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    Summary
    EudraCT Number:2021-005546-15
    Sponsor's Protocol Code Number:GESIDA122-21
    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:2021-12-22
    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 number2021-005546-15
    A.3Full title of the trial
    Simplified model of linkage & retention to care, using a mobile unit and a same-day test & treat approach among excluded population. The SIMPLIFIED Study
    Modelo simplificado de acceso y retención al sistema sanitario, utilizando una unidad móvil y una estrategia de diagnostico y tratamiento en el mismo día en poblaciones vulnerables. Estudio SIMPLIFIED
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Simplified model using a mobile unit and a s test & treat approach among excluded population.
    Modelo simplificado que utiliza una unidad móvil y un enfoque de test and treat entre la población excluida.
    A.3.2Name or abbreviated title of the trial where available
    Simplified model of linkage & retention to care, using a mobile unit
    Modelo simplificado de acceso y retención al sistema sanitario, utilizando una unidad móvil
    A.4.1Sponsor's protocol code numberGESIDA122-21
    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 SponsorGileas Science
    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 Science
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundacion SEIMC-Gesida
    B.5.2Functional name of contact pointMarta de Miguel Montero
    B.5.3 Address:
    B.5.3.1Street AddressC/ Agustín de Betancourt, 13-Entreplanta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28003
    B.5.3.4CountrySpain
    B.5.6E-mailmdemiguel@f-sg.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 BIKTARVY
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Science
    D.2.1.2Country which granted the Marketing AuthorisationIreland
    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.3.2Product code EMEA/H/C/004449
    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
    HIV AIDS
    VIH SIDA
    E.1.1.1Medical condition in easily understood language
    HIV and AIDS
    VIH y SIDA
    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
    Primary objective.
    To implement a model of access and retention in HIV care for vulnerable
    people using a mobile screening unit and a same-day diagnosis and
    treatment initiation strategy.
    Objetivo principal.
    Implementar un modelo de acceso y retencion de cuidados en la atención del VIH para personas vulnerables mediante una unidad móvil de cribado y una estrategia de diagnóstico y tratamiento en el mismo día.
    E.2.2Secondary objectives of the trial
    Secondary objectives.
    1) To evaluate the effectiveness of the strategy.
    2) To assess the safety of the strategy.
    3) To assess the implementation and feasibility of the intervention
    Objetivos secundarios.
    1) Evaluar la eficacia de la estrategia.
    2) Evaluar la seguridad de la estrategia.
    3) Evaluar la aplicación y la viabilidad de la intervención.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Participants wishing to take part in the study must meet all of the criteria listed below:
    1. Vulnerable person ≥18 years old.
    2. Understand and sign the informed consent form.
    3. Confirmed HIV infection.
    4. HIV viral load >1000 copies/mL
    Los participantes que deseen tomar parte en el estudio deben cumplir todos los criterios que se indican a continuación:
    1. Persona vulnerable ≥18 años de edad.
    2. Comprender y firmar el formulario de consentimiento informado.
    3. Infección confirmada por el VIH.
    4. Carga viral del VIH >1000 copias/m
    E.4Principal exclusion criteria
    Exclusion criteria.
    Participants with any of the following criteria will not be eligible to participate:
    1. inability to provide contact details.
    2. History of allergy to any of the following drugs: bictegravir, tenofovir alafenamide or emtricitabine.
    3. Have been on antiretroviral treatment for less than 6 months and have no evidence of poor adherence to ART or hospital appointments.
    4. Pregnancy or breastfeeding at the time of screening or gestational desires during the study period.
    5. Suspected or diagnosed active opportunistic disease.
    6. History of severe liver disease (Child-Pugh C) or history of decompensated liver disease (defined as the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, or persistent jaundice).
    7. History of renal disease CKP-EPI<30ml/min.
    8. Presenting any condition which, in the opinion of the researcher, makes the patient not a candidate for inclusion (active disease, social situation, intoxication, etc.).
    Criterios de exclusión.
    Los participantes que presenten alguno de los siguientes criterios no podrán participar:
    1. Incapacidad de proporcionar datos de contacto.
    2. Antecedentes de alergia a cualquiera de los siguientes medicamentos: bictegravir, tenofovir alafenamida o emtricitabina.
    3. Llevar menos de 6 meses en tratamiento antirretroviral y no tener evidencia de mala adherencia al TAR o a las citas hospitalarias.
    4. Embarazo o lactancia en el momento del cribado o deseos de gestación durante el periodo del estudio.
    5. Sospecha o diagnóstico de enfermedad oportunista activa.
    6. Antecedentes de enfermedad hepática grave (Child-Pugh C) o antecedentes de enfermedad hepática descompensada (definida como la presencia de ascitis, encefalopatía, coagulopatía, hipoalbuminemia, varices esofágicas o gástricas, o ictericia persistente).
    7. Antecedentes de enfermedad renal CKP-EPI<30ml/min.
    8. Presentar cualquier condición que, a juicio del investigador, haga que el paciente no sea candidato a la inclusión (enfermedad activa, situación social, intoxicación, etc.).
    E.5 End points
    E.5.1Primary end point(s)
    ASSESSMENT OF TRIAL ENDPOINTS.
    Assessing the effectiveness of the strategy Proportion of subjects who agree to participate in the study.
    Proportion of subjects initiating ART after enrolment.
    Median time from study enrolment to ART initiation.
    Proportion of subjects with plasma HIV-1 RNA <50 copies/mL at 24 weeks after enrolment.
    Absolute values and changes from baseline in CD4+ cell count and CD4:CD8 ratio at 24 weeks.
    Proportion of subjects making visits at weeks 24 and 48. To assess the safety of the strategy Incidence and severity of adverse events (clinical and laboratory) up to week 24.
    Incidence of adverse events leading to treatment discontinuation up to week 24.
    Incidence of genotypic resistance mutations in participants with virologic failure at week 48.
    EVALUACIÓN DE LOS CRITERIOS DE VALORACIÓN DEL ENSAYO.
    Evaluación de la eficacia de la estrategia Proporción de sujetos que aceptan participar en el estudio.
    Proporción de sujetos que inician la terapia antirretroviral después de la inscripción.
    Mediana de tiempo desde la inscripción en el estudio hasta el inicio del TAR.
    Proporción de sujetos con ARN del VIH-1 en plasma <50 copias/mL a las 24 semanas de la inscripción.
    Valores absolutos y cambios desde el inicio del estudio en el recuento de células CD4+ y en la proporción CD4:CD8 a las 24 semanas.
    Proporción de sujetos que realizan visitas en las semanas 24 y 48. Evaluar la seguridad de la estrategia Incidencia y gravedad de los acontecimientos adversos (clínicos y de laboratorio) hasta la semana 24.
    Incidencia de acontecimientos adversos que conduzcan a la interrupción del tratamiento hasta la semana 24.
    Incidencia de mutaciones genotípicas de resistencia en los participantes con fracaso virológico en la semana 48.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The duration of the study is defined for each participant as the date the signed written informed consent is provided until the last follow-up visit, which can be up to month 18
    La duración del estudio se define para cada participante como la fecha en que se proporciona el consentimiento informado por escrito hasta la última visita de seguimiento, que puede ser hasta el mes 18
    E.5.2Secondary end point(s)
    Evaluate strategy implementation
    - Assessment of the acceptability, convenience, appropriateness, usefulness, appropriateness, quality and perceived benefit and satisfaction of the intervention (see Appendix 6 ) at the baseline visit and at the week 24 visit. These parameters will be collected on a scale of 0 to 5.
    - To evaluate the implementation of this project, in addition to the aspects of the previous point, the endpoints referred to above will be used (Evaluate the effectiveness of the strategy and Evaluate the safety of the strategy).
    Evaluar la aplicación de la estrategia
    - Evaluación de la aceptabilidad, la conveniencia, la adecuación, la utilidad, la conveniencia, la calidad y el beneficio percibido y la satisfacción de la intervención (véase el Apéndice 6 ) en la visita inicial y en la visita de la semana 24. Estos parámetros se recogerán en una escala de 0 a 5.
    - Para evaluar la aplicación de este proyecto, además de los aspectos del punto anterior, se utilizarán los criterios de valoración referidos anteriormente (Evaluar la eficacia de la estrategia y Evaluar la seguridad de la estrategia).
    E.5.2.1Timepoint(s) of evaluation of this end point
    The duration of the study is defined for each participant as the date the signed written informed consent is provided until the last follow-up visit, which can be up to month 18
    La duración del estudio se define para cada participante como la fecha en que se proporciona el consentimiento informado por escrito hasta la última visita de seguimiento, que puede ser hasta el mes 18
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy No
    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 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
    The end date of the study will be the date of the last visit of the last participant completing week 12 of study completion.
    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 months18
    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: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 No
    F.3.3.7Others Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Homeless
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    Patients will continue with ART following European AIDS guidelines.
    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 Decision2022-04-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-04-07
    P. End of Trial
    P.End of Trial StatusOngoing
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