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    Summary
    EudraCT Number:2018-002310-12
    Sponsor's Protocol Code Number:IN-ES-380-4663
    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:2018-07-17
    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 number2018-002310-12
    A.3Full title of the trial
    Bictegravir concentrations and antiviral activity in genital fluids and rectal compartment in HIV-1 infected individuals (“BIGER Study”).
    Concentraciones de bictegravir y actividad antiviral en fluidos genitales y compartimento rectal en individuos infectados con VIH-1 ("Estudio BIGER").
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Bictegravir concentrations and antiviral activity in genital fluids and rectal compartment in HIV-1 infected individuals (“BIGER Study”).
    Concentraciones de bictegravir y actividad antiviral en fluidos genitales y compartimento rectal en individuos infectados con VIH-1 ("Estudio BIGER").
    A.3.2Name or abbreviated title of the trial where available
    BIGER
    BIGER
    A.4.1Sponsor's protocol code numberIN-ES-380-4663
    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 organisationHospital Universitari de Bellvitge
    B.5.2Functional name of contact pointUnidad de VIH
    B.5.3 Address:
    B.5.3.1Street AddressC/Feixa Llarga s/n
    B.5.3.2Town/ cityHospitalet de Llobregat-Barcelona
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number00349333590112876
    B.5.5Fax number0034932607669
    B.5.6E-maillacerete@bellvitgehospital.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 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 nameBictegravir, emtricitabine, tenofovir alafenamide
    D.3.2Product code J05AR20
    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 Bq/mg becquerel(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 Bq/mg becquerel(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 Bq/mg becquerel(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 male and female adults not previously exposed to ART.
    Hombres y mujeres adultos infectados con VIH-1 no expuestos previamente a TAR.
    E.1.1.1Medical condition in easily understood language
    HIV-1 infected male and female adults not previously exposed to ART.
    Hombres y mujeres adultos infectados con VIH-1 no expuestos previamente a TAR.
    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 evaluate HIV viral kinetics in seminal plasma and rectal fluid, and cervicovaginal fluid in HIV-1 infected ART naïve male and female individuals, respectively, initiating Bictegravir/FTC/TAF.

    - To determine Bictegravir concentrations in fluid and tissue from the male and female genital tract (seminal plasma and cervicovaginal fluid) and rectal compartment (rectal tissue and rectal fluid) in HIV-1 infected male and female individuals receiving ART with Bictegravir/FTC/TAF.
    1- Evaluar la velocidad a la que disminuye la carga viral del VIH-1 (RNA VIH-1) en el semen, fluido rectal y fluido cervicovaginal en hombres y mujeres con infección por VIH-1, que no han recibido tratamiento previamente e inician tratamiento antirretroviral con Bictegravir/FTC/TAF.
    2- Estudiar las concentraciones de bictegravir en semen, tejido y fluido rectal en hombres y fluido cervicovaginal en mujeres con infección por VIH-1 tratados/as con Bictegravir/FTC/TAF.
    E.2.2Secondary objectives of the trial
    there are no secondary objectives
    No se especifican objectivos secundarios
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. HIV-1 infected male and female ≥ 18 years of age.
    2. Not previously exposed to ART
    3. Plasma viral load (HIV-1 RNA) at screening >1000 copies/mL
    4. Signed and dated written informed consent prior to inclusion.
    5. Subjects must agree to utilize a highly effective method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study.
    1. Varón y mujer infectados por VIH-1 ≥ 18 años de edad.
    2. No expuesto previamente a ART
    3. Carga viral plasmática (ARN del VIH-1) en el cribado> 1000 copias / ml
    4. Firmado y fechado el consentimiento informado por escrito antes de la inclusión.
    5. 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
    1. Severe hepatic impairment (Child-Pugh Class C)
    2. Ongoing malignancy
    3. Active opportunistic infection
    4. Primary resistance to the study ARV drugs.
    5. Any verified Grade 4 laboratory abnormality
    6. ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN
    7. Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min
    8. Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.
    1. Insuficiencia hepática grave (clase C de Child-Pugh)
    2. Malignidad en curso
    3. infección oportunista activa
    4. Resistencia primaria al estudio ARV drogas.
    5. Cualquier anomalía verificada de laboratorio de Grado 4
    6. ALT o AST ≥ 3xULN y / o bilirrubina ≥ 1.5xULN
    7. Función renal adecuada: tasa estimada de filtración glomerular ≥ 50 ml / min
    8. Mujeres embarazadas (confirmadas por una prueba de embarazo en suero positiva) o amamantando.
    E.5 End points
    E.5.1Primary end point(s)
    -HIV-1 RNA decay in seminal plasma, rectal fluid and cervicovaginal fluid from baseline and up to 6 months after initiation of Bictegravir/FTC/TAF.
    - Concentration of Bictegravir in seminal plasma, cervicovaginal fluid, rectal tissue and rectal fluid at weeks 2 and 4 after initiation a first ART regimen with Bictegravir/FTC/TAF.
    IV-1 Decaimiento de ARN en plasma seminal, fluido rectal y fluido cervicovaginal desde el inicio y hasta 6 meses después del inicio de Bictegravir / FTC / TAF.
    - Concentración de Bictegravir en plasma seminal, fluido cervicovaginal, tejido rectal y líquido rectal en las semanas 2 y 4 después del inicio de un primer régimen de TAR con Bictegravir / FTC / TAF.
    E.5.1.1Timepoint(s) of evaluation of this end point
    10 months
    10 meses
    E.5.2Secondary end point(s)
    -HIV-1 RNA decay in blood plasma from baseline and up to 6 months after initiation of Bictegravir/FTC/TAF.

    - Concentration of Bictegravir in blood plasma at weeks 2 and 4 after initiation a first ART regimen with Bictegravir/FTC/TAF.
    -IV-1 Decaimiento de ARN en el plasma sanguíneo desde el inicio y hasta 6 meses después del inicio de Bictegravir / FTC / TAF.

    - Concentración de Bictegravir en el plasma sanguíneo en las semanas 2 y 4 después del inicio de un primer régimen de TAR con Bictegravir / FTC / TAF.
    E.5.2.1Timepoint(s) of evaluation of this end point
    10 MONTHS
    10 MESES
    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 No
    E.6.6Pharmacokinetic Yes
    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) 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 No
    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 Yes
    E.8.1.7.1Other trial design description
    prospectivo, abierto, brazo único
    prospective, open label, single arm
    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.8.3 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 concerned6
    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 ultima visita del ultimo 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 months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months10
    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: 23
    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 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 state23
    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 Decision2018-11-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-12-03
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