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    Summary
    EudraCT Number:2021-003299-15
    Sponsor's Protocol Code Number:METFORAGING
    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:2021-08-05
    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 number2021-003299-15
    A.3Full title of the trial
    A double blinded, phase II, placebo controlled, single center randomized clinical trial to evaluate metformin compared with placebo for reversal of accelerated biological aging in persons living with HIV 50 years or older and with suppressed virologic replication.
    Un ensayo clínico aleatorizado, doble ciego, de fase II, controlado con placebo, de un solo centro para evaluar la metformina en comparación con el placebo para la reversión del envejecimiento biológico acelerado en personas que viven con el VIH de 50 años o más y con replicación virológica suprimida
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Metformin vs placebo for reversal of accelerated biological aging in persons living with HIV 50 years or older and with suppressed virologic replication
    Metformina frente a placebo para la reversión del envejecimiento biológico acelerado en personas que viven con el VIH de 50 años o más y con replicación virológica suprimida
    A.3.2Name or abbreviated title of the trial where available
    Metformin vs placebo for reversal of accelerated biological aging in persons living with HIV 50 year
    Metformina frente a placebo para la reversión del envejecimiento biológico acelerado en personas que
    A.4.1Sponsor's protocol code numberMETFORAGING
    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 SponsorFundación para la Investigación Biomédica del Hospital La Paz
    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 supportFundación para la Investigación Biomédica del Hospital La Paz
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundación para la Investigación Biomédica del Hospital La Paz
    B.5.2Functional name of contact pointRocío María
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number​91 727 70 00
    B.5.5Fax number​91 207 14 66
    B.5.6E-mailrocioprieto.ucicec@gmail.com
    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 Metformina
    D.2.1.1.2Name of the Marketing Authorisation holderPENSA PHARMA, S.A.U.
    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 nameMetformina
    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 INNMETFORMIN
    D.3.9.1CAS number 657-24-9
    D.3.9.4EV Substance CodeSUB08831MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number850
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with HIV and accelerated biological aging
    Pacientes con VIH y envejecimiento acelerado
    E.1.1.1Medical condition in easily understood language
    Patients with HIV
    Pacientes con 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
    To evaluate the anti-aging affect of metformin compared to placebo as assessed by difference in epigenetic age acceleration (EAA) by Phenoage at week 96
    Evaluar el efecto antienvejecimiento de la metformina en comparación con el placebo según lo evaluado por la diferencia en la aceleración de la edad epigenética (EAA) por Phenoage en la semana 96
    E.2.2Secondary objectives of the trial
    • To evaluate the anti-ageing effect of metformin compared to placebo as assessed by difference in EAA by four epigenetic clocks at week 48, 96 and 144
    • To evaluate the effect of metformin compared to placebo as assessed by the immune profile recovery at week 48, 96 and 144
    • To evaluate the effect of metformin compared to placebo as assessed by the inflammatory biomarkers’ changes at week 48, 96 and 144
    • To evaluate the effect of metformin compared to placebo as assessed by the leucocyte telomere length changes at week 48, 96 and 144
    • To evaluate the effect of metformin compared to placebo as assessed by the different aging biomarkers changes at week 48, 96 and 144
    • To evaluate the effect of metformin compared to placebo as assessed by the frailty phenotype improvement at week 48, 96 and 144
    • To evaluate the security of metformin compared to placebo as assessed by lab parameters at week 24, 48, 72, 96, 120 and 144
    En las semanas 48, 96 y 144
    • Evaluar el efecto antienvejecimiento de la metformina vs. placebo según lo evaluado por la diferencia en EAA por cuatro relojes epigenéticos.
    • Evaluar el efecto de la metformina vs. placebo según lo evaluado por la recuperación del perfil inmunológico.
    • Evaluar el efecto de la metformina vs. placebo según lo evaluado por los cambios de los biomarcadores inflamatorios.
    • Evaluar el efecto de la metformina vs. placebo según lo evaluado por los cambios en la longitud de los telómeros leucocitarios.
    • Evaluar el efecto de la metformina vs. placebo según la evaluación de los diferentes cambios en los biomarcadores del envejecimiento.
    • Evaluar el efecto de la metformina vs. con el placebo según la evaluación de la mejora del fenotipo de fragilidad.

    • Evaluar la seguridad de la metformina en comparación con el placebo según la evaluación de los parámetros de laboratorio en las semanas 24, 48, 72, 96, 120 y 144
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age
    1. Participant must be 50 years old or older, at the time of signing the informed consent.
    Type of Participant and Disease Characteristics
    2. Participants with HIV-1 infection and an uninterrupted ART regimen in the 3 months prior to study entry
    a. Only switch for tolerability/convenience/access reasons to generic drugs or switch from ritonavir to cobicistat would be allowed in the 3-month window and as long as the components of the regimen are unchanged.
    3. HIV viral load (VL) <50 copies/mL at screening and in the year prior to study entry.
    a. A blip (50-200 copies/ml) would be allowed within 12 months prior to inclusion in the study, if preceded and followed by an undetectable VL determination.
    4. CD4 count > 500 cel/µL at screening.
    5. Participants with normal vitamin B12 levels at screening
    6. Participants with normal HOMA-IR (≤ 2.6)
    Weight
    7. Body mass index (BMI) less than 30 Kg/m2.

    Sex and Contraceptive/Barrier Requirements
    8. Female participants with suspected or documented menopause
    a. Peri- or post-menopausal, defined as having no menstrual periods for at least 12 months prior to study entry, or skipping at least one menstrual period in the 12 months prior to study entry. Peri- or post-menopausal status will be determined for candidates who have had the uterus removed by an assessment of blood follicle stimulating hormone (FSH). Women with an FSH level higher than 30 mlU/mL will be eligible for the study.
    Informed Consent
    9. Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
    Edad
    1. El participante debe tener 50 años o más, al momento de firmar el consentimiento informado.
    Tipo de participante y características de la enfermedad
    2. Participantes con infección por VIH-1 y un régimen de TAR ininterrumpido en los 3 meses anteriores al ingreso al estudio
    una. Solo se permitiría cambiar por razones de tolerabilidad / conveniencia / acceso a medicamentos genéricos o cambiar de ritonavir a cobicistat en la ventana de 3 meses y siempre que los componentes del régimen no se modifiquen.
    3. Carga viral del VIH (CV) <50 copias / ml en el momento de la selección y en el año anterior al ingreso al estudio.
    una. Se permitiría un blip (50-200 copias / ml) dentro de los 12 meses anteriores a la inclusión en el estudio, si está precedido y seguido de una determinación de VL indetectable.
    4. Recuento de CD4> 500 cel / µL en la selección.
    5. Participantes con niveles normales de vitamina B12 en la selección
    6. Participantes con HOMA-IR normal (≤ 2,6)
    Peso
    7. Índice de masa corporal (IMC) inferior a 30 kg / m2.

    Requisitos de sexo y anticonceptivos / barreras
    8. Participantes femeninas con menopausia sospechada o documentada
    una. Peri o posmenopáusica, definida como no tener períodos menstruales durante al menos 12 meses antes del ingreso al estudio, o saltarse al menos un período menstrual en los 12 meses anteriores al ingreso al estudio. Se determinará el estado perimenopáusico o posmenopáusico de las candidatas a las que se les haya extirpado el útero mediante una evaluación de la hormona estimulante del folículo sanguíneo (FSH). Las mujeres con un nivel de FSH superior a 30 mlU / ml serán elegibles para el estudio.
    Consentimiento informado
    9. Capaz de dar un consentimiento informado firmado como se describe en el Apéndice 1, que incluye el cumplimiento de los requisitos y restricciones enumerados en el formulario de consentimiento informado (ICF) y en este protocolo.
    E.4Principal exclusion criteria
    Medical Conditions

    1. Participants previously diagnosed with diabetes mellitus, prediabetes and body mass index > 30 kg/m2.
    2. Participants with chronic hepatitis B and/or active hepatitis C or concurrent active or progressive liver disease.
    3. Participants with history of any of the following comorbidities: stroke, heart failure, dementia, myocardial infarction and cancer or history of lactic acidosis.
    4. Participants with decreased tissue perfusion or hemodynamic instability due to infection or other causes
    5. Participants with active alcohol abuse:
    a. For men, heavy drinking is typically defined as consuming 15 drinks or more per week.
    b. For women, heavy drinking is typically defined as consuming 8 drinks or more per week.
    6. Participants unable to swallow study medication tablets during the treatment period.
    Prior/Concomitant Therapy
    7. Participants receiving other medications that according to study drug label are contraindicated with metformin.
    8. Participants with hypersensitivity or intolerance to any of the components of the study interventions as determined by the investigator.
    Prior/Concurrent Clinical Study Experience
    9. Participants that are unwilling to abstain from participating in another interventional clinical trial during the study follow up.
    Diagnostic assessments
    10. Impaired renal function (estimated glomerular filtration rate <60 mL/min).
    11. Liver laboratory abnormalities: alanine aminotransferase (ALT) over 5 times the upper limit of normal (ULN) or ALT over 3xULN and bilirubin over 1.5xULN or any verified Grade 4 laboratory abnormality that to the investigators criteria would affect the safety of the participant if included in the study.

    Other Exclusions
    12. Pregnant or breastfeeding women, women wishing to conceive or unwilling to commit to contraceptive methods.
    13. Any comorbidities or treatment with experimental drugs that according to the investigator could bias study results or entail additional risks for the participant.
    Condiciones médicas

    1. Participantes con diagnóstico previo de diabetes mellitus, prediabetes e índice de masa corporal> 30 kg / m2.
    2. Participantes con hepatitis B crónica y / o hepatitis C activa o enfermedad hepática activa o progresiva concurrente.
    3. Participantes con antecedentes de cualquiera de las siguientes comorbilidades: ictus, insuficiencia cardíaca, demencia, infarto de miocardio y cáncer o antecedentes de acidosis láctica.
    4. Participantes con disminución de la perfusión tisular o inestabilidad hemodinámica debido a una infección u otras causas.
    5. Participantes con abuso activo de alcohol:
    una. Para los hombres, el consumo excesivo de alcohol se define típicamente como consumir 15 bebidas o más por semana.
    B. Para las mujeres, el consumo excesivo de alcohol se define típicamente como consumir 8 bebidas o más por semana.
    6. Participantes que no puedan tragar las tabletas de la medicación del estudio durante el período de tratamiento.
    Terapia previa / concomitante
    7. Participantes que reciben otros medicamentos que, según la etiqueta del medicamento del estudio, están contraindicados con metformina.
    8. Participantes con hipersensibilidad o intolerancia a cualquiera de los componentes de las intervenciones del estudio según lo determine el investigador.
    Experiencia previa / concurrente en estudios clínicos
    9. Participantes que no estén dispuestos a abstenerse de participar en otro ensayo clínico intervencionista durante el seguimiento del estudio.
    Evaluaciones diagnósticas
    10. Función renal alterada (tasa de filtración glomerular estimada <60 ml / min).
    11. Anormalidades de laboratorio hepáticas: alanina aminotransferasa (ALT) por encima de 5 veces el límite superior de lo normal (LSN) o ALT por encima de 3xULN y bilirrubina por encima de 1,5xULN o cualquier anomalía de laboratorio de Grado 4 verificada que, según los criterios de los investigadores, afectaría la seguridad del participante. si se incluye en el estudio.

    Otras exclusiones
    12. Mujeres embarazadas o en período de lactancia, mujeres que deseen concebir o no estén dispuestas a comprometerse con métodos anticonceptivos.
    13. Cualquier comorbilidad o tratamiento con fármacos experimentales que según el investigador pueda sesgar los resultados del estudio o conllevar riesgos adicionales para el participante.
    E.5 End points
    E.5.1Primary end point(s)
    EAA difference by Phenoage epigenetic clock
    Diferencia EAA por reloj epigenético fenoage
    E.5.1.1Timepoint(s) of evaluation of this end point
    96 weeks
    96 semanas
    E.5.2Secondary end point(s)
    • EAA difference by Horvath´s clock, Hannum´s clock, GrimAge and PhenoAge
    • Immune profile: % and absolute number of CD4+ T cells, CD8+ T cells, CD4+/CD8+ ratio, haematopoietic progenitors, CD4+ and CD8+ T-cell subsets (recent thymic emigrants, naïve, central and effector memory, TEMRA, activated, exhausted and senescent), T-reg, B-cell subsets (naïve, class-switched memory, non-class switched memory), NK subsets (CD56dim CD16hi, CD56hi CD16-/low) and monocytes (classic, non-classic and intermediate)
    • Changes in the inflammatory markers: IL-6, CRP, D-Dimer
    • Changes in Telomere length in PBMC
    Changes in the following aging biomarkers:
    • TAME biomarkers: IL-6, TNFR II, hsCRP, GDF15, IGF-1, fasting insulin, cystatin C; NT-proBNP, haemoglobin A1c.
    • Oxidative stress and DNA damage: reactive oxygen species (ROS), catalase expression, superoxide dismutase 1 - 2 levels, γH2AX histone levels.
    • Other inflammatory and pro-coagulant biomarkers: IL-1 beta, TNF-alfa, D-dimer
    • Changes in the following Frailty battery: Fried frailty index, grip strength, walking speed and short physical performance battery
    • Changes in creatinine
    • Diferencia de EAA por el reloj de Horvath, el reloj de Hannum, GrimAge y PhenoAge
    • Perfil inmunológico:% y número absoluto de linfocitos T CD4 +, linfocitos T CD8 +, cociente CD4 + / CD8 +, progenitores hematopoyéticos, subconjuntos de linfocitos T CD4 + y CD8 + (emigrantes tímicos recientes, ingenuos, memoria central y efectora, TEMRA, activados, agotados y senescente), T-reg, subconjuntos de células B (ingenuo, memoria conmutada de clase, memoria conmutada sin clase), subconjuntos NK (CD56dim CD16hi, CD56hi CD16- / bajo) y monocitos (clásico, no clásico e intermedio)
    • Cambios en los marcadores inflamatorios: IL-6, PCR, D-Dimer
    • Cambios en la longitud de los telómeros en PBMC
    Cambios en los siguientes biomarcadores de envejecimiento:
    • Biomarcadores de TAME: IL-6, TNFR II, hsCRP, GDF15, IGF-1, insulina en ayunas, cistatina C; NT-proBNP, hemoglobina A1c.
    • Estrés oxidativo y daño al ADN: especies reactivas de oxígeno (ROS), expresión de catalasa, niveles de superóxido dismutasa 1 - 2, niveles de histonas γH2AX.
    • Otros biomarcadores inflamatorios y procoagulantes: IL-1 beta, TNF-alfa, dímero D
    • Cambios en la siguiente batería de fragilidad: índice de fragilidad frita, fuerza de agarre, velocidad al caminar y batería de rendimiento físico corto
    • Cambios en la creatinina
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Weeks 48, 96 and 144
    - Weeks 48, 96 and 144
    - Weeks 48, 96 and 144
    - Weeks 48, 96 and 144
    - Weeks 48, 96 and 144
    - Weeks 48, 96 and 144
    - Weeks 24, 48, 72, 96, 120 and 144
    - Semanas 48, 96 y 144
    - Semanas 48, 96 y 144
    - Semanas 48, 96 y 144
    - Semanas 48, 96 y 144
    - Semanas 48, 96 y 144
    - Semanas 48, 96 y 144
    - Semanas 24, 48, 72, 96, 120 y 144
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    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
    LVLP
    Última visita del último paciente incluido en el estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state60
    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
    Ninguno
    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 Decision2021-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-21
    P. End of Trial
    P.End of Trial StatusOngoing
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