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    Summary
    EudraCT Number:2009-016090-14
    Sponsor's Protocol Code Number:HCSKAL-2009-01
    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:2009-10-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2009-016090-14
    A.3Full title of the trial
    Análisis de los cambios en el tejido adiposo de pacientes con infección VIH y lipoatrofia en tratamiento con análogos de nucleósidos timidínicos, tras el cambio a monoterapia con Lopinavir/ritonavir
    A.3.2Name or abbreviated title of the trial where available
    BIOKAL
    A.4.1Sponsor's protocol code numberHCSKAL-2009-01
    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 SponsorDr. Vicente Estrada
    B.1.3.4CountrySpain
    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 KALETRA 200/50 mg comprimidos recubiertos con película
    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 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 INNLOPINAVIR
    D.3.9.3Other descriptive nameLOPINAVIR
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number133.3
    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/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number33.3
    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
    Pacientes infectados con ViH-1
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10020445
    E.1.2Term Human immunodeficiency virus type I infection with constitutional disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Cambio de las características histológicas del tejido adiposo y la expresión de genes involucrados en la adipogénesis y la inflamación tras 48 y 96 semanas del cambio de AZT+3TC+ABC a monoterapia con LPV/r. Para ello se evaluará de la biopsia de tejido adiposo ADN y ARN y los siguientes marcadores genéticos:
    (a) Involucrados en la adipogénesis. PPAR gamma, C/EBPalpha, Pref-1.
    (b) Asociados a los trastornos del metabolismo observados en la lipodistrofia. GLUT 4, Lipoprotein-lipasa.
    (c) Relacionados con el estado inflamatorio. TNF-alfa, MCP-1, Beta micloglobulina.
    (d) Toxicidad mitocondrial. COX-II, COX-IV.
    E.2.2Secondary objectives of the trial
    • Analizar los cambios en la capacidad funcional del tejido adiposo a través de la determinación de los niveles plasmáticos de leptina y adiponectina.
    • Examinar los cambios en los depósitos de grasa en las extremidades por medio de DEXA a las 48 y 96 semanas del cambio de TZV a LPV/r en monoterapia.
    • Evaluar la proporción de pacientes con respuesta virológica (ARN-VIH< 50 copias/mL) a las 48 y 96 semanas.
    • Evaluar el perfil de seguridad global a las 48 y 96 semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Pacientes infectados por VIH-1 documentada por prueba de anticuerpos frente a VIH-1 positiva y/o PCR positiva confirmadas para ARN del VIH-1
    - Pacientes en tratamiento con TARGA que contenga AZT+3TC+ABC (Trizivir®)
    - Pacientes con una carga viral indetectable definida como < 40 copias/mL en los últimos 6 meses.
    - Pacientes con evidencia clínica de lipoatrofia (definida como moderada o severa según la Lipodystrophy Severity Grading Scale)
    - Varones o mujeres de edad &#8805; 18 años.
    - Para mujeres en edad de procrear, prueba de embarazo en orina negativa en la visita de selección.
    - Pacientes que hayan otorgado el consentimiento informado por escrito antes de realizar cualquier procedimiento de selección específico del estudio.
    E.4Principal exclusion criteria
    - Pacientes con pruebas de haber fracasado a una terapia con inhibidores de proteasa (IP) y/o constancia documentada de mutaciones de resistencia en el gen de la proteasa, tanto previas como en el momento de la inclusión en el estudio.
    - Pacientes que por cualquier motivo no puedan ser tratados con LPV/r.
    - Caquexia, definida por un índice de masa corporal de <17 Kg/m2.
    - Mujeres embarazadas, o en período de lactancia, o mujeres en edad de procrear que no utilizan un método anticonceptivo adecuado según el criterio del investigador.
    - Enfermedad clínicamente significativa, a opinión del investigador, en los 3 meses previos a la inclusión en el estudio.
    - Uso concomitante de fármacos que puedan potencialmente afectar la morfología adipocitaria o a sus funciones, como ser: insulina, esteroides, anabolizantes, antiinflamatorios por más de tres meses.
    E.5 End points
    E.5.1Primary end point(s)
    cambio en la expresión de genes representativos de toxicidad del tejido adiposo (variable compuesta formada por la cuantificación de la expresión de genes involucrados en la adipogénesis, inflamación y metabolismo). Para ello se analizará:
    • Biopsias de grasa. Se hará una biopsia de la grasa subcutánea con una aguja tipo punch, con la finalidad de obtener un cilindro de grasa de aproximadamente 1 cm de longitud, en la cara lateral del abdomen. La biopsia se llevará a cabo por parte de un cirujano general experimentado, en el quirófano y bajo condiciones de asepsia. La biopsia será inmediatamente conservada en un criotubo, y se transportará en una nevera con nitrógeno líquido desde el quirófano hasta el laboratorio, hasta su congelación hasta -80ºC. Se harán tres biopsias: al inicio (antes del cambio del tratamiento), al año 1 y al año 2.
    • Determinaciones en el tejido adiposo. Las muestras de tejido graso se usarán para obtener DNA y RNA. Se analizará la expresión de determinados genes involucrados en la patogénesis de la lipodistrofia, a través del análisis de los niveles de transcripción. Los marcadores genéticos que se utilizarán serán los siguientes:
    (a) Involucrados en la adipogénesis. PPAR gamma, C/EBPalpha, Pref-1.
    (b) Asociados a los trastornos del metabolismo observados en la lipodistrofia. GLUT 4, Lipoprotein-lipasa.
    (c) Relacionados con el estado inflamatorio. TNF-alfa, MCP-1, Beta micloglobulina.
    (d) Toxicidad mitocondrial. COX-II, COX-IV.
    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) 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 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 concerned3
    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 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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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 No
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    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 Decision2009-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-12-04
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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