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    Summary
    EudraCT Number:2012-004970-24
    Sponsor's Protocol Code Number:2012-004970-24
    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:2013-04-09
    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 number2012-004970-24
    A.3Full title of the trial
    Virological and immunological safety of a dose reduction strategy antiretroviral regimen with efavirenz / tenofovir / emtricitabine
    Seguridad virológica e inmunológica de una estrategia de reducción de dosis con la pauta antirretroviral efavirenz/tenofovir/emtricitabina
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Virological and immunological safety of a dose reduction strategy antiretroviral regimen with efavirenz / tenofovir / emtricitabine
    Seguridad virológica e inmunológica de una estrategia de reducción de dosis con la pauta antirretroviral efavirenz/tenofovir/emtricitabina
    A.3.2Name or abbreviated title of the trial where available
    A-TRI-WEEK
    A-TRI-WEEK
    A.4.1Sponsor's protocol code number2012-004970-24
    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 Biomèdica
    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 supportInfectious disease Hospital Clinic of Barcelona
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU- Clinical Trial unit. Farmacologia clinica
    B.5.2Functional name of contact pointCTU
    B.5.3 Address:
    B.5.3.1Street Addressmallorca 138
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08036
    B.5.3.4CountrySpain
    B.5.6E-mailjaarnaiz@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 Atripla 600 mg/200 mg/245 mg comprimidos recubiertos con película.
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb and Gilead Sciences 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.3.1Product nameATRIPLA
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    HIV -1 infection
    infección por HIV-1
    E.1.1.1Medical condition in easily understood language
    HIV-1 infection
    infección por HIV-1
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    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
    The main objective of this study was to determine the feasibility of maintaining virologic suppression on standard plasma viral load (limit of detection 37 copies / mL) of a dose reduction strategy of ATRIPLA ® once a day to three tablets per weeks in patients infected with HIV-1 with sustained suppression of plasma viral load standard for more than two years.
    El objetivo principal de este estudio es conocer la viabilidad del mantenimiento de la supresión virológica sobre la carga viral plasmática estándar (límite de detección 37 copias/mL) de una estrategia de reducción de dosis de ATRIPLA® de una vez al día a tres comprimidos por semana en pacientes infectados por VIH-1 con supresión sostenida de la carga viral plasmática estándar durante más de 2 años.
    E.2.2Secondary objectives of the trial
    ● virological study including: ultrasensitive viral load in plasma (limit of detection 1 copy / mL), and HIV-1 reservoir mononucelares cells from peripheral blood,
    ● immune Study includes TRECs production, immune profile of activation (CD38 and HLA-DR) and senescence (CD57 and CD28) in the CD4 and CD8 lineage, apoptosis (annexin V staining), and naive T-cell ratios and effector and memory (CCR7 and CD45RA).
    ● Pharmacokinetic study, including basal plasma levels of efavirenz at the beginning and end of study.
    ● Safety study, including: test on sleep quality (Pittsburgh Sleep Quality Index), levels of vitamin-D 25OH, estimated glomerular filtration rate (CPK-EPI) and lipids (triglycerides, total cholesterol and HDL) plasma at the beginning and at end of study and overall tolerability.
    ● Estudio virológico que incluye: carga viral ultrasensible en plasma (límite de detección 1 copia/mL), y reservorio VIH-1 en células mononucelares de sangre periférica,
    ● Estudio inmunológico que incluye: producción de TRECs, perfil inmunológico de activación (CD38 y HLA-DR) y senescencia (CD57 y CD28) en los linajes CD4 y CD8, apoptosis (tinción con anexina V), y proporciones de células T naive y efectoras y de memoria (CCR7 y CD45RA).
    ● Estudio farmacocinético, que incluye los niveles plasmáticos basales de efavirenz al principio y al final del estudio.
    ● Estudio de seguridad, que incluye: test sobre calidad de sueño (Pittsburgh Sleep Quality Index), niveles de vitamina 25OH-D, tasa de filtrado glomerular estimada (CPK-EPI) y lípidos (triglicéridos, colesterol total y HDL) plasmáticos al principio y al final del estudio, así como la tolerabilidad general.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Adults (≥ 18 years)

    2. HIV-1 infection, clinical stability, and treatment with ATRIPLA ® for the past two years.

    3. Standard plasmárica viral load below the limit of detection for at least 2 years.

    4. CD4 count above 350/mm3 at the time of the consideration for the study.

    5. Negative pregnancy test in women of childbearing age, and commitment acceptable contraceptive use for at least 2 weeks before day 1 and until at least 6 months after the last dose of study drug.

    6. Patients should be given written informed consent

    7. In the opinion of the investigator, be able to follow the design of the protocol visits
    1. Adultos (≥18 años)

    2. Infección por VIH-1, estabilidad clínica, y tratamiento con ATRIPLA® durante los últimos dos años.

    3. Carga viral plasmárica estándar por debajo del límite de detección durante al menos los 2 últimos años.

    4. Cifra de CD4 superior a 350/mm3 en el momento de la consideración para el estudio.

    5. Prueba de embarazo negativa en mujeres en edad fértil, y compromiso de uso de métodos anticonceptivos aceptables desde al menos 2 semanas antes del día 1 y hasta como mínimo 6 meses después de la última dosis del fármaco del estudio.

    6. Los pacientes deben haber otorgado su consentimiento informado por escrito

    7. En opinión del investigador, ser capaces de seguir el diseño de las visitas del protocolo.
    E.4Principal exclusion criteria
    1. Patients who have experienced virologic failure prior to any antiretroviral regimen
    2. Evidence of previous mutations versus efavirenz, tenofovir and emtricitabine
    3. Use of any other chronic treatment plus ATRIPLA has been introduced in the 6 months prior to entry of the patient in the study
    4. Any cointraindicación to study drug
    5. Any condition not ensure proper adherence to the study at the discretion of the attending physician of the patient
    6. Uncontrolled preexisting psychiatric illness
    7. Any current sign of alcoholism or other drug use.
    1. Pacientes que hayan presentado fracaso virológico previo con cualquier pauta antirretroviral
    2. Evidencia de mutaciones previas frente a efavirenz, tenofovir o emtricitabina
    3. Uso de cualquier otro tratamiento crónico además de ATRIPLA que se haya introducido en los 6 meses previos a la entrada del paciente en el estudio
    4. Cualquier cointraindicación al medicamento del estudio
    5. Cualquier condición que no permita asegurar la adherencia correcta al estudio a discreción del médico a cargo del paciente
    6. Enfermedad psiquiátrica preexistente no controlada
    7. Cualquier signo actual de alcoholismo o de consumo de otras drogas.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be the proportion of patients who continue with a standard plasma viral load (<37 copies / mL) at 24 weeks by intention to treat analysis.
    La variable principal del estudio será la proporción de pacientes que continúan con una carga viral plasmática estándar (<37 copias/mL) a las 24 semanas mediante un análisis por intención de tratamiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 semanas
    E.5.2Secondary end point(s)
    1) The proportion of patients with ultrasensitive viral load (<1 copy / mL) after 24 weeks.
    2) The change from baseline to 24 weeks in the viral reservoir in peripheral blood mononuclear cells
    3) Changes from baseline to 24 weeks in the production of TRECs, the immunological profile of activation (CD38 and HLA-DR) and senescence (CD57 and CD28) in CD4 and CD8 lineages in the proportions of naive T cells effector and memory (CCR7 and CD45RA), and changes in the levels of apoptosis in vitro by staining with annexin V.
    4) Changes in plasma levels of efavirenz.
    5) Changes in sleep quality (Pittsburgh Sleep Quality Index), plasma levels of vitamin D and lipids, and estimated glomerular filtration rate.
    6) General Security (report side effects, serious side effects and treatment discontinuation due to side effects)
    1) La proporción de pacientes con carga viral ultrasensible (<1 copia/mL) al cabo de 24 semanas.
    2) El cambio desde la basal hasta las 24 semanas en el reservorio viral de células mononucleares de sangre periférica
    3) Los cambios desde la basal hasta las 24 semanas en la producción de TRECs, el perfil inmunológico de activación (CD38 y HLA-DR) y senescencia (CD57 y CD28) en los linajes CD4 y CD8, en las proporciones de células T naive y efectoras y de memoria (CCR7 y CD45RA), y los cambios en los niveles de apoptosis in vitro mediante tinción con anexina V.
    4) Cambios en los niveles plasmáticos de efavirenz.
    5) Cambios en la calidad del sueño (Pittsburgh Sleep Quality Index), niveles plasmáticos de vitamina D y lípidos, y tasa de filtrado glomerular estimada.
    6) Seguridad en general (reporte de efectos secundarios, efectos secundarios graves y discontinuación del tratamiento por efectos secundarios)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 No
    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) No
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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 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 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)
    none
    no
    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 Decision2013-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-21
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