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    Summary
    EudraCT Number:2017-003541-17
    Sponsor's Protocol Code Number:FIMHCSBR-2017
    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:2018-08-07
    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 number2017-003541-17
    A.3Full title of the trial
    Neuropsiquiatric Evolution After Introduction of Raltegravir QD in substitution of dolutegravir: NEAR QD Study
    Sustitución de Dolutegravir por Raltegravir 1200 mg QD en pacientes infectados con VIH que desarrollan síntomas neuropsiquiátricos tras iniciar triple terapia. Estudio clínico piloto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evolution of neurological symptoms after substitution of Dolutegravir for Raltegravir. NEAR QD Study
    Evolución de los síntomas neurológicos tras la sustitución de DOlutegravir por Raltegravir. Estudio NEAR QD
    A.3.2Name or abbreviated title of the trial where available
    NEAR QD
    NEAR QD
    A.4.1Sponsor's protocol code numberFIMHCSBR-2017
    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 SponsorFIMABIS Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    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 supportMSD Merck Sharp and Dohme
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIMABIS
    B.5.2Functional name of contact pointPlataforma de Estudios Clinicos
    B.5.3 Address:
    B.5.3.1Street AddressHospital Regional Universitario Pabellon A. Planta 7. Avda. Carlos Haya s/n
    B.5.3.2Town/ cityMalaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.4Telephone number+34951291447
    B.5.5Fax number+34951440263
    B.5.6E-mailalejandro.perez@fimabis.org
    B.Sponsor: 2
    B.1.1Name of SponsorAPES Costa del Sol (Agencia Pública Empresarial Sanitaria)
    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 supportMerck Sharp & Dohme
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIMABIS
    B.5.2Functional name of contact pointPlataforma de Estudios Clínicos
    B.5.3 Address:
    B.5.3.1Street AddressHospital Regional Universitario. Avda. Carlos Haya s/n
    B.5.3.2Town/ cityMálaga
    B.5.3.3Post code29010
    B.5.3.4CountrySpain
    B.5.6E-mailgloria.luque@fimabis.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 ISENTRESS
    D.2.1.1.2Name of the Marketing Authorisation holderMSD
    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.3.4Pharmaceutical form 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 INNRALTEGRAVIR
    D.3.9.1CAS number 518048-05-0
    D.3.9.4EV Substance CodeSUB25667
    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.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
    Human Inmunodeficiency Virus Infection (HIV)
    Infección por Virus de la Inmunodeficiencia Humana (VIH)
    E.1.1.1Medical condition in easily understood language
    Human Inmunodeficiency Virus Infection (HIV)
    Infección por Virus de la Inmunodeficiencia Humana (VIH)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Improvement in CNS symptoms at week 12 (DAIDS scale)
    Evaluar la mejora en los síntomas neuropsiquiátricos a las 12 semanas (escala DAIDS)
    E.2.2Secondary objectives of the trial
    • Interruptions due to adverse effects
    • Interruptions due to virological failure
    At week 24:
    • Presence of CNS symptoms
    • Intensity of CNS symptoms (visual scale 0 to 10 and DAIDS scale)
    • Modification of the quality of life (WHOQoL)
    • Modification in HAD scale
    • Modification in PSQY scale
    • Modification in Epworth scale
    • Modification in CSSR scale

    To identify, at 24 weeks, patterns of different uptake of the metabolic marker18F-FDG in patients suffering from central nervous system toxicity in relation to the use of Dolutegravir after the substitution to Raltegravir and the anatomical-functional pattern of these patients changes after the replacement of Dolutegravir by Raltegravir
    Evaluar a las 24 semanas:
    - Interrupciones de la medicación debidas a sus efectos adversos
    - Interrupciones de la medicación por cualquier causa
    - Interrupciones de la medicación por fracaso virológico
    - Presencia de síntomas neuropsiquiátricos
    - Intensidad de síntomas neuropsiquiátricos (escala visual 0 a 10)
    - Variación de la calidad de vida (cuestionario WHOQoL-bref)
    - Variación del resultado en la escala HAD
    - Variación del resultado en la escala PSQY
    - Variación del resultado en la escala Epworth
    - Variación del resultado en la escala CSSR
    -

    - Identificar a las 24 semanas patrones de diferente captación del marcador metabólico18F-FDG en los pacientes que sufren toxicidad de sistema nervioso central en relación con el uso de Dolutegravir tras la sustitución a Raltegravir y el patrón anatómico-funcional de estos pacientes cambia tras la sustitución de Dolutegravir por Raltegravir
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) ≥ 18 years old
    2) HIV-1 infection
    3) Receiving antiretroviral treatment whose backbone is ABC / 3TC or TDF / FTC or TAF / FTC, whose third component is DTG in doses of 50 mg / day.
    4) Presence of CNS symptoms (any of: insomnia, sleep disturbances, poor concentration, dizziness, headache, depression, restlessness or nervousness) at least intensity 2 on DAIDS
    5) Written informed consent to participate into the studyscale.
    1) Edad ≥ 18 años.
    2) Infección con VIH-1.
    3) En tratamiento antirretroviral de triple terapia basado en ABC/3TC o TDF/FTC o TAF/FTC, cuyo tercer componente es DTG en dosis de 50 mg/día.
    4) Presencia de síntomas neuropsiquiátricos (insomnio, alteraciones del sueño, concentración reducida, mareos, dolores de cabeza, depresión, inquietud o nerviosismo) con una intensidad ≥ 2 en la escala DAIDS.
    5) Consentimiento informado por escrito para participar en el estudio.
    E.4Principal exclusion criteria
    1) Breastfeeding, pregnancy or fertile women willing to be pregnant.
    2) Concomitant use at baseline of any drug with potential drug-drug interaction with study drugs included in https://www.hiv-druginteractions.org database.
    3) Prior documented intolerance, hypersensitivity or resistance to study drugs, or presence of any contraindication to use it.
    4) Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
    5) Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance.
    6) Subjects currently taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied have stopp ed for more than 12 weeks.
    7) AIDS event (CDC Category C) at the diagnosis of HIV infection or in the 3 months before inclusion the study
    8) Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
    9) Diagnosis of any of the CNS symptoms previously to DTG use.
    10) Presence of genotypic mutations that confer resistance to ABC, TDF / TAF, 3TC or FTC
    11) Chronic liver disease in the cirrhosis phase (either by ultrasound criteria, or fibroscan ≥ 14.5 KPa)
    12) Smoking habit ≥ 20 cigarettes/day.

    *For patients included in Hospirtal Costa del Sol de Marbella only (urdergoing PET and MRI scan:
    13) History of or suffers from claustrophobia or feels that they will be unable to lie still on their back in the PET or MRI camera for a period of 20 min.
    14) Contraindications to MRI, including presence of a cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI questionnaire.
    1) Mujeres embarazadas, lactantes o en edad fértil que quieran quedarse embarazadas.
    2) Uso concomitante de cualquier medicamento con riesgo potencial de interacción con la terapia en estudio. Se usará la base de datos de la Universidad de Liverpool (disponible en https://www.hiv-druginteractions.org) para catalogar las interacciones en “sin interacciones”, “interacciones potenciales” e “interacciones contraindicadas”, no permitiendo el uso de fármacos catalogados en esta última categoría.
    3) Intolerancia, hipersensibilidad o resistencia previa a la terapia en estudio o presencia de cualquier contraindicación de la misma.
    4) Sujetos en terapia con inmunosupresores o quimioterapia con citotóxicos, incluyendo interferón e interleukina-2 en el momento de su inclusión en el estudio.
    5) Abuso de alcohol o cualquier otra sustancia que a juicio del investigador pueda interferir en la adherencia al tratamiento.
    6) Sujetos que estén participando en cualquier otro estudio clínico con la excepción de aquellos en los que el tratamiento en estudio haya sido suspendido hace más de 12 semanas.
    7) Evento SIDA (evento que corresponde a la categoría C de los CDC (Centros para el Control y la Prevención de Enfermedades, EEUU)) en el momento de diagnostico de infección por VIH o en los 3 meses previos a su inclusión en el estudio
    8) Cualquier otra condición clínica o tratamiento previo que, a juicio del investigador, haga al sujeto inadecuado para el estudio o que comprometa su capacidad para cumplir con los requisitos de dosificación del tratamiento.
    9) Historia de enfermedad mental o diagnóstico de síntomas neuropsicológicos previos al uso de DTG.
    10) Presencia de mutaciones genotípicas que confieran resistencia a ABC, TDF/TAF, 3TC o FTC
    11) Hepatopatía crónica en fase de cirrosis (bien por criterio ecográfico, o por fibroscán ≥ 14.5 KPa)
    12) Consumo de tabaco ≥ 20 cigarrillos/día.

    *Para pacientes reclutados en el Hospital Costa del Sol de Marbella:
    13) Historia o diagnóstico de claustrofobia, o incapacidad para permanecer acostados de espaldas dentro de la cámara de PET o RM por un período de 20 minutos.
    14) Contraindicación para realizar una RM, incluyendo la presencia de un marcapasos cardíaco u otro dispositivo electrónico o de cuerpos extraños metálicos ferromagnéticos en posiciones vulnerables evaluadas mediante un cuestionario estándar previo al RM.
    E.5 End points
    E.5.1Primary end point(s)
    - Neuropsychiatric symptoms (visual scale 0 to 10, DAIDS scale, HAD scale, scale, Epworth scale, PSQY scale and CSSR scale)
    - Síntomas neuropsiquiátricos (escala visual 0 a 10, escala DAIDS, escala HAD, escala, escala Epworth, escala PSQY y escala CSSR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12 of treatment
    Semana 12 de tratamiento
    E.5.2Secondary end point(s)
    - Virological failure (detectable viral load)
    - Questionnaire WHOQoL-bref
    - Demographic characteristics (sex, age)
    - Evolution of HIV infection (age of infection, CD4 nadir, risk group)
    - Current ART and start date
    - Number of previous treatments
    - Comorbidities (DM, HBP, dyslipidemia, cancer, liver disease, renal insufficiency, osteopenia-osteoporosis)
    - Consumption of toxic substances (tobacco (cig./d and packages/year), alcohol (gr/d), use of illicit drugs (type and frequency))
    - Use of non-antiretroviral medication (Yes/No and specify which)
    - Fracaso virológico (carga viral detectable)
    - Cuestionario WHOQoL-bref
    - Características demográficas (sexo, edad)
    - Evolución de su infección VIH (antigüedad de la infección, nadir de CD4, grupo de riesgo)
    - TAR actual y fecha de inicio del TAR
    - Número de tratamientos previos
    - Comorbilidades (DM, HTA, dislipemia, cáncer, enfermedad hepática, insuf. renal, osteopenia-osteoporosis)
    - Consumo de tóxicos (tabaco (cig./d y paquetes/año); alcohol (gr/d); uso de drogas ilícitas (tipo y frecuencia))
    - Uso de medicación no antirretroviral (Si/No y especificar cuáles)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24 of treatment
    Semana 24 de tratamiento
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the 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 concerned3
    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
    Última visita (visita de seguridad) del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 No
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    patients with incurable disease
    pacientes con una patología incurable
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    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)
    At the end of the study, the participating subjects will receive the best treatment available or which their doctor considers the most appropriate for their illness. It is possible that they can not continue to administer the study medication. Therefore, neither the researcher nor the sponsor acquire any commitment to maintain this treatment once the study is completed.
    Al finalizar el estudio, los sujetos participantes recibirán el mejor tratamiento disponible y que su médico considere el más adecuado para su enfermedad, pero es posible que no se le pueda seguir administrando la medicación del estudio. Por lo tanto, ni el investigador ni el promotor adquieren compromiso alguno de mantener dicho tratamiento una vez finalizado este estudio.
    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 Decision2018-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-02
    P. End of Trial
    P.End of Trial StatusOngoing
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