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    Summary
    EudraCT Number:2018-000302-39
    Sponsor's Protocol Code Number:IN-ES-380-4475
    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:2018-04-09
    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 number2018-000302-39
    A.3Full title of the trial
    Bictegravir concentrations and antiviral activity in cerebrospinal fluid in HIV-1 Infected individuals
    Concentraciones de bictegravir y actividad antiviral en el líquido cefalorraquídeo en personas infectadas con VIH-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bictegravir concentrations and antiviral activity in cerebrospinal fluid in HIV-1 Infected individuals
    Concentraciones de bictegravir y actividad antiviral en el líquido cefalorraquídeo en personas infectadas con VIH-1
    A.3.2Name or abbreviated title of the trial where available
    BICS
    BICS
    A.4.1Sponsor's protocol code numberIN-ES-380-4475
    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 Lluita contra la SIDA
    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 supportFundació Lluita contra la SIDA
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundadció Lluita contra la SIDA
    B.5.2Functional name of contact pointAlbert Tuldrà
    B.5.3 Address:
    B.5.3.1Street AddressCtra. de Canyet s/n • Hosp. Univ. Germans Trias i Pujol, 2a planta Maternal
    B.5.3.2Town/ cityBadalona-Barcelona
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number0034934657897
    B.5.5Fax number0034934657602
    B.5.6E-mailatuldra@flsida.org
    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 Bictegravir/FTC/TAF
    D.2.1.1.2Name of the Marketing Authorisation holderGilead
    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 nameemtricitabine, tenofovir alafenamide and bictegravir
    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 INNBICTEGRAVIR
    D.3.9.2Current sponsor codeBIC
    D.3.9.4EV Substance CodeSUB182699
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/mg megabecquerel(s)/milligram
    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.3.9.2Current sponsor codeFTC
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/mg megabecquerel(s)/milligram
    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.3.9.2Current sponsor codeTAF
    D.3.9.4EV Substance CodeSUB121761
    D.3.10 Strength
    D.3.10.1Concentration unit MBq/mg megabecquerel(s)/milligram
    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-1 infected individuals
    Personas infectadas con VIH-1
    E.1.1.1Medical condition in easily understood language
    HIV-1 infected individuals
    Personas infectadas con VIH-1
    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
    - To assess Bictegravir concentrations in CSF and to estimate penetration into the CNS.
    -To evaluate antiviral activity of a combination of TAF/FTC/BIC in CSF.
    - Evaluar las concentraciones de Bictegravir en LCR y estimar la penetración en el SNC.
    - Evaluar la actividad antiviral de una combinación de TAF / FTC / BIC en CSF.
    E.2.2Secondary objectives of the trial
    - To assess Bictegravir concentrations in CSF and to estimate penetration into the CNS.
    -To evaluate antiviral activity of a combination of TAF/FTC/BIC in CSF.
    - Evaluar las concentraciones de Bictegravir en LCR y estimar la penetración en el SNC.
    - Evaluar la actividad antiviral de una combinación de TAF / FTC / BIC en CSF.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Asymptomatic, HIV-1 infected individuals ≥ 18 years of age
    - Be on a stable ART consisting of TDF/FTC or ABC/3TC plus 1NNRTI, 1 boosted PI or 1 integrase inhibitor, continously or ≥3 consecutive months preceding the screening visit. Patients already receiving TAF/FTC/BIC for at least three consecutive months will be eligible.
    - Plasma HIV-1 RNA at screening <40 copies/mL for at least 6 months at the Screening visit.
    - Signed and dated written informed consent prior to inclusion.
    - Subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study.
    - Individuos asintomáticos, infectados por VIH-1 ≥ 18 años de edad
    - Estar en un TAR estable que consiste en TDF / FTC o ABC / 3TC más 1NNRTI, 1 IP potenciado o 1 inhibidor de integrasa, continuamente o ≥ 3 meses consecutivos antes de la visita de selección. Los pacientes que ya reciban TAF / FTC / BIC durante al menos tres meses consecutivos serán elegibles.
    - ARN de VIH-1 plasmático en el cribado <40 copias / ml durante al menos 6 meses en la visita de cribado.
    - Firmado y fechado el consentimiento informado por escrito antes de la inclusión.
    - Los sujetos deben estar de acuerdo en utilizar un método anticonceptivo altamente efectivo durante las relaciones sexuales heterosexuales desde la visita de selección durante todo el estudio.
    E.4Principal exclusion criteria
    - Severe hepatic impairment (Child-Pugh Class C)
    - Ongoing malignancy
    - Active opportunistic infection
    - Primary resistance to any of the ARV included in the study or history of virologic failure with risk of resistance selection to any of the study drugs.
    - Any verified Grade 4 laboratory abnormality
    - ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN
    - Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min
    - Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.
    - Current treatment with antiaggregant or anticoagulant therapy.
    - History of any neurologic disease/condition/treatment may alter the blood brain barrier permeability.
    - Insuficiencia hepática grave (clase C de Child-Pugh)
    - Malignidad en curso
    - infección oportunista activa
    - Resistencia primaria a cualquiera de los ARV incluidos en el estudio o historial de falla virológica con riesgo de selección de resistencia a cualquiera de los medicamentos del estudio.
    - Cualquier anomalía verificada de laboratorio de Grado 4
    - ALT o AST ≥ 3xULN y / o bilirrubina ≥ 1.5xULN
    - Función renal adecuada: tasa estimada de filtración glomerular ≥ 50 ml / min
    - Mujeres embarazadas (confirmadas por una prueba de embarazo en suero positiva) o amamantando.
    - Tratamiento actual con terapia antiagregante o anticoagulante.
    - La historia de cualquier enfermedad / condición / tratamiento neurológico puede alterar la permeabilidad de la barrera hematoencefálica.
    E.5 End points
    E.5.1Primary end point(s)
    - To determine total and unbound Bictegravir concentrations in cerebrospinal fluid in HIV-1 infected individual receiving ART with TAF/FTC/Bictegravir.
    -Total Bictegravir concentrations in blood plasma.
    - Bictegravir CSF/plasma ratio.
    -HIV-1 RNA in cerebrospinal fluid.
    -HIV-1 RNA in blood plasma.
    - Determinar las concentraciones totales y sin unir de Bictegravir en el líquido cefalorraquídeo en individuos infectados con VIH-1 que reciben ART con TAF / FTC / Bictegravir.
    -Total de las concentraciones de Bictegravir en el plasma sanguíneo.
    - Bictegravir CSF / relación de plasma.
    -HIV-1 ARN en fluido cerebroespinal.
    -HIV-1 ARN en plasma sanguíneo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    4 months
    4 meses
    E.5.2Secondary end point(s)
    none
    ninguno
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    no aplica
    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 No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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
    la última visita del último sujeto
    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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months4
    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) 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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    In the patient information sheet there is a point with the informed consent for the legal representant
    En la Hoja de información al paciente existe un apartado con el Consentimiento informado para el representante legal
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    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)
    Expected normal treatment of the condition
    Tratamiento habitual de la enfermedad de estudio
    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 Decision2018-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-04-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-25
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