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    Summary
    EudraCT Number:2016-004646-29
    Sponsor's Protocol Code Number:GESIDA9016
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-04-21
    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 number2016-004646-29
    A.3Full title of the trial
    A phase IV open- label, randomized and pilot clinical trial, designed to evaluate the potential neurotoxicity of dolutegravir/lamivudine/abacavir in neurosymptomatic HIV patients and their reversibility after switching to elvitegravir/cobicistat/emtricitabina/tenofovir alafenamide
    Ensayo clínico fase IV, abierto, randomizado y piloto diseñado para evaluar la potencial neurotoxicidad de dolutegravir/lamivudina/abacavir en pacientes VIH neurosintomáticos y su reversibilidad tras el cambio a elvitegravir/cobicistat/emtricitabina/tenofovir alafenamida
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    DREAM study
    Estudio DREAM
    A.3.2Name or abbreviated title of the trial where available
    DREAM
    DREAM
    A.4.1Sponsor's protocol code numberGESIDA9016
    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 SEIMC-GESIDA
    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 supportGILEAD Sciencies S.A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación SEIMC-GESIDA
    B.5.2Functional name of contact pointMaria Yllescas
    B.5.3 Address:
    B.5.3.1Street AddressC/ Agustín de Betancourt nº 13 - entreplanta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034915568025
    B.5.5Fax number0034915542283
    B.5.6E-mailmyllescas@f-sg.org
    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 Triumeq
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare UK Limited
    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 nameTriumeq
    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 INNDOLUTEGRAVIR
    D.3.9.1CAS number 1051375-16-6
    D.3.9.3Other descriptive nameDOLUTEGRAVIR SODIUM
    D.3.9.4EV Substance CodeSUB130591
    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 INNLAMIVUDINE
    D.3.9.1CAS number 134678-17-4
    D.3.9.4EV Substance CodeSUB08392MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABACAVIR
    D.3.9.1CAS number 188062-50-2
    D.3.9.3Other descriptive nameABACAVIR SULFATE
    D.3.9.4EV Substance CodeSUB00231MIG
    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 Yes
    D.2.1.1.1Trade name Genvoya
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    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 nameGenvoya
    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 INNELVITEGRAVIR
    D.3.9.1CAS number 697761-98-1
    D.3.9.3Other descriptive nameELVITEGRAVIR
    D.3.9.4EV Substance CodeSUB69759
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOBICISTAT
    D.3.9.1CAS number 1004316-88-4
    D.3.9.4EV Substance CodeSUB33760
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENOFOVIR
    D.3.9.1CAS number 379270-37-8
    D.3.9.3Other descriptive nameTENOFOVIR ALAFENAMIDE FUMARATE
    D.3.9.4EV Substance CodeSUB178389
    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.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
    VIH
    E.1.1.1Medical condition in easily understood language
    HIV
    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 19.1
    E.1.2Level LLT
    E.1.2Classification code 10001509
    E.1.2Term AIDS
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC, perceived by patients randomised to begin isolated symptomatic treatment or treatment associated with switching antiretroviral therapy
    Comparar cambios en la intensidad de síntomas neuro-psiquiátricos potencialmente asociados con el uso de DTG/3TC/ABC, percibidos por pacientes aleatorizados a instaurar un tratamiento sintomáticos aislado o asociado al cambio del tratamiento antirretroviral
    E.2.2Secondary objectives of the trial
    - To evaluate changes in the severity of neuropsychiatric symptoms potentially associated with the use of DTG/3TC/ABC after switching to ELV/COBI/FTC/TAF
    -To evaluate changes in neurocognitive function and volumetric, spectroscopic, tractographic and cerebral perfusion markers, acquired by Magnetic Resonance Imaging, after switching from DTG/3TC/ABC to ELV/COBI/FTC/TAF
    - To evaluate the percentages of virologic failure after switching antiretroviral therapy from DTG/3TC/ABC to ELV/COBI/FTC/TAF
    - Evaluar cambios en la intensidad de síntomas neuro-psiquiátricos potencialmente asociados con el uso de DTG/3TC/ABC, tras el cambio a ELV/COBI/FTC/TAF.
    -Evaluar cambios en el funcionamiento neurocognitivo y en marcadores cerebrales de volumetría, espectroscopia, tractografía y perfusión, adquiridos mediante Resonancia Magnética, tras el cambio de DTG/3TC/ABC a ELV/COBI/FTC/TAF.
    - Evaluar los porcentajes de fallo virológico tras el cambio del tratamiento antirretroviral de DTG/3TC/ABC por ELV/COBI/FTC/TAF
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Patient > 18 years of age diagnosed with HIV using normal serology techniques.
    •Current antiretroviral therapy with DTG/3TC/ABC.
    •HIV viral load < 50 copies/mL for at least 12 weeks prior to signing the consent form [(]confirmed by two assays at least 12 weeks apart with viremia < 50 copies/mL between both
    •Appearance or worsening of the following symptoms compared to when DTG/3TC/ABC was started:
    - Symptoms of anxiety or depression
    - Insomnia or other sleep disturbances
    - Headache
    - Cognitive complaints (attention, concentration or memory)
    - Alterations in behaviour (irritability, aggressiveness or agitation)
    - Dizziness of neurological or neurologically-mediated origin
    •Paciente >18 años diagnosticado de VIH mediante técnicas serológicas habituales.
    •Tratamiento antirretroviral actual con DTG/3TC/ABC.
    •Carga viral VIH < 50 copias/mL durante al menos 12 semanas anteriores a la firma del consentimiento confirmada mediante dos determinaciones separadas por al menos 12 semanas con viremia < 50 copias/mL entre ambas
    •Aparición o empeoramiento en relación con el inicio de DTG/3TC/ABC de alguno de los siguientes síntomas:
    - Síntomas de ansiedad o depresión
    - Insomnio u otras alteraciones del sueño
    - Cefalea
    - Quejas cognitivas (atención, concentración o memoria)
    - Alteraciones del comportamiento (irritabilidad, agresividad o agitación)
    - Mareo de origen neurológico o neuromediado
    E.4Principal exclusion criteria
    •Determination of at least one HIV viral load ≥ 50 copies/mL in the last 12 weeks.
    •Allergy, intolerance or existence of resistance mutations to any of the components of ELV/COBI/FTC/TAF
    •History of active CNS infections
    •Active psychosis, major depression with psychotic symptoms or autolytic ideation
    •Dementia or mental retardation
    •Drug use with a diagnosis of abuse or dependence according to DSM-5 criteria
    •Illnesses that may interfere with the study procedures
    •Claustrophobia
    •Presence of magnetisable devices in the body
    •Inability to complete any of the study procedures
    •Pregnant or nursing women, as well as women of childbearing age who do not agree to use an adequate birth control method.
    •Determinación de al menos, una carga viral de VIH ≥50 copias/mL en las últimas 12 semanas.
    •Alergia, intolerancia o existencia de mutaciones de resistencia a cualquiera de los componentes de ELV/COBI/FTC/TAF
    •Historia de infecciones activas del SNC
    •Psicosis activa, depresión mayor con síntomas psicóticos o ideación autolítica
    •Demencia o retraso mental
    •Consumo de drogas con diagnóstico de abuso o dependencia de acuerdo con los criterios del DSM-5
    •Enfermedades que puedan interferir con los procedimientos del estudio
    •Claustrofobia
    •Presencia de dispositivos corporales magnetizables
    •Inhabilidad para completar cualquiera de los procedimientos del estudio
    •Mujeres embarazadas o lactantes, así como mujeres en edad fértil que no se comprometan a utilizar un método anticonceptivo adecuado.
    E.5 End points
    E.5.1Primary end point(s)
    The ACTG adverse effects scale, the Pittsburg sleep quality index and the hospital anxiety and depression scale.
    Escala ACTG de efectos adversos, la escala de calidad del sueño de Pittsburg y la escala hospitalaria de ansiedad y depresión.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Basal visit and week 4
    Visita Basal y semana 4
    E.5.2Secondary end point(s)
    -The ACTG adverse effects scale, the Pittsburg sleep quality index and the hospital anxiety and depression scale.
    - Volumes of the different structures of the brain ; the Change in levels of neuronal integrity, the change in the level of white matter integrity, and change in levels of brain inflammation.
    - Viral load
    - Escala ACTG de efectos adversos, la escala de calidad del sueño de Pittsburg y la escala hospitalaria de ansiedad y depresión.
    -Volúmenes de las diferentes estructuras cerebrales ; el cambio en los niveles de integridad neuronal, cambio en los niveles de integridad de la sustancia blanca Y el cambio en los niveles de inflamación cerebral
    - Carga Viral
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Weeks 4, 12 and 24 after the change.
    -Semanas 4, 12 y 24 tras el cambio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group 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 No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Ultima visita del ultimo paciente
    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
    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: 64
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state64
    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 according the clinical practic
    Tratamiento de acuerdo a la práctica clínica habitual
    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 Decision2017-05-31
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-04-23
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