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    Summary
    EudraCT Number:2014-003142-27
    Sponsor's Protocol Code Number:RALAM
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-03-27
    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 number2014-003142-27
    A.3Full title of the trial
    A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological suppression. RALAM Study
    Ensayo clínico piloto de 24 semanas, abierto, aleatorizado, y controlado para evaluar la seguridad, tolerabilidad y eficacia de terapia dual con Raltegravir/Lamivudina, en sustitución de la terapia combinada estándar en pacientes infectados por VIH con supresión virológica prolongada. Estudio RALAM
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A pilot 24-week open-label, randomized, controlled clinical trial to assess the safety, tolerability and efficacy of dual therapy with Raltegravir/Lamivudine combination when replacing standard combination therapy in HIV-infected patients with prolonged virological suppression. RALAM Study
    Ensayo clínico piloto de 24 semanas, abierto, aleatorizado, y controlado para evaluar la seguridad, tolerabilidad y eficacia de terapia dual con Raltegravir/Lamivudina, en sustitución de la terapia combinada estándar en pacientes infectados por VIH con supresión virológica prolongada. Estudio RALAM
    A.3.2Name or abbreviated title of the trial where available
    RALAM Study
    Estudio RALAM
    A.4.1Sponsor's protocol code numberRALAM
    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 Clinic per a la Recerca Biomédica
    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 supportMerck Sharp & Dohme
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU Clinic (Clinical Trial Unit)
    B.5.2Functional name of contact pointJaime Camacho
    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 number+349322754004386
    B.5.5Fax number+34932279877
    B.5.6E-mailjcamacho@clinic.ub.es
    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 DUTREBIS (MK0518B)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 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 INNLamivudine
    D.3.9.3Other descriptive nameLAMIVUDINE HYDRATE
    D.3.9.4EV Substance CodeSUB131071
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRaltegravir
    D.3.9.3Other descriptive nameRALTEGRAVIR POTASSIUM
    D.3.9.4EV Substance CodeSUB25668
    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
    Chronic HIV infection
    Infección VIH cronica
    E.1.1.1Medical condition in easily understood language
    Chronic HIV infection
    Infeccion VIH cronica
    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
    Efficacy in virological suppression assessed with standard plasma HIV-1 RNA detection (limit of detection 37 copies/mL).
    Evaluar la eficacia en la supresión virológica, mediante detección de HIV-1 RNA en plasma (límite de detección de 37 copias /ml).
    E.2.2Secondary objectives of the trial
    Efficacy in virological suppression assessed with ultrasensitive HIV-1 RNA detection (limit of detection 1 copy/mL); Changes in peripheral mononuclear blood cells HIV-1 reservoir; Changes in metabolic parameters including fasting plasma lipids and insulin resistance (HOMA-IR); Changes in body fat composition and bone mineral density; Changes in plasma 25-OH vitamin D levels; Changes in estimated glomerular filtration rate (CKD-EPI) and urine beta-2-microglobulin
    changes in immune activation markers including CD38 and HLA-DR; Changes in biomarkers of inflammation (IL-6, high sensitivity C-reactive protein) and biomarkers of mononuclear activation (SD-14, SD-163); Changes in sleep quality (Pittsburgh Sleep Quality Index); Changes in adherence in both treatment arms (Morisky-Green Test); overall tolerability
    Evaluar la eficacia mediante detección ultrasensible de HIV-1 RNA (límite de detección de 1 copia/ml); Cambios en el reservorio de VIH-1 en células mononucleares sanguíneas periféricas; Cambios en parámetros metabólicos, incluyendo lípidos plasmáticos (en ayunas) y resistencia a la insulina (HOMA-IR); Cambios en la composición de la grasa corporal y en la densidad mineral ósea; Cambios en los niveles plasmáticos de Vitamina D 25-OH; Cambios en el índice de filtración glomerular estimado (CKD-EPI) y en la microglobulina-beta-2 urinaria; Cambios en marcadores de activación inmune, incluyendo CD38 y HLA-DR; Cambios en biomarcadores de la inflamación (IL-6, proteína C reactiva de alta sensibilidad) y biomarcadores de activación mononuclear (SD-14, SD-163); Cambios en la calidad del sueño (Índice de Calidad de Sueño de Pittsburgh, PSQI); Cambios en la adherencia al tratamiento en ambos grupos (Morisky-Green Test); Tolerabilidad general
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.
    b. Patients seropositive for HIV-1 using standard diagnostic criteria.
    c. Patients virologicaly suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
    d. Patients on combination antiretroviral therapy (at least 2 antiretroviral drugs) for at least 12 months before being randomized in this study.
    e. Patients who are clinically stable in the opinion of the investigator at study entry (clinical status and chronic medication must not have not been modified at least 14 days prior to randomization).
    f. Patients who have signed informed consent to participate in the study
    a. Los pacientes elegibles serán hombres o mujeres de al menos 18 años de edad. Las mujeres en edad de procrear deben contar con un test de embarazo negativo en los 10 días anteriores a su aleatorización en el estudio.
    b. Pacientes seropositivos para VIH-1 mediante criterios diagnósticos habituales.
    c. Pacientes en supresión virológica durante al menos los 12 meses anteriores a su inclusión (carga viral <50 copias/mL).
    d. Pacientes en terapia antirretroviral combinada (al menos dos fármacos antirretrovirales) desde un mínimo de 12 meses previos a su aleatorización en este estudio.
    e. Pacientes que estén clínicamente estables, en opinión del investigador, al ingresar en el estudio (la situación clínica y la medicación crónica no deben haberse modificado al menos durante los 14 días previos a la aleatorización).
    f. Pacientes que hayan firmado el consentimiento informado para participar en el estudio.
    E.4Principal exclusion criteria
    a. Pregnancy, lactation, or planned pregnancy during the study period.
    b. Previous failure to an integrase inhibitor-containing regimen.
    c. Previous failure to a 3TC or FTC-containing regimen.
    d. Resistance mutations to 3TC or integrase inhibitor if any resistance test had been previously performed.
    e. Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
    f. Chronic hepatitis B.
    g. Current therapy with RAL+3TC
    a. Embarazo, lactancia o previsión de embarazo durante la duración del estudio.
    b. Fracaso previo a regímenes que contengan inhibidor de la integrasa.
    c. Fracaso previo a regímenes que contengan 3TC ó FTCP.
    d. Mutaciones de resistencia a 3TC o al inhibidor de la integrasa, si se ha realizado algún test de resistencia previamente.
    e. Cualquier enfermedad o antecedente de enfermedad que, en opinión del investigador, pueda confundir los resultados del estudio o plantear riesgos añadidos al tratamiento del paciente.
    f. Hepatitis B crónica.
    g. En tratamiento con RAL+3TC
    E.5 End points
    E.5.1Primary end point(s)
    The primary variable is the proportion of patients free of therapeutic failure at week 24. Therapeutic failure includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death.
    Virological failure is defined as two consecutive measurements of plasma viral load above 37 copies/ml (current detection limit in hospital lab) separated at least by 2 weeks during the assigned treatment, using the FDA snapshot method.
    La variable principal es la proporción de pacientes libre de fracaso terapéutico a las 24 semanas. El fracaso terapéutico incluye fracaso virológico, cambio en el tratamiento cualquiera que sea la causa, retirada del consentimiento del estudio, pérdida de seguimiento o muerte.
    El fracaso virológico se define como dos mediciones consecutivas de carga viral plasmática por encima de 37 copias/ml (límite actual de detección en el laboratorio del hospital).
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24
    24 semanas
    E.5.2Secondary end point(s)
    1.Proportion of patients with viral load below 37copies/ml at 24 weeks
    2.Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 24 weeks
    3.Changes from baseline in peripheral mononuclear blood cells HIV-1 reservoir at 24 weeks;
    4.Changes from baseline in metabolic parameters including fasting plasma lipids (cholesterol total, LDL, HDL and triglycerides) and insulin resistance (HOMA-IR) at 24 weeks;
    5.Changes from baseline in body fat composition at 24 weeks;
    6.Changes from baseline in lumbar and femoral bone mineral density at 24 weeks;
    7.Changes from baseline in plasma 25-OH vitamin D levels at 24 weeks;
    8.Changes from baseline in estimated glomerular filtration rate (CKD-EPI) and urine beta-2-microglobulin at 24 weeks;
    9.Changes from baseline in immune activation markers including CD38 and HLA-DR at 24 weeks;
    10.Changes from baseline in biomarkers of inflammation (IL-6, high sensitivity C-reactive protein) and biomarkers of mononuclear activation (SD-14, SD-163) at 24 weeks;
    11.Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) at 24 weeks;
    12.Incidence of adverse events in both treatment arms;
    13.Proportion of patients discontinuing study treatment due to adverse events related to medication;
    14.Proportion of patients with serious adverse events related to study medication;
    15.Changes in treatment adherence during all the study duration (Morisky-Green test)
    1.Proporción de pacientes con carga viral por debajo de 37 copias/ml a las 24 semanas.
    2.Proporción de pacientes con carga viral por debajo del límite de detección ultrasensible de HIV-1 RNA (límite de detección de 1 copia/ml) a las 24 semanas.
    3.Cambios en el reservorio de VIH-1 en células mononucleares sanguíneas periféricas a las 24 semanas.
    4. Cambios en parámetros metabólicos, incluyendo lípidos plasmáticos en ayunas (colesterol total, LDL, HDL y triglicéridos); y resistencia a la insulina (HOMA-IR) a las 24 semanas.
    5.Cambios en la composición de la grasa corporal a las 24 semanas.
    6.Cambios en la densidad mineral ósea lumbar y femoral a las 24 semanas.
    7.Cambios en los niveles plasmáticos de Vitamina D 25-OH a las 24 semanas.
    8.Cambios en el índice de filtración glomerular estimado (CKD-EPI) y en la microglobulina-beta-2 urinaria a las 24 semanas.
    9.Cambios en marcadores de activación inmune, incluyendo CD38 y HLA-DR a las 24 semanas.
    10.Cambios en biomarcadores de la inflamación (IL-6, proteína C reactiva de alta sensibilidad) y biomarcadores de activación mononuclear (SD-14, SD-163) a las 24 semanas.
    11.Cambios en la calidad del sueño (Índice de Calidad de Sueño de Pittsburgh, PSQI) a las 24 semanas.
    12.Incidenca de acontecimientos adversos en los dos brazos de pacientes del estudio a las 24 semanas.
    13.Proporción de pacientes que interrumpen el tratamiento del estudio debido a acontecimientos adversos relacionados con la medicación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas.
    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) 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 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 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 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
    última visita 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 months
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state75
    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)
    normal treatment of that condition
    tratamiento estándar de la enfermedad
    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 Decision2015-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-11-18
    P. End of Trial
    P.End of Trial StatusCompleted
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