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    Summary
    EudraCT Number:2021-001288-26
    Sponsor's Protocol Code Number:DASAHIVCURE
    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:2022-04-21
    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 number2021-001288-26
    A.3Full title of the trial
    Safety, tolerance and antiretroviral activity of dasatinib: a pilot clinical trial in patients with recent HIV-1 infection
    Seguridad, tolerancia y actividad antirretroviral de dasatinib: estudio clínico piloto en pacientes con infección reciente por el VIH-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, tolerance and antiretroviral activity of dasatinib: a pilot clinical trial in patients with recent HIV-1 infection
    Seguridad, tolerancia y actividad antirretroviral de dasatinib: estudio clínico piloto en pacientes con infección reciente por el VIH-1
    A.4.1Sponsor's protocol code numberDASAHIVCURE
    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 SponsorIDIBAPS
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Clinic -IDIBAPS
    B.5.2Functional name of contact pointJosep Maria Miró
    B.5.3 Address:
    B.5.3.1Street AddressVillarroel, 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.4Telephone number349322754002765
    B.5.5Fax number34934514438
    B.5.6E-mailjmmiro@clinic.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 Yes
    D.2.1.1.1Trade name Dasatinib
    D.2.1.1.2Name of the Marketing Authorisation holderTeva B. V.
    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.3.4Pharmaceutical form Capsule
    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 INNDasatinib
    D.3.9.1CAS number 302962-49-8
    D.3.9.4EV Substance CodeSUB23322
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number70
    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 placeboCapsule
    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
    Recent HIV-1 infection
    Infección reciente por VIH
    E.1.1.1Medical condition in easily understood language
    Recent HIV-1 infection
    Infección reciente por 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 20.1
    E.1.2Level LLT
    E.1.2Classification code 10058427
    E.1.2Term Primary HIV infection
    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
    The overall objective of the project is to evaluate the safety and tolerability of a new therapeutic strategy, based on the administration of dasatinib, an ITK.
    The safety and tolerability of dasatinib will be evaluated in patients with recent (3-12 months) asymptomatic HIV-1 infection.
    El objetivo global del proyecto es evaluar la seguridad y tolerancia de una nueva estrategia terapéutica, basada en la administración de dasatinib, un ITK.
    Se evaluará la seguridad y tolerancia del dasatinib en pacientes con infección reciente (entre 3 y 12 meses) asintomática por el VIH-1.
    E.2.2Secondary objectives of the trial
    1. To assess the in vivo antiretroviral capacity of dasatinib by quantification of plasma HIV-1 viral load during 4-week administration of dasatinib monotherapy.
    2. To assess changes in the viral reservoirs of patients with recent HIV-1 infection induced by dasatinib administration.
    3. To assess changes in markers of inflammation and immune activation induced by dasatinib administration.
    4. To assess the changes in SAMHD1 phosphorylation levels and cytotoxic activity against HIV-1 induced by dasatinib.
    5. To assess the tolerability and pharmacokinetic interactions of co-administration of non-boosted integrase inhibitor-based antiretroviral therapy with dasatinib.
    6. To assess the impact of dasatinib on markers of senescence.
    1. Evaluar la capacidad antirretroviral propia in vivo del dasatinib mediante la cuantificación de la carga viral plasmática de VIH-1 durante la administración de dasatinib en monoterapia durante 4 semanas.
    2. Evaluar los cambios en los reservorios virales de pacientes con infección reciente por el VIH-1 inducidos por la administración de dasatinib.
    3. Evaluar los cambios en los marcadores de inflamación y activación inmunológica inducidos por la administración de dasatinib.
    4. Evaluar los cambios en los niveles de fosforilación de SAMHD1 y en la actividad citotóxica frente al VIH-1 inducidas por el dasatinib.
    5. Evaluar la tolerancia y las interacciones farmacocinéticas de la coadministración del tratamiento antirretroviral basado en inhibidores de la integrasa no potenciados con dasatinib.
    6. Evaluar el impacto del dasatinib en los marcadores de senescencia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients included in the study must meet the following criteria:
    -18 to 65 years.
    -Documented asymptomatic HIV-1 infection of 3-12 months duration (all patients must have a positive Western blot, including the p31 band whose appearance indicates infection of more than 90 days duration).
    -Not having received ART
    -CD4 T-lymphocyte count> 350 / μl
    -Patient giving written informed consent
    Los pacientes incluidos en el estudio deberán cumplir los siguientes criterios:
    -18 a 65 años.
    -Infección asintomática por VIH-1 documentada de entre 3 y 12 meses de duración (todos los pacientes deben tener un Western blot positivo, incluyendo la banda p31 cuya aparición indica una infección de más de 90 días de duración).
    -No haber recibido TAR
    -Recuento de linfocitos T CD4> 350 / μl
    -Paciente que otorgue el consentimiento informado por escrito
    E.4Principal exclusion criteria
    Potential participants who meet any of the following criteria will be excluded from the study:
    -HBV positive serology (any marker except HBsAb after vaccination) or HCV positive RNA.
    -ALT> 2 UNL, glomerular filtration rate <70 mL / 1.73 m2, leukocytes <4000 / mm3, total lymphocyte count <1000 / mm3, platelets <100,000 / mm3 or Hg <12g / dL.
    -Pregnancy or active breastfeeding
    -Ongoing or previous pleural effusion
    -Chronic obstructive pulmonary disease, bronchial asthma or recent chest trauma.
    -History of gastrointestinal or other bleeding.
    -Any concomitant treatment with potentially dangerous drug interaction with dasatinib.
    -Any clinical condition, at the opinion of the investigator, contraindicating participation (for example,
    -Active neoplastic disease, active concomitant infection, etc.)
    -Resistance to integrase inhibitors (raltegravir, dolutegravir, bictegravir) or analogues
    Los potenciales participantes que cumplan algunos de los siguientes criterios serán excluidos del estudio:
    -Serología positiva para el VHB (cualquier marcador, excepto HBsAb después de la vacunación) o RNA positivo para el VHC.
    -ALT> 2 UNL, filtrado glomerular <70 mL / 1,73 m2, leucocitos <4000 / mm3, Recuento de linfocitos totales <1000 /mm3, Plaquetas <100.000 / mm3 o Hg <12g / dL
    -Embarazo o lactancia materna activa
    -Derrame pleural en curso o previo
    -Enfermedad pulmonar obstructiva crónica, asma bronquial o traumatismo torácico reciente.
    -Historia de sangrado digestivo o de otro tipo.
    -Cualquier tratamiento concomitante con interacción farmacológica potencialmente peligrosa con dasatinib
    -Cualquier condición clínica, a discreción del investigador, contraindicando la participación (por ejemplo,
    -enfermedad neoplásica activa, infección concomitante activa, etc.)
    -Resistencia a los inhibidores de la integrasa (raltegravir, dolutegravir, bictegravir) o análogos
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the study is to assess the safety and tolerability of dasatinib with and without antiretroviral therapy using the incidence of AA.
    La variable principal del estudio es evaluar la seguridad y tolerancia del dasatinib con y sin tratamiento antirretroviral mediante la incidencia de AA.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 weeks
    52 semanas
    E.5.2Secondary end point(s)
    Immunological endpoints:
    -immune recovery (CD4 subpopulation levels).
    -inflammatory markers (ultra-sensitive CRP, IL6, TNF alpha)
    -immune activation (CD4/CD8, CD25, CD69, CD38, HLA-DR+)
    -bacterial translocation (rsCD163)
    -levels of NK-mediated cytotoxic activity (NK phenotyping and in vitro replication inhibition tests).
    Virological endpoints:
    -decline in HIV viral load prior to ART initiation (4 weeks of dasatinib monotherapy)
    -impact on the viral reservoir (integrated DNA, genetically intact virus, residual and induced viral replication and determination of integration sites)
    -SAMHD1 phosphorylation levels
    senescence endpoints:
    -Expression in PBLs of beta-galactosidase, Bcl-2, Histone H2A, p16 and CD87.
    Criterios de valoración inmunológicos:
    -recuperación inmune (niveles de subpoblaciones CD4)
    -marcadores inflamatorios (PCR ultrasensible, IL6, TNF alfa)
    -activación inmunológica (CD4/CD8, CD25, CD69, CD38, HLA-DR+)
    -translocación bacteriana (rsCD163)
    -niveles de actividad citotóxica mediada por NK (fenotipado de NK y tests de inhibición de replicación “in vitro”
    Criterios de valoración virológicos:
    -disminución de la carga viral del VIH antes del inicio del TAR (4 semanas de monoterapia con dasatinib
    -impacto sobre el reservorio viral (DNA integrado, virus genéticamente intactos replicación viral residual e inducida y determinación de sitios de integración)
    -niveles de fosforilación de SAMHD1
    Criterios de valoración de senescencia:
    -Expresión en PBLs de beta-galactosidasa, Bcl-2, Histona H2A, p16 y CD87.
    E.5.2.1Timepoint(s) of evaluation of this end point
    These parameters will be measured at baseline (S0, start of dasatinib), at the start of ART (S4), at the end of dasatinib (S16) and at S48 of ART (S52).
    Estos parámetros se medirán basalmente (S0, inicio de dasatinib), al inicio del TAR (S4), al finalizar el dasatinib (S16) y a la S48 del tratamiento antirretroviral (S52).
    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 No
    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 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 concerned7
    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 Yes
    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
    LVLS (última visita último paciente)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months1
    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: 24
    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 state24
    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)
    After completion of the treatment the investigator will decide on the best available treatment for each patient.
    Tras la finalización del tratamiento el investigador decidirá el mejor tratamiento disponible para cada paciente.
    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 Decision2022-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-29
    P. End of Trial
    P.End of Trial StatusOngoing
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