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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2006-005256-33
    Sponsor's Protocol Code Number:1182.107
    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:2007-06-29
    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 number2006-005256-33
    A.3Full title of the trial
    Ensayo clínico multicéntrico, aleatorizado y abierto para evaluar tres dosis de Tipranavir potenciado con dosis bajas de ritonavir (500mg/200mg una vez al día, 250mg/100 mg dos veces al día y 500 mg/100 mg dos veces al día) mediante la evaluación farmacocinética en estado estacionario y la eficacia y seguridad a corto plazo en pacientes VIH-1 positivos que no hayan recibido tratamiento previo (naïve)
    Versión Final del 2007-04-27
    Más Enmienda 1 versión final del 2007-05-28 (No relevante)
    A.4.1Sponsor's protocol code number1182.107
    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 SponsorBoehringer Ingelheim España, S.A.
    B.1.3.4CountrySpain
    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 Aptivus 250mg cápsulas de gelatina blanda
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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 100mg capsulas blandas
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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, soft
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    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
    Los pacientes de este estudio deben ser varones y mujeres con edades comprendidas entre los 18 y los 65 años de edad infectados por VIH-1 y no tratados anteriormente con antirretrovirales.
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10020192
    E.1.2Term HIV-1
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El propósito de este estudio es identificar una(s) combinación(es) óptima de dosis de tipranavir (TPV) y ritonavir (RTV) para pacientes no tratados previamente con antirretrovirales infectados por VIH-1 que se pueda utilizar en un estudio pivotal mediante la evaluación de la farmacocinética en equilibrio y la eficacia y la seguridad a corto plazo.
    CRITERIOS PRINCIPALES DE VALORACIÓN

    Los criterios principales de valoración incluyen:
    • Farmacocinética del TPV
    o AUC0-24h para la pauta de una toma al día, AUC0-12h para la pauta de dos tomas diarias
    o Cp24h para la pauta de una toma al día, Cp12h para la pauta de dos tomas diarias
    o Cmín.
    o Cmáx.

    • Eficacia
    o Cambios con respecto al valor basal de la carga vírica, ARN del VIH (log10)
    E.2.2Secondary objectives of the trial
    CRITERIOS SECUNDARIOS DE VALORACIÓN
    • Farmacocinética del TPV
    o Aclaramiento oral aparente (CL/F)
    o Volumen de distribución (V/F)
    o Semivida terminal (t1/2)
    o Tmáx.

    • Farmacocinética del RTV
    o AUC0-24h para la pauta de una toma al día, AUC0-12h para la pauta de dos tomas diarias
    o Cp24h para la pauta una toma al día, Cp12h para la pauta de dos tomas diarias
    o Cpult y Tult
    o Cmáx. y Tmáx.
    o Aclaramiento oral aparente (CL/F)
    o Volumen de distribución (V/F)
    o Semivida terminal (t1/2)

    • Seguridad y tolerabilidad
    o Resultados de analíticas clínicas (hematología y bioquímica clínica)
    o Acontecimientos adversos
    o Exploración física
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    3.3.1 Criterios de inclusión
    Los pacientes que cumplan los siguientes criterios serán elegibles para su participación en este estudio:
    • Consentimiento informado firmado de acuerdo con la BPC y la legislación local antes de iniciar la participación en el estudio
    • Varones y mujeres no embarazadas infectados por el VIH-1 que no han recibido tratamiento previo y con una serología positiva (EIA) confirmada mediante Western blot.
    • Edad ≥18 y ≤ 65 años de edad
    • CD4 > 200 células/mm3
    • Carga vírica (ARNm del VIH-1) > 5.000 copias/ml
    • Capacidad para tragar sin dificultad varias cápsulas grandes.
    • Valores analíticos aceptables que indican una función orgánica basal adecuada en la visita de selección.
    • Los valores analíticos se consideran aceptables si la gravedad de todos los parámetros es de ≤ grado 2 según la escala de clasificación DAIDS/ACTG (véase el Apéndice 10.2).
    • Historia clínica, exploración física y ECG de 12 derivaciones aceptables en la visita de selección.
    • Disposición para no tomar los siguientes alimentos desde las 2 semanas anteriores a la administración de cualquier medicación del estudio y hasta el final del mismo.
    o Pomelo o zumo de pomelo, toronjas, hierba de San Juan y cardo mariano.
    • Disposición para no tomar alcohol desde 3 días antes de la administración de cualquier medicación del estudio y hasta el final del mismo.
    • Disposición para no tomar los siguientes alimentos desde 3 días antes de la obtención de muestras para PK:
    o Suplementos de ajo y alimentos o bebidas que contengan metilxantina (incluidos café, té, cola, bebidas energéticas, chocolate, etc.)
    • Disposición para no tomar hierbas medicinales de libre dispensación durante todo el estudio.
    • Disposición para no tomar ningún medicamento de libre dispensación desde 7 días antes de la administración de cualquier medicamento del estudio (incluidas vitaminas, minerales, complementos dietéticos y antiácidos) durante el estudio y hasta la finalización de todas las evaluaciones posteriores al mismo.
    E.4Principal exclusion criteria
    Criterios de exclusión
    Los pacientes con alguno de los siguientes criterios quedan excluidos de su participación en este estudio:
    • Mujeres en edad fértil que:
    o Presenten una prueba positiva de embarazo en suero.
    o No han estado empleando un método anticonceptivo de barrera durante al menos 3 meses antes de su participación en el estudio.
    o No accedan a utilizar un método anticonceptivo de barrera fiable (tal como un diafragma con crema o gel espermicida o preservativos con espuma espermicida) durante el estudio y hasta 60 días después de la finalización/interrupción del estudio.
    o Se encuentran en periodo de lactancia.
    • Sospecha de seroconversión o seroconversión confirmada en los últimos 6 meses.
    • Participación en otro estudio con un medicamento en investigación en los 2 meses anteriores al día 0 de este estudio.
    • Usen algún anticonceptivo farmacológico (incluidos anticonceptivos orales, parches o inyectables) en el mes anterior al día 0 y durante todo el estudio.
    • Usen tratamiento hormonal sustitutivo en el mes anterior al día 0 y en cualquier momento durante el estudio.
    • Antecedentes de enfermedad aguda en los 30 días anteriores al día 0.
    • Presenten signos de VHB o VHC activa o aguda.
    • Alcoholismo o toxicomanía en el año anterior a la selección o durante el estudio.
    • Pacientes con antecedentes de una enfermedad o alergia que, en opinión del investigador, pudiera confundir los resultados del estudio o suponer un riesgo adicional al administrar TPV.
    • Pacientes que hayan tomado (en los 7 días anteriores al día 0) alguna medicación de prescripción facultativa o de libre dispensación que, en opinión del investigador de acuerdo con el monitor BI del estudio clínico, podría interferir con la absorción, distribución o metabolismo de los medicamentos del estudio.
    • Hipersensibilidad conocida a alguno de los componentes del fármaco experimental.
    • Incapacidad para cumplir el protocolo.
    • Resistencia genotípica al tipranavir (definida como una puntuación de mutación del TPV > 4).
    E.5 End points
    E.5.1Primary end point(s)
    CRITERIOS PRINCIPALES DE VALORACIÓN
    Los criterios principales de valoración incluyen:
    • Farmacocinética del TPV
    o AUC0-24h para la pauta de una toma al día, AUC0-12h para la pauta de dos tomas diarias
    o Cp24h para la pauta de una toma al día, Cp12h para la pauta de dos tomas diarias
    o Cmín.
    o Cmáx.

    • Eficacia
    o Cambios con respecto al valor basal de la carga vírica, ARN del VIH (log10)
    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 Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    El final del ensayo será cuando el último paciente realice la última visita.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months12
    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 Information not present in EudraCT
    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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 84
    F.4.2.2In the whole clinical trial 84
    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 Decision2007-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-09-07
    P. End of Trial
    P.End of Trial StatusCompleted
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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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