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    Summary
    EudraCT Number:2019-004871-38
    Sponsor's Protocol Code Number:BIFAST
    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:2020-02-21
    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 number2019-004871-38
    A.3Full title of the trial
    Phase IV, single-center, open study to assess the benefits of the start of immediate treatment without immunovirological data (“Same Day Treatment”) compared to conventional treatment with BIC / FTC / TAF in naive patients with type 1 HIV infection
    Estudio de fase IV, unicéntrico, abierto, para evaluar los beneficios del inicio del tratamiento inmediato sin datos inmunovirológicos (“Same Day Treatment”) comparado con el tratamiento convencional con BIC/FTC/TAF en pacientes naives con infección por VIH tipo 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of the benefits of immediate versus conventional treatment with BIC / FTC / TAF in naive patients with type 1 HIV infection
    Evaluación de los beneficios del tratamiento inmediato versus convencional con BIC/FTC/TAF en pacientes naives con infección por VIH tipo 1
    A.4.1Sponsor's protocol code numberBIFAST
    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 SponsorFUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
    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 supportINSTITUTO DE SALUD CARLOS III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFUNDACION JIMENEZ DIAZ HEALTH RESEARCH INSTITUTE
    B.5.2Functional name of contact pointUNIDAD DE INVESTIGACION CLINICA
    B.5.3 Address:
    B.5.3.1Street AddressAVDA REYES CATOLICOS N2
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number+349155048003214
    B.5.6E-mailmireia.arcas@fjd.es
    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 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 INNBICTEGRAVIR
    D.3.9.3Other descriptive nameBICTEGRAVIR
    D.3.9.4EV Substance CodeSUB182699
    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.3.9.3Other descriptive nameEMTRICITABINE
    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
    D.3.9.1CAS number 147127-20-6
    D.3.9.3Other descriptive nameTENOFOVIR
    D.3.9.4EV Substance CodeSUB04721MIG
    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.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HIV infection
    INFECCION POR VIH
    E.1.1.1Medical condition in easily understood language
    HIV infection
    INFECCION POR 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
    Main efficacy objective: To determine the time from the first determination of CD4 and HIV-1 viral load to achieve HIV viral load <50 cop / ml.
    Secondary objectives of efficacy
    • Evaluate changes in CD4 T cell count.
    • Determine the time from HIV diagnosis to achieve undetectable HIV viral load.
    • Determine the degree of anxiety of patients.
    • Determine the number of sexual contacts with potential for transmission of HIV infection.
    • Determine the quality of patients before and after SDT.
    Objetivo principal de eficacia: Determinar el tiempo desde la primera determinación de CD4 y carga viral del VIH-1 hasta conseguir la carga viral de VIH < 50 cop/ml.
    Objetivos secundarios de la eficacia
    • Evaluar los cambios en el recuento de células T CD4.
    • Determinar el tiempo desde el diagnóstico de VIH hasta conseguir la carga viral del VIH indetectable.
    • Determinar el grado de ansiedad de los pacientes.
    • Determinar el número de contactos sexuales con potencial de transmisión de la infección por VIH.
    • Determinar la calidad de los pacientes antes y después del SDT.
    E.2.2Secondary objectives of the trial
    To assess the safety and tolerability of the administration of triple therapy (BIC / FTC / TAF) as ART.
    Evaluar la seguridad y la tolerabilidad de la administración de la triple terapia (BIC/FTC/TAF) como TAR.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Men and women  18 years old
    • Confirmed and documented diagnosis of HIV-1 infection
    • Without prior antiretroviral treatment (excluding 28-day post-exposure prophylaxis)
    • Signed informed consent
    • Negative pregnancy test (women of childbearing age only). Women of childbearing age are considered to be those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months
    • Hombres y mujeres  18 años
    • Diagnóstico confirmado y documentado de infección por VIH-1
    • Sin tratamiento antirretroviral previo (excluida la profilaxis post-exposición de 28 días de duración)
    • Consentimiento informado firmado
    • Prueba de embarazo negativa (sólo mujeres en edad fértil). Se considera mujer en edad fértil como aquellas mujeres que no hayan sido sometidas a procedimientos de infertilidad permanente o que sean amenorreicas desde hace menos de 12 meses
    E.4Principal exclusion criteria
    • Inability to obtain written informed consent to participate in the study
    • Pregnant or breastfeeding women or those who intend to become pregnant during the study period and do not undertake to use proven contraceptive methods
    • Any suspicion or confirmation of resistance to TAF, FTC or BIC
    • Estimated glomerular filtration rate (TFGe) <30 mg / ml / m2 measured by any of the available formulas. The determination of the TFGe of a routine prior analysis of ≤ 12 weeks prior to the signing of the consent is allowed
    • Contraindications to the use of TAF
    • Clinical condition of the patient in rapid deterioration or the investigator considers that there is no reasonable hope that the patient will end the study
    • Simultaneous participation in another clinical trial or research study that requires the need for treatment with other drugs outside the study or interferes with visits to it.
    • Any situation that, in the opinion of the investigator, may interfere with the patient's ability to comply with the treatment schedule and protocol evaluations
    • Imposibilidad de obtener el consentimiento informado por escrito para participar en el estudio
    • Mujeres embarazadas o en periodo de lactancia o aquellas que pretendan quedar embarazadas durante el periodo del estudio y no se comprometan a utilizar métodos anticonceptivos probados
    • Cualquier sospecha o confirmación de resistencia a TAF, FTC o BIC
    • Tasa de filtrado glomerular estimada (TFGe) < 30 mg/ml/m2 medida por cualquiera de las fórmulas disponibles. Se permite la determinación de la TFGe de una analítica previa rutinaria de ≤ 12 semanas previas a la firma del consentimiento
    • Contraindicaciones para el uso de TAF
    • Estado clínico del paciente en rápido deterioro o el investigador considera que no existe una esperanza razonable de que el paciente vaya a finalizar el estudio
    • Participación simultánea en otro ensayo clínico o estudio de investigación que requiera la necesidad de tratamiento con otros fármacos ajenos al estudio o interfiera en las visitas del mismo
    • Cualquier situación que, en opinión del investigador, pueda interferir con la capacidad del paciente para cumplir la pauta de tratamiento y las evaluaciones del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    • Changes in time since the first visit to the HIV specialist and the first determination of viral load <50 cop / ml.
    • Changes in CD4 T cell count from the start of treatment until week 48
    • Changes in viral suppression rates from the start of treatment until week 48
    • Changes in the anxiety scale from the first visit until week 48
    • Changes in the number of potential sexual contacts with risk of HIV transmission (due to the presence of detectable CV in the study subject) from the first visit to the specialist until week 48
    • Changes in the quality of life from the first visit until week 48
    • Cambios en el tiempo desde la primera visita al especialista de VIH y la primera determinación de cargar viral < 50 cop/ml.
    • Cambios en el recuento de linfocitos T CD4 desde el inicio del tratamiento hasta la semana 48
    • Cambios en las tasas de supresión viral desde el inicio del tratamiento hasta la semana 48
    • Cambios en la escala de ansiedad desde la primera visita hasta la semana 48
    • Cambios en el número de potenciales contactos sexuales con riesgo de transmisión de VIH (por presencia de CV detectable en el sujeto de estudio) desde la primera visita al especialista hasta la semana 48
    • Cambios en la calidad de vida desde la primera visita hasta la semana 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 semanas
    E.5.2Secondary end point(s)
    Evaluation of adverse events (AE) and severe AA (SAE)
    • Evaluación de los acontecimientos adversos (AA) y los AA graves (AAG)
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 WEEKS
    48 SEMANAS
    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) 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 No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    diseño cuasi experimental, el tratamiento a administrar es el mismo, cambia el momento de inicio
    It´s a quasi experimental design, where the treatment to be administered is the same
    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
    LVLS
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    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. AFTER THE END OF THE TRIAL, PATIENTS WILL BE MANAGED ACCORDING TO LOCAL STANDARD OF CARE
    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 Decision2020-06-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-20
    P. End of Trial
    P.End of Trial StatusOngoing
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