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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2009-011171-76
    Sponsor's Protocol Code Number:ANRS 145
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-04-09
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-011171-76
    A.3Full title of the trial
    Etude pilote évaluant l’intérêt d’une intensification par maraviroc (Celsentri®) chez des patients infectés par le VIH-1 présentant une restauration immunitaire insuffisante malgré une charge virale contrôlée par un traitement anti-rétroviral.
    A.3.2Name or abbreviated title of the trial where available
    MARIMUNO
    A.4.1Sponsor's protocol code numberANRS 145
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAgence nationale de recherches sur le sida et les hépatites virales. ANRS.
    B.1.3.4CountryFrance, Metropolitan
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 holderPfizer
    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 nameCelsentri
    D.3.2Product code UK-457-857
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNMaraviroc
    D.3.9.1CAS number 376348-65-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150 to mg
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMaraviroc
    D.3.9.1CAS number 376348-65-1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300 to mg
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Infection VIH
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11.1
    E.1.2Level LLT
    E.1.2Classification code 10020161
    E.1.2Term <Manually entered code. Term in E.1.1>
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer le bénéfice immunologique d’une intensification de 24 semaines par maraviroc (Celsentri®) chez des patients sous traitement anti-rétroviral stable (sup ou=6 mois) et efficace (CV<50 copies/mL), avec reconstitution immunologique incomplète (CD4<350 cellules/mm3 et gain de CD4<100/mm3 au cours des 24 derniers mois).
    E.2.2Secondary objectives of the trial
    - Etudier l’efficacité du maraviroc : proportion de patients ayant gagné + de 50 et + de 100 CD4/mm3 à S24, ayant charge virale < 50 copies/mL à S12 et S24, la pente de décroissance de l’ADN VIH entre S00 et S24, l'évolution du tropisme R5/X4 sous traitement - Etudier la durabilité de l'effet du maraviroc, - Mesurer la corrélation entre les concentrations plasmatiques et l’efficacité immunologique à S24, - Etudier la tolérance du traitement par maraviroc en décrivant la fréquence de survenue des évènements indésirables (EI) entre S00 et S36, la fréquence des syndromes de reconstitution immunitaire.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Il est prévu de réaliser au cours de l'étude plusieurs études complémentaires V.1.0 du 02-04-2009. 1) Sous études immunologiques pour étudier l'effet de l'antagoniste de CCR5 sur : - les profils de différentiation, d'activation et d'expression des chémorécepteurs des lymphocytes T CD4 et CD8 - l’éventuelle diminution de la cytopathogénicité via la réduction de l’apoptose - la possible diminution de l’activation immunitaire cellulaire ainsi que l’inhibition de l’internalisation des ligands de CCR5 que sont CCL3, CCL4 et CCL5 - les réponses des lymphocytes T CD4 et T CD8 spécifiques de divers agents infectieux.
    2) Sous études virologiques ayant pour objectifs : Quantification de la charge virale ARN VIH résiduelle en dessous de 50 copies/mL - Etude de la décroissance de l’ADN VIH-1 dans les réservoirs cellulaires - Etude génotypique et phénotypique de l’évolution du tropisme R5/X4 dans les réservoirs cellulaires - Etude de la reconstitution immunologique du GALT via la population de lymphocytes T CD4+ CCR9+ a4b7+ circulant.
    E.3Principal inclusion criteria
    Patient(e) VIH-1 +, âge = ou>18 ans, sous traitement ARV efficace bien toléré pouvant être maintenu pendant les 48 semaines de l’étude, non modifié au cours des 6 derniers mois, CD4 < 350 cellules/mm3, charge virale < 50 copies/mL depuis au moins 24 mois avant l’inclusion (3 mesures par an au moins espacées d'au moins 8 semaines), gain de CD4 < 100/mm3 au cours des 24 derniers mois (3 mesures par an au moins espacées d'au moins 8 semaines), - patient naïf de maraviroc, pour les femmes en âge de procréer, utilisation d’une contraception efficace
    E.4Principal exclusion criteria
    Infection par le VIH-2, Tropisme X4 pur à l’inclusion, patient(e)s ayant un projet d’enfant à court terme, enceintes ou allaitantes, traitement en cours par une molécule en cours de développement, par interféron, par tout autre traitement immuno-modulateur, par chimiothérapie actuelle ou passée, hypersensibilité à l’arachide et/ou au soja, hépatite aiguë non résolue à l’inclusion, ou cirrhose décompensée
    E.5 End points
    E.5.1Primary end point(s)
    Le critère de jugement principal est le gain de CD4 en valeur absolue et en pourcentage entre S00 et S24 en intention de traiter.
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned18
    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 Information not present in EudraCT
    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
    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 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state60
    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 Decision2009-05-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-01-31
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