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    Summary
    EudraCT Number:2016-001371-69
    Sponsor's Protocol Code Number:EVITAs
    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:2016-08-05
    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 number2016-001371-69
    A.3Full title of the trial
    Tenofovir DP concentrations in seminal cells and semen quality in HIV-1 infected patients receiving a TAF containing regimen
    Concentraciones de Tenofovir DP en células seminales y calidad del semen en pacientes infectados por el virus VIH-1 que reciben un régimen que contenga TAF
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Tenofovir DP concentrations in seminal cells and semen quality in HIV-1 infected patients receiving a TAF containing regimen
    Concentraciones de Tenofovir DP en células seminales y calidad del semen en pacientes infectados por el virus VIH-1 que reciben un régimen que contenga TAF
    A.4.1Sponsor's protocol code numberEVITAs
    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 supportGilead Sciences S.L.
    B.4.2CountryUnited States
    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 pointDr. Daniel Podzamczer
    B.5.3 Address:
    B.5.3.1Street AddressHospital Universitari de Bellvitge. HIV Unit. c/ Feixa Llarga, s/n
    B.5.3.2Town/ cityHospitalet de Llobregat - Barcelona
    B.5.3.3Post code08907
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493260736672884
    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 Yes
    D.2.1.1.1Trade name Genvoya
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd.
    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 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 INNELVITEGRAVIR
    D.3.9.1CAS number 697761-98-1
    D.3.9.3Other descriptive nameELVITEGRAVIR
    D.3.9.4EV Substance CodeSUB69759
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCOBICISTAT
    D.3.9.1CAS number 1004316-88-4
    D.3.9.4EV Substance CodeSUB33760
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.4EV Substance CodeSUB01882MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTENOFOVIR ALAFENAMIDE
    D.3.9.1CAS number 379270-37-8
    D.3.9.4EV Substance CodeSUB121761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 positive patients
    Pacientes VIH-1 positivos
    E.1.1.1Medical condition in easily understood language
    HIV-1 positive patients
    Pacientes VIH-1 positivos
    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
    To evaluate intracellular concentrations of tenofovir diphosphate (TFV-DP) in seminal mononuclear (SMC) cells of HIV-1 infected men receiving ART with TAF/FTC/EVG/COBI.
    Evaluar las concentraciones intracelulares de tenofovir difosfato (TFV-DP) in células seminales mononucleares (SMC) de varones infectados por el virus del VIH-1 que reciben un régimen antiretroviral con TAF/FTC/EVG/COBI
    E.2.2Secondary objectives of the trial
    - To evaluate TFV concentrations in seminal plasma (SP) of HIV-1 infected men receiving ART with TAF/FTC/EVG/COBI.
    - To evaluate intracellular TFV-DP exposure in peripheral blood mononuclear cells (PBMC) and extracellular TFV exposure in blood plasma (BP) and to compare with drug exposure in SMC and SP.
    - To compare TFV-DP and TFV concentrations in SMC and SP, respectively, at baseline and after switching
    - To compare TFV-DP and TFV concentrations in PBMC and BP, respectively, at baselineTDF/FTC/EVG/COBI) and after switching
    - To evaluate HIV-1 RNA suppression in SP after switching ART .
    - To compare HIV-1 suppression in BP and SP at baseline and after switching
    - To evaluate changes in semen quality after switching ART
    -Evaluar las concentraciones de TFV en plasma seminal (SP) en pacientes infectados por el virus del VIH-1 que reciben un régimen antiretroviral con TAF/FTC/EVG/COBI.
    -Evaluar la exposición intracelular de TFV-DP en células mononucleares de sangre periférica (PBMC) y la exposición extracelular de TFV en plasma sanguíneo (BP) y compararlos con ls exposición del fármaco en SMC y SP.
    -Comparar las concentraciones de TFV-DP y TFV en SMC y SP, respectivamente, en la visita basal y después del cambio -Comparar las concentraciones de TFV-DP y TFV en PBMC y BP respectivamente, en la visita basal y después del cambio
    -Evaluar la supresión del RNA del HIV-1 en SP después de cambiar el régimen antiretroviral de TDF/FTC/EVG/COBI a TAF/FTC/EVG/COBI.
    -Comparar la supresión del VIH-1 en BP y SP en la visita basal y depués del cambio
    -Evaluar los cambios en la calidad del semen después del cambio del régimen antiretroviral
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. HIV-1 infected men ≥ 18 years of age.
    2. Be on a stable ART consisting on TDF/FTC/EVG/COBI continously for ≥ 3 month preceeding the screening visit.
    3. HIV-1 RNA VL<40 c/mL for at least 6 months before switching to TDF/FTC/EVG/COBI and 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 throught the duration of the study.
    1. Hombres infectados por el VIH-1 ≥ 18 años de edad
    2. Estar con un régimen antirretroviral estable consistente de TDF/FTC/EVG/COBI de forma continua ≥ 3 meses anteriores a la visita de screening
    3. Carga viral del HIV-1 RNA VL<40 copias/mL al menos durante los 6 meses antes de cambiar a TDF/FTC/EVG/COBI y en la visita de Screening.
    4. Consentimiento informado firmado y fechado previamente a la inclusión del paciente en el estudio.
    5. Los pacientes han de utilizar un método anticonceptivo eficaz durante sus relaciones heterosexuales desde la visita del screening y durante toda la duración del estudio
    E.4Principal exclusion criteria
    1. Ongoing malignancy.
    2. Active opportunistic infection.
    3. Primary resistance to any of the ARV included in the study (genotypes without evidence of tenofovir (K65R, 3 or more TAMs including M41L, L210W), FTC (M184V/I), and EVG-associated mutations) or history of virologic failure with risk of resistance selection to any of the study drugs.
    4. Chronic HBV hepatitis.
    5. Any verified Grade 4 laboratory abnormality.
    6. ALT or AST ≥ 3xULN and/or bilirubin ≥ 1.5xULN.
    7. Severe renal impairment (Estimated creatinine clearance <50mL/min).
    8. Severe hepatic impairment (Child-Pugh Class C).
    1. Neoplasia maligna en curso.
    2. Enfermedad oportunista activa.
    3. Resistencia primaria a cualquiera de los fármacos antirretrovirales incluídos en el estudio (genotipos sin evidencia de mutaciones a tenofovir (K65R, 3 o más mutaciones a análogos de la timidina (TAMs) incluyendo M41L, L210W), FTC (M184V/I), y mutaciones asociadas a EVG o historial de fallo virológico con riesgo de resistencia selectiva a cualquiera de los fármacos del estudio.
    4. Hepatitis VHB crónica.
    5. Cualquier anormalidad de laboratorio de Grado 4 verificada
    6. ALT o AST ≥ 3xLSN y/o bilirubina ≥ 1.5xLSN.
    7. Insuficiencia renal severa (Aclaramiento estimado de creatinina <50mL/min).
    8. Insuficiencia hepática severa (Child-Pugh Clase C)
    E.5 End points
    E.5.1Primary end point(s)
    TFV-DP concentrations (ng/mL) in SMC 12 weeks after switching to TAF/FTC/EVG/COBI.
    Concentraciones de TFV-DP (ng/mL) en células seminales mononucleares (SMC) 12 semanas después de cambiar a TAF/FTC/EVG/COBI.
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after switching to TAF/FTC/EVG/COBI.
    12 semanas después de cambiar a TAF/FTC/EVG/COBI.
    E.5.2Secondary end point(s)
    - TFV concentrations (ng/mL) in SP 12 weeks after switching to TAF/FTC/EVG/COBI.
    - TFV-DP concentrations (ng/mL) in PBMC 12 weeks after switching to TAF/FTC/EVG/COBI.
    - TFV concentrations (ng/mL) in BP 12 weeks after switching to TAF/FTC/EVG/COBI.
    TFV and TFV-DP concentrations (ng/mL) in SP and SMC and BP nad PBMC, respectively, at baseline (whilst on TDF/FTC/EVG/COBI).
    - HIV-1 RNA in SP and BP at baseline (whilst on TDF/FTC/EVG/COBI) and12 weeks after switching to TAF/FTC/EVG/COBI.
    - Sperm quality evaluated according to World Health Organization (WHO) guidelines before and 12 weeks after switiching TAF/FTC/EVG/COBI.
    - Concentraciones de TFV (ng/mL) en plasma seminal (SP) 12 semanas después de cambiar a TAF/FTC/EVG/COBI.
    - Concentraciones de TFV-DP (ng/mL) en células mononucleares de sangre periférica (PBMC) 12 semanas después de cambiar a TAF/FTC/EVG/COBI.
    - Concentraciones de TFV (ng/mL) in plasma sanguíneo (BP) 12 semanas después de cambiar a TAF/FTC/EVG/COBI.
    - Concentrraciones de TFV y TFV-DP (ng/mL) en SP y seminal mononuclear cells (SMC) y BP y PBMC, respectivamente, en la visita basal (mientras el paciente esté con TDF/FTC/EVG/COBI).
    - RNA del HIV-1 en SP y BP en la visita basal (mientras el paciente esté con TDF/FTC/EVG/COBI) y 12 semanas después de cambiar a TAF/FTC/EVG/COBI.
    - Calidad del esperma evaluada conforme a las guías de la Orgamización Mundial de la Salud (OMS) antes y 12 semanas después del cambio a TAF/FTC/EVG/COBI.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Basal and 12 weeks after switching to TAF/FTC/EVG/COBI
    Basal y 12 semanas después del cambio a TAF/FTC/EVG/COBI
    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 No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    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 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
    Última Visita del 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 months7
    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: 15
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    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 state15
    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)
    At the end of the study, study participants will be offered to continue taking the same ARV regimen.
    Al finalizar el estudio se les ofrecerá a los pacientes la posibilidad de seguir tomando el mismo régimen antrirretroviral.
    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 Decision2016-09-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-10-19
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