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    Summary
    EudraCT Number:2015-004024-54
    Sponsor's Protocol Code Number:GS-US-380-1489
    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:2015-12-29
    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 number2015-004024-54
    A.3Full title of the trial
    A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of GS-9883/Emtricitabine/Tenofovir Alafenamide Versus Abacavir/Dolutegravir/Lamivudine in HIV-1 Infected, Antiretroviral Treatment-Naïve Adults
    Estudio de fase 3, aleatorizado y doble ciego para evaluar la seguridad y la eficacia de GS-9883/emtricitabina/tenofovir alafenamida en comparación con abacavir/dolutegravir/lamivudina en adultos infectados por el VIH-1 sin tratamiento antirretroviral previo
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This study will test an experimental drug called GS-9883/emtricitabine/tenofovir alafenamide (GS-9883/F/TAF) fixed dose combination (FDC) for the treatment of HIV-1 infection. The purpose of this study is to test safety and to test whether GS-9883/F/TAF as a FDC works as well as the FDC drug containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) (trade name Triumeq). The study will also test whether GS-9883/F/TAF maintains the control of HIV-1 infection effectively compared to ABC/DTG/3TC.
    Este estudio prueba el fármaco experimental (GS-9883/F/TAF) en combinación de dosis fija (CDF) de GS- 9883/emtricitabina/tenofovir alafenamida para el tratamiento de infección por VIH-1. Su proposito es probar la seguridad y si GS-9883/F/TAF como CDF funciona tan bien como abacavir FDC / dolutegravir / lamivudina (ABC/DTG/3TC) (nombre comercial Triumeq). También probará si GS-9883/F/TAF mantiene eficazmente el control de la infección por VIH-1 en comparación con ABC/DTG/3TC.
    A.4.1Sponsor's protocol code numberGS-US-380-1489
    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 SponsorGilead Sciences, Inc.
    B.1.3.4CountryUnited States
    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 supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+34913789830
    B.5.6E-mailclinical.trials@gilead.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGS-9883/F/TAF
    D.3.4Pharmaceutical form Film-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 INNGS-9883
    D.3.9.2Current sponsor codeGS-9883
    D.3.9.3Other descriptive nameGS-9883
    D.3.9.4EV Substance CodeSUB179805
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Alafenamide
    D.3.9.1CAS number 379270-37-8
    D.3.9.3Other descriptive nameTENOFOVIR ALAFENAMIDE
    D.3.9.4EV Substance CodeSUB121761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 Triumeq
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare UK 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 Film-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 INNDolutegravir
    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.3.8 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 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Human Immunodeficiency Virus (HIV-1) Infection
    Infección por el Virus de Inmunodeficiencia Humana (VIH-1)
    E.1.1.1Medical condition in easily understood language
    Human Immunodeficiency Virus (HIV-1) Infection
    Infección por el Virus de Inmunodeficiencia Humana (VIH-1)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of a fixed dose combination (FDC) containing GS-9883/emtricitabine/tenofovir alafenamide (GS-9883/F/TAF) versus a FDC containing abacavir/dolutegravir/lamivudine (ABC/DTG/3TC) in HIV-1 infected, antiretroviral treatment naïve-adult subjects as determined by the achievement of HIV-1 RNA < 50 copies/mL at Week 48
    Evaluar la eficacia de una combinación en dosis fijas (CDF) de GS-9883/emtricitabina/tenofovir alafenamida (GS-9883/F/TAF) en comparación con una CDF de abacavir/dolutegravir/lamivudina (ABC/DTG/3TC) en sujetos adultos infectados por el VIH-1
    sin tratamiento antirretroviral previo, según lo determinado por el logro de una concentración de ARN del VIH-1 < 50 copias/ml en la semana 48.
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy, safety, and tolerability of the two
    treatment groups through Weeks 48 and 96

    To evaluate the bone safety of the two treatment groups as determined by the percentage change from baseline in hip and spine bone mineral density (BMD) through Weeks 48 and 96
    Evaluar la eficacia, la seguridad y la tolerabilidad en los dos grupos de tratamiento hasta las emanas 48 y 96.

    Evaluar la seguridad ósea de los dos regímenes de tratamiento determinada por la variación porcentual de la densidad mineral ósea (DMO) de la cadera y la columna hasta las semanas 48 y 96.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    An intensive pharmacokinetic (PK) substudy will be performed at the Weeks 4 or 8 visits in a subset of subjects (target n=30) at study sites able to conduct this testing.

    A peripheral blood mononuclear cell (PBMC) substudy will be performed at Day 1 and Weeks 36 and 84 in a subset of subjects (target n=50) at select study sites. The substudy will assess HIV-1, PBMC function for HIV disease progression, and how the immune system functions in the presence of HIV.
    Se realizará un subestudio farmacocinético (FC) intensivo en las visitas de las semanas 4 u 8 en un subgrupo de sujetos (objetivo n = 30) en los centros del estudio capaces de realizar estos análisis.

    Se realizará un subestudio de células mononucleares de sangre periférica (CMSP) el día 1 y en las semanas 36 y 84 en una subpoblación de sujetos (objetivo n = 50) en determinados centros del estudio. En el subestudio se evaluará el VIH-1, la función de CMSP para la progresión de la enfermedad por el VIH y el modo en que funciona el sistema inmunitario en presencia del VIH.
    E.3Principal inclusion criteria
    1) The ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
    2) Age >= 18 years
    3) Antiretroviral treatment naïve (<= 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection) except the use for PrEP (pre-exposure prophylaxis) or PEP (post-exposure prophylaxis), up to one month prior to screening
    4) Plasma HIV-1 RNA levels >= 500 copies/mL at screening
    5) Normal ECG (or if abnormal, determined by the Investigator to be not clinically significant)
    6) Adequate renal function: Estimated glomerular filtration rate >= 50 mL/min (>= 0.83 mL/sec) according to the Cockcroft-Gault formula
    7) Hepatic transaminases (AST and ALT) <= 5 x upper limit of normal (ULN)
    8) Total bilirubin <= 1.5 mg/dL (<= 26 umol/L), or normal direct bilirubin
    9) Adequate hematologic function (absolute neutrophil count >= 750/mm3 (>= 0.75 GI/L);
    platelets >= 50,000/mm3 (>= 50 GI/L); hemoglobin >= 8.5 g/dL (>= 85 g/L))
    10) Serum amylase <= 5 × ULN (subjects with serum amylase > 5 × ULN will remain eligible if serum lipase is <= 5 × ULN)
    11) Females of childbearing potential must agree to utilize protocol recommended highly effective contraceptive methods or be non-heterosexually active or practice sexual abstinence from screening, throughout the duration of the study period, and for 30 days following the last dose of study drug.
    a) Female subjects who utilize hormonal contraceptive as one of their birth control methods must have used the same method for at least 3 months prior to study drug dosing.
    12) Male subjects who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception throughout the study period and for 90 days following the last dose of study drug
    13) Male subjects must agree to refrain from sperm donation from first study drug dose until at least 90 days following the last study drug dose
    14) Life expectancy >= 1 year
    15) Screening genotype report provided by Gilead Sciences must show sensitivity to FTC, TFV, 3TC, and ABC
    16) Negative screening test for HLA-B*5701 allele provided by Gilead Sciences
    1)Capacidad de entender y firmar el documento de consentimiento informado, que deberá obtenerse antes del inicio de los procedimientos del estudio.
    2) Edad >= 18 años.
    3) Ausencia de tratamiento antirretroviral previo (<= 10 días de tratamiento previo con un antirretroviral después del diagnóstico de infección por el VIH-1), excepto el uso de profilaxis previa o posterior a la exposición (PPrE o PPoE), hasta 1 mes antes de la selección.
    4) Concentración plasmática de ARN del VIH-1 >= 500 copias/ml en el momento de selección.
    5) ECG normal (o, si no lo es, el investigador ha determinado que carece de importancia clínica).
    6) Función renal adecuada:
    Índice de filtración glomerular estimado <= 50 ml/min (<= 0,83 ml/s) según la fórmula de Cockcroft-Gault
    7)Transaminasas hepáticas (ALT y AST) <= 5 veces el límite superior de la normalidad (LSN).
    8) Bilirrubina total <= 1,5 mg/dl (<= 26 umol/l) o bilirrubina directa normal.
    9) Función hematológica adecuada (recuento absoluto de neutrófilos >>= 750/mm3 (> 0,75 GI/l); plaquetas > 50.000/mm3 (>= 50 GI/l); hemoglobina >= 8,5 g/dl (>= 85 g/l)).
    10) Amilasa sérica <= 5 veces el LSN (los sujetos con amilasa sérica > 5 veces el LSN seguirán siendo elegibles si la lipasa sérica es <= 5 veces el LSN).
    11)Las mujeres con capacidad reproductiva deberán comprometerse a utilizar métodos anticonceptivos de gran eficacia recomendados en el protocolo o no mantener relaciones heterosexuales o practicar la abstinencia sexual desde la selección, durante todo el periodo del estudio y hasta 30 días después de la última dosis del fármaco del estudio.
    a)Las mujeres que utilicen anticonceptivos hormonales deberán haber usado el mismo método durante al menos tres meses antes de la administración del tratamiento del estudio.
    12)Los varones que mantengan relaciones heterosexuales deberán comprometerse a utilizar métodos anticonceptivos especificados en el protocolo durante todo el período del estudio y hasta 90 días después de la última dosis del fármaco del estudio.
    13) Los sujetos varones tendrán que comprometerse a no donar semen desde la primera dosis y hasta 90 días después, como mínimo, de la última dosis del fármaco del estudio.
    14) Esperanza de vida >= 1 año.
    15) Sensibilidad a FTC, TFV, 3TC y ABC según el informe del análisis genotípico de selección facilitado por Gilead Sciences.
    16) Resultado negativo en la prueba de detección del alelo HLA-B*5701 facilitado por Gilead Sciences.
    E.4Principal exclusion criteria
    1) An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior to screening
    2) Subjects experiencing decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)
    3) Have been treated with immunosuppressant therapies or chemotherapeutic agents within 3 months of study screening, or expected to receive these agents or systemic steroids during the study (e.g, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
    4) Current alcohol or substance use judged by the Investigator to potentially interfere with subject study compliance
    5) A history of or ongoing malignancy (including untreated carcinoma in-situ) other than cutaneous Kaposi's sarcoma (KS), basal cell carcinoma, or resected, non-invasive cutaneous squamous carcinoma. Subjects with biopsy-confirmed cutaneous KS are eligible, but must not have received any systemic therapy for KS within 30 days of Day 1 and are not anticipated to require systemic therapy during the study
    6) Active, serious infections (other than HIV-1 infection) requiring parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
    7) Participation in any other clinical trial, including observational studies, without prior approval from the sponsor is prohibited while participating in this trial
    8) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements
    9) Any known allergies to the excipients of GS-9883/F/TAF FDC or ABC/DTG/3TC FDC tablets
    10) Females who are pregnant (as confirmed by positive serum pregnancy test)
    11) Females who are breastfeeding
    12) Subjects receiving ongoing therapy with any protocol-specified medications including drugs not to be used with FTC, TAF, GS-9883, DTG, ABC and 3TC
    13) Acute hepatitis in the 30 days prior to study entry
    14) Chronic Hepatitis B Virus (HBV) infection, as determined by either:
    a) Positive HBV surface antigen and negative HBV surface antibody, regardless of HBV core antibody status, at the screening visit
    b) Positive HBV core antibody and negative HBV surface antibody, regardless of HBV surface antigen status, at the screening visit
    15) Active tuberculosis infection
    1) Enfermedad oportunista indicativa de estadio 3 de la infección por el VIH, diagnosticada en los 30 días previos a la selección
    2)Presencia de cirrosis descompensada (por ejemplo, ascitis, encefalopatía o varices hemorrágicas).
    3) Haber recibido tratamiento con inmunodepresores o quimioterapia en los 3 meses previos a la selección, o tener previsto recibir estos fármacos o esteroides sistémicos durante el estudio (por ejemplo, corticosteroides, inmunoglobulinas y otros tratamientos inmunitarios o basados en citocinas).
    4) Consumo activo de alcohol o sustancias que, según el criterio del investigador, podría afectar al cumplimiento del estudio.
    5) Antecedentes o presencia de una neoplasia maligna (incluido carcinoma in situ no tratado) distinta de un sarcoma de Kaposi (SK) cutáneo, carcinoma basocelular o carcinoma espinocelular cutáneo no invasivo y resecado. Los sujetos con SK cutáneo confirmado mediante biopsia podrán participar, pero no podrán haber recibido un tratamiento sistémico contra el SK en los 30 días previos al día 1 ni deberá preverse que necesiten tratamiento sistémico durante el estudio.
    6) Infecciones graves activas (aparte de la infección por el VIH-1) que requieran tratamiento parenteral con antibióticos o antifúngicos en los 30 días previos al día 1.
    7) Durante la participación en este estudio queda prohibida la participación en cualquier otro ensayo clínico, incluidos los observacionales, sin la aprobación previa del promotor.
    8) Cualquier otra afección clínica o tratamiento previo que, en opinión del investigador, haga que el sujeto no sea adecuado para el estudio o no sea capaz de cumplir los requisitos de administración.
    9) Cualquier alergia conocida a los excipientes de la CDF de GS-9883/F/TAF o la CDF de
    ABC/DTG/3TC en comprimidos.
    10) Embarazo (confirmado mediante un resultado positivo en la prueba de embarazo en suero).
    11) Mujeres en período de lactancia.
    12) Tratamiento en curso con alguno de los medicamentos recogidos en la siguiente tabla, incluidos los que no deben utilizarse con FTC, TAF, GS-9883, DTG, ABC y 3TC.
    13) Hepatitis aguda confirmada en los 30 días previos a la entrada en el estudio.
    14) Con infección crónica por el virus de la hepatitis B (VHB), según lo determinado por:
    - Resultado positivo para el antígeno de superficie del VHB y negativo para los anticuerpos contra el antígeno de superficie del VHB, con independencia del estado de anticuerpos contra el antígeno central del VHB, en la visita de selección.
    - Resultado positivo para los anticuerpos contra el antígeno central del VHB y negativo para los anticuerpos contra el antígeno de superficie del VHB, con independencia del resultado para el antígeno de superficie del VHB, en la visita de selección.
    15) Infección activa por tuberculosis
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the proportion of subjects who achieve HIV-1 RNA < 50 copies/mL at Week 48 as defined by the US FDA snapshot algorithm
    Proporción de sujetos con una concentración de ARN del VIH-1 < 50 copias/ml en la semana 48 según lo definido mediante el algoritmo de instantáneas de la FDA de EE.UU.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 48
    Semana 48
    E.5.2Secondary end point(s)
    The secondary endpoints of this study include:

    The proportion of subjects who achieve HIV-1 RNA < 50 copies/mL at Week 96 as defined by the US FDA snapshot algorithm

    The proportion of subjects who achieve HIV-1 RNA < 20 copies/mL at Weeks 48 and 96 as defined by the US FDA snapshot algorithm

    The change from baseline in log10 HIV-1 RNA and CD4+ cell count at Weeks 48 and 96

    The percentage change from baseline in hip and spine BMD at Weeks 48 and 96
    Los criterios de valoración secundarios de este estudio comprenden:
    - Proporción de sujetos con una concentración de ARN del VIH-1 < 50 copias/ml en la semana
    96 según lo definido mediante el algoritmo de instantáneas de la FDA de EE.UU.
    - Proporción de sujetos con una concentración de ARN del VIH-1 < 20 copias/ml en las
    semanas 48 y 96, según lo definido mediante el algoritmo de instantáneas de la FDA de
    EE.UU.
    - Variación respecto al momento basal del log10 del ARN del VIH-1 del recuento de linfocitos
    CD4+ entre el momento basal y las semanas 48 y 96.
    - Variación porcentual de la DMO de la cadera y la columna entre el momento basal y las
    semanas 48 y 96.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48 and Week 96
    Semana 48 y semana 96
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA21
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Canada
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    Última Visita Último Sujeto (UVUS)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months3
    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: 500
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 600
    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)
    After a subject has completed/terminated their participation in the study, long-term care for the subject will remain the responsibility of their primary treating physician.
    Después de que un paciente haya completado / terminado su participación en el estudio, el cuidado a largo plazo para el paciente seguirá siendo la responsabilidad de su médico de atención primaria.
    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 Decision2016-03-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-04
    P. End of Trial
    P.End of Trial StatusOngoing
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