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    Summary
    EudraCT Number:2016-002722-36
    Sponsor's Protocol Code Number:RAGTIME
    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:2017-01-04
    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 number2016-002722-36
    A.3Full title of the trial
    Randomized, double-blind, placebo-controlled clinical trial to evaluate the effect of Raltegravir intensification (1.200 mg QD) on the gut microbiota of chronically HIV-1 infected subject over time: THE RAGTIME STUDY
    Ensayo clínico aleatorizado, doble ciego, controlado con placebo para evaluar el efecto en el tiempo de la intensificación con raltegravir (1.200 mg QD) en la composición de la microbiota intestinal en sujetos con infección crónica por VIH-1: Estudio Ragtime
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the effect of Raltegravir intensification (1.200 mg QD) on the gut microbiota of chronically HIV-1 infected subject over time
    Ensayo clínico para evaluar el efecto en el tiempo de la intensificación con raltegravir (1.200 mg QD) en la composición de la microbiota intestinal en sujetos con infección crónica por VIH-1
    A.4.1Sponsor's protocol code numberRAGTIME
    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 SponsorFUNDACIÓ LLUITA CONTRA LA SIDA
    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 supportFundació Lluita contra la SIDA
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportMerck Sharp And Dohme
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació Lluita contra la SIDA
    B.5.2Functional name of contact pointCRA
    B.5.3 Address:
    B.5.3.1Street AddressCtra. Canyet sn
    B.5.3.2Town/ cityBadalona/Barcelona
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493497 84 14
    B.5.5Fax number+3493465 76 02
    B.5.6E-mailjtoro@fls-rs.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 No
    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 nameRaltegravir
    D.3.2Product code MK-0518
    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 INNRALTEGRAVIR
    D.3.9.1CAS number 518048-05-0
    D.3.9.4EV Substance CodeSUB25667
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    HIV-1
    VIH-1
    E.1.1.1Medical condition in easily understood language
    Human inmunodeficiency virus
    Virus de inmunodeficiencia humana
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 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
    To evaluate the ability of raltegravir intensification to increase gut microbiome richness and modify the gut microbiome composition of people living with HIV receiving stable ART.
    Evaluar la capacidad de la intensificación con raltegravir en aumentar la riqueza del microbioma intestinal y modificar la composición de éste en las personas que viven con la infección por VIH y que reciben un tratamiento antirretroviral estable.
    E.2.2Secondary objectives of the trial
    To correlate changes in the gut microbiota composition and richness with markers of inflammation, coagulation, enterocyte damage, bacterial translocation and T-cell maturation, activation, exhaustion and senescence during raltegravir intensification.
    Correlacionar los cambios en la composición y riqueza de la microbiota intestinal durante la intensificación con raltegravir con marcadores de inflamación, coagulación, daño enterocitario, translocación bacteriana y maduración de células T, activación y agotamiento y senescencia.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years old
    2. Documented HIV infection
    3. Stable antiretroviral treatment including PIi/r or NNRTIi-based 3 drugs ART for at least 6 months.
    4. Plasma HIV-1 RNA load <50 copies/mL for at least 12 months.
    5. Signed Informed Consent
    1. Edad ≥ 18 años
    2. Infección documentada del VIH
    3. Tratamiento antirretroviral estable con 3 antirretrovirales incluyendo PI/r o NNRTI durante al menos 6 meses.
    4. Carga viral <50 copias/ml durante al menos 12 meses.
    5. Consentimiento informado firmado
    E.4Principal exclusion criteria
    1. PI/r monoterapy
    2. INSTI therapy during the previous 6 months
    3. Evidence of previous INSTI resistance
    4. Creatine clearance <50 mL/min
    5. Child- Pugh B or C
    6. History of active uncontrolled GI disorders or diseases including:
    6.1. Major surgery of the GI tract, with the exception of cholecystectomy and appendectomy, in the previous 5 years.
    6.2. Any major bowel resection at any time
    6.3. Any chronic digestive disease such as peptic ulcer, Crohn’s disease, ulcerative colitis, coeliac disease, confirmed intolerance to lactose or indeterminate colitis.
    6.4. Persistent infectious gastroenteritis, colitis or gastritis; persistent or chronic diarrhea of unknown etiology; Clostridium difficile infection (recurrent) or Helicobacter pylori infection (untreated);
    6.5. Irritable bowel syndrome (moderate-severe)
    6.6. Chronic constipation
    6.7. Active proctitis
    7. Antibiotic therapy within the previous 2 months
    8. In women, pregnancy or breastfeeding
    1. IP/r en monoterapia
    En tratamiento con INSTI durante los 6 meses previos
    3. Evidencia de resistencia previa a INSTI
    4. Aclaramiento de creatinina <50 mL/mín
    5. Child-Pugh B o C
    6. Historia de alteraciones o enfermedades gastrointestinales activas incluyendo:

    6.1. Cirugía mayor del tracto GI, con la excepción de colecistectomía y apendicetomía, en los últimos 5 años.
    6.2. Cualquier resección intestinal importante.
    6.3. Cualquier enfermedad digestiva crónica como úlcera péptica, enfermedad de Crohn, colitis ulcerosa, enfermedad celíaca, intolerancia a la lactosa confirmada o colitis indeterminada.
    6.4. Gastroenteritis infecciosa persistente, colitis o gastritis; diarrea persistente crónica de etiología desconocida; infección por Clostridium difficile (recurrente) o infección por Helicobacter pylori (no tratada)
    6.5. Síndrome del intestino irritable (moderado- severo)
    6.6. Estreñimiento crónico
    6.7. Proctitis activa

    7. Tratamiento con antibiótico en los 2 meses previos.
    8. Mujeres embarazada o en periodo de lactancia
    E.5 End points
    E.5.1Primary end point(s)
    Increase in bacterial richness (observed species).
    Aumento de la riqueza bacteriana (especies observadas).
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 48, relative to baseline (week 0).
    En la semana 48, en relación con el basal (semana 0).
    E.5.2Secondary end point(s)
    •Longitudinal changes in:
    -Gut bacterial composition
    -Gut bacterial function
    -Other estimators of richness and diversity: Chao1, ACE, Shannon, 1/Simpson.
    •Association of the gut microbiome composition and richness with:
    -Inflammation: IL-6, IP-10
    -Coagulation: D-Dimer
    -Enterocyte damage: Intestinal Fatty Acid Binding Protein (I-FABP)
    -Bacterial translocation and monocyte activation: LPS-binding protein (LBP), soluble CD14.
    -Maturation, activation, exhaustion and immune senescence in CD4+ and CD8+ T-cells: CD3+, CD4+, CD8+, CD45RA, CCR7, CD28, CD27, HLA-DR, CD38, PD-1, CD57.
    -CD4 and CD8+ counts
    -CD4+/CD8+ ratio
    • Cambios longitudinales en:
    - Composición bacteriana intestinal
    - Función bacteriana intestinal
    - Otros estimadores de riqueza y diversidad: Chao1, ACE, Shannon, 1 / Simpson.
    • Asociación de la composición microbioma intestinal y la riqueza con:
    - Inflamación: IL-6, IP-10
    - Coagulación: D-Dimer
    - Daños Enterocito: proteína de unión intestinal de ácidos grasos (I-FABP)
    - Translocación Bacteriana y activación de monocitos: proteína de unión a LPS (LBP), CD14 soluble.
    - Maduración, activación, agotamiento y senescencia inmunitaria en T CD4 + y CD8 +: CD3 +, CD4 +, CD8 +, CD45RA, CCR7, CD28, CD27, HLA-DR, CD38, PD-1, CD57.
    - CD4 y CD8 +
    - % CD4 + / CD8 +
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, weeks 12, 24, 48
    Basal y semanas 12, 24, 48
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Evaluate the ability of raltegravir intensification to increase gut microbiome richness and modify the gut microbiome composition
    Evaluar la capacidad de la intensificación con raltegravir para aumentar la riqueza del microbioma intestinal y modificar su composición
    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) Yes
    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 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 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
    LVLS
    Última visita del 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 months9
    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: 60
    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 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)
    Continue to previous antiretroviral treatment
    Continuar con el tratamiento antirretroviral previo al estudio
    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 Decision2017-03-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-02-24
    P. End of Trial
    P.End of Trial StatusOngoing
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