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    The EU Clinical Trials Register currently displays   43692   clinical trials with a EudraCT protocol, of which   7246   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:2008-001749-25
    Sponsor's Protocol Code Number:MUH-TEL-2008-04
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2009-06-08
    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 number2008-001749-25
    A.3Full title of the trial
    Estudio Abierto para evaluar la seguridad de Fosamprenavir/Ritonavir (FPV/rtv) Administrado durante 96 semanas a Pacientes Co-infectados con HIV/HCV
    A.4.1Sponsor's protocol code numberMUH-TEL-2008-04
    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 SponsorMatter Misericoridiae University Hospital. Dublín
    B.1.3.4CountryIreland
    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 TELZIR 700 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderGLAXO GROUP 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 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 INNFOSAMPRENAVIR CALCICO
    D.3.9.3Other descriptive nameFOSAMPRENAVIR CALCICO
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Investigar si FPV/rtv se puede utilizar de una manera segura en pacientes co-infectados con VIH/VHC, y aquellos con alteraciones hepáticas, y evaluar si estos pacientes se podrían beneficiar de una dosificación ajustada adecuadamente.
    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
    Evaluar la seguridad/tolerabilidad hepática del tratamiento TARGA que incluya FPV/rtv, a las 48 semanas, valorado por la incidencia de los incrementos de grado 3-4 de las transaminasas.
    E.2.2Secondary objectives of the trial
    •Describir el efecto que FPV/rtv tenga en la progresión clínica de la enfermedad hepática durante 96 semanas.
    •Evaluar el papel de marcadores no-invasivos (APRI, Forms index, SHASTA y Fibroscan en la evaluación y vigilancia de pacientes co-infectados con HIV/HCV.
    •Investigar el papel del control terapéutico del medicamento (TDM) en la evaluación y manejo de estos pacientes.
    •Valorar el papel del control terapéutico del medicamento (TDM) para la monitorización y/o ajuste de dosis en pacientes con fibrosis/cirrosis hepática tomando FPV/rtv.
    •Describir la seguridad global de FPV/rtv en pacientes con alteración hepática leve o moderada.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Debe haber cumplido &#8805;18 años de edad.
    2.Puede haber recibido o no, terapia antirretroviral.
    3.Quiere y puede entender y proporcionar consentimiento informado antes de su participación en el estudio.
    4.Debe tener prueba de la co-infección de VHC (PCR positiva)
    5.Debe tener documentación de infección según prueba de anticuerpos al VIH
    6.Una mujer puede participar en el estudio, siempre y cuando:
    •No pueda concebir (es decir, sea fisiológica ente incapaz de quedarse embarazada, incluye mujeres post menopáusicas); o,
    •Si puede concebir, debe tener un test de embarazo negativo (niveles de &#946;-HCG en suero) en la visita de selección, y debe utilizar un método anticonceptivo de barrera y/u hormonal (cualquiera de los métodos anticonceptivos que se adopten, deberán ser utilizados consistente y correctamente, es decir, de acuerdo con las instrucciones del prospecto del producto y de su médico. Esterilización (que se hayan esterilizado bien a la mujer misma o a su pareja masculina).

    Todos los sujetos del estudio deben ser asesorados sobre la práctica del sexo seguro.
    E.4Principal exclusion criteria
    1.Sujetos que en la evaluación Basal se encuentren en la fase inicial de una infección aguda de la Categoría Clínica C, según la clasificación de la CDC (definiciones CDC Apéndice 9.4.0). Estos sujetos se podrían incluir si estuvieran recibiendo tratamiento para estas infecciones y estuvieran mejorando clínicamente en la visita Basal.
    2.Sujetos que participen en protocolos con medicamentos en investigación, que pueda impactar en la supresión del ARN del VIH.
    3.Sujetos que, en la opinión del investigador, no puedan completar el periodo de dosificación del estudio y sus evaluaciones.
    4.Pacientes con alteración hepática severa (puntuación CTP >9)
    5.Pacientes con co-infección VHB
    6.Sujetos que en la selección, muestren evidencia de resistencia genotípica a FPV (según definición del algoritmo actual de la ANRS AC-11) o evidencia documentada de resistencia genotípica o fenotípica a amprenavir/ritonavir (por encima del umbral de la susceptibilidad reducida)
    7.Pacientes con problemas de adicción al alcohol o drogas, que en opinión del investigador comprometan la participación en el estudio.
    8.Pacientes que estén en tratamiento para la infección de VHC en las primeras 48 semanas del estudio
    9.Mujeres que estén embarazadas o en periodo de lactancia.
    10.Sujetos que tengan alguna condición médica grave (tal como pancreatitis, diabetes, insuficiencia cardiaca, cardiomiopatía o alguna otra disfunción cardiaca), que en la opinión del Investigador, comprometería la seguridad del sujeto.
    11.Sujetos con previa enfermedad mental, física, o abuso de sustancias no permitidas que, en la opinión del investigador, puedan interferir en la habilidad del sujeto para cumplir con la dosificación del protocolo y sus evaluaciones.
    12.Sujetos con historia de enfermedad intestinal inflamatoria o cáncer intestinal, isquemia intestinal, malabsorbción, o alguna otra disfunción gastrointestinal, que en la opinión del Investigador pueda interferir con la absorción de la medicación o que haga que el sujeto no pueda tomar medicación oral.
    13.Sujetos con anomalías agudas de laboratorio en la evaluación de selección, que en la opinión del Investigador, descartaría la participación del sujeto en el estudio de un medicamento en investigación. Si los sujetos presentan una anomalía aguda de grado 4, la prueba podría repetirse una vez más en la ventana de 45 días de la selección. Si se confirmara la anomalía de grado 4, se excluiría al sujeto de la participación en el estudio.
    14.Sujetos con un aclaramiento de creatinina < 50 mL/min por el método de Cockcroft-Gault [Cockcroft, 1976]. Esta prueba podría repetirse una vez más en la ventana de 45 días de la selección. 15.Alanin aminotransferasa (ALT) >5 veces el límite superior de la normalidad (ULN).
    16.Sujetos que hayan recibido en los 14 días previos a la selección, medicación clasificada como “contraindicada” con el uso de FPV/rtv.
    17.Sujetos que hayan recibido radioterapia o quimioterapia citotóxica durante los 28 días antes de la selección del estudio, o se sabe de la necesidad de este tipo de tratamiento durante el periodo del estudio.
    18.Sujetos que hayan recibido tratamiento con una vacuna inmuno-terapéutica contra el VIH-1 o alguna otra medicación con actividad anti-VIH in vitro, durante los 28 días antes de la selección del estudio, o se sabe de la necesidad de este tipo de tratamiento durante el periodo del estudio.
    19.Sujetos que requieran tratamiento con medicaciones contraindicadas (descritas en el prospecto de FPV/rtv) en los 14 días previos al comienzo de la medicación en investigación, o se anticipa la necesidad de su uso durante el estudio.
    20.Sujetos con historia de alergia a cualquiera de los tratamientos del estudio o alguno de sus excipientes.
    E.5 End points
    E.5.1Primary end point(s)
    Incidencia de incrementos grado 3-4 de la ALT o la AST durante 48 semanas.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months9
    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 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 state90
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 160
    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 Decision2009-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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