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    Summary
    EudraCT Number:2016-005226-11
    Sponsor's Protocol Code Number:FIS-TAR-01-2016
    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:2017-01-25
    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 number2016-005226-11
    A.3Full title of the trial
    Phase 4 clinical trial, randomized to evaluate the effect on immune recovery of triple antiretroviral maintenance therapy (elvitegravir / cobicistat 150/150 mg + tenofovir + emtricitabine alapenamide 10 mg 200 mg) versus simplification of combination therapy (dolutegravir + lamivudine or darunavir / Cobicistat + lamivudine) in HIV-infected patients with sustained undetectable viremia.
    Ensayo clínico de fase 4, aleatorizado para evaluar el efecto sobre la recuperación inmune de la terapia de mantenimiento antiretroviral triple (elvitegravir / cobicistato 150/150 mg + tenofovir + emtricitabina alafenamida 10 mg 200 mg) versus simplificación de la terapia combinada (dolutegravir más lamivudina o darunavir / Cobicistat más lamivudina ) en pacientes con infección por VIH con viremia indetectable sostenida.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 4 clinical trial to evaluate the effect on immune recovery of antiretroviral treatment of three drugs versus two in in HIV-infected patients but not dectactable in blood.
    Ensayo clínico de fase 4 para evaluar el efecto sobre la recuperación inmunológica del tratamiento antiretroviral de tres fármacos frente a dos en pacientes con infección por VIH pero no dectactable en sangre.
    A.4.1Sponsor's protocol code numberFIS-TAR-01-2016
    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 SponsorFundación Pública Andaluza para la Gestión en Salud de Sevilla (FISEVI)
    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 supportOwn funding
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUnidad de Investigación Clínica y ensayos Clínicos
    B.5.2Functional name of contact pointUICEC-HUVR
    B.5.3 Address:
    B.5.3.1Street AddressAVENIDA MANUEL SIUROT S/N
    B.5.3.2Town/ citySEVILLA
    B.5.3.3Post code41013
    B.5.3.4CountrySpain
    B.5.4Telephone number0034955013414
    B.5.5Fax number0034954232992
    B.5.6E-mailclaram.rosso.sspa@juntadeandalucia.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tivicay®
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Lamivudina Teva
    D.2.1.1.2Name of the Marketing Authorisation holderTeva B.V.
    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.3.1Product nameLamivudina
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Rezolsta®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameDarunavir
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Rezolsta®
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationBelgium
    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 nameCobicistat
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Adult patients with HIV infection on stable therapy (≥ 6 months) with triple therapy and undetectable viremia for ≥ 1 year.
    Pacientes adultos con infección por el VIH en tratamiento estable (≥ 6 meses) con triple terapia y viremia indetectable durante ≥ 1 año.
    E.1.1.1Medical condition in easily understood language
    Adult HIV-infected patients on treatment of ≥ 6 months with triple therapy and no virus in the blood for ≥ 1 year.
    Pacientes adultos con infección por el VIH en tratamiento de ≥ 6 meses con triple terapia y sin presencia del virus en sangre durante ≥ 1 año.
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level LLT
    E.1.2Classification code 10049838
    E.1.2Term HIV viral load undetectable
    E.1.2System Organ Class 100000004848
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10077716
    E.1.2Term HIV viraemia
    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
    Evaluate the effect on immune recovery maintaining a triple antiretroviral therapy (elvitegravir / cobicistat 150/150 mg + tenofovir + emtricitabine alafenamide 10 mg 200 mg) versus combination therapy simplification (dolutegravir plus lamivudine or darunavir / cobicistat plus lamivudine) after 48 weeks Of treatment in HIV-infected patients with sustained undetectable viremia.
    Evaluar el efecto en la recuperación inmunológica del mantenimiento de una terapia antirretroviral triple (elvitegravir/cobicistat 150/150 mg + tenofovir alafenamide 10 mg + emtricitabina 200 mg) versus simplificación a biterapia (dolutegravir más lamivudina o darunavir/cobicistat más lamivudina) tras 48 semanas de tratamiento en pacientes con infección por el VIH con viremia indetectable de forma mantenida.
    E.2.2Secondary objectives of the trial
    Evaluate whether a triple therapy based on (elvitegravir / cobicistat 150/150 mg + tenofovir alafenamide 10 mg + emtricitabine 200 mg) will lead to a greater decrease in immune activation and inflammation compared to simplification to bitherapy (dolutegravir plus lamivudine or darunavir / Cobicistat plus lamivudine) in HIV-infected patients and sustained undetectable viremia.
    Evaluar si una triple terapia basada en (elvitegravir/cobicistat 150/150 mg + tenofovir alafenamide 10 mg + emtricitabina 200 mg) dará lugar a una disminución mayor de la activación inmunológica e inflamación comparado con la simplificación a biterapia (dolutegravir más lamivudina o darunavir/cobicistat más lamivudina) en pacientes con infección por el VIH y viremia indetectable de forma mantenida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patients with HIV infection and age ≥ 18 years.
    - Initiation of antiretroviral treatment after 01/01/2013
    - Undetectable viremia (<20 copies / ml for at least one year) with triple therapy.
    - Nadir and CD4 + T lymphocyte count ≥200 / μl at the time of inclusion.
    Informed written consent.
    - Pacientes con infección por el VIH y edad ≥ 18 años.
    - Inicio de tratamiento antirretroviral después del 01/01/2013
    - Viremia indetectable (<20 copias/ml durante al menos un año) con triple terapia.
    - Nadir y recuento de linfocitos T CD4+ ≥200/μl en el momento de la inclusión.
    - Consentimiento informado por escrito.
    E.4Principal exclusion criteria
    - Presence of major resistance mutations to any of the study drugs.
    - Opportunistic infections active at the time of inclusion.
    - Pregnancy at the time of inclusion or during the follow-up period.
    - Active co-infection with B or C virus of hepatitis.
    - Cirrhosis, portal hypertension and / or hypersplenism of any etiology.
    - Past or current neoplasms of steroid treatment, immunomodulators, or chemotherapy
    - Laboratory abnormalities grade 3 or 4.
    - Concomitant use of drugs with higher drug interactions with study drugs, according to respective product data sheets.
    - Estimated creatinine clearance <50ml / min.
    - Withdrawal of informed consent.
    - Patients who do not complete the follow-up period or with virological failure, defined as viremia> 200 copies in two consecutive determinations, during follow-up will be excluded from the analysis.
    - Presencia de mutaciones de resistencia mayores a cualquiera de los fármacos del estudio.
    - Infecciones oportunistas activas en el momento de la inclusión.
    - Embarazo en el momento de la inclusión o durante el periodo de seguimiento.
    - Co-infección active por virus B o C de la hepatitis.
    - Cirrosis, hipertensión portal y/o hiperesplenismo de cualquier etiología.
    - Neoplasias pasadas o actuales subsidiarias de tratamiento con esteroides, inmunomoduladores o quimioterapia
    - Anomalías de laboratorio grado 3 o 4.
    - Utilización concomitante de fármacos con interacciones farmacológicas mayores con los fármacos de estudio, según las respectivas fichas técnicas de los productos.
    - Aclaramiento estimado de creatinina <50ml/min.
    - Retirada del consentimiento informado.
    - Asimismo, se excluirán del análisis aquellos pacientes que no completen el periodo de seguimiento o con fracaso virológico, definido como viremia >200 copiasen dos determinaciones consecutivas, durante el seguimiento.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in the CD4 + / CD8 + T lymphocyte ratio after 48 weeks of treatment.
    Cambios en el cociente de linfocitos T CD4+/CD8+ tras 48 semanas de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 48 weeks of treatment.
    Tras 48 semanas de tratamiento.
    E.5.2Secondary end point(s)
    Changes in CD4 + / CD8 + T lymphocyte ratio after 96 weeks of treatment.
    Changes after 48 and 96 weeks of treatment in:
    Immunoactivation measured as HLA-DR and CD38 expression on CD4 + and CD8 + T lymphocytes and plasma levels of sCD14.
    Expression of the following markers on CD4 + and CD8 + T lymphocytes: Ki67, PD-1, CD57, TRAIL, Annexin V and CD31.
    Concentrations of the following proinflammatory mediators: IL-1β, IL-1ra, IL-2, IL-6, IL-10, IL-17, IFN-α and γ, IP-10, MIP-1 / 1β and dimers D.
    Changes in microbial translocation measured by plasma concentrations of LPS and 16S rDNA.
    Changes in proviral DNA (HIV-DNA) in PBMCs.
    Cambios en el cociente de linfocitos T CD4+/CD8+ tras 96 semanas de tratamiento.
    Cambios tras 48 y 96 semanas de tratamiento en:
    Inmuno-activación medida como expresión de HLA-DR y CD38 en linfocitos TCD4+ y CD8+y niveles plasmáticos de sCD14.
    Expresión de los siguientes marcadores en linfocitos T CD4+ y CD8+: Ki67, PD-1, CD57, TRAIL, Anexina V y CD31.
    Concentraciones de los siguientes mediadores pro-inflamatorios: IL-1β, IL-1ra, IL-2, IL-6, IL-10, IL-17, IFN-α y γ, IP-10, MIP-1/1β y dímeros D.
    Cambios en la translocación microbiana medida mediante concentraciones plasmáticas de LPS y 16S rDNA.
    Cambios en ADN proviral (HIV-DNA)en PBMCs.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Changes after 48 and 96 weeks of treatment according to variable.
    Cambios tras 48 y 96 semanas de tratamiento según variable.
    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) 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 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 trial3
    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
    Final visit of the last patient included.
    El día de la visita final del último paciente incluido.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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: 160
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    F.4.2.2In the whole clinical trial 180
    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)
    Treatment after study as per investigators juice according to GCP
    A juicio del investigador de acuerdo a BPCs
    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 Decision2017-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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