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    Summary
    EudraCT Number:2009-017013-29
    Sponsor's Protocol Code Number:TMC114-TiDP29-C232
    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:2010-05-17
    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 number2009-017013-29
    A.3Full title of the trial
    Acceso continuado a darunavir/ritonavir (DRV/rtv) de niños y adolescentes de 3 o más años de edad infectados por el VIH-1
    A.4.1Sponsor's protocol code numberTMC114-TiDP29-C232
    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 SponsorTibotec Pharmaceuticals
    B.1.3.4CountryBelgium
    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 Yes
    D.2.1.1.1Trade name PREZISTA 400 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderJANSSEN-CILAG INTERNATIONAL N.V
    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.3.4Pharmaceutical 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 INNDARUNAVIR ETANOLATO
    D.3.9.3Other descriptive nameDARUNAVIR ETANOLATO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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.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 NORVIR 100 mg cápsulas blandas
    D.2.1.1.2Name of the Marketing Authorisation holderABBOTT LABORATORIES LTD.
    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.3.4Pharmaceutical form Capsule*
    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 INNRITONAVIR
    D.3.9.3Other descriptive nameRITONAVIR
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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-1
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 11
    E.1.2Level LLT
    E.1.2Classification code 10020161
    E.1.2Term Infección por VIH
    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 de este ensayo es el de continuar el suministro de DRV para pacientes
    pediátricos que hayan completado el tratamiento con DRV en los ensayos clínicos TMC114-C212, TMC114-TiDP29-C228 o TMC114-TiDP29-C230 del promotor Tibotec Pharmaceuticals, y que continúen beneficiándose de su uso, en países donde DRV no se comercializa para el paciente pediátrico, no es reembolsable o no es posible acceder a él a través de otra fuente (p. ej. un programa de acceso o un programa gubernamental).
    E.2.2Secondary objectives of the trial
    Además, se evaluará la información sobre la seguridad de DRV/rtv en combinación con otros ARV.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Se considerarán aptos para este estudio los pacientes que cumplan la totalidad de los siguientes requisitos:
    1. Varones o mujeres, de más de 3 años de edad.
    2. Pacientes que hayan completado el ensayo TMC114-C212, TMC114-TiDP29-C228, TMC114 TiDP29-C230 y que, a juicio del investigador, continúen obteniendo beneficios del uso de DRV.
    3. DRV no se comercializa para el paciente pediátrico, no es reembolsable o no es accesible a través de otra fuente (p. ej.: programa de acceso, programa gubernamental) en la región en la que el paciente tiene su domicilio.
    4. El paciente (si procede, en función de la edad) y los progenitores o representantes legales han firmado el Formulario de Consentimiento Informado voluntariamente. Se informará a los niños sobre el programa y se les pedirá que den su asentimiento (si procede, en función de la edad).
    E.4Principal exclusion criteria
    No podrán ser seleccionados los pacientes que cumplan uno o más de los siguientes criterios:
    1. Cualquier enfermedad (incluidos, entre otros, el alcoholismo y la toxicomanía) que, en opinión del investigador, pueda afectar a la seguridad del paciente o al cumplimiento del tratamiento con DRV.
    2. Cualquier enfermedad activa clínicamente significativa (p. ej.: pancreatitis, disfunción cardíaca) o resultados de la anamnesis, el reconocimiento médico o pruebas de laboratorio que, a juicio del investigador, puedan afectar a la seguridad del paciente durante el tratamiento con DRV.
    3. Manifestación previa de alergia o hipersensibilidad clínicamente significativa a DRV o a
    ritonavir, o a cualquiera de sus excipientes.
    4. Pacientes embarazadas o en período de lactancia.
    5. Mujer en edad fértil que no use métodos anticonceptivos eficaces o no esté dispuesta a
    seguir utilizando estos métodos anticonceptivos durante al menos 30 días después de finalizar el período de tratamiento.
    Nota: La anticoncepción hormonal con estrógenos puede no ser fiable al tomar DRV/rtv.
    Por tanto, para poder participar en este ensayo las mujeres en edad fértil deben:
    a. Utilizar dos anticonceptivos de barrera para prevenir el embarazo (esto es, utilizar un preservativo junto con un diafragma o un capuchón cervical)*; o
    b. Usar anticonceptivos hormonales no estrogénicos en combinación con un anticonceptivo de barrera (p. ej., un preservativo, diafragma, capuchón cervical o
    condón femenino); o
    c. Usar un dispositivo intrauterino (DIU) en combinación con un anticonceptivo de barrera
    (es decir, un preservativo, diafragma o capuchón cervical, o un condón femenino); od. No ser heterosexualmente activo, practicar la abstinencia heterosexual o tener relaciones con una persona vasectomizada (estéril confirmada).
    * No se usarán juntos un preservativo masculino y uno femenino debido al riesgo de rotura o daños provocados por la fricción del látex.
    6. Varón heterosexualmente activo que no use métodos anticonceptivos eficaces o no esté
    dispuesto a seguir utilizando estos métodos anticonceptivos durante al menos 30 días después de finalizar el período de tratamiento.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo principal de este ensayo es el de continuar el suministro de DRV para pacientes
    pediátricos que hayan completado el tratamiento con DRV en los ensayos clínicos TMC114-C212, TMC114-TiDP29-C228 o TMC114-TiDP29-C230 del promotor Tibotec Pharmaceuticals, y que continúen beneficiándose de su uso, en países donde DRV no se comercializa para el
    paciente pediátrico, no es reembolsable o no es posible acceder a él a través de otra fuente (p. ej.
    un programa de acceso o un programa gubernamental).
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Proporcionar acceso continuado
    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 Yes
    E.8.1.1Randomised No
    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 Yes
    E.8.1.7.1Other trial design description
    De un sólo brazo
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years5
    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 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Niños (2-11 años); Adolescentes (12-17 years)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state1
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 4
    F.4.2.2In the whole clinical trial 65
    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 Decision2010-08-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-11-23
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