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    Summary
    EudraCT Number:2017-003428-61
    Sponsor's Protocol Code Number:GS-US-380-4449
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-05-25
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-003428-61
    A.3Full title of the trial
    A Phase 3b, Multicenter, Open-Label Study to Evaluate Switching from an Elvitegravir/ Cobicistat/ Emtricitabine/Tenofovir Alafenamide Fixed-Dose Combination Regimen or a Tenofovir Disoproxil Fumarate Containing Regimen to Fixed-Dose Combination of Bictegravir/ Emtricitabine/Tenofovir Alafenamide in Elderly, Virologically- Suppressed, HIV-1 Infected Subjects Aged = 65 Years
    Studio di fase 3b multicentrico, in aperto per valutare il passaggio da un regime con elvitegravir/ cobicistat/ emtricitabina/tenofovir alafenamide in combinazione a dose fissa o un regime a base di tenofovir disoproxil fumarato a un regime in combinazione a dose fissa di bictegravir/emtricitabina/tenofovir alafenamide in pazienti anziani, infettati da HIV-1, virologicamente soppressi, di età = 65 anni
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The study will test an experimental drug called B/F/TAF
    (bictegravir/emtricitabine/tenofovir alafenamide) fixed-dose combination (FDC) for the treatment of HIV-1 infection. The purpose of this study is to evaluate the effectiveness of switching to B/F/TAF FDC in HIV-1 infected adults aged = 65 years who are virologically suppressed (HIV-1 RNA test <50 copies/mL) currently on elvitegravir/ cobicistat/emtricitabine/tenofovir alafenamide FDC or tenofovir disoproxil fumarate containing regimens.
    Lo studio testerà un farmaco sperimentale denominato B/F/TAF (bictegravir/ emtricitabine/tenofovir alafenamide) a dose fissa per il trattamento di pazienti affetti da HIV-1. Lo scopo è quello di valutare la efficacia nello switch a B/F/TAF a dose fissa in adulti con età = 65 anni infetti da HIV-1 che sono virologicamente soppressi ( <50 copies/mL) con un trattamento di elvitegravir/ cobicistat/emtricitabina/tenofovir alafenamide a dose fissa o regimi contenti tenofovir disoproxil fumarate
    A.3.2Name or abbreviated title of the trial where available
    The study will test an experimental drug called B/F/TAF (bictegravir/emtricitabine/tenofovir alafena
    The study will test an experimental drug called B/F/TAF (bictegravir/emtricitabine/tenofovir alafena
    A.4.1Sponsor's protocol code numberGS-US-380-4449
    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 SponsorGILEAD SCIENCES INCORPORATED
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGilead Sciences, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressFlowers Building, Granta Park
    B.5.3.2Town/ cityAbington, Cambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223897284
    B.5.5Fax number+441223897284
    B.5.6E-mailclinical.trials@gilead.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 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 nameB/F/TAF
    D.3.2Product code [-]
    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 INNBICTEGRAVIR
    D.3.9.1CAS number 1611493-60-7
    D.3.9.2Current sponsor codeBIC
    D.3.9.4EV Substance CodeSUB182699
    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 INNEMTRICITABINE
    D.3.9.1CAS number 143491-57-0
    D.3.9.2Current sponsor codeFTC
    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.3.9.2Current sponsor codeTAF
    D.3.9.4EV Substance CodeSUB121761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/l milligram(s)/litre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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 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
    Human Immunodeficiency Virus (HIV-1) Infection
    Human Immunodeficiency Virus (HIV-1) Infection
    E.1.1.1Medical condition in easily understood language
    Human Immunodeficiency Virus (HIV-1) Infection
    Human Immunodeficiency Virus (HIV-1) Infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10068341
    E.1.2Term HIV-1 infection
    E.1.2System Organ Class 100000004862
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To characterize the virologic efficacy of switching virologically
    suppressed subjects on an E/C/F/TAF FDC or TDF-containing regimen to
    B/F/TAF FDC defined by HIV-1 RNA <50 copies/mL at Week
    • Caratterizzare l’efficacia virologica del passaggio di soggetti virologicamente soppressi, da un regime con E/C/F/TAF in combinazione a dose fissa o a base di TDF a un regime con B/F/TAF in combinazione a dose fissa, definita da una concentrazione di HIV-1 RNA <50 copie/ml alla Settimana 24
    E.2.2Secondary objectives of the trial
    - To characterize the safety and tolerability of switching to B/F/TAF FDC
    from an E/C/F/TAF FDC or TDF-containing regimen up to week 96 (week 96 included)
    - To characterize the virologic efficacy of switching to B/F/TAF FDC
    defined by HIV-1 RNA <50 copies/mL at Week 48, Week 72 and Week 96.
    -Caratterizzare la sicurezza e tollerabilità del passaggio da un regime E/C/F/TAF in combinazione a dose fissa o a base di TDF a B/F/TAF in combinazione a dose fissa fino alla Settimana 96 compresa
    -Caratterizzare l’efficacia virologica del passaggio a B/F/TAF in combinazione a dose fissa definita da una concentrazione di HIV-1 RNA <50 copie/ml alla Settimana 48, alla Settimana 72 e alla settimana 96.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    e ability to understand and sign a written informed consent form,
    which must be obtained prior to initiation of study procedures
    2) Age = 65 years
    3) Currently receiving an ARV regimen of E/C/F/TAF FDC (or FTC/TDF +
    3rd agent if currently or previously participated in GS-US-292-1826) for
    = 3 months
    4) Documented plasma HIV-1 RNA < 50 copies/mL during treatment
    with E/C/F/TAF (or FTC/TDF + 3rd agent if currently or previously
    participated in GS-US-292-1826) for the last 2 visits preceding the
    Screening Visit (or undetectable HIV-1 RNA level according to the local
    assay being used if the limit of detection is = 50 copies/mL)
    a) Unconfirmed virologic elevations of = 50 copies/mL but < 400
    copies/mL (transient detectable viremia, or "blip") in the past are
    acceptable.
    b) If the lower limit of detection of the local HIV-1 RNA assay is < 50
    copies/mL (eg, < 20 copies/mL), the plasma HIV-1 RNA level cannot
    exceed 50 copies/mL on two consecutive HIV-1 RNA tests after < 50
    copies/mL has been achieved.
    5) Plasma HIV-1 RNA levels < 50 copies/mL at Screening Visit6) Have no documented or suspected resistance to FTC, TFV, or BIC
    including, but not limited, to the reverse transcriptase resistance
    mutations K65R and M184V/I
    7) Normal ECG (or if abnormal, determined by the Investigator to be not
    clinically significant)
    8) Adequate renal function: eGFR = 30 mL/min according to the
    Cockcroft-Gault formula for creatinine clearance
    9) Male subjects who are fertile and engage in heterosexual intercourse
    with women who are of child-bearing potential must agree to use
    protocol specified method(s) of contraception
    10) Male subjects must agree to refrain from sperm donation from first
    study drug dose until after the end of relevant systemic exposure
    11) Life expectancy >1 year
    12) Hepatic transaminases (AST and ALT) = 5 upper limit of normal(ULN)
    13) Total bilirubin = 1.5X ULN or normal direct bilirubin
    14) Adequate hematologic function (absolute neutrophil count = 750/mm3 (= 0.75
    GI/L); platelets = 50,000/mm3 (= 50 GI/L); hemoglobin = 8.5 g/dL (= 85 g/L))
    Per i criteri di inclusione/ esclusione fare riferimento alla sezione 4 del protocollo
    E.4Principal exclusion criteria
    Subjects who meet any of the following exclusion criteria are not to be
    enrolled in this study.
    1) An opportunistic illness indicative of stage 3 HIV diagnosed within the
    30 days prior to screening
    2) Subjects experiencing decompensated cirrhosis (eg, ascites,
    encephalopathy, or variceal bleeding)
    3) Have been treated with immunosuppressant therapies or
    chemotherapeutic agents within 3 months of study screening, or
    expected to receive these agents or systemic steroids (e.g. prednisone
    doses > 10 mg daily or equivalent) during the study (eg, corticosteroids,
    immunoglobulins, and other immune- or cytokine-based therapies)
    4) Current alcohol or substance use judged by the Investigator to
    potentially interfere with subject study compliance
    5) Malignancy within 5 years of screening other than cutaneous Kaposi's
    sarcoma, completely resected non-melanoma skin cancer (basal cell
    carcinoma or non-invasive cutaneous squamous carcinoma), or
    completely resected carcinoma in-situ of the cervix (CIN 3) or anus
    (AIN 3). A prior malignancy treated with curative therapy and for which
    there has been no evidence of disease for at least five years prior to
    screening is allowed.
    6) Active, serious infections (other than HIV-1 infection) requiring
    parenteral antibiotic or antifungal therapy within 30 days prior to Day 1
    7) Participation in any other clinical trial, including observational
    studies, without prior approval from the Medical Monitor
    8) Any other clinical condition or prior therapy that, in the opinion of the
    Investigator, would make the subject unsuitable for the study or unable
    to comply with the dosing requirements
    9) Known hypersensitivity to B/F/TAF FDC tablets, their metabolites, or
    formulation excipient
    10) Subjects receiving ongoing therapy with any of the medications
    listed in the protocol, including drugs not to be used with BIC, FTC, and
    TAF
    11) Acute hepatitis in the 30 days prior to study entry
    12) Active tuberculosis infection
    Per i criteri di inclusione/ esclusione fare riferimento alla sezione 4 del protocollo
    E.5 End points
    E.5.1Primary end point(s)
    HIV-1 RNA <50 copies/mL at Week 24 - defined by the Food and Drug
    Administration (FDA) snapshot algorithm
    • Caratterizzare l’efficacia virologica del passaggio di soggetti virologicamente soppressi, da un regime con E/C/F/TAF in combinazione a dose fissa o a base di TDF a un regime con B/F/TAF in combinazione a dose fissa, definita da una concentrazione di HIV-1 RNA <50 copie/ml alla Settimana 24
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Settimana 24
    E.5.2Secondary end point(s)
    - Adverse events through Week 24
    - Adverse events through Week 48
    - HIV-1 RNA <50 copies/mL at Week 48 - defined by the Food and Drug
    Administration (FDA) snapshot algorithm
    -HIV-1 RNA <50 copies/mL at Week 72 - defined by the Food and Drug
    Administration (FDA) snapshot algorithm
    -HIV-1 RNA <50 copies/mL at Week 96 - defined by the Food and Drug
    Administration (FDA) snapshot algorithm
    -Concentrazione di HIV-1 RNA <50 copie/ml alla Settimana 48 - definita dall’algoritmo snapshot della Food and Drug Administration (FDA)
    -Concentrazione di HIV-1 RNA <50 copie/ml alla Settimana 72 - definita dall’algoritmo snapshot della Food and Drug Administration (FDA)
    -Concentrazione di HIV-1 RNA <50 copie/ml alla Settimana 96 - definita dall’algoritmo snapshot della Food and Drug Administration (FDA)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24, Week 48, Week 72 and Week 96
    Settimana 24, 48, 72 e 96
    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 Yes
    E.6.13.1Other scope of the trial description
    Patient reported outcomes
    Patient reported outcomes
    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 No
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA31
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    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 years3
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 80
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    After a subject has completed/terminated their participation in the
    study, long-term care for the subject will remain the responsibility of
    their primary treating physician.
    After a subject has completed/terminated their participation in the
    study, long-term care for the subject will remain the responsibility of
    their primary treating physician.
    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 Decision2018-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-06-20
    P. End of Trial
    P.End of Trial StatusCompleted
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