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    Summary
    EudraCT Number:2014-004331-39
    Sponsor's Protocol Code Number:INDOOR
    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:2014-11-25
    Trial results View 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 number2014-004331-39
    A.3Full title of the trial
    HIV Reservoir Dynamics After Switching To Dolutegravir in Patients on a PI/r Based Regimen. A Phase IV Open Randomized Trial
    Dinámica de los reservorios de HIV después de cambiar a Dolutegravir en pacientes en un régimen basado en IP / r. Un ensayo aleatorizado de fase IV abierto
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HIV Reservoir Dynamics After Switching To Dolutegravir in Patients on a PI/r Based Regimen. A Phase IV Open Randomized Trial
    Dinámica de los reservorios de HIV después de cambiar a Dolutegravir en pacientes en un régimen basado en IP / r. Un ensayo aleatorizado de fase IV abierto
    A.3.2Name or abbreviated title of the trial where available
    INDOOR
    INDOOR
    A.4.1Sponsor's protocol code numberINDOOR
    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 SponsorFundació Vall Hebron Institut de Recerca
    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 supportViiV Healthcare
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación Vall Hebron Institut de Recerca
    B.5.2Functional name of contact pointUnitat de malalties infeccioses
    B.5.3 Address:
    B.5.3.1Street AddressPasseig de la Vall Hebron
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08035
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934893000
    B.5.6E-mailmcrespo@vhebron.net
    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®
    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 nameTivicay®
    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.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HIV-1 Infection
    Infección por VIH-1
    E.1.1.1Medical condition in easily understood language
    HIV-1 Infection
    Infección por VIH-1
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.1
    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 assess the HIV reservoir dynamics after the change of IP / r by dolutegravir in HIV-1 infected patients that they maintain suppressed the viral load (HIV RNA <50 copies / ml) with AN ART 2 and 1 IP / r
    Evaluar la dinámica de los reservorios del VIH tras el cambio de IP/r por dolutegravir en pacientes infectados por VIH-1 que mantienen la carga viral suprimida (ARN-VIH < 50 cop/ml) con TAR con 2 AN y 1 IP/r
    E.2.2Secondary objectives of the trial
    To study the evolution of immune activation and inflammatory markers in both treatment groups
    Estudiar la evolución de la activación inmune y los marcadores inflamatorios en ambos grupos de tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Adult patients infected with HIV-1
    - HIV-RNA <50 copies / mL for ? 1 year with stable regimen of ART (? 3 months) based on a IP / r 2 AN
    - CD4+ lymphocytes > 200 / mm3
    - Voluntary signature of informed consent
    - A woman, may be eligible to enter and participate in the study if:

    a. no-childbearing potential, defined as post-menopausal (12 months of spontaneous amenorrhea and ? 45 years of age) or physically unable to get pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy.
    b. You are of a child-bearing age with a negative pregnancy test on the day of screening and on day 1 and agrees to use one of the following contraceptive methods to prevent pregnancy:

    - Complete abstinence from penile-vaginal intercourse from 2 weeks before administration of the IP, over the course of the study and for at least 2 weeks after discontinuation of all study drugs;
    - Double barrier method (male condom / spermicide, condom male / diaphragm, diaphragm / spermicide);
    - Any intrauterine device (IUD) with published data that show that the expected rate of failure is <1% per year (not all IUDs meet this criterion);
    - Confirmed male sterilization before to entry of the female subject in the study, and that this man is the only sexual partner for the woman;
    - Hormonal Contraception Approved
    - Any other method with published data that show that the expected rate of failure is <1% per year.
    - Pacientes adultos infectados por VIH-1
    - ARN-HIV < 50 copies/mL durante ? 1 año con un régimen de TAR estable (? 3 meses) basado en un IP/r y 2 AN
    - Linfocitos CD4+ > 200/mm3
    - Firma voluntaria del consentimiento informado
    - Una mujer, puede ser elegible para entrar y participar en el estudio si:

    a. no tiene potencial de procreación-definido como post-menopáusica
    (12 meses de amenorrea espontánea y ? 45 años de edad) o físicamente incapaz de quedarse embarazada con documentada ligadura de trompas, histerectomía u ooforectomía bilateral.
    b. Está en edad fértil con una prueba de embarazo negativa en el día
    del Screening y en el día 1 y se compromete a utilizar uno de los
    siguientes métodos anticonceptivos para evitar el embarazo:

    La abstinencia completa de relaciones sexuales pene-vagina a partir
    de 2 semanas antes de la administración de IP, a lo largo del estudio,
    y durante al menos 2 semanas después de la interrupción de todos los
    medicamentos del estudio;
    Método de doble barrera (condón masculino / espermicida, condón
    masculino / diafragma, diafragma / espermicida);
    Cualquier dispositivo intrauterino (DIU) con datos publicados que
    muestran que la tasa esperada de fracaso es <1% por año (no todos
    los DIU cumplen con este criterio)
    La esterilización masculina confirmada antes de la entrada del sujeto
    femenino en el estudio, y que este hombre es la única pareja sexual
    para la mujer.;
    Anticoncepción hormonal Aprobada
    Cualquier otro método con los datos publicados muestran que la tasa
    de fracaso esperado es <1% por año.
    E.4Principal exclusion criteria
    - Prior virologic failure with a integrase inhibitor
    - AIDS defining disease in the last 48 weeks
    - Glomerular filtration rate <50 mL / min, estimated by the formula CKD-EP*I
    - ALT ?5 times the upper limit of normal (ULN) or ALT ?3 times ULN and total bilirubin ?1,5 ULN (with> 35% of direct bilirubin) and / or unstable liver disease (presence of ascites, hepatic encephalopathy, hypoalbuminemia, presence of esophageal varices or persistent jaundice) or biliary disorders known excluding Gilbert's syndrome or asymptomatic urolithiasis)
    - Hepatitis B positive (HBsAg +) or need of treatment HCV during the study.
    - Subjects with severe hepatic damage (Child Pugh Class C).
    - Patients unable to understand the study protocol or any other condition that in the investigator's opinion would compromise the protocol compliance.
    - Pregnant or nursing women
    - History or presence of allergy to any of the study drugs or their components.
    - Fracaso virológico previo con un inhibidor de la integrasa
    - Enfermedad definitoria de SIDA en las últimas 48 semanas
    - Filtrado glomerular < 50 mL/min, estimado por la fórmula CKD-EP*I
    - ALT ?5 veces el límite superior de la normalidad (LSN) o ALT ?3 veces
    el LSN y bilirrubina total ?1,5 veces el LSN (con > 35% de bilirrubina
    directa) y/o enfermedad hepática inestable (con presencia de ascitis,
    encefalopatía hepática, hipoalbuminemia, presencia de varices
    esofágicas o ictericia persistente) o alteraciones biliares conocidas
    excluido el síndrome de Gilbert o litiasis asintomática)*.
    - Positividad para hepatitis B (AgHBs+) o necesidad de tratamiento del
    VHC durante el estudio**.
    - Sujetos con Daño hepático severo ( Clase C de Child Pugh).
    - Pacientes incapaces de entender el protocolo del estudio o cualquier
    otra condición que en opinión del investigador pueda comprometer el
    cumplimiento del protocolo
    - Mujeres embarazadas o en periodo de lactancia
    - Historia o presencia de alergia a alguno de los fármacos del estudio o
    a sus componentes
    E.5 End points
    E.5.1Primary end point(s)
    Changes in mean CD4 + T 2LTR in peripheral blood collected at weeks 1, 2, 4, 12 and 24 of the study lymphocytes compared to day 0
    Cambios en la media de 2LTR en linfocitos T CD4+ de sangre periférica obtenida en las semanas 1, 2, 4 12 y 24 del estudio, respecto al día 0
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 1, 2, 4, 12 and 24
    Semanas 1, 2, 4, 12 y 24 del estudio
    E.5.2Secondary end point(s)
    - Analysis by qPCR of DNA-HIV associated to CD4+ lymphocytes peripheral blood, obtained on day 0 and weeks 12 and 24 of the study and in CD4+ lymphocytes from ileum biopsies performed on day 0 and week 24 of the study.
    - Analysis by nested-qPCR (Alu-HIV PCR) of DNA-HIV integrated in T CD4+ lymphocytes from peripheral blood obtained on day 0 and weeks 12 and 24 of the study and CD4+ lymphocytes obtained from ileum biopsies performed on day 0 and week 24 of the study.
    - Analysis of residual plasma viremia by an ultrasensitive technique capable of detecting a copy of HIV RNA, at day 0 and weeks 12 and 24 of the study
    - Analysis by ddPCR (digital droplet-PCR) of HIV RNA expression in T CD4+ lymphocytes from peripheral blood obtained on day 0 and at weeks 1, 2, 12 and 24 of the study
    - Assessing the change in the percentage of T CD4 + naïve lymphocytes, memory and activated at weeks 1, 2, 12 and 24 of the study compared to day 0, in peripheral blood and lymphoid tissue samples, obtained by biopsy of ileum at the 24 week in relative to day 0 of the study
    - Assessing the change in inflammatory markers (sCD14, CRP, IL-6, IP-10, TRAIL) and pro-thrombotic (d-dimer) at weeks 12 and 24 of the study.
    - Plasma trough concentration(Ctrough) en una muestra obtenida 24 horas después de la última dosis de dolutegravir y el fármaco de comparación, IP / r, semana 1, 2, 4, 12 y 24 del estudio
    - Análisis mediante qPCR del ADN-VIH asociado a linfocitos CD4+ de sangre periférica, obtenida el día 0 y las semanas 12 y 24 del estudio y en linfocitos CD4+ obtenidos de biopsias de íleo realizadas los días 0 y la semana 24 del estudio.
    - Análisis mediante nested-qPCR (Alu-HIV PCR) del ADN-VIH
    integrado en linfocitos T CD4+ de sangre periférica obtenida el día 0
    y las semanas 12 y 24 del estudio y en linfocitos CD4+ obtenidos de
    biopsias de íleo realizadas los días 0 y la semana 24 del estudio.
    - Análisis de la viremia residual plasmática mediante un técnica
    ultrasensible capaz de detectar una copia de ARN VIH, el día 0 y las
    semanas 12 y 24 del estudio
    - Análisis mediante ddPCR (digital droplet-PCR) de la expresión de
    ARN-VIH en linfocitos T CD4+ de sangre periférica obtenida el día 0
    y en las semanas 1, 2, 12 y 24 del estudio
    - Evaluar el cambio en el porcentaje de linfocitos T CD4+ naïve,
    memoria y activados en las semanas 1, 2, 12 y 24 del estudio,
    respecto al día 0, en sangre periférica, y en muestras de tejido
    linfoide, obtenido mediante biopsia de íleo en la semana 24 respecto
    al día 0 del estudio
    - Evaluar el cambio en los marcadores inflamatorios (sCD14, CRP, IL-
    6, IP-10, TRAIL) y pro-trombóticos (d-dimer) en las semanas 12 y 24
    del estudio.
    - Concentración plasmática valle (Ctrough) de dolutegravir y del
    fármaco comparador, IP/r, las semanas 1, 2, 4, 12 y 24 del estudio
    E.5.2.1Timepoint(s) of evaluation of this end point
    Depending on the endpoint the timepoint will be different: Weeks 1, 2, 4, 12 and 24
    Dependiendo de la variable, el momento de evaluación puede ser diferente: Semanas 1, 2, 4, 12 y 24 del estudio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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 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
    Safety call on week 30. This call will be done 6 weeks after the last on site visit of the patient (week 24)
    Llamada de seguridad en la semana 30 del estudio. Esta llamada se realizará 6 semanas después de la última visita del paciente (semana 24)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    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: 44
    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 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 state44
    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)
    None
    Ninguna
    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 Decision2015-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
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