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    Summary
    EudraCT Number:2017-000986-60
    Sponsor's Protocol Code Number:RALAM-Roll-Over
    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:2017-08-28
    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 number2017-000986-60
    A.3Full title of the trial
    Phase 3b, single arm, single site simplification study of HIV-1 infected patients with virological suppression under the combination of 3TC (150 mg BID) plus Raltegravir (400 mg BID) switching to 3TC (300 mg QD) plus Raltegravir (1200 mg QD) : Roll-over study of the RALAM clinical trial (NCT02284035)
    Fase 3b, un brazo, estudio unicéntrico de simplificación en pacientes infectados por VIH-1 con supresión virológica con la combinación de 3TC (150 mg BID) más Raltegravir (400 mg BID) a cambiar a 3TC (300 mg QD) y Raltegravir (1200 mg QD): estudio de Roll-over del ensayo clínicos RALAM (NCT02284035)
    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 of HIV-1 infected patients with virological suppression under the combination of 3TC (150 mg BID) plus Raltegravir (400 mg BID) switching to 3TC (300 mg QD) plus Raltegravir (1200 mg QD) : Roll-over study of the RALAM clinical trial (NCT02284035)
    Fase 3b, un brazo, estudio unicéntrico de simplificación en pacientes infectados por VIH-1 con supresión virológica con la combinación de 3TC (150 mg BID) más Raltegravir (400 mg BID) a cambiar a 3TC (300 mg QD) y Raltegravir (1200 mg QD): estudio de Roll-over del ensayo clínicos RALAM (NCT02284035)
    A.4.1Sponsor's protocol code numberRALAM-Roll-Over
    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
    Patients of RALAM study (NCT02284035)
    Pacientes del estudio RALAM (NCT02284035)
    E.1.1.1Medical condition in easily understood language
    Patients of RALAM study
    Pacientes del estudio RALAM
    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 50 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
    - efficacy assessed with ultrasensitive HIV-1 RNA detection
    - change in peripheral mononuclear blood cells HIV-1 reservoir
    - changes in metabolic parameters including fasting plasma lipids and insulin resistance
    - change in body fat distribution
    - change in lumbar and femoral bone mineral density
    - change in plasma 25-OH vitamin D levels
    - change in estimated glomerular filtration rate, urine protein/creatinine ratio and urine beta-2-microglobulin
    - changes in immune activation markers including CD38 and HLA-DR
    - changes in biomarkers of inflammation and biomarkers of mononuclear activation
    - change in sleep quality
    - change in quality of life and overall satisfaction
    - overall tolerability
    - evaluar eficacia con la detección ultrasensible de ARN del VIH-1
    - cambio en el reservorio de células mononucleares periféricas de la sangre VIH-1
    - cambios en parámetros metabólicos incluyendo plasma lípidos en ayunas y resistencia a la insulina
    - cambios en la composición de grasa corporal
    - cambios en la densidad mineral ósea de los huesos femoral y lumbares
    - cambios en la concentración plasmática de 25-OH vitamina D
    - cambios en la tasa de filtración glomerular estimada, en el cociente proteína/creatinina de orina y en la concentración de beta-2-microglobulina
    - cambios en los marcadores de activación inmune
    - cambios en biomarcadores de la inflamación y biomarcadores de activación celular mononuclear
    - cambios en la la calidad del sueño
    - cambios en la calidad de vida y satisfacción
    - tolerabilidad general
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    a. Patients in the switch arm who have completed the 24-week follow-up of RALAM (NCT02284035) study and remain virologically suppressed (viral load <50 copies/mL) on dual therapy with 3TC plus Raltegravir
    b. Patients who have signed informed consent to participate in the study.
    a. Los pacientes en el brazo de cambio que han completado el seguimiento de 24 semanas de RALAM (NCT02284035) estudio y permanecer virológicamente suprimido (carga viral <50 copias / mL) en la terapia dual con 3TC más Raltegravir
    b. 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. Any disease or history of disease which, in opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment
    c. Hepatitis B co-infection
    a. Embarazo, lactancia o planificar embarazo durante el período de estudio
    b. Cualquier enfermedad o antecedente de enfermedad que, en opinión del investigador, pudiera confundir los resultados del estudio o plantear un riesgo adicional al tratamiento del paciente
    c. Co-infección por hepatitis B
    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)
    - Proportion of patients with viral load below ultrasensitive HIV-1 RNA detection limit (limit of detection 1 copy/mL) at 48 weeks
    - Change from baseline in peripheral mononuclear blood cells HIV-1 reservoir to week 48
    - Changes from baseline in metabolic parameters including fasting plasma lipids (cholesterol total, LDL, HDL and triglycerides) and insulin resistance (HOMA-IR) at 48 weeks
    - Change from baseline in lumbar and femoral bone mineral density to week 48
    - Change from baseline in plasma 25-OH vitamin D levels to week 48
    - Change from baseline in estimated glomerular filtration rate (CKD-EPI), urine protein/creatinine ratio and urine beta-2-microglobulin to week 48
    - 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 quality of life (QoL) and overall satisfaction (VAS) at 48 weeks
    - Incidence of adverse events
    - 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
    - Cambio de la línea de base en el depósito de VIH-1 de las células sanguíneas mononucleares periféricas a la semana 48
    - 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
    - Cambio desde la línea base de la densidad mineral ósea lumbar y femoral a las 48 semanas
    - Cambio desde la línea de base en los niveles plasmáticos de 25-OH de vitamina D a las 48 semanas
    - Cambio desde la línea de base en la tasa estimada de filtración glomerular (CKD-EPI), relación orina proteína / creatinina y beta-2-microglobulina en la orina 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) y 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 Decision2017-10-11
    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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