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    Summary
    EudraCT Number:2018-001285-41
    Sponsor's Protocol Code Number:EU5332
    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:2018-10-09
    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 number2018-001285-41
    A.3Full title of the trial
    A PHASE 3 STUDY EVALUATING THE EFFECT OF PITAVASTATIN TO PREVENT CARDIOVASCULAR EVENTS IN HIV-1 INFECTED INDIVIDUALS
    Estudio en fase III para evaluar el efecto de la pitavastatina para prevenir los acontecimientos cardiovasculares en personas con infección por VIH-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized Trial to Prevent Vascular Events in HIV infected patients
    Ensayo aleatorizado para prevenir acontecimientos vasculares en pacientes infectados por el VIH
    A.3.2Name or abbreviated title of the trial where available
    REPRIEVE EU
    REPRIEVE EU
    A.4.1Sponsor's protocol code numberEU5332
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02344290
    A.5.4Other Identifiers
    Name:IND NumberNumber:119127
    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 SponsorNEAT ID Foundation
    B.1.3.4CountryBelgium
    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 supportDivision of- AIDS, NIAID, NIH
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportKOWA Pharmaceuticals America, Inc
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportMassachusetts General Hospital
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportNHLBI, National Heart Lung and Blood Institut
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeat ID Foundation
    B.5.2Functional name of contact pointClaire Gaultier
    B.5.3 Address:
    B.5.3.1Street AddressPL 709, Rue Haute 322
    B.5.3.2Town/ cityBrussels
    B.5.3.3Post code1000
    B.5.3.4CountryBelgium
    B.5.4Telephone number00442038597747
    B.5.6E-mailclaire.gaultier@neat-id.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 LIVALO 4mg Film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderKowa Pharmaceuticals America, Inc
    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 namepitavastatin Calcium
    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 INNPitavastatin calcium
    D.3.9.1CAS number 147526-32-7
    D.3.9.3Other descriptive namePITAVASTATIN CALCIUM
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the effects of pitavastatin as a primary prevention strategy for major adverse cardiovascular events (MACE) in HIV.
    Determinar los efectos de la pitavastatina como una estrategia de prevención principal para los acontecimientos adversos cardiovasculares importantes (AACI) en el VIH.
    E.2.2Secondary objectives of the trial
    The effects of pitavastatin on the components of MACE and all-cause mortality.
    The effects of pitavastatin on LDL and non-HDL in relationship to MACE.
    Whether baseline traditional risk factors and time updated HIV-specific immunological risk factors are predictive of MACE and pitavastatin effects on MACE.
    The effects of pitavastatin on the incidence of serious non-CVD events.
    The safety of pitavastatin in the HIV population.
    Los efectos de la pitavastatina en los componentes de los AACI y en la mortalidad por cualquier causa.
    Los efectos de la pitavastatina en el colesterol LDL y no HDL en relación con los AACI.
    Si el valor inicial de los factores de riesgo tradicionales y los factores de riesgo inmunitario específicos del VIH actualizados con el tiempo son
    predictivos de los AACI y los efectos de la pitavastatina sobre los AACI.
    Los efectos de la pitavastatina en la incidencia de acontecimientos no ECV graves.
    La seguridad de la pitavastatina en la población de VIH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Documentation of HIV-1 infection

    Combination antiretroviral therapy (ART) for at least 180 days prior to study entry.

    CD4+ cell count >100 cells/mm3 obtained within 180 days prior to study entry.

    Laboratory values drawn at screen and/or obtained from clinical care (as indicated in section 6.1 Schedule of Events) within 90 days prior to study entry as follows:

    Fasting LDL cholesterol:

    If ASCVD risk score <7.5%, LDL cholesterol must be <190 mg/dL
    If ASCVD risk score ≥7.5% and ≤10%, LDL must be <160 mg/dL
    If ASCVD risk score >10% and ≤15%, LDL must be <130 mg/dL

    Fasting triglycerides <500 mg/dL.
    Hemoglobin [Symbol]8 g/dL for female subjects and [Symbol]9 g/dL for male subjects.
    Glomerular filtration rate (GFR) ≥60 mL/min/1.73m2 or creatinine clearance (CrCl) ≥60 mL/min.
    ALT ≤2.5 x ULN.

    For persons with known chronic active hepatitis B or C, calculated FIB-4 score must be ≤3.25.

    Female subjects of reproductive potential must have a negative serum or urine pregnancy test within 48 hours prior to entry.

    For women of reproductive potential, willingness to use contraceptives as described in the product information for pitavastatin.

    Men and women age ≥40 and ≤75 years of age.

    Ability and willingness of subject or legal representative to provide written informed consent.
    Documentación de infección por el VIH-1
    Combinación de un tratamiento antirretroviral (TAR) durante al menos 180 días antes de la entrada en el estudio.
    Recuento de linfocitos CD4+ >100 células/mm3 obtenido en el plazo de 180 días antes de la entrada en el estudio.
    Los valores analíticos obtenidos en la selección y/o obtenidos a partir de la atención clínica (tal como se indica en la sección 6.1 Calendario de acontecimientos) en el plazo de 90 días antes de la entrada en el estudio de la siguiente manera:
    Colesterol LDL en ayunas:
    o Si la puntuación del riesgo de ECVAE es <7,5 %, el colesterol LDL debe ser <190 mg/dl
    o Si la puntuación del riesgo de ECVAE es ≥7,5 % y ≤10 %, el LDL debe ser <160 mg/dl
    o Si la puntuación del riesgo de ECVAE es >10 % y ≤15 %, el LDL debe ser <130 mg/dl

    Triglicéridos en ayunas <500 mg/dl.
    Hemoglobina 8 g/dl para los sujetos de sexo femenino y 9 g/dl sujetos de sexo masculino.
    Índice de filtración glomerular (IFG) ≥60 ml/min/1,73 m2 o aclaramiento de creatinina (ACr) ≥60 ml/min.
    ALT ≤2,5 x LSN.
    Para las personas con hepatitis B o C conocida activa crónica, puntuación de FIB-4 calculada debe ser ≤3,25
    Los sujetos de sexo femenino en edad fértil deben tener un resultado negativo en la prueba de embarazo en suero o en orina en las 48 horas previas a la entrada.
    Para las mujeres en edad fértil, con voluntad de usar métodos anticonceptivos como se describe en la información del producto para la pitavastatina.
    Hombres y las mujeres de ≥40 y ≤75 años de edad.
    Capacidad y voluntad del sujeto o del representante legal para proporcionar consentimiento informado por escrito
    E.4Principal exclusion criteria
    Clinical ASCVD, as defined by 2013 ACC/AHA guidelines, including a previous diagnosis of any of the following:

    AMI
    Acute coronary syndromes
    Stable or unstable angina
    Coronary or other arterial revascularization
    Stroke
    TIA
    Peripheral arterial disease presumed to be of atherosclerotic origin

    Current diabetes mellitus if LDL ≥70 mg/dL.

    10-year ASCVD risk score estimated by Pooled Cohort Equations >15%.

    Active cancer within 12 months prior to study entry.

    Known decompensated cirrhosis.

    History of myositis or myopathy with active disease in the 180 days prior to study entry.
    ECVAE clínica, como se define en las directrices de la ACC/AHA de 2013, incluido un diagnóstico previo de cualquiera de los siguientes:

    IAM
    Síndrome coronario agudo
    Angina de pecho estable o inestable
    Revascularización coronaria u otro tipo de revascularización arterial
    Accidente cerebrovascular
    AIT
    Enfermedad arterial periférica que se supone es de origen aterosclerótico

    Diabetes mellitus actual, si el LDL ≥70 mg/dl.
    Puntuación de riesgo de ECVAE de 10 años estimada ecuaciones de cohortes agrupadas >15 %.
    Cáncer activo dentro de los 12 meses previos a la entrada en el estudio.
    Antecedentes conocidos de cirrosis descompensada.
    Antecedentes de miositis o miopatía con enfermedad activa en los 180 días previos a la entrada en el estudio
    E.5 End points
    E.5.1Primary end point(s)
    Major adverse cardiovascular events (MACE)
    Acontecimientos adversos cardiovasculares importantes (AACI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary endpoint will be time to the first Major adverse cardiovascular event (MACE).
    El endpoint primario será cuando ocurra el primer evento cardiovascular importante.
    E.5.2Secondary end point(s)
    Primary components of MACE, all-cause mortality, LDL cholesterol, immune function, non-CVD events (malignancy, end stage liver and kidney disease, AIDS-defining events), and safety endpoints, including diabetes mellitus.
    Componentes principales de los AACI, mortalidad por cualquier causa, colesterol LDL, función inmunitaria, acontecimientos no ECV (neoplasia maligna, enfermedad hepática y renal en fase terminal, acontecimientos definitorios de SIDA) y los criterios de valoración de la seguridad, incluida la diabetes mellitus.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time to secondary end point events: all-cause mortality, LDL cholesterol, immune function, non-CVD events (malignancy, end stage liver and kidney disease, AIDS-defining events), and safety endpoints, including diabetes mellitus.
    Tiempo de endpoints secundarios: mortalidad por cualquier causa, colesterol LDL, función inmunitaria, acontecimientos no ECV (neoplasia maligna, enfermedad hepática y renal en fase terminal, acontecimientos definitorios de SIDA) y los criterios de valoración de la seguridad, incluida la diabetes mellitus.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety No
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned15
    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 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
    LVLS
    última visita de último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months
    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: 230
    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 state250
    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)
    Standard of care
    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 Neat ID Foundation (The European treatment network for HIV, hepatitis and global infectious diseases)
    G.4.3.4Network Country Belgium
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-11-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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