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    Summary
    EudraCT Number:2014-002281-70
    Sponsor's Protocol Code Number:2014-002281-70
    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:2014-12-15
    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 number2014-002281-70
    A.3Full title of the trial
    Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV-1?infected patients (<100 CD4+ T cells/?L) taking antiretroviral regimens based on dolutegravir or ritonavir-boosted darunavir (the AdvanZ-4 Trial).
    Reconstitución inmune en pacientes con infección por el VIH-1 no tratados previamente y con cifras de linfocitos CD4+ inferiores a 100 céls/mm3 que reciben un régimen de fármacos antirretrovirales basado en dolutegravir o darunavir/ritonavir. Estudio AdvanZ-4.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immune reconstitution in severely immunosuppressed antiretroviral-naive HIV-1?infected patients (<100 CD4+ T cells/?L) taking antiretroviral regimens based on dolutegravir or ritonavir-boosted darunavir (the AdvanZ-4 Trial).
    Reconstitución inmune en pacientes con infección por el VIH-1 no tratados previamente y con cifras de linfocitos CD4+ inferiores a 100 céls/mm3 que reciben un régimen de fármacos antirretrovirales basado en dolutegravir o darunavir/ritonavir. Estudio AdvanZ-4.
    A.3.2Name or abbreviated title of the trial where available
    ADVANZ-4
    ADVANZ-4
    A.4.1Sponsor's protocol code number2014-002281-70
    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 SponsorFundació Clínic per a la Recerca Biomèdica
    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 supportViiV Healthcare UK Limited 980 Great West Road Brentford Middlesex TW8 9GS Reino Unido
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU Clinic (Clinical Trial Unit)
    B.5.2Functional name of contact pointAnna Cruceta
    B.5.3 Address:
    B.5.3.1Street AddressRosello 138
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number+349322754004380
    B.5.5Fax number+34932279877
    B.5.6E-mailacruceta@clinic.ub.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 KIVEXA( Abacavir 600 mg/ Lamivudine 300 mg) recovered tablets
    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.3.1Product nameCoatedTablet600 mg de abacavir ( sulfate) 300 mg de lamivudine
    D.3.4Pharmaceutical form Coated 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
    D.3.9.1CAS number 136470-78-5
    D.3.9.4EV Substance CodeSUB07356MIG
    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 number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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 PREZISTA 300 mg recovered Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Bélgica
    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 namePREZISTA 300 mg comprimidos recubiertos con película darunavir
    D.3.4Pharmaceutical form Coated 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 INNDARUNAVIR
    D.3.9.1CAS number 206361-99-1
    D.3.9.4EV Substance CodeSUB25394
    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: 3
    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 100 mg soft Tablets
    D.2.1.1.2Name of the Marketing Authorisation holderAbbVie Ltd Maidenhead SL6 4XE Reino Unido
    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 100 mg soft tablets
    D.3.4Pharmaceutical form Capsule, soft
    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: 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 TRIUMEQ®: Lamivudine(3TC) 300 mg+ Abacavir(ABC) 600 mg + dolutegravir(DGT) 50 mg : 1 comprimido
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare UK Limited 980 Great West Road Brentford Middlesex TW8 9GS Reino Unido
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 nameTriumeq
    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 INNLAMIVUDINE
    D.3.9.1CAS number 134678-17-4
    D.3.9.2Current sponsor codeACH-126,443
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNABACAVIR sulfate
    D.3.9.1CAS number 188062-50-2
    D.3.9.2Current sponsor codeGSK1349572
    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 INNDOLUTEGRAVIR
    D.3.9.1CAS number 1051375-16-6
    D.3.9.2Current sponsor codeGSK1349572
    D.3.9.3Other descriptive nameDOLUTEGRAVIR
    D.3.9.4EV Substance CodeSUB35122
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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
    tratement HIV infection
    tratamiento de la infección por HIV
    E.1.1.1Medical condition in easily understood language
    HIV infection
    infección por HIV
    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
    -Compare the change in the absolute number of CD4 in peripheral blood to 48 to 96 weeks of initiating treatment.
    -Comparar el cambio en la cifra absoluta de CD4 en sangre periférica a las 48 y 96 semanas de iniciar el tratamiento.
    E.2.2Secondary objectives of the trial
    -Compare the proportion of patients with undetectable viral load at 48 and 96 weeks.
    -Compare the proportion of patients with CD4 above 200 celsmm3 to the
    48 and 96 weeks of initiating treatment.
    -Compare the change in the parameters of immune activation (especially in CD8 and CD8CD38 cells).
    -Compare the change in the parameters of bacterial translocation (sCD14), inflammation (IL.6, TNF-alpha and ultrasensitive PCR) and coagulation (Dimer-D).
    -To compare the changes in the intestinal Microbiome.
    -Describe the proportion of patients who develop (SIRI) immune reconstitution syndrome.
    -Describe the clinical tolerability and toxicity of the three guidelines.
    -Describe the plasma lipid profile.
    -Determine the pattern of mutations of resistance in cases of treatment failure.
    -To compare the rate of progression of the disease and survival.
    - Comparar la proporción de pacientes con carga viral indetectable a las 48 y 96 semanas.
    - Comparar la proporción de pacientes con CD4+ por encima de 200 céls/mm3 a las
    48 y 96 semanas de iniciar el tratamiento.
    - Comparar el cambio en los parámetros de activación inmune (en especial en las células CD8+ y CD8+CD38+).
    - Comparar el cambio en los parámetros de translocación bacteriana (sCD14), inflamación (IL.6, TNF-alfa y PCR ultrasensible) y coagulación (Dímero-D).
    - Comparar los cambios en el microbioma intestinal.
    - Describir la proporción de pacientes que desarrollan síndrome de reconstitución inmune (SIRI).
    - Describir la tolerabilidad clínica y la toxicidad de las tres pautas.
    - Describir el perfil lipídico plasmático.
    - Determinar el patrón de mutaciones de resistencia en los casos de fracaso terapéutico.
    - Comparar la tasa de progresión de la enfermedad y la supervivencia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. chronic infection by HIV-1.
    2. equal to or more than 18 years old.
    3 that you have not previously received anti-retroviral treatment.
    4 digit baseline CD4 count 100 Celsµl (confirmed by two determinations).
    5 result of baseline genotypic resistance study showing absence of mutations of resistance to drugs in the study.
    6 that, properly informed, you grant your consent in writing to participate in the study and submit to the tests and scans that entails.
    1. Infección crónica por VIH-1.
    2. Edad igual o superior a 18 años.
    3. Que no hayan recibido previamente tratamiento antirretroviral.
    4. Cifra basal de CD4+ <100 céls/µL (confirmada por dos determinaciones).
    5. Resultado del estudio de resistencias genotípicas basal que muestre ausencia de mutaciones de resistencia a los fármacos en estudio.
    6. Que, adecuadamente informados, otorguen su consentimiento por escrito para participar en el estudio y someterse a las pruebas y exploraciones que ello comporta.
    E.4Principal exclusion criteria
    Known hypersensitivity to drugs in the study.
    2. hypersensitivity documented to sulfonamides and derivatives.
    3 positivity in the determination of the HLA B5701.
    4 pregnant women, nursing mothers, or those who intend to become pregnant during the study period.
    5 lymphomas and other active Neoplasms that require chemotherapy.
    6. less than 50 mlmin creatinine clearance.
    7 liver failure moderate or severe (Child-Pugh classification C class).
    8 ALT ?5 times the upper limit of normal (ULN), or ALT ?3 times the ULN and total bilirubin ?1, 5 times the ULN (with 35 of direct bilirubin).
    9. need for treatment of HCV during the study.
    10. current or recent treatment with nephrotoxic drugs.
    11. treatment with immunomodulators, or products under investigation.
    12. treatment with drugs or products whose pharmacokinetic interaction potential decrease efficiency or increase the toxicity of antiretroviral drugs in the study.
    13. any formal contraindication to be treated with the drugs in the study.
    1. Hipersensibilidad conocida a los medicamentos en estudio.
    2. Hipersensibilidad documentada a sulfamidas y derivados.
    3. Positividad en la determinación del HLA B5701.
    4. Mujeres embarazadas, en periodo de lactancia, o aquellas que pretendan quedar embarazadas durante el periodo del estudio.
    5. Linfomas y otras neoplasias activas que requieran quimioterapia.
    6. Aclaramiento de creatinina inferior a 50 ml/min.
    7. Insuficiencia hepática moderada o grave (Clase C de la clasificación de Child-Pugh).
    8. ALT ?5 veces el límite superior de la normalidad (LSN) o ALT ?3 veces el LSN y bilirrubina total ?1,5 veces el LSN (con > 35% de bilirrubina directa).
    9. Necesidad de tratamiento del VHC durante el estudio.
    10. Tratamiento actual o reciente con fármacos nefrotóxicos.
    11. Tratamiento con fármacos inmunomoduladores, o productos en fase de investigación.
    12. Tratamiento con fármacos o productos cuyo potencial de interacción farmacocinética disminuya la eficacia o aumente la toxicidad de los antirretrovirales en estudio.
    13. Cualquier contraindicación formal para ser tratado con los fármacos del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Compare the change in the absolute number of CD4 in peripheral blood to 48 to 96 weeks of initiating treatment.
    Comparar el cambio en la cifra absoluta de CD4+ en sangre periférica a las 48 y 96 semanas de iniciar el tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Average increase in the absolute number of CD4 in peripheral blood to 48 to 96 weeks of initiating treatment.
    Incremento medio en la cifra absoluta de CD4+ en sangre periférica a las 48 y 96 semanas de iniciar el tratamiento.
    E.5.2Secondary end point(s)
    -Compare the proportion of patients with undetectable viral load at 48 and 96 weeks.
    -Compare the proportion of patients with CD4 above 200 celsmm3 to the
    48 and 96 weeks of initiating treatment.
    -Compare the change in the parameters of immune activation (especially in CD8 and CD8CD38 cells).
    -Compare the change in the parameters of bacterial translocation (sCD14), inflammation (IL.6, TNF-alpha and ultrasensitive PCR) and coagulation (Dimer-D).
    -To compare the changes in the intestinal Microbiome.
    -Describe the proportion of patients who develop (SIRI) immune reconstitution syndrome.
    -Describe the clinical tolerability and toxicity of the three guidelines.
    -Describe the plasma lipid profile.
    -Determine the pattern of mutations of resistance in cases of treatment failure.
    -To compare the rate of progression of the disease and survival.
    - Comparar la proporción de pacientes con carga viral indetectable a las 48 y 96 semanas.
    - Comparar la proporción de pacientes con CD4+ por encima de 200 céls/mm3 a las
    48 y 96 semanas de iniciar el tratamiento.
    - Comparar el cambio en los parámetros de activación inmune (en especial en las células CD8+ y CD8+CD38+).
    - Comparar el cambio en los parámetros de translocación bacteriana (sCD14), inflamación (IL.6, TNF-alfa y PCR ultrasensible) y coagulación (Dímero-D).
    - Comparar los cambios en el microbioma intestinal.
    - Describir la proporción de pacientes que desarrollan síndrome de reconstitución inmune (SIRI).
    - Describir la tolerabilidad clínica y la toxicidad de las tres pautas.
    - Describir el perfil lipídico plasmático.
    - Determinar el patrón de mutaciones de resistencia en los casos de fracaso terapéutico.
    - Comparar la tasa de progresión de la enfermedad y la supervivencia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Proportion of patients presenting with undetectable viral load (50 copiasmL or ultrasensitive) after 48 and 96 weeks for inclusion in the study.

    -Proportion of patients with CD4 above 200 celsmm3 to the 48 and 96 weeks of initiating treatment.
    -Compare the change in cells CD8 and CD8CD38 48 and 96 weeks of initiating treatment.
    -
    -Proportion of patients with immune reconstitution syndrome.
    -Incidence of clinical adverse events and laboratory abnormalities causing the withdrawal of treatment in study.
    -Changes in triglycerides, total cholesterol and HDL and LDL cholesterol.
    -Incidence and type of resistance mutations in patients presenting virologic failure.
    -Rate of progression to AIDS and death.
    Proporción de pacientes que presentan carga viral indetectable (<50 copias/mL o ultrasensible) al cabo de 48 y 96 semanas de la inclusión en el estudio.

    - Proporción de pacientes con CD4+ por encima de 200 céls/mm3 a las 48 y 96 semanas de iniciar el tratamiento.
    - Comparar el cambio en las células CD8+ y CD8+CD38+ a las 48 y 96 semanas de iniciar el tratamiento.
    -
    - Proporción de pacientes con síndrome de reconstitución inmune.
    - Incidencia de acontecimientos adversos clínicos y alteraciones de laboratorio que provoquen la retirada del tratamiento en estudio.
    - Cambios en los triglicéridos, colesterol total y colesterol HDL y LDL.
    - Incidencia y tipo de mutaciones de resistencia en los pacientes que presenten fracaso virológico.
    - Tasa de progresión a SIDA y de mortalidad.
    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 No
    E.6.5Efficacy No
    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 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 concerned8
    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
    LVLS
    LVLS
    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 months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero 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: 108
    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 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 state108
    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)
    none
    ninguna
    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 Decision2015-02-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-17
    P. End of Trial
    P.End of Trial StatusOngoing
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