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    Summary
    EudraCT Number:2017-000985-31
    Sponsor's Protocol Code Number:RALAM-II
    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:2017-09-04
    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 number2017-000985-31
    A.3Full title of the trial
    Phase 3b, single arm, single site simplification study with dual therapy including 3TC (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected atients experiencing inconvenience, toxicity, negative impact on co-morbidities or risk of drug-drug interactions with their current regimen. RALAM-II study
    Estudio fase 3b de simplificación, de un solo brazo, con terapia dual formada por 3TC (300 mg de QD) más Raltegravir (1200 mg de QD) en pacientes infectados por el VIH-1 virológicamente suprimidos que presentan molestias, toxicidad, impacto negativo sobre sus comorbilidades o riesgo o riesgo de interacciones de fármacos con su régimen actual. Estudio RALAM-II
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3b, single arm, single site simplification study with dual therapy including 3TC (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected atients experiencing inconvenience, toxicity, negative impact on co-morbidities or risk of drug-drug interactions with their current regimen. RALAM-II study
    Estudio fase 3b de simplificación, de un solo brazo, con terapia dual formada por 3TC (300 mg de QD) más Raltegravir (1200 mg de QD) en pacientes infectados por el VIH-1 virológicamente suprimidos que presentan molestias, toxicidad, impacto negativo sobre sus comorbilidades o riesgo o riesgo de interacciones de fármacos con su régimen actual. Estudio RALAM-II
    A.4.1Sponsor's protocol code numberRALAM-II
    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 - Clinical Trials Unit
    B.5.2Functional name of contact pointDavid Garcia Cinca
    B.5.3 Address:
    B.5.3.1Street Addressc/ Villarroel 170
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.6E-maildgarcia@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 Isentress
    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.3.1Product nameRaltegravir
    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.IMP: 2
    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 Epivir
    D.2.1.1.2Name of the Marketing Authorisation holderViiV Healthcare
    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.3.1Product nameLamivudine
    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 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
    Virologically suppressed Human Immunodeficiency Virus-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen
    Pacientes infectados por Virus de la Inmunodeficiencia Humana-1 virológicamente suprimidos experimentando molestias, toxicidad, impacto negativo sobre sus comorbilidades o riesgo de interacciones de fármacos con su régimen actual
    E.1.1.1Medical condition in easily understood language
    Human Immunodeficiency Virus-1 controlled patients with problems in their current treatment
    Pacientes controlados con virus de la inmunodeficiencia humana-1 con problemas en su tratamient actual
    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 10020445
    E.1.2Term Human immunodeficiency virus type I infection with constitutional disease
    E.1.2System Organ Class 100000020168
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Efficacy assessed with standard plasma HIV-1 RNA detection (limit of detection 5037 copies/mL) at 48 weeks
    Evaluar la eficacia con la detección de ARN del VIH-1 en plasma estándar (definiendo el límite de detección en 50 copias/mL) a las 48 semanas
    E.2.2Secondary objectives of the trial
    - Change in the reason (inconvenience, toxicity, negative impact on co-morbidities or risk of drug-drug interactions) leading to antiretroviral therapy switch
    - Efficacy assessed with ultrasensitive HIV-1 RNA detection at 48 weeks
    - Changes in metabolic parameters including fasting plasma lipids and insulin resistance at 48 weeks
    - Change in estimated glomerular filtration rate, urine protein/creatinine ratio and beta-2-microglobulin at 48 weeks
    - Change in body fat distribution at 48 weeks
    - Change in lumbar and femoral bone mineral density at 48 weeks
    - Changes in immune activation markers including CD38 and HLA-DR at 48 weeks
    - Changes in biomarkers of inflammation and biomarkers of mononuclear activation at 48 weeks
    - Change in sleep quality at 48 weeks
    - Change in quality of life and overall satisfaction at 48 weeks
    - Overall tolerability at 48 weeks
    -Cambio en la razón (molestias, toxicidad, impacto en comorbilidades o riesgo de interacciones medicamentosas) la modificación en la terapia antirretroviral
    -Evaluar eficacia con detección ultrasensible de ARN del VIH-1 a las 48 semanas
    -Cambios en parámetros metabólicos incluyendo concentración plasmática de lípidos y resistencia a la insulina en ayunas a las 48 semanas
    -Cambio en la tasa de filtración glomerular estimada, cociente proteína/creatinina y beta-2-microglobulina a las 48 semanas
    -Cambio en la distribución de la grasa corporal a las 48 semanas
    -Cambio en la densidad mineral ósea lumbar y femoral a las 48 semanas
    -Cambios en los marcadores de activación inmunológica incluyendo CD38 y HLA-DR a las 48 semanas
    -Cambios en los biomarcadores de la inflamación y biomarcadores de activación mononuclear a las 48 semanas
    -Cambio en la calidad del sueño a las 48 semanas
    -Cambios en la calidad de vida y satisfacción a las 48 semanas
    -Tolerabilidad total a las 48 semanas
    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 experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen
    d. Patients virologically suppressed during at least 12 months prior to inclusion (viral load <50 copies/mL).
    e. 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 fértil deben tener una prueba de embarazo negativa dentro de los 10 días previos a la asignación al azar en el estudio.
    b. Pacientes seropositivos para el VIH-1 utilizando criterios de diagnóstico estándar.
    c. Los pacientes que experimentan inconvenientes, toxicidad, impacto negativo en las comorbilidades o riesgo de interacciones medicamentosas con su régimen actual
    d. Pacientes virológicamente suprimidos durante al menos 12 meses antes de la inclusión (carga viral <50 copias / mL).
    e. Pacientes que han 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.
    a. Embarazo, lactancia o embarazo planificado durante el período de estudio.
    b. Fracaso anterior a un régimen que contenía inhibidores de la integrasa.
    c. Fracaso anterior en un régimen que contenía 3TC o FTC.
    d. Mutaciones de resistencia a 3TC o inhibidor de integrasa si alguna prueba de resistencia se había realizado previamente.
    e. Cualquier enfermedad o antecedente de enfermedad que, a juicio del investigador, pueda confundir los resultados del estudio o suponer un riesgo adicional para el tratamiento del paciente.
    f. Hepatitis B crónica
    E.5 End points
    E.5.1Primary end point(s)
    Therapeutic failure at week 48, includes virological failure, change in treatment for any reason, consent withdrawal, loss to follow-up or death.
    Fracaso terapéutico en la semana 48, incluye el fracaso virológico, cambios en tratamiento por cualquier motivo, retiro de consentimiento, pérdida de seguimiento o muerte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 semanas
    E.5.2Secondary end point(s)
    - Change from baseline in the reason of change of the ARV treatment at 48 weeks. Defined as: changes in quality of life (QoL) calculated by EQ-5D-5L in patients that the reason of switch was inconvenience, Improvement in toxicity in patients that the reason of switch was toxicity or impact on co-morbidities (defined as Changes on Pittsburgh Sleep Quality Index (PSQI) for neurological toxicity, Changes on plasma lipids (cholesterol total, LDL, HDL and triglycerides) on cardiovascular toxicity or co-morbidity, Changes on DXA bone density in skeletal toxicity, Changes on CKD-EPI on kidney toxicity or co-morbidity, Changes proportion of patients that resolve their digestive toxicity: as diarrhea or digestive discomfort) ; changes in the proportion of drug-drug interaction in patients that the reason of switch was drug-drug interactions
    - Virological failure is defined as two consecutive measurements of plasma viral load above 5037 copies/ml (current detection limit in hospital lab) separated at least by 2 weeks during the assigned treatment, using the FDA snapshot method.
    - Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks
    - Changes from baseline in metabolic parameters including fasting plasma lipids (cholesterol total, LDL, HDL and triglycerides) and insulin resistance (HOMA-IR) at 48 weeks
    - Changes from baseline in body fat composition at 48 weeks
    - Changes from baseline in immune activation markers including CD38 and HLA-DR at 48 weeks
    - Changes from baseline in biomarkers of inflammation (IL-6, high sensitivity C-reactive protein) and biomarkers of mononuclear activation (SD-14, SD-163) at 48 weeks
    - Changes from baseline in sleep quality (Pittsburgh Sleep Quality Index) at 48 weeks
    - Change from baseline in EQ-5D-5L quality of life (QoL) and overall satisfaction (VAS) at 48 weeks
    - Incidence of adverse events
    - Cambio desde la línea base en la razón del cambio del tratamiento antirretroviral a las 48 semanas. Definido como: cambios en la calidad de vida (QoL) calculados por EQ-5D-5L en pacientes que la razón de cambio fue inconveniente, Mejora en la toxicidad en pacientes que la razón de cambio fue la toxicidad o el impacto en comorbilidades (definido como cambios En el Índice de Calidad del Sueño de Pittsburgh (PSQI) para la toxicidad neurológica, Cambios en los lípidos plasmáticos (colesterol total, LDL, HDL y triglicéridos) en la toxicidad cardiovascular o co-morbilidad, Cambios en la densidad ósea DXA en toxicidad esquelética, Cambios en CKD-EPI en riñón Toxicidad o co-morbilidad, Cambia la proporción de pacientes que resuelven su toxicidad digestiva: como diarrea o malestar digestivo); Cambios en la proporción de la interacción fármaco-fármaco en pacientes que la razón de cambio fue interacciones medicamentosas
    - El fracaso virológico se define como dos mediciones consecutivas de la carga viral plasmática por encima de 5037 copias / ml (límite de detección actual en el laboratorio del hospital) separadas al menos por 2 semanas durante el tratamiento asignado, utilizando el método de instantánea de la FDA.
    - Proporción de pacientes con carga viral por debajo del límite de detección del ARN del VIH-1 ultrasensible (límite de detección 1 copia / mL) a las 48 semanas
    - Cambios desde la línea de base en los parámetros metabólicos incluyendo los lípidos plasmáticos en ayunas (colesterol total, LDL, HDL y triglicéridos) y resistencia a la insulina (HOMA-IR) a las 48 semanas
    - Cambios desde la línea base en la composición de la grasa corporal a las 48 semanas
    - Cambios desde la línea de base en los marcadores de activación inmune incluyendo CD38 y HLA-DR a las 48 semanas
    - Cambios desde la línea base en biomarcadores de inflamación (IL-6, proteína C reactiva de alta sensibilidad) y biomarcadores de activación mononuclear (SD-14, SD-163) a las 48 semanas
    - Cambios desde la línea de base en la calidad del sueño (índice de calidad del sueño de Pittsburgh) a las 48 semanas
    - Cambio de la calidad de vida (QoL) de EQ-5D-5L y de la satisfacción general (VAS) a las 48 semanas
    - Incidencia de eventos adversos
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 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 Yes
    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 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 No
    E.8.1.1Randomised No
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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
    DSMB will review the data if 4 episodes of treatment failure are detected and subsequently every 4 new episodes of treatment failure. Study will be interrupted as soon as 5 episodes (10%) of confirmed virological failure are detected.
    DSMB revisará los datos si se detectan 4 episodios de fracaso del tratamiento y posteriormente cada 4 nuevos episodios de fracaso del tratamiento. Estudio se interrumpirá en cuanto se detectan 5 episodios (10%) de fracaso virológico confirmado.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months18
    E.8.9.2In all countries concerned by the trial 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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state50
    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 Decision2017-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-27
    P. End of Trial
    P.End of Trial StatusOngoing
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