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    The EU Clinical Trials Register currently displays   43841   clinical trials with a EudraCT protocol, of which   7281   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:2010-023008-29
    Sponsor's Protocol Code Number:FH-10
    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:2010-11-22
    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 number2010-023008-29
    A.3Full title of the trial
    Estudio Fase 3, Aleatorizado, Abierto, Controlado de Lopinavir/Ritonavir y Lamivudina versus terapia estándar en Pacientes Infectados con HIV-1 Naïve.
    A.3.2Name or abbreviated title of the trial where available
    GARDEL
    A.4.1Sponsor's protocol code numberFH-10
    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 SponsorFundación Huésped
    B.1.3.4CountryArgentina
    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 milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 number50
    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 RoleComparator
    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 LAMIVUDINA NORMON 150 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderLABORATORIOS NORMON, S.A.
    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 INNLAMIVUDINA
    D.3.9.3Other descriptive nameLAMIVUDINE
    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
    El propósito del estudio es comparar la seguridad y la eficacia de la combinación de Lopinavir/Ritonavir más 3TC versus terapia estándar con 2 INTIs y Lopinavir/Ritonavir en pacientes infectados con HIV-1 naïve. Pacientes estarán bajo tratamiento durante 48 semanas; seguridad y eficacia virológica se evaluarán en forma preliminar en semana 24.
    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
    Explorar la eficacia de Lopinavir/Ritonavir plus 3TC como una terapia dual
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Edad &#8805;18 años.
    2. Paciente con infección por HIV-1 documentada definida por ELISA positivo más Western Blot confirmatorio; o una carga viral ARN-HIV plasmática &#8805;10.000 copias/mL documentada.
    3. El paciente ha firmado voluntariamente y fechado el formulario de consentimiento informado aprobado por el Comité de Ética, luego que se le haya explicado en qué consiste el estudio y el paciente haya tenido oportunidad de hacer preguntas. El consentimiento informado deberá firmarse antes de realizar cualquier procedimiento específico del estudio.
    4. El paciente está de acuerdo en no tomar medicación durante el estudio, incluyendo aquellas de venta libre, vitaminas, minerales o preparados con hierbas sin la aprobación del médico del estudio.
    5. Carga viral HIV-ARN >1.000 copias/mL.
    6. Sujeto naïve para tratamiento ARV (está permitido, pacientes que hayan recibido ARV &#8804;48 horas).
    7. Sujetos que presenten indicación de tratamiento antirretroviral.
    8. Sujetos que pueden cumplir con los requerimientos del protocolo.
    9. La condición médica general del paciente, a criterio del investigador, no interfiere con las evaluaciones ni la finalización del estudio.
    10. Si el paciente es mujer, deberá estar postmenopáusica durante por lo menos un año, estéril quirúrgicamente (ligadura de trompas bilateral, ooforectomía bilateral o histerectomía) o la paciente debe:
    a. utilizar doble método anticonceptivo que incluya al menos un método de barrera, que sea aceptado tanto por el sujeto como por el investigador; y
    b. tener examen de embarazo en orina realizado tanto en la visita de selección como en la basal, cuyos resultados deberán ser negativos.
    c. Deberá continuar utilizando doble método anticonceptivo que incluya al menos un método barrera durante por lo menos 30 días luego de haber concluido el período de fin de tratamiento.
    E.4Principal exclusion criteria
    1. Evidencia de resistencia al Lopinavir/Ritonavir, y/o FTC o 3TC, y/u otros análogos nucleosídicos basado en el resultado del test de resistencia realizado en la visita de selección, considerando resistencia según el panel IAS-USA, versión diciembre 2009.
    Se considera resistencia a Lopinavir/Ritonavir a la presencia de cualquiera de las siguientes mutaciones mayores: V32I; I47V/A; L76V; V82A/F/T/S o la presencia de 2 o más mutaciones menores en las posiciones 10, 20, 24, 33, 46, 50, 53, 54, 63, 71, 73, 84, 90.
    Se considera resistencia a 3TC y/o FTC a la presencia de la mutación M184V/I y/o K65R.
    A criterio del investigador y basado en el test de resistencia, no pueda construirse un régimen basado en Lopinavir/Ritonavir, más 3TC o FTC y otro análogo nucleósido/nucleótido activo.
    2. Infección previa por HIV-2 documentada.
    3. Utilizar medicaciones concomitantes no permitidas (ver Anexo H).
    4. El paciente tiene diagnóstico de hepatitis aguda activa por cualquier causa o hepatitis C crónica CON aspartato aminotransferasa (AST) y/o alanino aminotransferasa (ALT) >5 veces el límite superior de lo normal (ULN, por sus siglas en inglés) Y/O probablemente requiera tratamiento en el período de un año.
    5. Infección por Hepatitis B activa (cualquiera sea el estadio de infección).
    6. Cualquier enfermedad activa clínicamente significativa (por ej. tuberculosis, disfunción cardíaca, pancreatitis) o hallazgos de historia clínica o examen físico durante la selección que, en opinión del investigador, podría comprometer la seguridad del paciente o el resultado del estudio o la adherencia a las normas del protocolo.
    7. El paciente tiene una enfermedad marcadora de SIDA actualmente activa (Condiciones Categoría C según el sistema de Clasificación del CDC para infecciones de HIV 1993) dentro de los 30 días de la selección. Aquellos pacientes que estén estabilizados y recibiendo tratamiento para una enfermedad marcadora pueden ingresar al estudio.
    8. Expectativa de vida <1 año según el investigador.
    9. Los exámenes de laboratorio realizados en la visita de selección muestran cualquiera de las siguientes alteraciones:
    Hemoglobina <8.0 g/dL
    b. Recuento absoluto de neutrófilos <750 cel/&#956;L
    c. Recuento de Plaquetas <50.000 cel/mm3
    d. Creatinina &#8805;1,5 veces el límite superior normal
    10. Pacientes enrolados en otros estudios clínicos que hayan incluido muestras de sangre, recolección de muestras, u otros procedimientos de intervención. La participación en estudios de observación sin intervención no se considera un criterio de exclusión.
    11. Uso de cualquier agente en investigación dentro de los 30 días de la selección.
    12. Uso de drogas inmunosupresoras, inhibidores de la citoquina u otras citoquinas en el último año.
    13. Cualquier condición (incluyendo pero no limitado al uso de, alcohol o drogas) que en la opinión del investigador podría comprometer la seguridad del paciente o su adherencia al protocolo.
    14. Paciente embarazada o en período de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    o Proporción de pacientes con niveles de ARN-HIV menores a 50 copias/mL en un análisis de intención de tratamiento a la semana 48.
    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 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 Yes
    E.8.1.1Randomised Yes
    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
    abierto
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 concerned2
    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 years1
    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) 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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2010-11-22. Yes
    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
    Representante legal o testigo
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state38
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 410
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    No esta descrito
    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 Decision2011-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-06-26
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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