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    Summary
    EudraCT Number:2021-002565-17
    Sponsor's Protocol Code Number:WODDOL
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-10-18
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2021-002565-17
    A.3Full title of the trial
    Multi-center study to evaluate virological efficacy, safety tolerability, drug exposure and patients’ reported outcomes over 48 weeks following randomization to 2-drug therapy with DTG/3TC FDC or continuing current antiretroviral tenofovir (TAF or TDF)-containing regimen (T-CR) in HIV-1 infected virologically suppressed women
    Studio multicentrico che mira a valutare l'efficacia virologica, la tollerabilità di sicurezza, l'esposizione al farmaco e gli outcomes riportati dai pazienti nelle 48 settimane che seguono la randomizzazione alla terapia a 2 farmaci con DTG/3TC FDC o alla prosecuzione del regime in corso (T- CR) contenente l’antiretrovirale tenofovir (TAF o TDF) in donne infette da HIV-1 virologicamente soppresse
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate virological efficacy, safety tolerability of the to 2-drug therapy with DTG/3TC FDC or the antiretroviral tenofovir (TAF or TDF) -containing regimen (T-CR) in HIV-1 infected virologically suppressed women
    Studio che mira a valutare l'efficacia virologica, la tollerabilità di sicurezza della terapia a 2 farmaci con DTG/3TC FDC o della prosecuzione del regime in corso con l’antiretrovirale tenofovir (TAF o TDF) in donne infette da HIV-1 virologicamente soppresse
    A.3.2Name or abbreviated title of the trial where available
    Multi-center study to evaluate virological efficacy, safety tolerability, drug exposure and patients
    Studio multicentrico che mira a valutare l'efficacia virologica, la tollerabilità di sicurezza, l'es
    A.4.1Sponsor's protocol code numberWODDOL
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    B.1.3.4CountryItaly
    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 supportviiv healthcare
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology
    B.5.2Functional name of contact pointInformazione sulla Sperimentazione
    B.5.3 Address:
    B.5.3.1Street AddressVia San Leonardo trav Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number089301545
    B.5.5Fax number0897724155
    B.5.6E-mailwoddol@cr-technology.com
    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 DOVATO - 50 MG / 300 MG - COMPRESSA RIVESTITA CON FILM - USO ORALE - FLACONE (HDPE) - 30 COMPRESSE
    D.2.1.1.2Name of the Marketing Authorisation holderVIIV HEALTHCARE BV
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameDolutegravir (DTG) - lamivudine (3TC)
    D.3.2Product code [DTG/3TC]
    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 INNDOLUTEGRAVIR
    D.3.9.2Current sponsor codeDTG
    D.3.9.3Other descriptive namedolutegravir (DTG)
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLAMIVUDINA
    D.3.9.2Current sponsor code3TC
    D.3.9.3Other descriptive namelamivudine (3TC)
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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-infected adult women of >18 years of age, without previous virologic failure, currently receiving an effective (HIV-RNA < 50 copies/ml) triple-drug cART, containing tenofovir (TAF or TDF) in the regimen
    Donne adulte con infezione da HIV-1 di età> 18 anni, senza precedente fallimento virologico, che attualmente ricevono una terapia cART a tre farmaci efficace (HIV-RNA <50 copie/ml), con tenofovir (TAF o TDF) nel regime
    E.1.1.1Medical condition in easily understood language
    Women who are virologically suppressed without previous virological failure currently receiving tenofovir (TAF or TDF) in the regimen
    Donne con soppressione virologica in assenza di precedente fallimento virologico che attualmente ricevono una terapia con tenofovir (TAF o TDF) nel regime
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10021428
    E.1.2Term Immune system disorders
    E.1.2System Organ Class 10021428 - Immune system disorders
    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 efficacy of switching to a two-drug one-pill regimen with DTG/3TC compared to maintaining the three-drugs regimen in women currently receiving any three-drug regimen containing Tenovofir (TAF or TDF) (e.g. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) who are virologically suppressed. Primary analysis will be performed after 48 weeks on the ITT population, according to the FDA snapshot algorithm
    Valutare l'efficacia dello switching ad un regime di una pillola combinata a due farmaci con DTG / 3TC rispetto al mantenimento del regime a tre farmaci nelle donne che attualmente ricevono un regime a tre farmaci contenente Tenovofir (TAF o TDF) (ad esempio TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) con soppressione virologica. L'analisi primaria verrà eseguita dopo 48 settimane sulla popolazione ITT, secondo l'algoritmo snapshot della FDA
    E.2.2Secondary objectives of the trial
    A) Safety
    B) Patient reported outcomes (PRO)
    C) Pharmacokinetics
    D) Virological paramethers
    E) Immunological paramethers:
    F) Viral Resistance
    G) Drug interaction benefit
    H) On a subset of participant (25 per arm) a substudy on cervico-vaginal shedding of HIV-RNA and inflammation markers will be performed in order to identify the different risk of viral genital shedding in the two arms
    A) Sicurezza
    B) Outcomes riportati dai pazienti (PRO)
    C) Farmacocinetica
    D) Parametri Virologici:
    E) Parametri immunologici:
    F) Resistenza virale
    G) Benificio dell’interazione tra farmaci
    H) Su un sottogruppo di partecipanti (25 per braccio) un sotto-studio cervico-vaginale relativo allo spargimento dell'HIV-RNA e dei markers di infiammazione verrà eseguito per identificare il diverso rischio di diffusione virale genitale nei due bracci
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: On a subset of participant (about 25 per arm) an optional substudy on cervico-vaginal shedding of HIV-RNA and inflammation markers will be performed in order to identify the different risk of viral genital shedding in the two arms

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Su un sottogruppo di partecipanti (25 per braccio) verrà eseguito un sottostudio sulla diffusione cervico-vaginale di HIV-RNA e sui marcatori di infiammazione al fine di identificare il diverso rischio di spargimento virale genitale nei due bracci
    E.3Principal inclusion criteria
    Major inclusion criteria:
    · Female individuals
    · HIV-1 documented infection
    · Age > 18 years
    · Being on an effective (pVL < 50 copies/ml) three-drug cART regimen containing tenofovir (TAF or TDF) (e.g. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TDF/F/PI/c; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) for at least 3 months before the screening. Two consecutive HIV-1 RNA determinations below the determination threshold before enrollment are required
    · No known allergy or intolerance to NRTIs, NNRTIs or INSTIs
    · Women of childbearing potential will be required to adopt an effective birth control system throughout the study period
    · Subjects able to comply with the protocol requirements
    · Informed consent signed
    Principali Criteri di inclusione:
    • Donne
    • Infezione documentata da HIV-1
    • Età > 18 anni
    • Essere in regime efficace di cART (pVL <50 copie/ml) a tre farmaci contenente tenofovir (TAF o TDF) (ad es. TAF/F/E/C; TAF/F/RPV; TDF/F/RPV; TAF/F+PI/C; TDF/F/PI/c; TAF/F+PI/r; TDF/F/PI/r; TAF/F+DTG; TDF/F/DTG; TAF/F+RTG; TDF/F/RTG; TAF/F/BIC) da almeno tre mesi prima dello screening. Sono necessarie due accertamenti consecutivi di HIV-1 RNA al di sotto della soglia di determinazione prima dell'arruolamento
    • Nessuna allergia o intolleranza nota a NRTIs, NNRTIs or INSTIs
    • Alle donne in età fertile sarà richiesto di adottare un efficace sistema di controllo delle nascite durante il periodo di studio
    • Soggetti in grado di soddisfare le richieste del protocollo
    • Firma del consenso informato
    E.4Principal exclusion criteria
    Major exclusion criteria:
    · Having failed virologically any previous ART regimen
    · Evidence of any 3TC (presence of M184V/I or K65R/E/N) or INSTI resistance
    · Having ever been treated with mono or dual ARV therapies subsequently intensified to three-drug cART regimen
    · Pregnancy or breast-feeding or not willing to use effective contraception if they are of child-bearing potential
    · An active malignancy or OI requiring active treatment (prophylactic regimens are allowed)
    · HBV infection
    · A life expectancy < 2 years
    Principali Criteri di esclusione:
    • Avere fallito virologicamente qualsiasi precedente regime ART
    • Prova di qualsiasi resistenza a 3TC (presenza di M184V/I o K65R/E/N) o INSTI
    • Non essere mai stato trattato con terapie ARV mono o duali successivamente intensificate con il regime cART a tre farmaci
    • Gravidanza o allattamento o mancanza di volontà ad utilizzare un metodo contraccettivo efficace se in età fertile
    • Un tumore maligno attivo o OI che richiedono un trattamento attivo (i regimi profilattici sono consentiti)
    • Infezione da HBV
    • Un'aspettativa di vita <2 anni
    E.5 End points
    E.5.1Primary end point(s)
    1. Proportion of patients maintaining a HIV-RNA < 50 copies/ml according to FDA snapshot algorithm at 48 weeks according to an ITT NC = failure approach in which all randomized patients will be included and considered failures independently of the reason they did not complete the follow-up. The sample size has been calculated on this end-point according to a non-inferiority design.
    2. At 48 weeks, a secondary analysis will be performed according a per protocol (PP) approach. In this case only patients fulfilling protocol-defined timeline and continuing to take the randomized therapy will be considered
    1. Proporzione di pazienti che mantengono un HIV-RNA <50 copie/ml secondo l'algoritmo snapshot della FDA a 48 settimane in accordo ad un approccio ITT NC = fallimento in cui tutti i pazienti randomizzati saranno inclusi e considerati fallimenti indipendentemente dal motivo per cui non hanno completato il follow-up. La dimensione del campione è stata calcolata sulla base di questo endpoint seguendo un disegno di non inferiorità.
    2. A 48 settimane, verrà eseguita un'analisi secondaria secondo un approccio per protocollo (PP). In questo caso saranno presi in considerazione solo i pazienti che soddisfano le tempistiche definite dal protocollo e che continuano a seguire la terapia randomizzata
    E.5.1.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 settimane
    E.5.2Secondary end point(s)
    1. Change in protein-creatinine ratio (PCR), at baseline and at week 48
    2. Change in fasting lipids parameters (TC, LDL, HDL, TC/HDL), at baseline and at week 48. A descriptive analysis of all reported AEs and a quantitative analysis of AEs leading to treatment interruption/change will be used to evaluate long-term tolerability of the simplification treatment
    3. Change in metabolic parameters: 1) HOMA-IR; 2) BMI; 3) metabolic syndrome (according to International Diabetes Federation definition) at baseline, at week 24 and week 48.
    4. Change of self-reported adherence level and proportion of patients with different adherence level (95%; 90%; 80%) at baseline and at week 48.
    5. Change in QoL (HIVDQOL) and PROs items from baseline to week 48 by standardized validate self-reported questionnaires: treatment satisfaction [HIVTSQ], Health Status [EQ-5D-5L], adherence [ACTG modified questionnaire], symptoms [HIVSRQ], wellbeing [W-BQ16]
    6. Change in neuropsychiatric questionnaire assessment on different items: a) anxiety (Beck Anxiety Inventory); b) depression (Beck Depression Inventory); c) other psychiatric symptoms (SCID, module B); d) sleep quality (Pittsburgh sleep quality index PSQI); e) suicidality risk (C-SSRS)
    7. 3TC and DTG plasma concentrations (Cthrough)
    8. Change in CD4+ and CD8+ T-lymphocyte count (absolute and percentage), and in CD4+/CD8+ ratio in the peripheral blood from baseline and week 48
    9. Change in markers of inflammation and immune activation
    10. Percentage of subjects with HIV-1 RNA <2.5 copies/mL at week 48 by ultrasensitive assay
    11. Change in total viral HIV-1 DNA in peripheral blood mononuclear cells (PBMCs) at baseline and at week 48
    12. Change in viral shedding in vaginal swab at baseline and at week 48
    13. Change in inflammatory cytokine in vaginal swab at baseline and at week 48
    14. Proportion of patients developing resistance-conferring mutations (to NRTI, NNRTI or INSTI drug class) will be cumulatively described throughout the study period
    15. Drug interaction benefit: evaluation of the improvement for the drug interaction potential when switching from any antiretroviral regimen to dolutegravir and lamivudine
    1 Modifica del rapporto proteina-creatinina (PCR), al basale e alla settimana 48
    2 Modifica dei parametri dei lipidi a digiuno (TC, LDL, HDL, TC/HDL), al basale e alla settimana 48. Per valutare la tollerabilità a lungo termine del trattamento di semplificazione sarà utilizzata un'analisi descrittiva di tutti gli eventi avversi riportati e un'analisi quantitativa degli eventi avversi che conducono all'interruzione/modifica del trattamento
    3 Modifica dei parametri metabolici: 1) HOMA-IR; 2) BMI; 3) sindrome metabolica (secondo la definizione dell'International Diabetes Federation) al basale, alla settimana 24 e alla settimana 48.
    4 Modifica del livello di aderenza auto-riferito e percentuale di pazienti con diversi livelli di aderenza (95%; 90%; 80%) al basale e alla settimana 48
    5 Modifica degli items QoL (HIVDQOL) e PRO dal basale alla settimana 48 mediante questionari standardizzati di convalida auto-riferiti: soddisfazione del trattamento [HIVTSQ], stato di salute [EQ-5D-5L], aderenza [questionario modificato ACTG], sintomi [HIVSRQ], benessere [W-BQ16]
    6 Cambiamento nella valutazione del questionario neuropsichiatrico su diversi items: a) ansia (Beck Anxiety Inventory); b) depressione (Beck Depression Inventory); c) altri sintomi psichiatrici (SCID, modulo B); d) qualità del sonno (indice di qualità del sonno di Pittsburgh PSQI); e) rischio di suicidio (C-SSRS)
    7 Concentrazione plasmatica (Cthrough) di 3TC e DTG
    8 Variazione della conta dei linfociti T CD4+ e CD8+ (assoluta e percentuale) e del rapporto CD4+/CD8+ nel sangue periferico rispetto al basale e alla settimana 48
    9 Cambiamento nei marker di infiammazione e attivazione immunitaria
    10 Percentuale di soggetti con HIV-1 RNA <2,5 copie/mL alla settimana 48 mediante test ultrasensibile
    11 Variazione del HIV-1 DNA virale totale nelle cellule mononucleate del sangue periferico (PBMC) al basale e alla settimana 48
    12 Variazione della diffusione virale nel tampone vaginale al basale e alla settimana 48
    13 Variazione delle citochine infiammatorie nel tampone vaginale al basale e alla settimana 48
    14 La proporzione di pazienti che sviluppano mutazioni conferenti resistenza (alla classe di farmaci NRTI, NNRTI o INSTI) sarà descritta cumulativamente durante il periodo di studio
    15 Beneficio dell'interazione farmacologica: valutazione del miglioramento del potenziale di interazione farmacologica quando si passa da qualsiasi regime antiretrovirale a dolutegravir e lamivudina
    E.5.2.1Timepoint(s) of evaluation of this end point
    48 weeks
    48 settimane
    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 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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.2.3.1Comparator description
    Prosecuzione di un regime standard contenente Tenofovir
    Continuing a Tenofovir standard regimen
    E.8.2.4Number of treatment arms in the trial2
    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 concerned20
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 state290
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 290
    F.4.2.2In the whole clinical trial 290
    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)
    Continuation with DTG / 3TC therapy, if clinically indicated
    Continuazione con terapia DTG/3TC, se indicato clinicamente
    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 Decision2021-09-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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