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    Summary
    EudraCT Number:2005-006179-11
    Sponsor's Protocol Code Number:TMC114-C212
    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:2006-06-28
    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 number2005-006179-11
    A.3Full title of the trial
    A Phase II, open-label trial, to investigate pharmacokinetics, safety, tolerability and antiviral activity of TMC114/rtv b.i.d. in treatment-experienced HIV-1 infected children and adolescents.

    Estudio en Fase II, abierto, para investigar la farmacocinética, seguridad, tolerabilidad y actividad antiviral de TMC114/rtv (Ritonavir) dos veces al día en niños y adolescentes infectados por VIH-1 previamente tratados
    A.4.1Sponsor's protocol code numberTMC114-C212
    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 SponsorTibotec Pharmaceuticals Ltd.
    B.1.3.4CountryBelgium
    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 Information not present in EudraCT
    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 nameTMC114 ethanolate
    D.3.2Product code TMC114
    D.3.4Pharmaceutical form Film-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 INNdarunavir
    D.3.9.1CAS number 206361-99-1
    D.3.9.2Current sponsor codeTMC114 (F016)
    D.3.9.3Other descriptive nameTMC114 ethanolate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 nameTMC114 ethanolate
    D.3.2Product code TMC114
    D.3.4Pharmaceutical form Film-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 INNdarunavir
    D.3.9.1CAS number 206361-99-1
    D.3.9.2Current sponsor codeTMC114 (F027)
    D.3.9.3Other descriptive nameTMC114 ethanolate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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: 3
    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
    D.2.1.1.2Name of the Marketing Authorisation holderABBOT 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.3.1Product nameNorvir
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNritonavir
    D.3.9.1CAS number 155213-67-5
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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: 4
    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
    D.2.1.1.2Name of the Marketing Authorisation holderABBOT 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.3.1Product nameNorvir
    D.3.4Pharmaceutical form Oral solution
    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.3.9.1CAS number 155213-67-5
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    HIV-1
    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
    OBJETIVOS DE LA PARTE I

    Los objetivos son:
    - Evaluar el perfil farmacocinético de dos dosis diferentes de TMC114 en combinación con ritonavir a dosis bajas administrado dos veces al día a la población pediátrica en fase estacionaria. AUC12h, Cmáx. y Cmín.;
    - Determinar una recomendación de dosis de TMC114 en función del peso corporal para sujetos infantiles con un peso ≥ 20 Kg. y < 50 Kg.
    - Evaluar la seguridad, la tolerabilidad y la actividad antiviral a corto plazo de dos dosis diferentes de TMC114/rtv administrado dos veces al día a sujetos infantiles previamente tratados.


    OBJETIVO PRINCIPAL DE LA PARTE II

    - Evaluar la seguridad, la tolerabilidad y la eficacia a largo plazo de TMC114 en combinación con ritonavir a dosis bajas administrado dos veces al día y de otros ARV durante un período de tratamiento de 24 semanas en las dosis pediátricas (≥ 20 Kg. y < 50 Kg.) y de adultos (≥ 50 Kg.) recomendadas.
    E.2.2Secondary objectives of the trial
    OBJETIVOS SECUNDARIOS DE LA PARTE II

    - Evaluar la seguridad, la tolerabilidad y la eficacia a largo plazo de TMC114 en combinación con ritonavir a dosis bajas administrado dos veces al día y de otros ARV durante un período de tratamiento de 48 semanas en las dosis pediátricas (≥ 20 Kg. y < 50 Kg.) y de adultos (≥ 50 Kg.) recomendadas.
    - Evaluar la inmunología, las características de resistencia, los parámetros farmacocinéticos y la relación farmacocinética/farmacodinámica de TMC114/rtv durante un período de tratamiento de 48 semanas.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Se considerarán aptos para este estudio los sujetos que cumplan con los siguientes requisitos:
    1. Niños y adolescentes de ambos sexos con edades entre los 6 y los 17 años.
    2. Sujetos con infección por el VIH-1 demostrada.
    3. Peso corporal para la Parte I: ≥ 20 a < 50 kg.
    Peso corporal para la Parte II: ≥ 50 kg y de ≥20 a < 50 kg después de la selección de dosis pediátrica.
    4. Capacidad de tragar los comprimidos de TMC114 y las cápsulas de ritonavir, y de tolerar la formulación líquida de ritonavir (la formulación líquida sólo se administrará a los sujetos < 40 kg).
    5. Porcentaje de linfocitos T CD4+ estable: no haber tenido una disminución de más del 5% en el porcentaje de CD4+ entre la visita de selección y la última medida disponible de CD4+ (con un tiempo mínimo de 4 semanas y máximo de 24 semanas entre la visita de selección y la última medida).
    6. Sujetos sometidos actualmente a un tratamiento antirretroviral estable que necesiten cambiar por fracaso terapéutico (tiempo mínimo en el tratamiento de 12 semanas) con una carga viral de >1.000 copias/ml.
    7. Que los padres o representantes legales e sujetos del estudio (siempre que sea adecuado, dependiendo de la edad y de las normativas locales) deseen y tengan capacidad para dar su consentimiento. A los niños se les informará sobre el estudio y se les pedirá que den su aprobación tal y como se describe en el Capítulo II, Apartado 6.4.
    8. Sujetos capaces de cumplir con las exigencias del protocolo.
    9. Que el estado de salud general, según la opinión del investigador, no interfiera con las evaluaciones y la realización completa del estudio.
    10. Durante el estudio, las pacientes activas sexualmente y con posibilidades de quedar embarazadas deberán usar un método anticonceptivo eficaz y seguro, como la abstinencia sexual o los métodos anticonceptivos de barrera aceptados médicamente (diafragma y preservativos, entre otros). El control de la natalidad con métodos hormonales, no se considerará válido por si sólo, pues no se dispone de datos de interacción entre el fármaco del estudio y estos métodos (ver la Tabla 2).
    E.4Principal exclusion criteria
    No podrán ser seleccionados los sujetos que cumplan uno o más de los siguientes criterios:
    1. Parte I: no está permitida la utilización del ITINN efavirenz como parte del tratamiento actual.
    Parte II: está permitida la utilización del efavirenz como parte del tratamiento actual (ver Tabla 2).
    2. La presencia de cualquier enfermedad asociada al SIDA activa [Estadio C según la Clasificación de la CDC de 1993 para la Infección por el VIH o según la Clasificación de la CDC revisada de 1994 para la infección por el VIH en niños menores de 13 años(ver Anexo 6; Apartado 7.6)]:
    Atención: una enfermedad asociada al SIDA no estabilizada clínicamente durante un mínimo de 30 días será considerada como activa.
    Atención: está permitida la profilaxis primaria y secundaria para las enfermedades asociadas al SIDA en aquellos casos en los que los medicamentos administrados no estén incluidos en la lista de medicamento prohibidos (ver el Apartado 5.5.12).
    3. La utilización de sustancias o principios activos determinados por el investigador durante la anamnesis que incluye, entre otros, la ingesta diaria o frecuente de alcohol, el consumo de disolventes, barbitúricos, anfetaminas y estupefacientes o narcóticos.
    Atención: está permitido el consumo de metadona con receta médica (ver la Tabla 2).
    4. La utilización de un tratamiento simultáneo prohibido (ver el Apartado 5.5.12).
    5. La utilización de fármacos antirretrovirales y no antirretrovirales en fase de investigación clínica en los 30 días anteriores al selección, a excepción del tenofovir, tipranavir, atazanavir y fosamprenavir.
    Atención: no es recomendable el suministro de TMC114 en los 14 días siguientes a la utilización de tipranavir. Es necesario un período mínimo de lavado de 14 días en el que o bien se debe interrumpir el suministro de tipranavir, o bien debe ser sustituido por un tratamiento de IP seleccionado por el investigador hasta la visita basal (Día 1).
    6. Una esperanza de vida de menos de 6 meses.
    7. La participación conjunta en otros estudios clínicos y/o de cohortes sin permiso por escrito del promotor.
    8. El embarazo o la lactancia.
    9. Cualquier enfermedad significativa clínicamente activa (por ejemplo, tuberculosis, disfunción cardíaca, pancreatitis, infecciones víricas agudas) o cualquier hallazgo durante el selección en los antecedentes médicos o en la exploración física que, a juicio del investigador, pueda comprometer la seguridad del individuo o el resultado del estudio.
    10. Alergia o hipersensibilidad significativas, demostradas clínicamente, a cualquiera de los excipientes de la medicación en fase de investigación clínica (TMC114) o al ritonavir.
    Atención: el TMC114 es una sulfamida. Aquellos sujetos que anteriormente hayan padecido alergia a la sulfamida podrán entrar en el estudio. Hasta el momento no se ha identificado la posibilidad de sensibilidad cruzada entre fármacos del grupo de las sulfamidas y el TMC114 en sujetos participando en estudios en fase II.
    11. Sujetos con insuficiencia hepática demostrada.
    Atención: los sujetos infectados conjuntamente con hepatitis crónica B o C (determinada por el antígeno de superficie de la hepatitis C, anticuerpo IgG anti-hepatitis B (anti core) y el anticuerpo hepatitis C) podrán entrar en el estudio si su estado es clínicamente estable y no tienen que seguir un tratamiento durante el período de estudio y presentan niveles de ALT o AST < 3 veces el límite superior normal. No podrán entrar en el estudio los sujetos a los que se les haya diagnosticado hepatitis vírica aguda durante el selección (por ejemplo anticuerpo IgM de la hepatitis A).
    12. Sujetos con las siguientes anomalías analíticas tal y como las define el esquema de evaluación de la DAIDS:
    • cualquier toxicidad de grado 3 o 4 con las siguientes excepciones siempre que una evaluación clínica no prevea un riesgo inmediato para la salud del individuo:
    - sujetos con diabetes preexistente o aumentos asintomáticos de la glucemia de grado 3 o 4.
    - sujetos con aumentos asintomáticos de los niveles de triglicéridos o colesterol de grado 3 o 4.
    E.5 End points
    E.5.1Primary end point(s)
    PARTE I

    El parámetro de eficacia principal será la respuesta virológica durante la Semana 2, definida como una disminución de la carga viral (copias/ml) de por lo menos 0,5 log10 con respecto al valor basal. En el análisis principal se aplicará el criterio NC = F, es decir, todos los sujetos que interrumpan el estudio prematuramente serán considerados como fracasos.

    PARTE II

    El parámetro de eficacia principal será la respuesta virológica demostrada (TLOVR) durante la Semana 24, definida como una disminución de la carga viral (copias/ml) de por lo menos 1 log10 con respecto al valor basal.
    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 Yes
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerabilidad / Dosis recomendada en pediatría / Inmunología
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled No
    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 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) No
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) No
    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 2006-06-28. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Menores
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 45
    F.4.2.2In the whole clinical trial 80
    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)
    Después de la finalización del estudio, Tibotec Pharmaceuticals Ltd. proporcionará TMC114 a todos aquellos sujetos que continúen obteniendo algún beneficio del tratamiento. Esto se hará hasta que la formulación pediátrica esté disponible en el mercado o hasta que se interrumpa su desarrollo.
    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 Decision2006-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-05-11
    P. End of Trial
    P.End of Trial StatusOngoing
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