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    Summary
    EudraCT Number:2007-003654-29
    Sponsor's Protocol Code Number:1100.1486
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2007-11-30
    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 number2007-003654-29
    A.3Full title of the trial
    Ensayo clínico aleatorizado, doble ciego, doble enmascarado, de grupos paralelos con control activo para evaluar la eficacia antiviral de 400mg QD de Nevirpaina liberación prolongada (neVirapine Extended Release) en comparación con 200mg BID de nevirapina liberación inmediata (neVirapinE immediate release) en combinación con Truvada® en pacientes infectados por VIH-1 que no hayan recibido tratamiento antirretroviral previo (naïve) (VERVE)

    A randomised, double blind, double dummy, parallel group, active
    controlled trial to evaluate the antiviral efficacy of 400 mg QD
    nevirapine extended release formulation in comparison to 200 mg BID
    nevirapine immediate release in combination with Truvada® in
    antiretroviral therapy naïve HIV-1 infected patients
    A.4.1Sponsor's protocol code number1100.1486
    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 Sponsor
    B.1.3.4Country
    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
    B.Sponsor: 2
    B.1.1Name of SponsorBoehringer Ingelheim España, S.A.
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsor
    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 nameNevirapine Tablets, Extended Release, 400 mg
    D.3.2Product code Nevirapine K25% XR 400 mg
    D.3.4Pharmaceutical form Prolonged-release 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 INNNEVIRAPINE
    D.3.9.1CAS number 129618402
    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 Information not present in EudraCT
    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 Viramune 200 mg Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim Pharmaceuticals, Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameViramune 200 mg Tablets
    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 INNNEVIRAPINE
    D.3.9.1CAS number 129618402
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboProlonged-release tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infección por VIH-1

    HIV-1 infection
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020160
    E.1.2Term HIV disease
    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 es evaluar la eficacia de 400 mg QD de nevirapina liberación prolongada (NVP ER) frente a 200 mg BID de nevirapina liberación inmediata (NVP IR) en pacientes infectados por VIH-1 que no hayan recibido tratamiento ARV previo (naïve), después de 48 semanas de tratamiento.


    The primary objective of this study is to evaluate the efficacy of 400 mg QD nevirapine extended release (NVP XR) formulation versus 200 mg BID nevirapine immediate release (NVP IR) in ARV therapy naïve HIV-1 infected patients after 48 weeks of treatment.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios son evaluar la seguridad y la farmacocinética de NVP ER y de NVP IR



    Secondary objectives are to evaluate safety and pharmacokinetics of NVP XR and NVP IR.

    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Subestudio farmacocinético opcional: Los centros elegidos participarán en el subestudio farmacocinético, que consiste en la obtención intensiva de muestras de sangre el Día 28. En este subestudio está previsto incluir aproximadamente unos 30 pacientes. Un paciente que sea apto para el estudio automáticamente será apto para el subestudio FC. Para participar en el subestudio será necesario completar un formulario de consentimiento informado independiente. Sólo los centros que tengan experiencia previa y que estén equipados para manejar las muestras FC serán elegibles para participar en el subestudio. Se espera que la inclusión del subestudio FC termine antes de completar el estudio principal. En este caso, el promotor informará a los centros designados para que continúen la inclusión en el estudio principal, sin incluir más casos en el subestudio de FC.
    E.3Principal inclusion criteria
    1. Consentimiento informado firmado de acuerdo con la BPC y la legislación local antes de iniciar la participación en el estudio.

    2. Hombres y mujeres infectados por VIH-1, ≥ 18 años de edad con serología positiva (ELISA) confirmada mediante Western blot.

    3. Sin tratamiento antirretroviral previo.

    4. Hombres con recuentos de linfocitos CD4+ >50 - <400 células/μl o mujeres con recuentos de linfocitos CD4+ >50 - <250 células/μl.

    5. Función renal adecuada, definida como un aclaramiento de creatinina (CLCr) calculado mayor o igual a 50 ml/min según la fórmula de Cockcroft-Gault, como se indica a continuación:

    Hombre: (140 – edad en años) x (peso en kg) / 72 x (creatinina sérica en mg/dl) = CLCr (ml/min).

    Mujer: (140 – edad en años) x (peso en kg) / 72 x (creatinina sérica en mg/dl) x 0,85= CLCr (ml/min).

    6. Puntuación de Karnofsky >70 (ver el Anexo 10.4).

    7. Una carga viral de VIH ≥ 1.000 copias/ml.

    8. Disposición para iniciar quimioprofilaxis guiada por el recuento de linfocitos CD4+ para prevenir las infecciones oportunistas como se define en el Anexo 10.2.

    9. Disposición para no ingerir sustancias que puedan alterar las concentraciones plasmáticas del fármaco del estudio por interacción con el sistema del citocromo P450 (indicadas en el Anexo 10.3 del protocolo) durante el estudio.

    10. Sólo para centros que participen en el subestudio FC: Consentimiento informado por escrito de acuerdo con la BPC y la legislación local para participar en el estudio de FC. La negativa a participar en el subestudio de FC no es un criterio de exclusión para participar en el estudio principal. Sólo los centros que tengan experiencia previa y que estén equipados para manejar las muestras FC serán elegibles para participar en el subestudio
    E.4Principal exclusion criteria
    1. Abuso de sustancias activas o alcoholismo crónico según el criterio del investigador.

    2. Hepatitis B o C activa, definida como analítica positiva del HBsAg y ADN del VHB o ARN del VHC.

    3. Mujeres en edad fértil que:

    a. Tengan una prueba de embarazo positiva en suero en el momento de selección,
    b. Se encuentran en periodo de lactancia,
    c. tienen previsto un embarazo,
    d. no acepten utilizar un método anticonceptivo de doble barrera, o
    e. no están dispuestas a usar métodos anticonceptivos que no sean anticonceptivos orales con etinilestradiol.

    Nota: Durante la participación en este estudio, los pacientes de ambos sexos deberán usar métodos anticonceptivos de barrera además o en lugar de anticonceptivos orales que contengan etinilestradiol,.
    Estos métodos de barrera son: diafragma con espermicida, Femidom (preservativos femeninos), capuchón cervical y preservativos.

    4. Parámetros analíticos de > Grado 2 en la escala DAIDS.

    5. ALT/AST de > Grado 1 en la escala DAIDS.

    6. Hipersensibilidad a cualquiera de los componentes del producto en estudio.

    7. Uso previo de Viramune® (nevirapina) o cualquier otro fármaco antirretroviral (no se incluye el uso de dosis únicas de NVP como prevención de la transmisión madre-hijo).

    8. Resistencia a los ITINN o a uno de los componentes de Truvada® (emtricitabina o tenofovir disoproxil fumarato) o lamivudina (3TC) basada en el informe del estudio de resistencia genotípica del VIH-1 realizado en la visita de selección.

    9. Pacientes que estén recibiendo otros tratamientos concomitantes que no están permitidos, tal y como se describe en la información de prescripción.

    10. Uso de fármacos en investigación (cualquier fármaco experimental aparte de la pauta del estudio) en los 30 días anteriores a la entrada del estudio o durante el mismo
    11. Uso de fármacos inmunomoduladores en los 30 días previos a la entrada en el estudio o durante el mismo (p. ej., interferón, ciclosporina, hidroxiurea o interleucina 2).

    12. Pacientes diagnosticados de una enfermedad maligna.

    13. Pacientes que, en opinión del investigador, no son candidatos para su inclusión en el estudio.

    14. Pacientes que presentan leucoencefalopatía multifocal progresiva (LMP), sarcoma de Kaposi visceral (SK) y/o cualquier linfoma.

    15. Cualquier enfermedad definitoria de SIDA no resuelta, sintomática o inestable, que lleve en tratamiento durante al menos 12 semanas en el momento de la visita de selección
    E.5 End points
    E.5.1Primary end point(s)
    El criterio de valoración principal de este estudio es la respuesta virológica en la semana 48. La respuesta virológica se define como CV <50 copias/ml antes de la semana 48 y sin rebote virológico posterior ni cambio del tratamiento ARV antes de la semana 48.

    El rebote virológico se define por dos mediciones consecutivas de la CV ≥500 copias/ml, separadas por un intervalo de al menos dos semanas, después de la medición de la CV <50 copias/ml.

    Si la primera CV ≥500 copias/ml se detecta en la semana 48 y este es el primer valor secuencial de la CV ≥500 copias/ml después de la respuesta virológica, es necesaria otra medición al menos dos semanas más tarde para confirmar si se ha producido el rebote virológico.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    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) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) Yes
    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 No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA71
    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
    Se producirá una visita FDE cuando el paciente complete todo el ensayo (semana 144) o si discontinúa el tto prematuramente (la semana 144 es la duración máx. de tto permitida para cada paciente). Esta visita tendrá lugar dentro de los 7 dias siguientea a la última administración del fármaco para evaluar eficacia, AA, AAG y analítica final. La FDE por discontinuación prematura es para obtener información de eficacia/seguridad de pacientes q abandonen el estudio antes de tiempo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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 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 Information not present in EudraCT
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 958
    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)
    Standard of care based on physician judgment.
    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 Decision2008-01-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-12-14
    P. End of Trial
    P.End of Trial StatusOngoing
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