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    Summary
    EudraCT Number:2014-002134-31
    Sponsor's Protocol Code Number:HLS14/01
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2014-10-08
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2014-002134-31
    A.3Full title of the trial
    Evalutation of maraviroc therapy in PI-treated HIV+ patients at intermediate-low risk for cardiovascular diseases: a phase IV, randomized, open study
    VALUTAZIONE DELLA TERAPIA CON MARAVIROC IN PAZIENTI HIV+ A INTERMEDIO-BASSO RISCHIO CARDIOVASCOLARE IN TRATTAMENTO CON PI: STUDIO di FASE IV, RANDOMIZZATO, IN APERTO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Maraviroc and cardiovascular risk in HIV+ patients.
    Maraviroc e rischio cardiovascolare in pazienti HIV+.
    A.4.1Sponsor's protocol code numberHLS14/01
    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 SponsorOspedale L. Sacco - Azienda Ospedaliera-Polo Universitario
    B.1.3.4CountryItaly
    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 supportOspedale L. Sacco - Azienda Ospedaliera-Polo Universitario
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOspedale L. Sacco - Azienda Ospedaliera-Polo Universitario
    B.5.2Functional name of contact pointI Divisione di Malattie Infettive
    B.5.3 Address:
    B.5.3.1Street Addressvia G.B. Grassi, 74
    B.5.3.2Town/ cityMilan
    B.5.3.3Post code20157
    B.5.3.4CountryItaly
    B.5.4Telephone number00390239043480
    B.5.5Fax number00390239042568
    B.5.6E-mailpiconi.stefania@hsacco.it
    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 Celsentri
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare LTD, UK
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameNA
    D.3.2Product code NA
    D.3.4Pharmaceutical form Film-coated 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 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 Celsentri
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare LTD, UK
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameNA
    D.3.2Product code NA
    D.3.4Pharmaceutical form Film-coated 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
    HIV-1 infection.
    Infezione da HIV-1.
    E.1.1.1Medical condition in easily understood language
    HIV-1
    HIV-1
    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
    Evaluate the effects of Maraviroc implementation on intima media thickness in aviremic PI-treated HIV-positive patients at intermediate-low risk for cardiovascular diseases (FRS 5%).
    Valutare gli effetti dell’aggiunta della terapia con MVC, in pazienti a rischio intermedio-basso cardiovascolare, ad un regime PIs sulla IMT (FRS 5%).
    E.2.2Secondary objectives of the trial
    Evaluate the effects of MVC therapy addiction on:
    Cholesterol parameters
    Microbial traslocation
    Linphocytes and monocytes immuno-activation parameters
    Immunological parameters associated with atherosclerotic process
    reversibile effect of maraviroc
    valutare gli effetti di maraviroc su:
    parametri lipidici
    traslocazione microbica
    parametri di immunoattivazione linfo-monocitica
    parametri immunologici connessi con il processo aterosclorotico
    effetto reversibile di maraviroc
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    HIV+
    Stable 2NRTI+PI-based therapy for at least one year
    VL < 37copies/ml for at least 6 months
    X5 viral tropism
    Framingham score 5%
    HIV+
    In ART con 2NRTI+ PI stabile da almeno un anno
    VL soppresso stabilmente da almeno 6 mesi
    Genotipo virale X5
    Framingham compreso tra 10-20%.
    E.4Principal exclusion criteria
    Creatine Clereance <50ml/min
    GFR < 60 ml/ml
    Statine therapy
    tipranavir/ritonavir therapy
    Immunomodulants treatments in the previous year before the recruitment.
    Cardiovascular events in the last year
    Clereance della creatinina <50ml/min
    GFR< 60 ml/ml
    terapia con statine
    in terapia con tipranavir/ritonavir
    Soggetti in terapia con immunostimolanti
    Eventi cardiologici-ischemici sintomatici negli ultimi 12 mesi
    E.5 End points
    E.5.1Primary end point(s)
    Difference of variation of 0.25 mm in comparison to the basal value of the intimate-media carotidea thickness(IMT) in the 80% of the patients after six months the introduction of Maraviroc
    Differenza di una variazione di 0,25 millimetri rispetto al valore basale dello spessore di carotidea di intimo-media (IMT) nel 80% dei pazienti dopo sei mesi l'introduzione del maraviroc
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months
    6 mesi
    E.5.2Secondary end point(s)
    descriptive analysis of the effects of MVC therapy addiction in HIV PIs-treated patients at intermediate risk of cardiovascular diseases on:
    Cholesterol parameters
    Microbial traslocation
    Linphocytes and monocytes immuno-activation parameters
    Immunological parameters associated with atherosclerotic process
    % of HIV-specific CD4 positive cells.
    reversibile effect of maraviroc
    analisi descrittiva degli effetti di maraviroc su:
    parametri lipidici
    traslocazione microbica
    parametri di immunoattivazione linfo-monocitica
    parametri immunologici connessi con il processo aterosclorotico
    sull’espressione di PD-1 e sull’immunità HIV-specifica.
    effetto reversibile di maraviroc
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year.
    1 anno.
    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 No
    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 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 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
    LVLS
    LVLS
    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
    E.8.9.2In all countries concerned by the trial years1
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state40
    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)
    follow up 14 day
    follow-up a 14 giorni
    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 Decision2015-05-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-07-22
    P. End of Trial
    P.End of Trial StatusOngoing
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