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    Summary
    EudraCT Number:2019-004140-30
    Sponsor's Protocol Code Number:DORAVIPEP
    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:2020-01-23
    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 number2019-004140-30
    A.3Full title of the trial
    Evaluation of (doravirine / lamivudine / tenofovir disoproxil fumarate) (Delstrigo®) as a New Strategy for non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of (doravirine / lamivudine / tenofovir disoproxil fumarate) (Delstrigo®) as a New Strategy for non-occupational Post Exposure Prophylaxis, a Prospective Open Label Study.
    Evaluación de (doravirina / lamivudina / tenofovir disoproxil fumarato) (Delstrigo®) como una nueva estrategia para la profilaxis post-exposición no ocupacional, un estudio prospectivo de etiqueta abierta.
    A.4.1Sponsor's protocol code numberDORAVIPEP
    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 Clínic 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 supportMerck Sharp & Dohme B.V.
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCTU CLINIC
    B.5.2Functional name of contact pointJoan Albert Arnaiz
    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.5.4Telephone number34932279838
    B.5.5Fax number34932279877
    B.5.6E-mailjaarnaiz@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 Destilgro
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme B.V.
    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 nameDelstrigo
    D.3.4Pharmaceutical form 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 INNDORAVIRINE
    D.3.9.1CAS number 1338225-97-0
    D.3.9.4EV Substance CodeSUB177834
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtenofovir disoproxil
    D.3.9.1CAS number 147127-20-6
    D.3.9.3Other descriptive nameTENOFOVIR DISOPROXIL
    D.3.9.4EV Substance CodeSUB20643
    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
    non-occupational Post Exposure Prophylaxis of HIV
    Profilaxis post-exposición no ocupacional del VIH
    E.1.1.1Medical condition in easily understood language
    HIV profilaxys
    Profilaxis del 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 20.1
    E.1.2Level PT
    E.1.2Classification code 10020161
    E.1.2Term HIV 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 estimate the proportion of subjects who correctly complete (for 28 days) the entire antiretroviral treatment proposed in the study.
    Estimar la proporción de sujetos que completan correctamente (durante 28 días) todo el tratamiento antirretroviral propuesto en el estudio.
    E.2.2Secondary objectives of the trial
    1. Incidence and description of adverse effects (clinical and laboratory) that appear during antirretroviral treatment.
    2. 2. Description of adherence to antirretroviral treatment, including the time until loss of adherence .
    3. Proportion of patients that maintain follow-up at 1 and 3 months.
    4. Rate of HIV Seroconversions
    1. Evaluar las características basales asociadas a la no finalización.
    2. Incidencia y descripción de los efectos adversos (clínicos y de laboratorio) que aparecen durante el tratamiento antirretroviral.
    3. Descripción de la adherencia al tratamiento antirretroviral, incluido el tiempo hasta la pérdida de adherencia.
    4. Proporción de pacientes que mantienen un seguimiento a las 4 a las 12 semanas.
    5. Tasa de seroconversión del VIH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients attending emergency room due to potential HIV exposition of either sex:
    2. Aged 18 years or more.
    3. Who have been exposed to non-occupational HIV and who meet the prerequisites for the current recommendations to begin post expostion prophylaxis with three antiretroviral drugs.
    4. Who after being fully informed, give their written consent to participate in the study and undergo the tests and examinations required.
    5. Individuals able to do follow up correctly.
    1. Pacientes que acuden a la sala de emergencias debido a la posible exposición al VIH de ambos sexos:
    2. De 18 años o más.
    3. Quienes han estado expuestos al VIH no ocupacional y cumplen con los requisitos previos para las recomendaciones actuales para comenzar la profilaxis post exposición con tres medicamentos antirretrovirales.
    4. Quienes, después de estar completamente informados, den su consentimiento por escrito para participar en el estudio y someterse a las pruebas y exámenes requeridos.
    5. Individuos capaces de hacer un seguimiento correctamente.
    E.4Principal exclusion criteria
    1. Pregnant women or nursing mothers or women trying to conceive during the study period.
    2. Patients in whom it is known or suspected that the source case has a resistance to one of the drugs from the study treatment regimens.
    3. Treatment with drugs that are contraindicated in the study or products that are in the investigational phase.
    4. Allergic reactions or intolerance to the compounds of the study treatment regiments
    5. Sexual assault victims
    6. Past history of pre exposition prophylaxis use in several occasions without accomplishing Follow-up testing
    1. Mujeres embarazadas o madres lactantes o mujeres que intentan concebir durante el período de estudio.
    2. Pacientes en quienes se sabe o se sospecha que el caso fuente tiene resistencia a uno de los medicamentos de los regímenes de tratamiento del estudio.
    3. Tratamiento con medicamentos que están contraindicados en el estudio o productos que están en fase de investigación.
    4. Reacciones alérgicas o intolerancia a los compuestos de los regímenes de tratamiento del estudio.
    5. Víctimas de agresión sexual
    6. Historial de uso de profilaxis pre exposición en varias ocasiones sin realizar pruebas de seguimiento.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects that achieved treatment completion at day 28. Pre exposition prophylaxis non-completion is considered in cases:
    1. If subject dies
    2. Does not go to visits (loss of follow-up)
    3. Changes or suspends the treatment under study for any reason.
    4. Consent withdrawal.
    Proporción de sujetos que lograron completar el tratamiento en el día 28. La no finalización de profilaxis pre exposición se considera en los casos:
    1. Si el sujeto muere
    2. No va a las visitas (pérdida de seguimiento)
    3. Cambia o suspende el tratamiento en estudio por cualquier motivo.
    4. Retirada de consentimiento.
    E.5.1.1Timepoint(s) of evaluation of this end point
    28 days
    28 días
    E.5.2Secondary end point(s)
    1. Assess the baseline characteristics associated to non-completion.
    2. Incidence and description of adverse effects (clinical and laboratory) that appear during antirretroviral treatment.
    3. Description of adherence to antirretroviral treatment, including the time until loss of adherence .
    4. Proportion of subjectsthat maintain follow-up at 1 and 3 months.
    5. Rate of HIV Seroconversion
    1. Evaluar las características basales asociadas a la no finalización.
    2. Incidencia y descripción de los efectos adversos (clínicos y de laboratorio) que aparecen durante el tratamiento antirretroviral.
    3. Descripción de la adherencia al tratamiento antirretroviral, incluido el tiempo hasta la pérdida de la adherencia.
    4. Proporción de sujetos que mantienen el seguimiento a 1 y 3 meses.
    5. Tasa de seroconversión del VIH
    E.5.2.1Timepoint(s) of evaluation of this end point
    At any time during the follow-up (up to 3 months)
    En cualquier momento durante el seguimiento (hasta 3 meses)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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 years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 380
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    no, participants will not need the treatment after the study.
    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 Decision2020-06-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-07-28
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