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    Summary
    EudraCT Number:2014-002632-14
    Sponsor's Protocol Code Number:ODYSSEY(PENTA20)
    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:2016-01-13
    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 number2014-002632-14
    A.3Full title of the trial
    A randomised trial of dolutegravir (DTG)-based antiretroviral therapy vs. standard of care (SOC) in children with HIV infection starting first-line or switching to second-line ART
    Ensayo aleatorizado de tratamiento antirretroviral con dolutegravir (DTG) comparado con el tratamiento estándar (TE) en niños con infección VIH que inician tratamiento de primera línea o de segunda línea
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomised trial of dolutegravir (DTG)-based antiretroviral treatment vs standard of care (SOC) in children with HIV infection starting first treatment or switching to second-line antiretrovirals
    Ensayo aleatorizado de tratamiento antirretroviral con dolutegravir (DTG) comparado con el tratamiento estándar (TE) en niños con infección VIH que inician tratamiento de primera línea o de segunda línea
    A.3.2Name or abbreviated title of the trial where available
    ODYSSEY (Once daily DTG-based ART in young people vs standard therapy)
    A.4.1Sponsor's protocol code numberODYSSEY(PENTA20)
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN91737921
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02259127
    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 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 Ltd
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportFondazione PENTA ONLUS
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital doce de Octubre / PENTA
    B.5.2Functional name of contact pointPablo Rojo
    B.5.3 Address:
    B.5.3.1Street Addressav Andalucia S/n - Servicio de Pediatria/Seccion de Infectologia Pediatrica
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.4Telephone number0034913908569
    B.5.5Fax number0034913908772
    B.5.6E-mailpablo.rojo@salud.madrid.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 Yes
    D.2.1.1.1Trade name Tivicay 50mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderViiv Healthcare UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTivicay (dolutegravir) 50mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDolutegravir (as sodium)
    D.3.9.1CAS number 1051375-19-9
    D.3.9.2Current sponsor codeGSK1349572
    D.3.9.4EV Substance CodeAS1
    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 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 nameDolutegravir 25mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    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 (as sodium)
    D.3.9.1CAS number 1051375-19-9
    D.3.9.2Current sponsor codeGSK1349572
    D.3.9.4EV Substance CodeAS5
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 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 nameDolutegravir 10mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Yes
    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 (as sodium)
    D.3.9.1CAS number 1051375-19-9
    D.3.9.2Current sponsor codeGSK1349572
    D.3.9.4EV Substance CodeAS7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 4
    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 Triumeq 50mg/600mg/300mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTriumeq 50mg/600mg/300mg
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDolutegravir (as sodium)
    D.3.9.1CAS number 1051375-19-9
    D.3.9.2Current sponsor codeGSK1349572
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAbacavir (as sulphate)
    D.3.9.1CAS number 188062-50-2
    D.3.9.4EV Substance CodeAS3
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 CodeAS4
    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
    Paediatric HIV infection
    Infección por el VIH en la población pediátrica
    E.1.1.1Medical condition in easily understood language
    Paediatric HIV infection
    Infección por el VIH en la población pediátrica
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    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
    To evaluate whether treatment with DTG works as well as the standard anti-HIV treatment in children.
    Evaluar si el tratamiento con DTG funciona como el tratamiento estándar VIH en los niños
    E.2.2Secondary objectives of the trial
    ? To evaluate if treatment with DTG is better in terms of safety than standard anti-HIV treatment in children.
    ? To compare the adherence to treatment and the quality of life of children receiving DTG to those receiving standard anti-HIV treatment.
    ? Evaluar si el tratamiento con DTG es mejor en términos de seguridad que el tratamiento estándar VIH en los niños.
    ? Comparar la adherencia del tratamiento y la calidad de vida de los niños que reciben DTG en comparación con los que reciben el tratamiento VIH estándar.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic substudy in participants developing TB while on DTG: To confirm DTG dosing in children receiving concomitant rifampicin for the treatment of TB. This substudy will be carried out in regions where TB is prevalent (ie not in Spain).

    Immunology/virology substudy: To compare mechanisms of CD4 reconstitution, immune activation and HIV reservoir and replication in DTG vs SOC arms.
    Estudio farmacocinética en participantes que desarrollen TB durante su tratamiento con DTG:
    Se confirmarán las dosis de DTG en los niños que reciben tratamiento concomitante con rifampicina para la TB. Se realizará este estudio en los regiones donde la TB es prevalente (no en España).
    E.3Principal inclusion criteria
    ? Children <18 years with confirmed HIV-1 infection and DTG dose known for child?s age/weight-band*
    ? Parents/carers and children, where applicable, give informed written consent
    ? Girls who have reached menses must have a negative pregnancy test at screening and randomisation and be willing to adhere to effective methods of contraception if sexually active
    ? Children with co-infections who need to start ART can be enrolled into ODYSSEY according to local/national guidelines
    ? Parents/carers and children, where applicable, willing to adhere to a minimum of 96 weeks' follow-up

    *Recruitment will start from children aged ?6 and<18 years for whom dosing information and formulations are currently available. Additional formulations for younger children will become available during the trial and dosing information will be updated.

    Additional criteria for ODYSSEY A:
    ? Planning to start first-line ART

    Additional criteria for ODYSSEY B:
    ? Planning to start second-line ART defined as switch of at least 2 ART drugs due to treatment failure
    ? Treated with only one previous ART regimen. Single drug substitutions for toxicity are allowed.
    ? At least one NRTI with predicted preserved activity available for a background regimen
    ? In settings where resistance tests are routinely available, at least one new active NRTI from tenofovir, abacavir or zidovudine should have preserved activity based on cumulative results of resistance tests within 3 months
    ? In settings where resistance tests are not routinely available, children who are due to switch according to national guidelines should have at least one new NRTI available from tenofovir, abacavir or zidovudine
    ? Viral load >1000 c/ml at screening visit
    ? Menores <18 años infectados con VIH y a los que se le conoce la dosis de DTG apropiada a su categoría de edad/peso*
    ? Padres/guardianes de los niños, según los requisitos, han dado su consentimiento expreso por escrito
    ? Las niñas que hayan tenido su primera menstruación deben tener un test negativo de embarazo en el momento de la visita de selección y en la visita de asignación aleatoria. Si son sexualmente activas, han de comprometerse a usar métodos de anticoncepción efectivos.
    ?Los niños con otras infecciones adicionales que tienen que empezar una terapia TAR pueden ser incluidos en ODYSSEY si se ajusta a las normas locales/nacionales.
    ?Los padres/guardianes y los niños, según los requisitos, han de comprometerse a un seguimiento de al menos 96 semanas.
    *El alistamiento debe de ser de niños entre 6 y 18 años para los que existen recomendaciones de dosis y fármacos. Para los niños más jóvenes, nuevas formulaciones y posologías estarán disponibles a lo largo del estudio y se irán actualizando.

    Criterio adicional para ODYSSEY A:
    ?Van a iniciar terapia TAR de primera línea.

    Criterios adicionales para ODYSSEY B:
    ?Con intención de comenzar TAR de segunda línea definido como un cambio de más de dos medicamentos TAR debido a un fracaso terapéutico.
    ?Sólo ha sido tratado anteriormente con una terapia TAR. Están permitidas substituciones de un único compuesto por razones de toxicidad o simplificación del tratamiento.
    ?Existe al menos un NRTI que se supone mantendrá su actividad en caso de su uso como medicamento en la terapia de base.
    ?En situaciones en las que existan pruebas de resistencia farmacológica rutinarias, al menos un NRTI activo de entre TDF, ABC o ZDV ha de haber mantenido su actividad según las pruebas de resistencia acumuladas durante los tres meses anteriores
    ?En situaciones en las que no existan pruebas de resistencia farmacológica rutinarias, los niños que estén en situación de cambiar de terapia según la normativa nacional vigente, deberán de optar por un nuevo NRTI de entre TDF, ABC o ZDV.
    ?Carga Viral >1000 c/ml en la visita de selección.
    E.4Principal exclusion criteria
    ? History or presence of known allergy or some other contraindication to the study drugs or their components
    ? Alanine aminotransferase (ALT) ?5 times the upper limit of normal (ULN), OR ALT ?3xULN and bilirubin ?2xULN
    ? Patients with severe hepatic impairment or unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones)
    ? Anticipated need for Hepatitis C virus (HCV) therapy during the study
    ? Pregnancy or breastfeeding
    ? Evidence of lack of susceptibility to integrase inhibitors or more than a 2-week exposure to antiretrovirals of this class
    ? Contraindications to proposed available NRTI backbone.
    ? Historial o presencia de reacciones alérgicas conocidas o cualquier otra contraindicación a los fármacos del ensayo o a alguno de sus compuestos.
    ? Valores de ALT ?5 veces el valor máximo normal (VMN), o ALT ?3xVMN y bilirrubina ?2xVMN
    ? Pacientes con deficiencia hepática severa o una enfermedad hepática inestable (definida como la presencia de ascitis, encefalopatía, coagulopatía, hipoalbuminemia, varices gástricas o esofágicas, o ictericia persistente) o anormalidades biliares conocidas (con la excepción del síndrome de Gilbert o cálculos asintomáticos)
    ? Se prevé la necesidad de administrar un tratamiento contra el virus de la Hepatitis C.
    ? Embarazo o lactancia
    ? Evidencias de una falta de susceptibilidad a los inhibidores de integrasa o cuando han sido expuestos a antirretrovirales de esta clase durante más de dos semanas.
    ? Contraindicaciones a los NRTI sugeridos para la terapia de base
    E.5 End points
    E.5.1Primary end point(s)
    Difference in the probability of virological or clinical failure at 96 weeks, estimated by Kaplan-Meier methods, using time to the first occurrence of any of the following components:
    ? Insufficient virological response defined as <1 log10 drop at week 24
    ? Viral load >400 c/ml at or after 36 weeks confirmed by next visit
    ? Death due to any cause
    ? Any new or recurrent AIDS defining event (WHO 4) or severe WHO 3 events, confirmed by the Endpoint Review Committee
    Diferencia en la proporción de resultados fallidos (clínicos o virales) a las 96 semanas, calculados como la primera vez que se detectan uno de los siguientes casos :
    ?Respuesta viral insuficiente definida como una disminución <1 log10 en la semana 24
    ?Carga viral >400 c/ml a partir de las 36 semanas con confirmación en la visita posterior
    ?Defunción por cualquier causa
    ?Un acontecimiento definitorio de SIDA (OMS 4) o OMS 3 severo, asignado por el comité de revisión de eventos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    96 weeks
    96 semanas
    E.5.2Secondary end point(s)
    Secondary efficacy outcomes:
    ? Difference in proportion with clinical or virological failure (as defined above) over 48 weeks.
    ? Time to any new or recurrent AIDS defining event (WHO 4) or severe WHO 3 events, confirmed by the Endpoint Review Committee
    ? Proportion of children with VL ?50 c/ml at 48 and 96 weeks
    ? Proportion of children with VL ?400 c/ml at 48 and 96 weeks
    ? Rate of clinical events over 96 weeks: WHO 4, severe WHO 3 events and death
    ? Change in CD4 count and percentage and CD4/CD8 ratio from baseline to weeks 48 and 96
    ? Proportion developing new resistance mutations with a subgroup analysis according to the activity of the background regimen

    Secondary safety outcomes:
    ? Change in total cholesterol, triglycerides and lipid fractions (LDL, HDL) from baseline to weeks 48 and 96. These safety outcomes will be used to formally assess superiority of DTG based regimen vs. SOC
    ? Incidence of serious adverse events
    ? Incidence of new clinical and laboratory grade 3 and 4 adverse events
    ? Incidence of adverse events (of any grade) leading to treatment modification

    Other secondary outcomes:
    ? Quality of life
    ? Adherence and acceptability
    Medidas secundarias con respecto a la eficacia:
    ? Diferencias en la proporción de resultados fallidos clínicos o virales (definidos con anterioridad) en un plazo de 48 semanas
    ? Tiempo en el que aparece un acontecimiento definitorio de SIDA (OMS 4) o OMS 3 severo después de 24 semanas desde la aleatorización, adjudicado por el comité de revisión de eventos.
    ? Proporción de niños con una disminución de la CV <50 c/ml en las semanas 48 y 96
    ? Proporción de niños con una disminución de la CV <400 c/ml at 48 and 96 semanas
    ? Frecuencia de acontecimientos clínicos durante 96 semanas: OMS 4, OMS 3 severos y defunciones
    ? Cambios en el recuento CD4 y en el porcentaje con respecto al valor base en las semanas 48 y 96
    ? Cambios en la tasa CD4 / CD8 con respecto al valor inicial en las semanas 48 y 96
    ? Proporción de niños que desarrollan nuevas mutaciones resistentes en aquellos con cargas virales >1000 c/ml

    Medidas secundarias con respecto a la seguridad:
    ? Cambios en colesterol total, triglicéridos y fracciones de lípidos (LDL, HDL en sus siglas en inglés) con respecto a los valores base en las semanas 48 and 96. Estas medidas serán usadas para la evaluación formal de los brazos DTG y TE
    ? Incidencia de efectos adversos graves
    ? Incidencia de acontecimientos clínicos o de laboratorio nuevos de categoría 3 o 4
    ? Incidencia de efectos adversos (de cualquier categoría) que resulten en una modificación del tratamiento
    Otras medidas secundarias:
    ? Calidad de vida
    ? Aceptación y adherencia
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks and 96 weeks
    48 semanas y 96 semanas
    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) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA35
    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
    Argentina
    Brazil
    France
    Germany
    Italy
    Portugal
    South Africa
    Spain
    Thailand
    Uganda
    United Kingdom
    United States
    Zimbabwe
    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
    The trial will be considered closed when the last patient to be enrolled reaches 96 weeks of follow-up and exits the trial (for all other patients the exit visit will be their scheduled visit immediately prior to this), all data has been entered in the database, and queries have been resolved.
    El ensayo se considerará cerrado después de que el último paciente alcance las 96 semanas de seguimiento, todos los datos han sido incluidos en la base de datos y todas las consultas han sido resueltas.
    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 months2
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days4
    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: 700
    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: 455
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 245
    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
    Children and young people under 18 years of age
    Niños y adultos jovenes menos de 18 anos.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 700
    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)
    If DTG is not licensed for their patient population at the end of the study, Viiv will continue to provide it for those children randomised to the DTG arm.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation PENTA-ID
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2016-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-29
    P. End of Trial
    P.End of Trial StatusOngoing
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