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    Summary
    EudraCT Number:2018-003921-27
    Sponsor's Protocol Code Number:DORAGEN
    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:2019-04-12
    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 number2018-003921-27
    A.3Full title of the trial
    Doravirine concentrations and antiviral activity in genital fluids in HIV-1 infected individuals.
    Concentraciones de doravirina y actividad antiviral en fluidos genitales en individuos infectados con VIH-1.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Doravirine concentrations and antiviral activity in genital fluids in HIV-1 infected individuals.
    Concentraciones de doravirina y actividad antiviral en fluidos genitales en individuos infectados con VIH-1.
    A.3.2Name or abbreviated title of the trial where available
    DORAGEN
    DORAGEN
    A.4.1Sponsor's protocol code numberDORAGEN
    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 SponsorLluita contra la SIDA Foundation
    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 supportLluita contra la SIDA Foundation in collaboration with Merck Sharp & DOme
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHospital Universitari de Bellvitge
    B.5.2Functional name of contact pointDaniel Podzamczer
    B.5.3 Address:
    B.5.3.1Street AddressC/Feixa Llarga s/n
    B.5.3.2Town/ cityHospitalet de Llobregat
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number+34932607667
    B.5.5Fax number+34932607669
    B.5.6E-maildpodzamczer@bellvitgehospital.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 No
    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 nameDORAVIRINE
    D.3.2Product code MK-1439
    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.3.9.1CAS 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.3.11 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 Yes
    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 infected individuals
    Individuos infectados por VIH
    E.1.1.1Medical condition in easily understood language
    HIV infected individuals
    Individuos infectados por VIH
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine Doravirine concentrations in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving ART with Doravirine plus TAF/FTC.
    Determinar las concentraciones de doravirina en plasma seminal y líquido cervicovaginal en individuos y mujeres infectados con VIH-1 que reciben TAR con Doravirina más TAF / FTC.
    E.2.2Secondary objectives of the trial
    Evaluate HIV-1 viral load in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals receiving ART with Doravirine plus TAF/FTC.
    Evaluar la carga viral de VIH-1 en plasma seminal y líquido cervicovaginal en individuos y mujeres infectados con VIH-1 que reciben TAR con Doravirine más TAF / FTC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Asymptomatic, HIV-1 infected individuals ≥ 18 years of age.
    2. Be on a stable ART consisting of TAF/FTC, tenofovir disoproxil fumarate/emtricitabine or abacavir/lamivudina, plus an non-nucleoside reverse transcriptase inhibitor, a boosted protease inhibitor or an integrase inhibitor, continously for at least 3 consecutive months preceding the screening visit.
    3. Plasma HIV-1 RNA <40 copies/mL for at least 6 months at the Screening visit.
    4. Signed and dated written informed consent prior to inclusion.
    5. Subjects must agree to utilize a highly effective* method of contraception during heterosexual intercourse from the screening visit throughout the duration of the study
    (*) Highly effective methods of contraception as defined by the Clinical Trial Facilitation Group (CTFG) (“Recommendations related to contraception and pregnancy testing in clinical trials”, version 15/09/2014): 1. Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal); 2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable); 3. Intrauterine device (IUD); 4. Intrauterine hormone-releasing system (IUS); 5. Bilateral tubal occlusion; 6. Vasectomised partner; 7. Sexual abstinence.
    1. Asintomáticos, individuos infectados por VIH-1 ≥ 18 años de edad.
    2. Estar en tratamiento estable con TAF / FTC, tenofovir disoproxil fumarato / emtricitabina o abacavir / lamivudina, más un inhibidor no nucleosídico de la transcriptasa inversa, un inhibidor de la proteasa reforzado o un inhibidor de la integrasa, de manera continua durante al menos 3 meses consecutivos antes del visita de selección
    3. ARN del VIH-1 en plasma <40 copias / ml durante al menos 6 meses en la visita de selección.
    4. Consentimiento informado por escrito firmado y fechado antes de la inclusión.
    5. Los sujetos deben acordar utilizar un método anticonceptivo altamente efectivo * durante las relaciones sexuales heterosexuales de la visita de selección durante todo el estudio.
    (*) Métodos anticonceptivos altamente efectivos, según lo define el Grupo de Facilitación de Ensayos Clínicos (CTFG, por sus siglas en inglés) (“Recomendaciones relacionadas con la anticoncepción y las pruebas de embarazo en ensayos clínicos”, versión 15/09/2014): 1. Combinada (contiene estrógeno y progestágeno) anticoncepción hormonal asociada con la inhibición de la ovulación (oral, intravaginal, transdérmica); 2. Anticoncepción hormonal de progestágeno solo asociada con la inhibición de la ovulación (oral, inyectable, implantable); 3. Dispositivo intrauterino (DIU); 4. Sistema de liberación de hormona intrauterina (SIU); 5. Oclusión tubárica bilateral; 6. Socio vasectomizado; 7. La abstinencia sexual.
    E.4Principal exclusion criteria
    1. Severe hepatic impairment (Child-Pugh Class C)
    2. Ongoing malignancy
    3. Active opportunistic infection
    4. Primary resistance to any of the ARV included in the study or history of virologic failure with risk of resistance selection to any of the study drugs.
    5. Any verified Grade 4 laboratory abnormality
    6. ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN
    7. Severe renal impairment (Estimated creatinine filtration rate <50mL/min).
    8. Females who are pregnant (as confirmed by positive serum pregnancy test) or breastfeeding.
    1. Insuficiencia hepática grave (clase C de Child-Pugh)
    2. malignidad en curso
    3. Infección oportunista activa.
    4. Resistencia primaria a cualquiera de los ARV incluidos en el estudio o historial de falla virológica con riesgo de selección de resistencia a cualquiera de los fármacos del estudio.
    5. Cualquier anormalidad verificada de laboratorio de Grado 4
    6. ALT o AST ≥ 3xULN y / o bilirrubina ≥ 1.5xULN
    7. Insuficiencia renal grave (tasa de filtración de creatinina estimada <50 ml / min).
    8. Mujeres embarazadas (según lo confirmado por una prueba de embarazo con suero positiva) o amamantando.
    E.5 End points
    E.5.1Primary end point(s)
    - Concentration of Doravirine in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals, respectively, 8 weeks after switching to Doravirine plus TAF/FTC.
    -HIV-1 RNA in seminal plasma and cervicovaginal fluid in HIV-1 infected male and female individuals, respectively, 8 weeks after switching to Doravirine plus TAF/FTC.
    Concentración de Doravirina en plasma seminal y líquido cervicovaginal en individuos masculinos y femeninos infectados con VIH-1, respectivamente, 8 semanas después de cambiar a Doravirina más TAF / FTC.
    - ARN del VIH-1 en plasma seminal y líquido cervicovaginal en individuos masculinos y femeninos infectados con VIH-1, respectivamente, 8 semanas después de cambiar a Doravirina más TAF / FTC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 semanas
    E.5.2Secondary end point(s)
    Secondary endpoints have not been established
    no se han establecido variables secundarias
    E.5.2.1Timepoint(s) of evaluation of this end point
    not applicable
    no aplica
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    prevention
    prevenció
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    E.8.1.7.1Other trial design description
    unicéntrico
    unicenter
    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 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 ultimo 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 months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months4
    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: 30
    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 state30
    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 investigator will provide appropriate medical care both at the end of the study and in the event of premature discontinuation of the study.
    El investigador proporcionará el cuidado médico apropiado tanto al final del estudio como ante la discontinuacion prematura del mismo
    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 Decision2019-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-06
    P. End of Trial
    P.End of Trial StatusOngoing
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