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    Summary
    EudraCT Number:2020-001070-29
    Sponsor's Protocol Code Number:CRF005
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2023-02-09
    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 number2020-001070-29
    A.3Full title of the trial
    Efficacy, tolerability and acceptability of the single tablet regimen (STR) Biktarvy® by trans people living with HIV (TPLWH)
    Eficacia, tolerabilidad y aceptabilidad de régimen de un comprimido diario (STR) Biktarvy® en personas trans con VIH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, tolerability and acceptability of the single tablet regimen (STR) Biktarvy® by trans people living with HIV (TPLWH)
    Eficacia, tolerabilidad y aceptabilidad de régimen de un comprimido diario (STR) Biktarvy® en personas trans con VIH
    A.3.2Name or abbreviated title of the trial where available
    Efficacy, tolerability and acceptability of Biktarvy by TPLWH
    Eficacia, tolerabilidad y aceptabilidad de Biktarvy® en personas trans con VIH
    A.4.1Sponsor's protocol code numberCRF005
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04944654
    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 SponsorChelsea and Westminster NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChelsea and Westminster NHS Foundation Trust
    B.5.2Functional name of contact pointResearch and Development Office
    B.5.3 Address:
    B.5.3.1Street AddressUnit G2 Harbour Yard, Chelsea Harbour
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeSW10 0XD
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailchelwest.research@nhs.net
    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 Ltd, Ireland, Location: Dublin, Ireland
    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 nameBiktarvy
    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.3.9.1CAS number 1611493-60-7
    D.3.9.4EV Substance CodeAS1
    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 CodeAS2
    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 fumarate
    D.3.9.1CAS number 379270-37-8
    D.3.9.4EV Substance CodeAS3
    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
    Human Immunodeficiency Virus (HIV) infection
    Infección por el virus de la inmunodeficiencia humana (VIH)
    E.1.1.1Medical condition in easily understood language
    Human Immunodeficiency Virus (HIV) infection
    Infección por el virus de la inmunodeficiencia humana (VIH)
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10020441
    E.1.2Term Human immunodeficiency virus infection, unspecified
    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 assess the proportion of patients with HIV viral load of less than 50 copies/mL at week 48
    Evaluar la proporción de pacientes con carga viral VIH menor a 50 copias/mL a la semana 48
    E.2.2Secondary objectives of the trial
    - Proportion of subject with HIV viral load < 50 copies/mL from baseline to week 24 and 96
    - To evaluate the potential for drug-drug interactions in TPLWH who switch from their cART to Biktarvy® based on the University of Liverpool Drug interaction website or other sources of drug interaction knowledge, including prescribed drugs, hormones, over the counter medications and recreational drugs.
    - Occurrence of adverse events, severity of adverse events and occurrence of treatment discontinuations due to tolerability of treatment.
    - To assess improvement in the quality of life and perception of health (patient reported outcomes will be collected following the administration of specific questionnaires (including wellness thermometer, sleep questionnaire, PHQ9, GAD-7 and barriers to adherence questionnaire) in relation to the drug switch)
    - To assess change from baseline in clinical outcomes (e.g. bone health by FRAX, BMD). Data will be collected from routine care clinical records
    -Proporción de sujetos con carga viral de VIH <50 copias/mL del basal a semana 24 y 96
    -Evaluar la potencial interacción farmacológica en personas trans que viven con el VIH (PTVV) que cambian de ARTc a Biktarvy® basado en la web de interacciones de la Univ. Liverpool u otras fuentes de conocimiento de interacciones farmacológicas, incluyendo fármacos prescritos, hormonas, medicamentos de venta libre y drogas recreativas.
    -Frecuencia y severidad de eventos adversos, y frecuencia de discontinuación debido a tolerabilidad al tratamiento.
    -Evaluar la mejoría en la calidad de vida y percepción de salud (los resultados informados por los pacientes se recogerán aplicando de cuestionarios específicos en relación al cambio de fármaco.
    -Evaluar cambios respecto al basal en resultados clínicos (e.j. salud ósea por FRAX, DMO). Los datos serán recogidos de registro médicos de la práctica médica habitual
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    •Participant self-identifies as transgender and/or has a current gender identity which differs from gender assigned at birth (includes all gender diverse people)
    •Age > 18 years
    •HIV infection diagnosis at any time before study consent
    •Willing to sign an informed consent and take part in the study
    •On an antiretroviral regimen with an undetectable viral load or off an antiretroviral regimen with a detectable viral load (the cART can have been stopped for any clinical or personal reason; if on cART with a detectable viral load and no resistance to any of the component of Biktarvy, the patient is also eligible.
    .Participantes que se auto-identifican como transgénero y/o tiene una identidad de género actual que difiere del género asignado al nacer (incluye a todas las personas con diversidad de género)
    .Edad > 18 años
    .Infección por VIH diagnosticado en cualquier momento previo al consentimiento al estudio
    .Dispuesto a firmar un consentimiento informado y participar en el estudio
    .Bajo un régimen antirretrovial con carga viral indetectable o fuera de un régimen antirretroviral con carga viral detectable (los ARTc pueden haber sido retirados por cualquier razón clínica o personal); si bajo ARTc con carga viral detectable y no presentarse resistencia a ninguno de los componentes de Biktarvy, el paciente también es elegible.
    E.4Principal exclusion criteria
    •Age < 18 years
    •Unable to take part in the study according to the Investigator opinion (example: unable to understand the study information leaflet, unable to provide written consent, etc.)
    •History of virological failure while on a cART containing NRTIs and InSTIs and development of resistance to NRTIs and InSTI
    •Use of medications that are known to interact with Biktarvy. Contraindications and full information on drug-drug interactions given in SmPC.
    •Hypersensitivity to active substance or excipient of Biktarvy as listed in SmPC.
    •Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical or anal intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the subject prior to initiation of treatment
    •Known acute or chronic viral hepatitis including, but not limited to, A, B, or C. Chronic hepatitis B and history of hepatitis C (cured) are allowed
    •Any investigational drug within 30 days prior to the trial drug administration
    •Any other condition (including illicit drug use or alcohol abuse) or laboratory results which, in the investigator’s opinion, interfere with assessments or completion of the trial.
    .Edad < 18 años
    .Incapacidad para participar en el estudio de acuerdo a la opinión del investigador (ejemplo: incapacidad para entender el folleto de información del estudio, incapacidad de de dar su consentimiento por escrito, etc.)
    .Antecedentes de falla virológica al estar bajo ARTc conteniendo NRTIs e InSTIs y desarrollo de resistencia a NRTI e InSTi
    .Uso de medicación de la cual se sabe interactua con Biktarvy. Contraindicaciones e información completa de interacciones farmacológicas descritos en el resumen de las características del producto (RCP)
    .Hipersensibilidad al principio activo o excipiente de Biktarvy como se enumera en RCP
    .Neoplasia maligna en curso distinta al sacroma de Kaposi cutáneo, carcinoma de células basales, o resecado, carcinoma cutáneo de células escamosas no invasivo, o neoplasia intraepitelial cervical o anal; otras neoplasias malignas localizadas requieren un acuerdo entre el investigador y el monitor médico del estudio para la inclusión de sujetos previo a la iniciación del tratamiento.
    .Hepatitis viral aguda o crónica conocida, incluyendo, pero no limitado a A,B, o C. Hepatitis B crónica e historia de hepatitis C (curada) están permitidos
    .Cualquier fármaco bajo investigación dentro de los últimos 30 días previos a la administración del fármaco del ensayo
    .Cualquier otra condición (incluyendo uso de drogas ilícitas o abuso de alcohol) o resultados de laboratorio cuales, bajo la opinión del investigador, interfieren con valoraciones o finalización del estudio)
    E.5 End points
    E.5.1Primary end point(s)
    To assess the proportion of subject with HIV viral load < 50 copies/mL from baseline to week 48
    Evaluar la proporción de sujetos con carga viral de VIH < 50 copias/mL desde el basal a semana 48
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks from baseline visit
    48 semanas desde la visita inicial
    E.5.2Secondary end point(s)
    •Proportion of subject with HIV viral load < 50 copies/mL from baseline to week 24 and 96.
    •Occurrence of changes in laboratory parameters to week 96 from baseline
    •To evaluate the potential for drug-drug interactions in TPLWH who switch from their cART to Biktarvy® based on the University of Liverpool Drug interaction website or other sources of drug interaction knowledge, including prescribed drugs, hormones, over the counter medications and recreational drugs.
    •Occurrence of adverse events, severity of adverse events and occurrence of treatment discontinuations due to tolerability of treatment.
    •Changes in CD4 count and CD4:CD8 ratio during the study.
    •Patient reported outcomes will be collected following the administration of specific questionnaires (including Wellness thermometer, sleep questionnaire, barriers to adherence questionnaire) in relation to the drug switch) at baseline and w
    48 and 96. Questionnaire such as GAD-7 and PHQ-9 will also be administered at baseline and at week 48.
    •To record data on retention into care, missed appointments, and particular clinical needs.
    •To assess change in waist circumference at baseline and week 48.

    Exploratory endpoints

    •Metabolic and/or metabolomics changes following the switch to Biktarvy at baseline and weeks 48 and 96.
    .Proporción de sujetos con carga viral de VIH < 50 copias/mL desde el basal hasta la semana 24 y 96
    .Aparición de cambios de parámetros de laboratorio en la semana 96 respecto a la basal
    .Evaluar la potencial interacción farmacológica en personas trans que viven con el VIH (PTVV) que cambian su ARTc a Biktarvy® basado en la página web de interacciones de la Universidad de Liverpool u otras fuentes de conocimiento de interacciones farmacológicas, incluyendo fármacos prescritos, hormonas, medicamentos de venta libre y drogas recreativas.
    .Aparición de eventos adversos, severidad de eventos adversos y casos de discontinuación del tratamiento debido a tolerabilidad.
    .Cambios en recuento de CD4 y razón CD4:CD8 durante el estudio.
    .Resultados informados por los pacientes se recogerán aplicando cuestionarios específicos (incluyendo un termómetro de bienestar, cuestionario de sueño, cuestionario sobre barreras a la adherencia) en relación al cambio de fármaco) basal y a la semana 48 y 96. Cuestionarios como el GAD-7 y PHQ-9 se aplicarán también basalmente y a la semana 48.
    .Registrar datos sobre la retención en el cuidado, citas médicas perdidas, y necesidades clínicas particulares.
    .Evaluar cambios en la circunferencia de la cintura a nivel basal y a la semana 48.
    Evaluación de objetivos finales
    .Cambios metabólicos y/o metabolómicos posteriores al cambio a Biktarvy tanto basal como en las semanas 48 y 96.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Between weeks 24 and 96
    Entre las semanas 24 y 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 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 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 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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 45
    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 state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 50
    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)
    Provision for continued treatment has not been made. At the end of the treatment period patients will need to consider their options for continued antiretroviral treatment with their clinician within NHS treatment guidelines.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-17
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2023-05-31
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