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    Summary
    EudraCT Number:2019-000812-27
    Sponsor's Protocol Code Number:055
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-19
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-000812-27
    A.3Full title of the trial
    Initiation of first-line antiretroviral treatment with TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the first clinical contact in France: Trial IMEA 055 – FAST
    Instauration immédiate, dès le 1er contact médical, d’un traitement antirétroviral par TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR : ESSAI IMEA 055 - FAST
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Initiation of first-line antiretroviral treatment with TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR at the first clinical contact in France: Trial IMEA 055 – FAST
    Instauration immédiate, dès le 1er contact médical, d’un traitement antirétroviral par TENOFOVIR ALAFENAMIDE - EMTRICITABINE - BICTEGRAVIR : ESSAI IMEA 055 - FAST
    A.3.2Name or abbreviated title of the trial where available
    FAST
    A.4.1Sponsor's protocol code number055
    A.5.4Other Identifiers
    Name:RCBNumber:2019-A00390-57
    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 SponsorIMEA
    B.1.3.4CountryFrance
    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 supportIMEA
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIMEA
    B.5.2Functional name of contact pointBENALYCHERIF
    B.5.3 Address:
    B.5.3.1Street AddressHôpital Bichat Claude Bernard-46 rue Henri Huchard
    B.5.3.2Town/ cityPARIS
    B.5.3.3Post code75018
    B.5.3.4CountryFrance
    B.5.4Telephone number33140256365
    B.5.5Fax number33140256356
    B.5.6E-mailaida.benalycherif@gmail.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 BIKTARVY
    D.2.1.1.2Name of the Marketing Authorisation holderEU/1/18/1289/001
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    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 positive
    age > 18 years
    - newly diagnosed HIV-infected individual evidenced by any tests
    - antiretroviral-treatment naive
    - negative urine pregnancy test
    - willing to sign an informed written consent–
    - regular health insurance
    - willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between Day 0 and Day 7
    E.1.1.1Medical condition in easily understood language
    - adult patients (>18 years )newly diagnosed HIV-infected, antiretroviral-treatment naive ,- no pregnancy and compliant
    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 achieve virological suppression (plasma HIV-RNA < 50 copies/ml) at Week 24 on study treatment with a first-line treatment with TAF / FTC/ BIC initiated at the first clinical contact (Snapshot method)
    E.2.2Secondary objectives of the trial
    proportion of participants with a false positive HIV screening test
    proportion of participants with plasma HIV-RNA < 50 copies/ml
    change in CD4 T cell count, change in CD4/CD8 ratio
    proportion of participants requiring discontinuation/modification of TAF/FTC/Bictegravir
    proportion of participants experiencing a grade 3-4 adverse event
    proportion of participants with protocol defined virological failure
    proportion of participants harboring a virus developing resistance-associated mutations
    number and type of comedications used during the 48-week study period
    adherence to study treatment evaluated by self-assessed auto-questionnaires drug concentrations measurement in plasma and in hair,
    proportion of participants lost to follow-up throughout the 48-week study period
    - participants' acceptability of immediate cART initiation (self-assessed auto-questionnaires at visit D0, Week 12, Week 24 and Week 48)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - age > 18 years
    - newly diagnosed HIV-infected individual evidenced by any of the following tests: (i) positive self-test, (ii) positive HIV Rapid antibody test, (iii) positive HIV immunoassay (ELISA 4th generation) test
    - antiretroviral-treatment naive
    - negative urine pregnancy test for women of childbearing potential and willing to use effective contraception (mechanical or medicamental)
    - willing to sign an informed written consent–
    - regular health insurance
    - willing to provide two distinct contact information (telephone number and/or email) in order to be easily reached if needed between Day 0 and Day 7
    E.4Principal exclusion criteria
    - clinical symptoms suggestive of opportunistic infections
    - participant not willing to provide two distinct contact information
    - a woman who is pregnant or breast-feeding or planning to become pregnant during the expected study period.
    - Co-medication with deleterious interaction with study treatment (eg enzyme inducer)
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants with plasma RNA-HIV < 50 copies/mL at week 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    - proportion of participants with a false positive HIV screening test (i.e. a first positive test that has not been confirmed)
    - proportion of participants with plasma HIV-RNA < 50 copies/ml at Week 4, Week, 12, Week 24, Week 36, Week 48
    - change in CD4 T cell count between Baseline and Weeks 12, 24, 48
    - change in CD4/CD8 ratio between Baseline, W24 and Week 48
    - proportion of participants requiring discontinuation/modification of TAF/FTC/Bictegravir due to (i) Baseline resistance to one of the study drugs, (ii) adverse events leading to study treatment discontinuation/Modification
    - proportion of participants experiencing a grade 3-4 adverse event (related or not related to study treatment)
    - proportion of participants with protocol defined virological failure (plasma HIV-RNA > 400 copies/ml at Week 12 confirmed on a second sample drawn 15-21 days later, or two consecutive plasma HIV-RNA > 50 copies/ml within 15-21 days as of Week 24)
    - proportion of participants harboring a virus developing resistance-associated mutations at the time of protocol-defined virological failure
    - number and type of comedications used during the 48-week study period
    - adherence to study treatment evaluated by (i) self-assessed auto-questionnaires (4-day recall), (ii) drug concentrations measurement in plasma and in hair,
    - proportion of participants lost to follow-up throughout the 48-week study period (LFU = having missed more than two consecutive visits except for W24 and W48 visit)
    - participants' acceptability of immediate cART initiation (self-assessed auto-questionnaires at visit D0, Week 12, Week 24 and Week 48)
    E.5.2.1Timepoint(s) of evaluation of this end point
    D0,W12,W24 and W48
    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 Yes
    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 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 concerned18
    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 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
    Last visit of the last subject
    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 months24
    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: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state110
    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
    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 Decision2019-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-09
    P. End of Trial
    P.End of Trial StatusOngoing
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