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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2006-004306-50
    Sponsor's Protocol Code Number:A4001050
    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:2007-04-02
    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 number2006-004306-50
    A.3Full title of the trial
    ENSAYO MULTICENTRICO Y ABIERTO DE ACCESO EXPANDIDO A MARAVIROC.
    A.4.1Sponsor's protocol code numberA4001050
    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 SponsorPFIZER, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 No
    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 nameMaraviroc
    D.3.2Product code UK-427,857
    D.3.4Pharmaceutical form 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.3.9.1CAS 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
    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
    VIH
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level LLT
    E.1.2Classification code 10020192
    E.1.2Term HIV-1
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal del programa de acceso expandido a maraviroc es facilitar acceso a maraviroc a los pacientes que tienen opciones de tratamiento limitadas y recabar datos de seguridad en una población más amplia y de pacientes más variados que los participantes en los ensayos clínicos en fase 2/3.
    E.2.2Secondary objectives of the trial
    El objetivo secundario del programa de acceso expandido a maraviroc es evaluar la eficacia del maraviroc en pacientes tratados previamente, sometidos a seguimiento según la práctica médica local.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Entrega del documento de consentimiento informado y, si procede, de asentimiento, firmados y fechados, en los que se indique que el sujeto (o su representante legal) ha sido informado de todos los aspectos pertinentes del ensayo;
    2. Edad mínima de 18 años en la visita de selección;
    3. Sujetos con opciones terapéuticas mínimas o nulas entre los medicamentos autorizados, ya sea por resistencia o por intolerancia;
    4. Sujetos que no hayan conseguido una supresión virológica suficiente con su pauta actual y que presenten un ARN del VIH 1 ≥1000 copias/ml en la selección;
    5. Presencia de únicamente VIH 1 de tropismo R5 en la selección, verificado mediante el análisis Trofile de Monogram Biosciences;
    6. Resultados negativos en la prueba de embarazo en orina en la visita basal, antes de la primera dosis del fármaco del estudio, únicamente en el caso de las mujeres en edad fértil (MEF); NOTA: se define como MEF a todas aquellas mujeres que han experimentado la menarquia y que no se han sometido a una esterilización quirúrgica con éxito ni son posmenopáusicas (es decir, no han menstruado en los últimos dos años). Se considerará que todas las mujeres que utilicen anticonceptivos hormonales orales, implantables o inyectables o anticonceptivos mecánicos (métodos de barrera, como el preservativo o el diafragma junto con espermicida) para evitar el embarazo, las que practiquen la abstinencia sexual o aquéllas cuya pareja sea estéril (por ejemplo, vasectomía) están en edad fértil.
    7. Compromiso de utilizar un método anticonceptivo de barrera eficaz. Además, las MEF deben utilizar otro anticonceptivo aceptable durante todo el estudio, entre los que puede mencionarse, a título indicativo, el tratamiento hormonal oral, implantable o inyectable;
    8. Voluntad y capacidad para cumplir las visitas programadas, los planes de tratamiento, los análisis clínicos y otros procedimientos del estudio
    9. Podrán participar en este estudio sujetos que estén tomando antirretrovirales en fase de investigación que estén disponibles mediante programas de acceso expandido o a través de un estudio clínico en fase 3 ó 4, siempre que:
    • Los dos fármacos en fase de investigación sean necesarios para ofrecer al paciente un régimen con 2 ó 3 antirretrovirales activos (es decir, el paciente dispone como máximo de un tratamiento autorizado debido a la resistencia o la intolerancia experimentadas anteriormente),
    • ninguno de los protocolos prohíba la administración del otro antirretroviral Y
    • se conozca la posología de ambos fármacos cuando se administran en asociación Y/O esté respaldada por una carta de los farmacólogos clínicos de Pfizer en la que estipulen la dosis de maraviroc a utilizar con otros agentes experimentales.
    E.4Principal exclusion criteria
    1. Incapacidad de prestar el consentimiento informado;
    2. Fracaso de un tratamiento anterior con un antagonista del CCR5 en cualquiera de los estudios actuales del CCR5 o bien tras retirarse prematuramente de un ensayo con maraviroc. Los sujetos que actualmente reciban maraviroc u otro antagonista del CCR5 en cualquiera de los estudios actuales en fase de finalización o los sujetos que hayan completado la fase de administración activa del ensayo podrán ser reclutados tras consultar al monitor clínico si:
    • El sujeto sólo tuviera VIH R5 en el momento de la selección para otro estudio de evaluación de la seguridad y la eficacia de maraviroc o de otro antagonista de CCR5 Y
    • El sujeto hubiera logrado una respuesta virológica (reducción ≥ 0,5 log10 copias/ml con respecto al valor basal de ARN del VIH) y nunca hubiera cumplido la definición de fracaso virológico.
    3. Anomalías analíticas o trastornos potencialmente mortales (grado 4, según la tabla de la Division of AIDS para la clasificación de la intensidad de los acontecimientos adversos en adultos) que sigan investigándose, a menos que se haya elaborado un diagnóstico y se considere que no afectan a la evaluación del riesgo/beneficio ni a la interpretación de los resultados de seguridad, tras comentarlo entre el investigador y el monitor médico.
    4. Todo trastorno (inclusive alcoholismo o toxicomanía) que, en opinión del investigador, pueda perjudicar la seguridad del sujeto o su cumplimiento del protocolo del estudio;
    5. Embarazo o lactancia materna o intención de concebir;
    6. Intolerancia a la medicación oral;
    7. Necesidad de recibir un medicamento contraindicado (véase el apartado 5.4 Medicación concomitante);
    O
    8. Hipersensibilidad conocida al maraviroc o a alguno de sus excipientes o colorantes, a saber:
    • Excipientes del comprimido: celulosa microcristalina, fosfato de calcio dibásico (anhidro), glicolato de almidón sódico, estearato de magnesio.
    • Recubrimiento pelicular: [Azul Opadry II (85G20583)] contiene laca aluminio azul FD&C #2, lecitina de soja, polietilenglicol (macrogol 3350), alcohol polivinílico, talco y dióxido de titanio.
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de este estudio es la seguridad.
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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.8.3 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 concerned35
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA225
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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 years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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.1.3Elderly (>=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 state350
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 2000
    F.4.2.2In the whole clinical trial 6000
    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 Decision2007-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-05-14
    P. End of Trial
    P.End of Trial StatusCompleted
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