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    Summary
    EudraCT Number:2012-003595-39
    Sponsor's Protocol Code Number:APACHE
    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:2012-11-29
    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 number2012-003595-39
    A.3Full title of the trial
    A randomized, pilot clinical trial designed to compare, in human immunodeficiency virus infected patients who never have received antiretroviral therapy, the evolution of cerebral function and the neurocognitive efficient after 24 weeks of treatment with 2 regimens of highly efficacy antiretroviral treatment with different levels of central nervous system penetration.
    Ensayo clínico, randomizado, piloto, diseñado para comparar, en sujetos infectados por el virus de la inmunodeficiencia humana que nunca han recibido tratamiento antorretroviral, la evolucion del funcionamiento cerebral y del rendimiento neurocognitivo tras 24 semanas de tratamiento con dos regimenes de tratamiento antirretroviral de gran eficacia con distintos niveles de penetración en el sistema nerviosos central.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to compare brain function and neurocognitive performance in antiretroviral treatments with different levels of penetration in the central nervous system.
    Ensayo clínico para comparar el funcionamiento cerebral y rendimiento neurocognitivo en tratamientos antirretrovirales con distintos niveles de penetracion en el sistema nervioso central.
    A.3.2Name or abbreviated title of the trial where available
    Apache
    Apache
    A.4.1Sponsor's protocol code numberAPACHE
    A.5.4Other Identifiers
    Name:Eudra CTNumber:2012-003595-39
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundación para la Investigación Biomédica del Hospital Universitario La Paz
    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 supportFundacion para la Investigacion Biomédica del Hospital Universitario La Paz
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFIBHULP
    B.5.2Functional name of contact pointMaria Yllescas
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castella 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number0034917277558
    B.5.5Fax number0034912071876
    B.5.6E-mailmaria.yllescas@idipaz.es
    D. IMP Identification
    D.IMP: 1
    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 Reyataz
    D.2.1.1.2Name of the Marketing Authorisation holderBRISTOL-MYERS SQUIBB PHARMA EEIG
    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 nameATAZANAVIR
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNAtazanavir sulfato
    D.3.9.3Other descriptive nameATAZANAVIR SULFATE
    D.3.9.4EV Substance CodeSUB20595
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Norvir
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories Limited
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    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.3.9.4EV Substance CodeSUB10342MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Kivexa
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare UK Limited
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNABACAVIR SULFATE
    D.3.9.1CAS number 188062-50-2
    D.3.9.3Other descriptive nameABACAVIR SULFATE
    D.3.9.4EV Substance CodeSUB00231MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLAMIVUDINE
    D.3.9.1CAS number 134678-17-4
    D.3.9.4EV Substance CodeSUB08392MIG
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 Sustiva
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma EEIG
    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 Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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 INNEFAVIRENZ
    D.3.9.1CAS number 154598-52-4
    D.3.9.4EV Substance CodeSUB06463MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 5
    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 Truvada
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    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 INNTENOFOVIR DISOPROXIL
    D.3.9.1CAS number 147127-20-6
    D.3.9.4EV Substance CodeSUB20643
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Patients infected with human immunodeficiency virus who have never received antiretroviral treatment.
    Pacientes infectados con virus de inmunodeficiencia humana que nunca han recibido tratamiento antirretroviral.
    E.1.1.1Medical condition in easily understood language
    HIV
    VIH
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    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
    Changes in the levels of N-acetyl-aspartate (NAA) in the basal brain ganglia
    Variación de los niveles de N-Acetil-Aspartato (NAA) en los ganglios basales cerebrales
    E.2.2Secondary objectives of the trial
    - Change in neurocognitive functioning
    - Changes in the levels of NAA in the frontal lobe
    - Changes in the levels of choline, myoinositol and glutamate in the basal ganglia and frontal lobe
    - Change in the volume of brain structures
    - Changes in the white matter abnormalities
    - Virologic failure
    - Therapeutic failure
    - Changes in the levels of CD4
    - Adherence to HAART
    - Adverse effects
    - Variación del funcionamiento neurocognitivo
    - Variación de los niveles de NAA en el lóbulo frontal
    - Variación de los niveles de Colina, mioinositol y glutamato en los ganglios basales y el lóbulo frontal
    - Variación del volumen de las estructuras cerebrales
    - Variación de las anomalías de la sustancia blanca
    - Fallo virológico
    - Fallo terapeútico
    - Variación de los niveles de CD4
    - Adherencia al TARGA
    - Efectos adversos
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - HIV-positive by ELISA and confirmed by WB
    - Age> 18 years
    - Never have received antiretroviral treatment for HIV
    - CV baseline of HIV> 100,000 copies / mL
    - No evidence of genotypic resistance against antiretroviral
    - Study HLA B5701 negative
    - Having a VL <100,000 copies / mL
    - Able to understand and give written informed consent.
    - Meet the criteria to initiate the AR treatment according to Gesida 2012 Guideline.
    -Women of childbearing potential should have a pregnancy test negative in blood or urine during the 7 days prior to initiation of therapy and postmenopausal women should have amenorrhea for at least 12 months to consider that they are of childbearing age.
    - Non pregnant or lactating without heterosexual activity during the entire study or heterosexual activity and willing to use two methosds of contraception. The two methods of contraception can be 2 barrier methods or a barrier method and a method to prevent pregnancy hormone, used during the entire study and for 12 weeks after completion.
    -VIH positivo mediante ELISA y confirmado mediante WB
    - Edad > 18 años
    - No haber recibido nunca tratamiento antiretroviral frente al VIH
    - CV basal de VIH > 100.000 copias/mL
    - Ausencia de evidencia de resistencias genotípicas frente a antiretrovirales
    - Estudio HLA B5701 negativo
    - Tener una CV < 100.000 copias/mL
    - Capaz de entender y dar su consentimiento informado por escrito.
    - Cumplir criterios para el inicio del tratamiento antirretroviral de acuerdo con las recomendaciones recogidas en las guías de GESIDA 2012.
    - Las mujeres en edad fértil deberán tener una prueba de embarazo en sangre o en orina negativa durante los 7 días anteriores al Inicio del tratamiento y las mujeres posmenopáusicas deben presentar amenorrea desde hace al menos 12 meses para considerar que no están en edad fértil.
    - Puede incluirse a mujeres no embarazadas ni lactantes sin actividad heterosexual durante la totalidad del estudio O con actividad heterosexual y dispuestas a utilizar 2 métodos anticonceptivos. Los 2 métodos anticonceptivos pueden ser 2 métodos de barrera 0 un método de barrera y un método hormonal para prevenir el embarazo, utilizados durante la totalidad del estudio y hasta 12 semanas tras la finalización del mismo.
    E.4Principal exclusion criteria
    1. Pregnant or lactating women and women of childbearing age who are not committed to use adequate contraception method.
    2. Previous history of serious confounding neurological comorbidities defined as:
    - Dependence on drugs or alcohol
    - CNS opportunistic infections
    - Major depression or psychosis
    - Previous diagnosis of dementia
    - Mental retardation
    - CNS neurological disease
    - Co-infection with hepatitis C virus
    3. Claustrophobia
    4. Existence of magnetizable body devices
    5. Inability to perform and complete a full neurologic assessment
    6. Renal insufficiency (creatinine clearance <60 mL / min)
    7. Diabetes mellitus or cardiovascular risk> 10% calculated by Framingham
    8. The following analytical criteria:
    - Neutropenia <750 cells / ?L
    - Hemoglobin <8.0 g / dL
    - Platelets <50,000 cells / ?L
    - Levels of GOT, GPT and GGT greater than 5 times the baseline levels
    1. Mujeres embarazadas o lactantes, así como mujeres en edad fértil que no se comprometan a utilizar un método anticonceptivo adecuado2. Historia previa de comorbilidades neurológicas de confusión graves definidas como:
    - Dependencia de drogas o alcohol
    - Infecciones oportunistas del SNC
    - Depresión mayor o psicosis
    - Diagnóstico previo de demencia
    - Retraso mental
    - Enfermedad neurológica del SNC
    - Coinfección por el virus de la hepatitis C
    3. Claustrofobia
    4. Existencia de dispositivos corporales magnetizables
    5. Inhabilidad para realizar y completar una evaluación neurológica completa
    6. Presencia de insuficiencia renal (Aclaramiento de creatinina <60 mL/min)
    7. Diabetes mellitus o un riesgo cardiovascular > 10% calculado por Framingham
    8. Los siguientes criterios analíticos:
    - Neutropenia < 750 células/?L
    - Hemoglobina < 8,0 g/dL
    - Plaquetas < 50.000 células/?L
    - Niveles de GOT, GPT o GGT superiores a 5 veces los niveles de referencia
    E.5 End points
    E.5.1Primary end point(s)
    Variation of NAA levels in the cerebral basal ganglia, measured by NMR spectroscopy between two different HAART regimens with different penetration in the CNS
    Variación de los niveles de NAA en los ganglios basales cerebrales, medidos mediante RMN con espectroscopia entre dos regímenes de TARGA con distinta penetración en el SNC
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline to week 24
    Desde la visita basal hasta la semana 24
    E.5.2Secondary end point(s)
    1-Variation of the "Global Defict Score" (GDS)
    2-Variation of NAA levels in the structures of the frontal cortex as measured by NMR spectroscopy
    3-Glutamate and choline levels in the basal ganglia structures and frontal cortex as measured by NMR spectroscopy
    4-Evolution of brain volumes measured by MRI volumetry
    5-White matter abnormalities on MRI measured by MRI, by anisotropy
    6-HIV-CV> 50 copies / mL. Development of resistance mutations to any of the antiretrovirals used
    7-Modification of HAART for another with different CNS penetration (exchange of CPE Score> ± 1); presence of virological failure, loss or removal of the monitoring from the study for any reason
    8-Variation in the absolute levels of CD4 +
    9-Levels of adherence to HAART, as measured by adherence questionnaire GEMMA
    10-Number of general and specific adverse effects of CNS related and unrelated to HAART, and cumulative incidence of them
    1-Variación del "Global Defict Score" (GDS)
    2-Variación de los niveles de NAA en las estructuras de la corteza frontal, medidos mediante RMN con espectroscopia
    3-Niveles de colina y glutamato en las estructuras de los ganglios basales y la corteza frontal, medidos mediante RMN con espectroscopia
    4-Evolución de los volúmenes cerebrales medidos mediante volumetría por RMN
    5-Anomalías en la sustancia blanca medidas por RMN, mediante anisotropía
    6-CV de VIH > 50 copias/mL. Desarrollo de mutaciones de resistencia a alguno de los antiretrovirales utilizados
    7-Modificación del TARGA por otro con distinta penetración en el SNC (cambio del CPE Score > ± 1); presencia de fallo virológico; pérdida de seguimiento o retirada del estudio por cualquier razón
    8-Variación de los niveles absolutos de linfocitos CD4+
    9-Niveles de adherencia al TARGA, medidos por el cuestionario de adherencia GEMMA
    10-Número de efectos adversos generales y específicos del SNC relacionados y no relacionados con el TARGA; incidencia acumulada de los mismos
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-From baseline to week 24
    2-From baseline to week 24
    3-From baseline to week 24
    4-From baseline to week 24
    5-From baseline to week 24
    6-From baseline to week 24
    7-From baseline to week 24
    8-From baseline to week 24
    9-Baseline and weeks 4, 12 and 24
    10-Baseline and weeks 4, 12 and 24
    1-Desde la visita basal hasta el la semana 24
    2-Desde la visita basal hasta el la semana 24
    3-Desde la visita basal hasta el la semana 24
    4-Desde la visita basal hasta el la semana 24
    5-Desde la visita basal hasta el la semana 24
    6-Desde la visita basal hasta el la semana 24
    7-Desde la visita basal hasta el la semana 24
    8-Desde la visita basal hasta el la semana 24
    9-Visitas basal y semanas 4, 12 y 24
    10-Visitas basal y semanas 4, 12 y 24
    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 No
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 No
    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
    LPLV
    Ultima visita del último paciente
    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 months
    E.8.9.1In the Member State concerned days
    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.1.2.1Number of subjects for this age range: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    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)
    Treatment according to standard of care
    Tratameiento según la práctica clínica habitual
    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 Decision2013-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-11-21
    P. End of Trial
    P.End of Trial StatusOngoing
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