50,000 cells/mm3
    - Confirmed QTcF value > 450 msec, regardless of sex, at Screening or Day 1
    - Current (defined as taking the medication within 14 days of Day 1) or anticipated treatment with medication considered prohibited or restricted as per Appendix II. Certain medication will be carefully evaluated as acceptable, see Appendix II.
    - Participation in an experimental drug and/or
    HIV-1 vaccine trial(s) within the previous 30 days
    - Child in governmental care, e.g. child is a ward of the state. Note: This criterion does not apply if the child is officially adopted by a family/guardian.
    Antecedentes médicos y enfermedades concurrentes:
    • Incapacidad para cumplir los requisitos de administración (tragar la forma farmacéutica sólida del producto en fase de investigación clínica).
    • Incapacidad para cumplir con las visitas del estudio.
    • Presencia de síndrome de malabsorción u otra disfunción gastrointestinal que pudiera interferir en la absorción del fármaco o hacer que el participante no pueda tomar medicación por vía oral.
    • Cualquier afección clínica (incluido, entre otros, el consumo recreativo de drogas) o tratamiento anterior que, en opinión del investigador, haga que el participante no sea apto para el estudio.
    •Embarazo y lactancia.

    Resultados de las pruebas físicas y analíticas:
    • Infección crónica por el virus de la hepatitis B (VHB) no tratada (sin embargo, los participantes con infección crónica por VHB tratada o VHB con remisión espontánea son aptos).
    • Infección por VIH-2.
    • Alanina aminotransferasa (ALT) ≥ 5 veces el límite superior de la normalidad (LSN) O ALT ≥ 3 × LSN y bilirrubina ≥ 1,5 × LSN (con bilirrubina directa > 35 %).
    • Antecedentes de enfermedad hepática inestable, cirrosis descompensada o trastorno biliar conocido.
    • Antecedentes de insuficiencia cardíaca congestiva o síndrome del intervalo QT prolongado congénito/adquirido u otras enfermedades cardíacas que predispongan a la prolongación del intervalo QTc.
    • Hemoglobina < 8,0 g/dl.
    • Plaquetas < 50 000 células/mm3.
    • Valor confirmado del intervalo QTcF > 450 ms, independientemente del sexo, en la selección o en el día 1.
    • Tratamiento actual (definido como la toma del medicamento en los 14 días anteriores al día 1) o previsto con medicamentos considerados prohibidos o restringidos según el Anexo II. Determinados medicamentos se evaluarán cuidadosamente como aceptables; véase el Anexo II.
    • Participación en un estudio de investigación con fármacos experimentales y/o vacuna contra el VIH-1 en los 30 días anteriores.
    • Niño/a en custodia gubernamental, p. ej., el/la niño/a está tutelado/a por el Estado. Nota: este criterio no se aplica si el/la niño/a ha sido adoptado oficialmente por una familia/tutor legal.
    E.5 End points
    E.5.1Primary end point(s)
    ● Occurrence of the following events through Week 24: adverse events (AEs), treatment-related AEs, AEs of Grade 3 or higher, serious AEs, and AEs leading to premature study treatment discontinuation.
    ● AUC(0-tau), Cmax, Ctau of temsavir across weight bands.
    • Aparición de los siguientes acontecimientos hasta la semana 24: acontecimientos adversos (AA), AA relacionados con el tratamiento, AA de grado 3 o superior, AA graves y AA que provocaron la suspensión prematura del tratamiento del estudio.
    • AUC(0-tau), Cmáx, Ctau de temsavir en las distintas franjas de peso.
    E.5.1.1Timepoint(s) of evaluation of this end point
    ● at each visit through Week 24
    ● At week 1, week 4, week 12, week 24, week 48
    - en cada visita hasta la semana 24
    - A la Semana 1, Semana 4, Semana 12, Semana 24, Semana 48
    E.5.2Secondary end point(s)
    ● Proportion of patients with HIV-1 RNA <50 copies/mL at Week 24 and Week 48 using the Food and Drug Administration (FDA) snapshot algorithm.
    ● Change in log10 HIV-1 RNA from baseline to Week 24 and Week 48
    ● Occurrence of the following events through Week 48 and End of Study: AEs, treatment-related AEs, AEs of Grade 3 or higher, serious AEs, and AEs leading to premature study treatment discontinuation.
    ● Occurrence of new AIDS defining events (Centers for Disease Control Class C events, or WHO 3 or 4 events) or death through end of study visit.
    ● Emergence of genotypic or phenotypic resistance to TMR and components of OBT.
    ● Change in CD4 T-cell count and CD4 T-cell percentage from baseline to Week 24, and Week 48 and End of Study.
    ● Acceptability and swallowability measures.
    • Proporción de pacientes con ARN del VIH-1 < 50 copias/ml en las semanas 24 y 48 utilizando el algoritmo de imagen de la Administración de Alimentos y Medicamentos de los EE. UU. (Food and Drug Administration, FDA).
    •Cambio en el log10 del ARN del VIH-1 desde el inicio hasta la semana 24 y la semana 48.
    • Aparición de los siguientes acontecimientos hasta la semana 48 y el final del estudio: AA, AA relacionados con el tratamiento, AA de grado 3 o superior, AA graves y AA que provocaron la suspensión prematura del tratamiento del estudio.
    • Aparición de nuevos episodios que definen el SIDA (acontecimientos de clase C según los Centros para el Control y la Prevención de Enfermedades de los EE. UU. [Centers for Disease Control, CDC], o acontecimientos de clase 3 o 4 según la OMS) o muerte hasta la visita de final del estudio.
    • Aparición de resistencia genotípica o fenotípica a TMR y componentes del TBO.
    • Cambio en la cifra de linfocitos T CD4 y el porcentaje de linfocitos T CD4 entre el inicio y la semana 24, la semana 48 y el final del estudio.
    • Medidas de la aceptabilidad y la deglutibilidad.
    E.5.2.1Timepoint(s) of evaluation of this end point
    ● At Week 24 and Week 48
    ● From baseline to Week 24 and Week 48
    ● Through Week 48 and End of Study
    ● Through end of study visit.
    ● From baseline to Week 24, and Week 48 and End of Study.
    ● A la Semana 24 y Semana 48
    ● Desde Basal hasta la Semana 24 y Semana 48
    ● Hasta la semana 48 y el final del estudio
    ● Hasta la visita de fin de estudio.
    ● Desde el inicio hasta la semana 24 y desde la semana 48 hasta el final del estudio.
    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 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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    First administration to a pediatric population
    Primera administración a población pediátrica
    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 Yes
    E.8.1.7.1Other trial design description
    Multicéntrico, Abierto, Fase I/II, ensayo de único brazo
    A multicenter, phase I/II open-label, single-arm trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned 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 EEA5
    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
    Mexico
    South Africa
    United States
    Portugal
    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 years4
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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 Yes
    F.1.1Number of subjects for this age range: 60
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 30
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 30
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects who could be not able to give informed written assent/consent as minor
    Sujetos que no pudieron dar su asentimiento/consentimiento informado por escrito como menores
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 35
    F.4.2.2In the whole clinical trial 60
    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)
    After the end of the trial FTR will be provided by ViiV for all children continuing to benefit from the treatment until it is available and recommended for children in their country of residence. Continued provision of OBT will also be provided to participants on a cases by cases basis by ViiV healthcare.
    Una vez finalizado el ensayo, ViiV se proporcionará FTR a todos los niños que continúen beneficiándose del tratamiento hasta que esté disponible y recomendado para los niños en su país de residencia. La provisión continua de OBT también se proporcionará a los participantes caso por caso por parte de ViiV healthcare.
    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 Decision2021-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
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