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    Summary
    EudraCT Number:2011-002853-77
    Sponsor's Protocol Code Number:TULIP
    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:2011-08-09
    Trial results View 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 number2011-002853-77
    A.3Full title of the trial
    PROSPECTIVE, RANDOMISED, CROSSOVER, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL TO ASSESS THE LIPID-LOWERING EFFECT OF ADDING TENOFOVIR/EMTRICITABINE CO-FORMULATION VS PLACEBO TO HIV-1-INFECTED SUBJECTS WITH DYSLIPIDEMIA AND SUSTAINED VIRAL LOAD SUPPRESSION UNDER MONOTHERAPY WITH RITONAVIR-BOOSTED PROTEASE INHIBITORS.
    ENSAYO PROSPECTIVO, ALEATORIZADO, CRUZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO PARA EVALUAR EL EFECTO DE LA CO-FORMULACIÓN DE TENOFOVIR/EMTRICITABINA VS PLACEBO SOBRE LA REDUCCIÓN DE LOS LÍPIDOS EN PACIENTES INFECTADOS POR VIH-1 CON DISLIPEMIA Y SUPRESIÓN VIROLÓGICA SOSTENIDA EN MONOTERAPIA CON INHIBIDORES DE LA PROTEASA POTENCIADOS CON RITONAVIR.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to assess the lipid-lowering effect of adding tenofovir/emtricitabine co-formulation vs placebo to HIV-1 infected subjects with dyslipidemia and sustained viral load suppression under monotherapy with ritonavir-boosted protease inhibitors
    ENSAYO PARA EVALUAR EL EFECTO DE LA CO-FORMULACIÓN DE TENOFOVIR/EMTRICITABINA VS PLACEBO SOBRE LA REDUCCIÓN DE LOS LÍPIDOS EN PACIENTES INFECTADOS POR VIH-1 CON DISLIPEMIA Y SUPRESIÓN VIROLÓGICA SOSTENIDA BAJO MONOTERAPIA CON INHIBIDORES DE LA PROTEASA POTENCIADOS CON RITONAVIR.
    A.4.1Sponsor's protocol code numberTULIP
    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.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 number93 497 8414
    B.5.5Fax number93 465 76 02
    B.5.6E-mailjtoro@flsida.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 Truvada 200mg/ 245mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited
    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.3.4Pharmaceutical 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 INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.4EV Substance CodeSUB12607MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number245
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNemtricitabina
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 infection
    Infección por el VIH-1
    E.1.1.1Medical condition in easily understood language
    HIV infection
    Infección por el 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 14.0
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the cholesterol-lowering ability of TDF/FTC co-formulation in HIV-1-infected subjects with high cholesterol levels.
    Evaluar la capacidad para reducir el colesterol de TDF / FTC co-formulado en sujetos infectados por VIH-1 con niveles altos de colesterol.
    E.2.2Secondary objectives of the trial
    - To assess the ability of TDF/FTC co-formulation to decrease trygliceride levels and increase HDL-cholesterol levels in HIV-1-infected subjects with dyslipidemia.
    - To evaluate changes in CD4-cell count, liver enzymes, phosphate, creatinine and glomerular filtration rate during the addition of TDF/FTC co-formulation.
    - To evaluate the rates of sustained RNA HIV viral load suppression <50 copies/mL during the study, particularly during the addition of TDF/FTC co-formulation.
    - To evaluate adverse events, including laboratory abnormalities.
    - Evaluar la capacidad de TDF / FTC co-formulado para disminuir los niveles de triglicéridos y aumentar el colesterol HDL en pacientes infectados por el VIH-1 con dislipidemia.

    - Evaluar los cambios en el recuento de células CD4, las enzimas hepáticas, fosfato, creatinina y la tasa de filtrado glomerular durante la adición de TDF / FTC co-formulado.

    - Evaluar las tasas del mantenimiento de la supresión viral (RNA < 50 copias/mL) durante el estudio, en particular durante la adición de TDF / FTC co-formulado.

    - Evaluar los eventos adversos, incluyendo anomalías de laboratorio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥ 18 years
    2. Chronic HIV-1 infection
    3. Antiretroviral treatment with either DRV/r (800/100 mg QD) or LPV/r (400/100 mg BID) monotherapy during at least 6 months prior to screening.
    4. Fasting total cholesterol or LDL-cholesterol levels ? 200 and ?130 mg/dL respectively, in the previous two consecutive tests obtained at least 4 weeks apart before screening.
    5. Calculated creatinine clearance ? 60 mL/min, according to the Cockcroft-Gault formula.
    6. Undetectable plasma HIV-1 RNA levels (< 50 copies/mL) during at least 6 months prior to screening.
    7. Adequate treatment adherence.
    8. Absence of TDF or FTC resistances.
    9. Written informed consent to participate into the study.
    1. Edad ≥ 18 años
    2. Infección crónica por VIH-1
    3. Tratamiento antirretroviral, ya sea con DRV/r (800/100 mg QD) o LPV/r (400/100 mg BID) durante al menos 6 meses previos a la visita screening.
    4. Niveles de colesterol total en ayunas o colesterol-LDL ≥ 200 y ≥ 130 mg / dL, respectivamente, en las dos últimas determinaciones consecutivas obtenidas al menos 4 semanas antes del screening.
    5. Clearance de creatinina ≥ 60 mL / min, de acuerdo con la fórmula de Cockcroft-Gault.
    6. Niveles de VIH-1 ARN en plasma indetectables (<50 copias/ml) durante al menos 6 meses anteriores al screening.
    7. Adecuada adherencia al tratamiento
    8. Ausencia de resistencias a TDF o FTC.
    9. Consentimiento informado por escrito para participar en el estudio.
    E.4Principal exclusion criteria
    1. Acute infections or uncontrolled chronic infection in the 2 months previous to the inclusion or physical examination that, in the investigator's opinion, would compromise the patient's safety or outcome of the study
    2. Lactating, pregnancy or fertile women willing to be pregnant.
    3. Concomitant use of any drug with potential drug-drug interaction with DRV/r, LPV/r or TDF/FTC co-formulation at study entry.
    4. Concomitant use of any lipid-lowering drugs at study entry.
    5. Prior documented intolerance or hypersensitivity to TDF, FTC, LPV/r or DRV/r.
    6. Therapies including interferon, interleukin-2, cytotoxic chemotherapy or immunosuppressors at study entry.
    7. Acute or chronic renal documented pathologies.
    8. Documented resistance to any of the study drugs (either genotypic or phenotypic)
    9. Life expectancy less or equal to 1 year.
    10. Current alcohol or substance use judged by the investigator to potentially interfere with subject study compliance.
    11. Subjects currently taking part in any other clinical trial using an investigational product, with the exception of studies where the treatment studied have stopped for more than 12 weeks.
    12. Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing requirements.
    1. Infecciones agudas o infecciones crónicas no controlados en los 2 meses anteriores a la inclusión o exploración física que, en opinión del investigador, podría comprometer la seguridad del paciente o el resultado del estudio.
    2. Período de lactancia, embarazo o mujeres en edad fértil dispuestas a quedarse embarazada.
    3. Uso concomitante de cualquier fármaco con potencial interacción con DRV/r, LPV/r o TDF/FTC co-formulado al inicio del estudio.
    4. Uso concomitante de medicamentos hipolipemiantes al inicio del estudio.
    5. Intolerancia o hipersensibilidad previa documentada a TDF, FTC, LPV/r o DRV/r.
    6. Terapias que incluyan interferón, interleucina-2, quimioterapia citotóxica o inmunosupresores al inicio del estudio.
    7. Patología renal aguda o crónica documentada.
    8. Resistencia documentada a cualquiera de los fármacos del estudio (ya sea genotípica o fenotípica).
    9. Esperanza de vida menor o igual a 1 año.
    10. Uso actual de alcohol o otras sustancias que en opinión del investigador pueda interferir potencialmente en el cumplimiento del sujeto en el estudio.
    11. Sujetos que participan actualmente en cualquier otro ensayo clínico con un producto en investigación, con la excepción de estudios en los que el tratamiento estudiado se haya detenido desde hace más de 12 semanas.
    12. Cualquier otra condición clínica o terapia previa que, en opinión del investigador, pudiera hacer que el sujeto no fuera apto para el estudio o no estuviera en condiciones de cumplir con los requisitos de la administración.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in median fasting total and LDL cholesterol levels during TDF/FTC co-formulation addition compared to placebo.
    Cambios en las madianas del los niveles en ayunas de colesterol total y LDL durante la adición de TDF/FTC co-formulado comparado con placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Every 3 months throughout the study
    Cada 3 meses a lo largo del estudio.
    E.5.2Secondary end point(s)
    - Percentage of patients with dyslipidemia during TDF/FTC co-formulation addition, compared to placebo. Hypercholesterolemia will be defined according to the National Cholesterol Education Program, ATP III guidelines, i.e.: total cholesterol >= 200 mg/dL, LDL cholesterol >= 130 mg/dL and HDL cholesterol =< 40 mg/dL.
    - Proportion of patients with virological failure, defined as 2 consecutive RNA HIV-1 viral loads > 50 copies/mL while receiving ART.
    - Median changes in CD4-cell count, triglycerides, liver enzymes, phosphate, creatinine and glomerular filtration rate during the addition of TDF/FTC.
    - Percentage of patients with >= grade 3 toxicity.
    - Percentage of patients who withdraw from the study.
    - Percentage of patients who withdraw from the study due to toxicity.
    - Percentage of patients requiring lipid-lowering drugs.
    - Porcentaje de pacientes con dislipemia durante la adición de TDF/FTC co-formulado, comparado con la adición de placebo. La hipercolesterolemia se definirá según las Guías ATP III del National Cholesterol Education Program, que son: Colesterol total >= 200 mg/dL, Colesterol LDL >= 130 mg/dL y colesterol HDL => 40 mg/dL.
    - Proporción de pacientes con fracaso virológico, definido como 2 cargas virales de RNA VIH-< por encima de 50 copias/mL mientras se recibe tratamiento antirretroviral.
    - Media de los cambios en el recuento de CD4, triglicéridos, enzimas hepáticas, fosfato, creatinina y tasa de filtrado glomerular (MDRD) durante la adición de TDF/FTC co-formulado.
    - Porcentaje de pacientes con toxicidad >= a grado 3.
    - Porcentaje de pacientes que abandonan el estudio
    - Porcentaje de pacientes que abandonan el estudio por toxicidad
    - Porcentaje de pacientes que requiere agentes hipolipemiantes
    E.5.2.1Timepoint(s) of evaluation of this end point
    Every 3 months throughout the study
    Cada 3 meses a lo largo del estudio.
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    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
    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 months1
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months1
    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: 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)
    The blind will be opened at the end of statistical analysis. Patients will follow with the active treatment, according to routine clinical practice and physician's criteria.
    El ciego se abrirá después de la realización del análisis estadístico. Los pacientes seguirán tomando el tratamiento activo, de acuerdo con la práctica clínica habitual y con el criterio del médico.
    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 Decision2011-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
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