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    Summary
    EudraCT Number:2020-000601-89
    Sponsor's Protocol Code Number:BIC-PHI
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-02-17
    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 number2020-000601-89
    A.3Full title of the trial
    Bictegravir/FTC/TAF for the treatment of primary HIV infection (BIC-PHI trial).
    Bictegravir/FTC/TAF para el tratamiento de la infección primaria por HIV (BIC-PHI trial).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bictegravir/FTC/TAF for the treatment of primary HIV infection (BIC-PHI trial).
    Bictegravir/FTC/TAF para el tratamiento de la infección primaria por HIV (BIC-PHI trial).
    A.3.2Name or abbreviated title of the trial where available
    BIC-PHI
    BIC-PHI
    A.4.1Sponsor's protocol code numberBIC-PHI
    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 Clinic 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 supportGilead Sciences
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Trial unit (CTU)
    B.5.2Functional name of contact pointana cruceta
    B.5.3 Address:
    B.5.3.1Street AddressRossello 138
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.6E-mailacruceta@clinic.cat
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name BIKTARVY
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) 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
    primary HIV infection
    Infección primaria por HIV
    E.1.1.1Medical condition in easily understood language
    primary HIV infection treatment
    tratamiento de Infección primaria por HIV
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 28.0
    E.1.2Level LLT
    E.1.2Classification code 10058427
    E.1.2Term Primary HIV infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Proportion of patients with rapid ART initiation with Bictegravir/FTC/TAF regimen who reached a VL <50 copies at 48 weeks (FDA snapshot algorithm) in the intention-to-treat (ITT) population.
    1- Proporción de pacientes con inicio de ART en régimen de Bictegravir / FTC / TAF que alcanzaron un VL <50 copias a las 48 semanas (algoritmo de la FDA) en la población por intención de tratar (ITT)
    E.2.2Secondary objectives of the trial
    1-virological efficacy at 4, 8, 12, and 24, 48 weeks
    2- immunological efficacy normality (>900 cell CD4+ at 24 and 48-week)
    3- Same day ART therapy
    4- To compare virological and immunological efficacy and safety of Bictegravir/FTC/TAF regimen with an historical matched PHI cohort treated with other InSTI based ART regimens.
    5- CD4 and CD4/CD8 ratio at 4, 8, 12, 24 and 48 weeks
    6- Safety and tolerance
    7- Patient quality of life and satisfaction
    8- Effects on microbiome composition and -HIV reservoir
    1-eficacia virológica a las 4, 8, 12 y 24, 48 semanas
    2- eficacia inmunológica (> 900 células CD4 + a las 24 y 48 semanas)
    3- Terapia ART (el mismo nº de dias)
    4- Comparar la eficacia y seguridad virológica e inmunológica del régimen de Bictegravir / FTC / TAF con una cohorte histórica de PHI similar tratada con otros regímenes de ART.
    5-relación CD4 / CD8 a las 4, 8, 12, 24 y 48 semanas
    6- seguridad y tolerancia
    7- Calidad de vida y satisfacción del paciente.
    8- Efectos sobre la composición del microbioma y marcadores inflamatorios y el reservorio del VIH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Male and female patients aged 18-65 years
    -ART naïve
    -HIV infection of less than 100 days post-infection (documented 3 month previous negative serology or incomplete WB test with negative p31 band)
    - Women of child-bearing potential must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods, including intrauterine device, bilateral tubal occlusion or a vasectomized partner.
    -Personas de 18 a 65 años.
    -que no hayan tomado ningún TARV previo
    - Infección por VIH de menos de 100 días después de la infección (serología negativa documentada previa de 3 meses o prueba de WB incompleta con banda p31 negativa)
    - Las mujeres en edad fértil deben tener una prueba de embarazo negativa en suero antes de la inclusión en el estudio y aceptar el uso de métodos anticonceptivos altamente efectivos, incluidos dispositivos intrauterinos, oclusión tubárica bilateral o una pareja vasectomizada.
    E.4Principal exclusion criteria
    -Known hypersensitivity to any drug included in Bictegravir/FTC/TAF regimen
    -AST >5 times UNL
    -Creatinine Clearance <30 mL/min/1.73m2
    -Any end-stage organ disease
    -Acute or chronic HCV co-infection
    -Use of PrEP with Truvada® until 4 weeks before the onset of symptoms of PHI (risk of acquired-drug resistance to FCT or TDF).
    -Hipersensibilidad conocida a cualquier medicamento incluido en el régimen de Bictegravir / FTC / TAF
    -AST> 5 veces UNL
    - Aclaramiento de creatinina <30 mL / min / 1.73m2
    -Cualquier enfermedad terminal
    - coinfección aguda o crónica por VHC
    -Uso de PrEP con Truvada® hasta 4 semanas antes del inicio de los síntomas de PHI (riesgo de resistencia a fármacos adquiridos para FCT o TDF).
    E.5 End points
    E.5.1Primary end point(s)
    - Proportion of patients with rapid ART initiation with Bictegravir/FTC/TAF regimen who reached a VL <50 copies at 48 weeks (FDA snapshot algorithm) in the intention-to-treat (ITT) population
    1- Proporción de pacientes con inicio de ART en régimen de Bictegravir / FTC / TAF que alcanzaron un VL <50 copias a las 48 semanas ( según el algoritmo de la FDA) en la población por intención de tratar (ITT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    - Proportion of patients with rapid ART initiation with Bictegravir/FTC/TAF regimen who reached a VL <50 copies at 48 weeks (FDA snapshot algorithm) in the intention-to-treat (ITT) population
    1- Proporción de pacientes con inicio de ART en régimen de Bictegravir / FTC / TAF que alcanzaron un VL <50 copias a las 48 semanas ( según el algoritmo de la FDA) en la población por intención de tratar (ITT).
    E.5.2Secondary end point(s)
    1.VL at 4, 8, 12, and 24, 48 weeks.
    2.Proportion of patients with >900 cells CD4+ at 24 and 48 weeks.
    3. Days elapsed between diagnosis and Bictegravir/FTC/TAF initiation,
    days elapsed between first clinical visit and Bictegravir/FTC/TAF
    initiation.

    4. In comparison with other InSTI-, based ART regimens:
    4.1. Proportion of patients treated with Bictegravir/FTC/TAF who
    reached a VL<50 copies at 48 weeks in the intentio-to-treat (ITT)
    population.
    4.2 Proportion of patients treated with Bictegravir/FTC/TAF with >900
    cells CD4+ at 24 and 48 weeks.
    4.3 AE leading to discontinuation rate.

    5. CD4, CD4/CD8 ratio at 4, 8, 12, 24 and 48 weeks
    6.AE rate (overall and AE leading to discontinuation)
    7.Number of required regimen changes stratified by: adverse
    events/toxicity, virological failure, simplification, transmitted drug-
    resistance (including polymorphisms for InSTIs(6)).

    8.Quality of life and satisfaction evaluated through a CESTA questionay
    at 4 and 48 weeks (or at the end of study in case of early
    termination) of the study period, and Pittsburgh Sleep Quality Index
    (PSQI) at day 0, 4 week and 48 weeks (or at the end of study in case
    of early termination) of the study period.

    9.Viral reservoir, inflammatory and immunological markers and fecal
    microbiome composition at W0 and W48
    1.VL (Carga viral) a las 4, 8, 12 y 24, 48 semanas.
    2. Proporción de pacientes con> 900 células CD4 + a las 24 y 48 semanas.
    3. Días transcurridos entre el diagnóstico y el inicio de Bictegravir / FTC /
    TAF, días transcurridos entre la primera visita clínica y Bictegravir / FTC /
    TAF inicio.
    4. En comparación con otros InSTI, inhibidores de proteasa y regímenes de
    ART basados en inhibidores de la transcriptasa inversa nucleósidos:
    4.1. Proporción de pacientes tratados con Bictegravir / FTC / TAF que
    alcanzó un VL <50 copias a las 48 semanas en la población por intención
    de tratar (ITT).
    4.2 Proporción de pacientes tratados con Bictegravir / FTC / TAF con> 900
    células CD4 + a las 24 y 48 semanas.
    4.3 AE que conduce a la tasa de interrupción.
    5. Relación CD4, CD4 / CD8 a las 4, 8, 12, 24 y 48 semanas
    6.Tasa de EA (general y AE que conduce a la interrupción)
    7. Número de cambios de régimen requeridos estratificados por: efectos
    adversos / toxicidad, fallo virológica, simplificación, fármacos
    resistentes (incluidos polimorfismos para InSTI (6)).
    8. Calidad de vida y satisfacción evaluada a través de un cuestionario
    CESTA a las 4 y 48 semanas (o al final del estudio en caso de terminación
    temprana) del período de estudio y el índice de calidad del sueño de
    Pittsburgh (PSQI) al día 0, 4 semanas y 48 semanas (o al final del estudio
    en caso de finalización precoz) del período de estudio.
    9. Reservorio viral, marcadores inflamatorios e inmunológicos y heces
    composición de microbioma en s 0 y s 48
    E.5.2.1Timepoint(s) of evaluation of this end point
    1.VL at 4, 8, 12, and 24, 48 weeks.
    2. patients with >900 cells CD4+ at 24, 48 weeks.
    3. Days elapsed between diagnosis and Bictegravir/FTC/TAF initiation,
    4. comparison with other InSTI-, based ART regimens:
    4.1. Proportion of patients with Bictegravir/FTC/TAF who
    reached a VL<50 copies at 48 weeks (ITT)
    4.2 Proportion of patients treated with Bictegravir/FTC/TAF with >900 cells CD4+ at 24 and 48 weeks.
    4.3 AE leading to discontinuation rate.
    5. CD4, CD4/CD8 ratio at 4, 8, 12, 24 and 48 weeks
    6.AE rate
    7.Number of required regimen changes stratified

    8.Quality questionaries
    at 4 and 48 weeks

    9.Viral reservoir, inflammatory and immunological markers and
    microbiome W0 and W48
    1.VL a las 4, 8, 12 y 24, 48 semanas.
    2. pacientes con> 900 células CD4 + a 24 y 48 semanas.
    3. Días entre el diagnóstico e inicio trat
    TAF, días transcurridos entre 1ºv yTRAT inicio.
    4. En comparación con otros InSTI, inhibidores de proteasa y
    ART basados en ITIN:
    4.1. % tratados con Bictegravir / FTC / TAF con VL <50 copias a 48 semanas (ITT).
    4.2 pacientes tratados con Bictegravir / FTC / TAF con> 900
    CD4 a 24 y 48s.
    4.3 AE interrupción trat.
    5. Relación CD4, CD4 / CD8 a las 4, 8, 12, 24 y 48 semanas
    6.Tasa de EA
    7. Número de cambios trat estratificados .
    8. Calidad y satisfacción cuestionarios
    4 y 48 s
    9. Reservorio viral, marcadores inflamatorios e inmunológicos y microbioma 0, 48
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 Yes
    E.8.2.3.1Comparator description
    TARV
    TARV
    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 concerned7
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 66
    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 state66
    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
    ninguno
    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 Decision2020-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-08-29
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