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    Summary
    EudraCT Number:2020-004454-30
    Sponsor's Protocol Code Number:DORA-HD
    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:2020-11-19
    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 number2020-004454-30
    A.3Full title of the trial
    Removal of Doravirine by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease
    Extracción de doravirina por la hemodiálisis en pacientes VIH con insuficiencia renal crónica terminal.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Removal of Doravirine by Hemodialysis in HIV-Infected Patients with End-Stage Renal Disease
    Extracción de doravirina por la hemodiálisis en pacientes VIH con insuficiencia renal crónica terminal.
    A.3.2Name or abbreviated title of the trial where available
    DORA-HD
    DORA-HD
    A.4.1Sponsor's protocol code numberDORA-HD
    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 FLS de Lluita contra la SIDA, les Malalties Infeccioses i la Promoció de la Salut i La Ciència
    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 FLS de Lluita contra la SIDA, les Malalties Infeccioses i la Promoció de la Salut i La Ciència
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportStudy Program Initiated by Merck Sharp & Dohme Corp Researcher
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundació FLS de Lluita contra la SIDA, les Malalties Infeccioses i la Promoció de la Salut i La Ciència
    B.5.2Functional name of contact pointFLS-Research Support
    B.5.3 Address:
    B.5.3.1Street AddressCarretera de Canyet sn
    B.5.3.2Town/ cityBadalona
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number+34934978414
    B.5.5Fax number+34934657602
    B.5.6E-mailcherrero@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 Pifeltro
    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.3.4Pharmaceutical 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 INNDORAVIRINE
    D.3.9.3Other descriptive nameDORAVIRINE
    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.3.11 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 with HIV and end stage renal disease (ESRD) undergoing on intermittent hemodialysis
    Pacientes con VIH y insuficiencia renal crónica terminal sometidos a sesiones intermitentes de hemodiálisis
    E.1.1.1Medical condition in easily understood language
    Patients with HIV and end stage renal disease undergoing on intermittent hemodialysis
    Pacientes con VIH y insuficiencia renal crónica terminal sometidos a hemodiálisis
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10014646
    E.1.2Term End stage renal disease (ESRD)
    E.1.2System Organ Class 100000004857
    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 assess the hemodialysis extraction ratio of doravirine in HIV-infected patients with ESRD undergoing intermittent hemodialysis.
    Calcular el coeficiente de extracción de doravirina mediante hemodiálisis en participantes VIH con IRC terminal.
    E.2.2Secondary objectives of the trial
    To evaluate the safety of doravirine un HIV-infected participants with ESRD on hemodialysis

    To evaluate the effect of a hemodialysis session on doravirine concentrations in plasma in HIV-infected participants with ESRD
    - Evaluar la seguridad (eventos adversos grado 3-4) de doravirina en participantes VIH con
    insuficiencia renal crónica terminal sometidos a hemodiálisis.

    - Evaluar los cambios en las concentraciones plasmáticas de doravirina durante una sesión
    de hemodiálisis en participantes VIH con insuficiencia renal crónica terminal
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Males and females aging ≥ 18 years.
    2.Documented HIV infection.
    3.Stable antiretroviral treatment for at least 2 weeks prior to enrolment.
    4.Optimal adherence to antiretroviral treatment, defined as less than 2 missed doses within the previous week.
    5.End-stage renal disease in renal replacement therapy with periodic hemodialysis.
    6.Agree with the study procedures and signature of the informed consent.
    1. Hombres y mujeres edad ≥ 18 años.
    2. Infección documentada por VIH
    3. Tratamiento antirretroviral estable durante al menos 2 semanas antes de la inclusión en el
    estudio.
    4. Adherencia óptima al tratamiento antirretroviral, definida como menos de 2 dosis olvidadas
    durante la semana anterior a la inclusión en el estudio.
    5. Insuficiencia renal crónica terminal en tratamiento renal sustitutivo con hemodiálisis periódica.
    6. Aceptar los procedimientos del estudio y la firma del consentimiento informado.
    E.4Principal exclusion criteria
    1.Evidence or clinical suspicion that the patient will not be able to comply with the study protocol.
    2.Hypersensitivity to doravirine
    3.Concomitant therapy within the previous 4 weeks with any of the following drugs:
    - Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin
    - Androgen receptor inhibitor: enzalutamide
    - Antimycobacterials: rifampin, rifapentine
    - Cytotoxic agent: mitotane
    - St. John’s wort (Hypericum perforatum)
    4.Females who are pregnant or breastfeeding.
    5.ALT and/ or AST ≥ 4 times the upper limit of normal (ULN) at screening.
    6.Hemoglobin < 7,5 g/dL at screening.
    1.Evidencia o sospecha clínica de que el paciente no podrá cumplir con el protocolo del estudio.
    2.Hipersensibilidad a la doravirina
    3.Tratamiento concomitante durante las 4 semanas previas a la inclusión con cualquiera de los siguientes tratamientos:
    - Anticonvulsivos: carbamazepina, oxcarbazepina, fenobarbital, fenitoína
    - Antiandrógenos: enzalutamida
    - Antimicrobianos: rifampicina, rifapentina
    - Agente citotóxico: mitotano
    - Hierba de San Juan (Hypericum perforatum)
    4.Mujeres embarazadas o en período de lactancia.
    5.ALT y / o AST ≥ 4 veces el límite superior de normalidad (LSN) en el screening.
    6.Hemoglobina <7,5 g / dL en el screening
    E.5 End points
    E.5.1Primary end point(s)
    - To calculate the hemodialysis extraction ratio for doravirine in HIV-infected participants with ESRD
    Calcular la tasa de extracción de hemodiálisis de doravirina en participantes con VIH e insuficiencia renal crónica terminal
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 6
    Dia 6
    E.5.2Secondary end point(s)
    • Adverse events grade 3-4 related to doravirine
    • Doravirine concentrations in plasma at the beginning and at the end of a dialysis session
    - Eventos adversos de grado 3-4 relacionados con la doravirina

    - Concentraciones de doravirina en plasma al inicio y final de la sesión de diálisis
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Day 6
    - Día 6
    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 No
    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 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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    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
    Ultima visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    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: 8
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 8
    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 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    HIV-infected participants
    Pacientes con VIH
    F.4 Planned number of subjects to be included
    F.4.1In the member state8
    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 Decision2021-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-01-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-14
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