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    Summary
    EudraCT Number:2019-000199-41
    Sponsor's Protocol Code Number:GESIDA10918
    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:2019-06-11
    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 number2019-000199-41
    A.3Full title of the trial
    A phase IV, multicenter, open and randomized study to evaluate the impact of the change of antiretroviral treatment from dual therapy to triple therapy on inflammation in patients with type 1 HIV infection.
    Estudio de fase IV, multicéntrico, abierto y aleatorizado, para evaluar el impacto del cambio de tratamiento antirretroviral de terapia dual a terapia triple sobre la inflamación en pacientes con infección por VIH tipo 1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the impact of the change of antiretroviral treatment from dual therapy to triple therapy on inflammation in HIV+ patients.
    Estudio para evaluar el impacto del cambio de tratamiento antirretroviral de terapia dual a terapia triple sobre la inflamación en pacientes VIH +
    A.3.2Name or abbreviated title of the trial where available
    INSTINCT
    INSTICT
    A.4.1Sponsor's protocol code numberGESIDA10918
    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 SEIMC-GESIDA
    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 supportGilead Sciences, S.L
    B.4.2CountrySpain
    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 pointMaria Yllescas
    B.5.3 Address:
    B.5.3.1Street AddressC/ Agustín de Betancourt nº 13
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28003
    B.5.3.4CountrySpain
    B.5.4Telephone number0034915568025
    B.5.5Fax number0034915542283
    B.5.6E-mailmyllescas@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 Bictarvy
    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 nameBictarvy
    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.3.9.3Other descriptive nameBICTEGRAVIR SODIUM
    D.3.9.4EV Substance CodeSUB188200
    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 CodeSUB01882MIG
    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 alafensmide
    D.3.9.3Other descriptive nameTENOFOVIR ALAFENAMIDE FUMARATE
    D.3.9.4EV Substance CodeSUB178389
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Tivicay
    D.2.1.1.2Name of the Marketing Authorisation holderTivicay
    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 nameTivicay
    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 INNDolutegravir
    D.3.9.3Other descriptive nameDOLUTEGRAVIR SODIUM
    D.3.9.4EV Substance CodeSUB130591
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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 Epivir
    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 nameEpivir
    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 INNLAMIVUDINE
    D.3.9.1CAS number 134678-17-4
    D.3.9.4EV Substance CodeSUB08392MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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
    VIH
    E.1.1.1Medical condition in easily understood language
    HIV
    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 10001509
    E.1.2Term AIDS
    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 compare the levels plasma of sCD14 in patients who change from dual therapy ART to triple therapy vs patients who continue with dual therapy (DTG + 3TC) throughout the 96 weeks
    Comparar los niveles plasmáticos de sCD14 en pacientes que cambian de TAR de terapia dual a terapia triple vs pacientes que continúan con terapia dual (DTG + 3TC) a lo largo de las 96 semanas
    E.2.2Secondary objectives of the trial
    - To evaluate the levels plasma levels biomarkers that predict the mortality during the treatment of HIV infection over 96 weeks:
    - Inflammation (signaling pathways of IL-6): Ultrasensitive C-reactive protein (PCR-us)
    - Activation of monocytes / macrophages: sCD163
    - Induction IDO-1: kynurenine / tryptophan ratio
    - Coagulation: dimer D
    - Immunoactivation: CD4 / CD8 ratio
    - Compare the results of all biomarkers mentioned above between both treatment arms
    - Evaluate changes in viral suppression rate
    - Evaluate changes in the CD4 T cell count
    - Evaluate the longitudinal trajectories of plasma biomarkers and the CD4 / CD8 ratio.
    - To assess the safety and tolerability of the administration of triple therapy (BIC / FTC / TAF) as ART
    - Evaluar los niveles plasmáticos de los biomarcadores que predicen mortalidad durante el tratamiento de la infección por el VIH a lo largo de 96 semanas:
    - Inflamación (vías de señalización de la IL-6): Proteína C reactiva ultrasensible (PCR-us)
    - Activación de monocitos / macrófagos: sCD163
    - Inducción IDO-1: cociente quinurenina / triptófano
    - Coagulación: dímero D
    - Inmunoactivación: cociente CD4/CD8
    - Comparar los resultados de todos los biomarcadores mencionados anteriormente entre ambos brazos de tratamiento
    - Evaluar los cambios en la tasa de supresión viral
    - Evaluar cambios en el recuento de células T CD4
    - Evaluar las trayectorias longitudinales de los biomarcadores plasmáticos y el cociente CD4 / CD8.
    - Evaluar la seguridad y la tolerabilidad de la administración de la triple terapia (BIC / FTC / TAF) como TAR
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Men and women ≥ 18 years
    - Confirmed and documented diagnosis of HIV-1 infection
    - Virological suppression of more than 48 weeks (confirmed with HIV RNA <50 copies / ml). The determination of the QoL of a routine routine analysis of ≤ 12 weeks prior to the signing of the consent is allowed.
    - ART in stable dual therapy (> 48 weeks) with DTG + 3TC
    - Signed informed consent
    - Negative pregnancy test (only women of childbearing age). A woman of childbearing age is considered to be a woman who has not undergone permanent infertility procedures or who has been amenorrheic for less than 12 months.
    - Hombres y mujeres ≥ 18 años
    - Diagnóstico confirmado y documentado de infección por VIH-1
    - Supresión virológica de más de 48 semanas (confirmado con ARN de VIH < 50 copias / ml). Se permite la determinación de la CV de una analítica previa rutinaria de ≤ 12 semanas previas a la firma del consentimiento.
    - TAR en terapia dual estable (> 48 semanas) con DTG + 3TC
    - Consentimiento informado firmado
    - Prueba de embarazo negativa (sólo mujeres en edad fértil). Se considera mujer en edad fértil como aquellas mujeres que no hayan sido sometidas a procedimientos de infertilidad permanente o que sean amenorreicas desde hace menos de 12 meses.
    E.4Principal exclusion criteria
    - Impossibility of obtaining written informed consent to participate in the study
    - Pregnant or lactating women or those who intend to become pregnant during the study period and do not commit to using proven contraceptive methods
    - Any suspicion or confirmation of resistance to TAF, FTC, DTG or BIC.
    - Patients with known hypersensitivity to any excipient used with TAF, 3TC, FTC, DTG or BIC
    - Any autoimmune or chronic inflammatory disease
    - Use of immunomodulatory or immunosuppressive agents, including steroids
    - Chronic treatment with aspirin, statins and other anti-inflammatory agents
    - Any acute infection in the last 2 months
    - Estimated glomerular filtration rate (eGFR) <30 mg / ml / m2 measured by any of the available formulas. The determination of the eGFR of a routine preliminary analysis of ≤ 12 weeks prior to the signing of the consent is allowed
    - Contraindication for the use of TAF
    - Clinical status of the patient in rapid deterioration or the researcher considers that there is no reasonable hope that the patient will complete the study
    - Simultaneous participation in another clinical trial or research study that requires the need for treatment with other drugs outside the study or interfere with the visits of the same.
    - Any situation that, in the investigator opinion, could interfere with the patient's ability to comply with the treatment guideline and the protocol evaluations
    - Imposibilidad de obtener el consentimiento informado por escrito para participar en el estudio
    - Mujeres embarazadas o en periodo de lactancia o aquellas que pretendan quedar embarazadas durante el periodo del estudio y no se comprometan a utilizar métodos anticonceptivos probados
    - Cualquier sospecha o confirmación de resistencia a TAF, FTC, DTG o BIC.
    - Pacientes con hipersensibilidad conocida a cualquier excipiente utilizado con TAF, 3TC, FTC, DTG o BIC
    - Cualquier enfermedad autoinmune o inflamatoria crónica
    - Uso de agentes inmunomoduladores o inmunosupresores, incluidos los esteroides
    - Tratamiento crónico con aspirina, estatinas y otros agentes antiinflamatorios
    - Cualquier infección aguda en los últimos 2 meses
    - Tasa de filtración glomerular estimada (TFGe) < 30 mg/ml/m2 medida por cualquiera de las fórmulas disponibles. Se permite la determinación de la TFGe de una analítica previa rutinaria de ≤ 12 semanas previas a la firma del consentimiento
    - Contraindicación para el uso de TAF
    - Estado clínico del paciente en rápido deterioro o el investigador considera que no existe una esperanza razonable de que el paciente vaya a finalizar el estudio
    - Participación simultánea en otro ensayo clínico o estudio de investigación que requiera la necesidad de tratamiento con otros fármacos ajenos al estudio o interfiera en las visitas del mismo.
    - Cualquier situación que, en opinión del investigador, pueda interferir con la capacidad del paciente para cumplir la pauta de tratamiento y las evaluaciones del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Changes in the concentration of sCD14 from the beginning of treatment until week 96.
    Cambios en la concentración de sCD14 desde el inicio del tratamiento hasta la semana 96.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visita basal, semana 0,4,12,24, 36, 48, 60, 72, 84 y 96
    Visita basal, semana 0,4,12,24, 36, 48, 60, 72, 84 y 96
    E.5.2Secondary end point(s)
    - Changes in plasma biomarkers that predict mortality during the treatment of HIV infection, indicators of different pathways involved in HIV immunopathogenesis up to week 96:
    o Inflammation (signaling pathways of IL-6): PCR-us
    o Activation of monocytes / macrophages: sCD163
    o IDO-1 induction: kynurenine / tryptophan ratio
    o Coagulation: dimer D
    o Immunoactivation: CD4 / CD8 ratio
    - Changes in the CD4 + lymphocyte count from the start of treatment until week 96.
    - Changes in viral suppression rates from the beginning of treatment until week 96.
    - Longitudinal trajectories of the plasmatic biomarkers and the CD4 / CD8 ratio from the beginning of treatment until week 96.
    - Evaluation of AAs and GAEs from the start of treatment until week 96
    - Cambios en los biomarcadores plasmáticos que predicen mortalidad durante el tratamiento de la infección por VIH indicadores de diferentes vías implicadas en la inmunopatogenia del VIH hasta la semana 96:
    o Inflamación (vías de señalización de la IL-6): PCR-us
    o Activación de monocitos / macrófagos: sCD163
    o Inducción IDO-1: cociente quinurenina / triptófano
    o Coagulación: dímero D
    o Inmunoactivación: cociente CD4/CD8
    - Cambios en el recuento de linfocitos CD4+ desde el inicio del tratamiento hasta la semana 96.
    - Cambios en las tasas de supresión viral desde el inicio del tratamiento hasta la semana 96.
    - Trayectorias longitudinales de los biomarcadores plasmáticos y el cociente CD4 / CD8 desde el inicio del tratamiento hasta la semana 96.
    - Evaluación de los AA y los AAG desde el inicio del tratamiento hasta la semana 96
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Basal visit, week 0,23,24, 47, 48, 95 y 96
    -Visita basal, semana 0,4,12,24, 36, 48, 60, 72, 84 y 96
    -Basal visit, week 0,23,24, 47, 48, 95 y 96
    -Visita basal, semana 0,4,12,24, 36, 48, 60, 72, 84 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 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 Yes
    E.6.13.1Other scope of the trial description
    Impact on inflammation
    Impacto en la inflamación
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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) Yes
    E.8.2.2Placebo No
    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 concerned17
    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
    LPLV
    última visita de 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 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: 234
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state234
    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)
    According to the routine medical practice
    De acuerdo a la práctica médica habitual
    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 Decision2019-07-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-08
    P. End of Trial
    P.End of Trial StatusOngoing
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