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    Summary
    EudraCT Number:2014-002111-41
    Sponsor's Protocol Code Number:AI438-047/205888
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-06
    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 ConcernedGreece - EOF
    A.2EudraCT number2014-002111-41
    A.3Full title of the trial
    A Multi-arm Phase 3 Randomized Placebo Controlled Double Blind Clinical Trial to Investigate the Efficacy and Safety of Fostemsavir in Heavily Treatment Experienced Subjects Infected with Multi-drug Resistant HIV-1 (BRIGHTE study).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    HIV-1 Attachment Inhibitor comparison in Heavily Treatment Experienced patients
    A.4.1Sponsor's protocol code numberAI438-047/205888
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02362503
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1161-2082
    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 SponsorViiV Healthcare UK Limited
    B.1.3.4CountryUnited Kingdom
    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 supportViiV Healthcare UK (No.4) Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointClinical Trials HelpDesk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ cityBrentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number44 0800 783 9733
    B.5.6E-mailGSKClinicalSupportHD@gsk.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 nameFostemsavir
    D.3.2Product code BMS-663068/GSK3684934
    D.3.4Pharmaceutical form Prolonged-release 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 INNNA
    D.3.9.1CAS number SUB32084
    D.3.9.2Current sponsor codeAI438-047/205888
    D.3.9.3Other descriptive nameBMS663068/GSK3684934
    D.3.9.4EV Substance CodeSUB32084
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HIV, Adult
    E.1.1.1Medical condition in easily understood language
    HIV, Adult
    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 PT
    E.1.2Classification code 10020161
    E.1.2Term HIV infection
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The purpose of this study is to compare the efficacy of Fostemsavir relative to placebo, when given on the background of a failing regimen, by determining the mean change in log10 HIV-1 RNA from Day 1 at Day 8 in the Randomized Cohort.
    E.2.2Secondary objectives of the trial
    -assess the efficacy of fostemsavir 600 mg BID relative to placebo, when
    given on the background of a failing regimen
    -assess the durability of the subjects' responses to fostemsavir when
    given with an OBT by determining the proportion of subjects with plasma
    HIV-1 RNA < 40 c/mL at Week 24, Week 48, and Week 96
    -assess the safety and tolerability of fostemsavir + OBT in subjects by
    measuring frequency of serious adverse events, adverse events
    -assess disease progression during OBT as measured by the occurrence
    of new AIDS-defining events or death in the Randomized Cohort.
    -assess the emergence of antiretroviral drug resistance among subjects
    with protocol defined virologic failure (VF) in the Randomized Cohort.
    -assess the efficacy of fostemsavir + OBT, by examining the changes
    from baseline in log10 HIV-1 RNA, CD4 + T-cell counts, and the
    percentage of CD4 + T cells through Week 24, Week 48, and Week 96 in
    the Randomized Cohort.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Signed and written informed consent
    2) Target population:
    -) Men and non-pregnant women with chronic HIV-1 infection
    -) Age 18 and older
    -) Subject re-enrollment: this study permits the re-enrollment of a
    subject that has discontinued the study as a pre-treatment failure
    -) Antiretroviral-experienced with documented historical or baseline
    resistance, intolerability, and/or contraindications to antiretrovirals in at
    least three classes
    -) Failing current antiretroviral regimen with a confirmed plasma HIV-1
    RNA of more or equal to 400 c/mL (first value from Investigator within 6
    months of screening visit, with the second value obtained from
    Screening labs). Subjects with a screening HIV-1 RNA <400 c/mL should
    be counted as screen failures; repeat testing is not permissible.
    -) Must have at least one fully-active and available agent in < or = 2 ARV classes, based on current and/or documented historical resistance
    testing, taking into account tolerability and other safety concerns
    3) Age and Reproductive Status
    -) Willingness to use approved highly effective methods of contraception
    to avoid pregnancy (men and women of child bearing potential only).
    -) Males and Females, ages 18 years of age or older (or minimum age as
    determined by local regulatory or as legal requirements dictate)
    -) Women of childbearing potential (WOCBP) must have a negative
    serum or urine pregnancy test (minimum sensitivity 25 IU/L or
    equivalent units of HCG) within 24 hours prior to the start of study drug.
    -) Women must not be breastfeeding
    -) WOCBP must agree to follow instructions for method(s) of
    contraception for the duration of treatment with the Attachment
    Inhibitor and for at least 60 hours after drug exposure.
    -) Males, whether azoospermic or not, who are sexually active with
    WOCBP must use condoms and agree to follow instructions for
    method(s) of contraception for the duration of treatment with the
    Attachment Inhibitor and for at least 60 hours after drug exposure.
    -) WOCBP who are continuously not heterosexually active are exempt
    from contraceptive requirements. However, they must still undergo
    pregnancy testing as described in protocol.
    E.4Principal exclusion criteria
    1) Any other clinical condition (including but not limited to substance
    use) or prior therapy that, in the opinion of the Investigator, would
    make the subject unsuitable for the study
    2) Physical and Laboratory Test Findings
    -) Chronic untreated HBV (however, patients with chronic treated HBV
    are eligible)
    -) HIV-2 infection
    -) ALT or AST > 7 x ULN
    -) Alkaline Phosphatase > 5 x ULN
    -) Bilirubin of more or = 1.5 x ULN (unless subject has Gilbert's disease,
    and/or is currently on atazanavir, and has predominantly unconjugated
    hyperbilirubinemia)
    -) History of decompensated cirrhosis or active decompensated cirrhosis
    -) History of congestive heart failure or congenital prolonged QT
    syndrome
    -) Hemoglobin < 8.0 g/dL (Randomized Cohort); Hemoglobin < 6.0 g/dL
    (Non-Randomized Cohort)
    -) Platelets < 50,000 cells/mm3 (Randomized Cohort); Platelets <
    20,000 cells/mm3 (Non-Randomized Cohort);
    -) Confirmed QT value > 500 msec at Screening or Day 1
    -) Confirmed QTcF value > 470 msec for women and > 450 msec for men
    at Screening or Day 1
    -) Confirmed PR Interval > 260 msec (severe first degree AV block) at
    Screening or Day 1
    -) Confirmed second or third degree heart block at Screening or Day 1
    -) Current or anticipated treatment with any of the following
    medications: rifampin, Hypericum perforatum (St. John's wort),
    efavirenz, nevirapine, carbemazepine, phenobarbital, phenytoin, amiodarone disopyramide, dofetilide, ibutilide,
    procainamide, sotalol, and quinidine. Simvastatin and lovastatin should
    not be co-administered with boosted protease inhibitors.
    -) Participation in an experimental drug and/or HIV-1 vaccine trial(s)
    within the previous 30 days (Randomized Cohort only)
    3) Other Exclusion Criteria
    -) Prisoners or subjects who are involuntarily incarcerated
    -) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

    E.5 End points
    E.5.1Primary end point(s)
    The efficacy of fostemsavir, relative to placebo, is assessed using the
    mean change in log10 HIV-1 RNA from Day 1 at Day 8 as determined by
    ANCOVA in the randomized cohort.

    E.5.1.1Timepoint(s) of evaluation of this end point
    week 24 visit
    E.5.2Secondary end point(s)
    - The proportions of subjects in the randomized cohort with HIV-1 RNA
    decreases from Day 1 that exceed 0.5 log10c/mL and 1 log10 c/mL are
    determined by comparing each subject's HIV-1 RNA Day 1 measurement
    to their Day 8 measurement. This is a mITT analysis based on treated
    subjects that classifies subjects without HIV-1 RNA at Day 1 or Day 8 as
    failures
    -The durability of response (HIV-1 RNA < 40 c/mL) at Week 24 of OBT is
    assessed using the FDA snapshot algorithm. This is a mITT analysis
    based on treated subjects that classifies subjects without HIV-1 RNA at
    Week 24 or those who changed OBT due to lack of efficacy through Week
    24 as failures.
    -The frequency of SAEs, AEs leading to discontinuation, and Grade 3-4
    laboratory abnormalities during OBT are tabulated from Case Report
    Forms (CRFs) and laboratory data
    -Disease progression during OBT is assessed is assessed using the
    occurrence of new AIDS defining events (CDC Class C events) or death
    as tabulated from CRFs
    -Drug resistance is assessed through phenotypic and genotypic
    resistance testing of isolates from subjects identified as meeting the
    criteria for virologic failure
    -The changes in CD4+ T-cells counts and percentages, for Fostemsavir
    and placebo are determined using the mean changes from Day 1 at Day 8
    in the randomized cohort.
    -The changes from baseline in HIV-1 RNA, CD4+ cell counts, and
    percentage of CD4+ T-cells, for Fostemsavir when given with OBT, are
    assessed using laboratory results collected through Week 24 in the
    randomized cohort.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 48 visit
    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 Yes
    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
    Resistance testing
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Chile
    Colombia
    Mexico
    Peru
    Puerto Rico
    Russian Federation
    South Africa
    Taiwan
    United States
    Belgium
    Denmark
    France
    Germany
    Greece
    Ireland
    Italy
    Netherlands
    Norway
    Poland
    Portugal
    Romania
    Spain
    United Kingdom
    Argentina
    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
    Last follow-up 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 months40
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    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: 418
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 441
    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 study end subjects who continue to demonstrate clinical benefit will be eligible to receive it. Study drug will be provided via study extension, rollover study or another mechanism.BMS can terminate access to study drug if:a) marketing application rejected by responsible HA;b) study terminated due to safety concerns;c) subject can obtain medication from a government sponsored or private health program; or d) therapeutic alternatives become available in local market

    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 Decision2015-06-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-28
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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