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    Summary
    EudraCT Number:2011-003329-89
    Sponsor's Protocol Code Number:AI467003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-02-07
    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 ConcernedGermany - BfArM
    A.2EudraCT number2011-003329-89
    A.3Full title of the trial
    A Phase IIb Randomized, Controlled, Partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose.

    Revised Protocol 01 to incorporate Protocol Amendment 02
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety, Efficacy and Dose response study of BMS-986001 in subjects with HIV-1 Infection who are treatment-naive.
    A.4.1Sponsor's protocol code numberAI467003
    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 SponsorBristol Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    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 supportBristol Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol Myers Squibb International Corporation
    B.5.2Functional name of contact pointEU Study Start Up Unit
    B.5.3 Address:
    B.5.3.1Street Address8 avenue de Finlande
    B.5.3.2Town/ cityBraine l'alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.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 nameBMS-986001
    D.3.2Product code BMS-986001
    D.3.4Pharmaceutical form Capsule
    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 INNBMS-986001
    D.3.9.1CAS number 634907-30-5
    D.3.9.2Current sponsor codeBMS-986001
    D.3.9.3Other descriptive name1-((2R,5R)-5-ethynyl-5-(hydroxymethyl)-2,5-dihydro-2-furanyl)-5-methyl-2,4(1H,3H)-pyrimidinedione
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Viread
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTenofovir
    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 INNTENOFOVIR DISOPROXIL FUMARATE
    D.3.9.1CAS number 202138-50-9
    D.3.9.4EV Substance CodeSUB12607MIG
    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 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 placeboCapsule
    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
    Human Immunodeficiency Virus type 1 (HIV-1) infection
    E.1.1.1Medical condition in easily understood language
    Human immunodeficiency virus (HIV) is a virus that causes a condition in humans in which progressive failure of the immune system allows life-threatening opportunistic infections to thrive.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    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 assess the efficacy of three doses of BMS-986001 by determining the proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses at
    Week 24
    • To assess the safety of three doses of BMS-986001 in treatment-naive HIV-1 infected subjects as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuations through Week 24, as reported on case report forms
    E.2.2Secondary objectives of the trial
    • To assess the efficacy of BMS-986001 by determining the proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by PCR analyses through Week 48 and
    96
    • To assess the safety of BMS-986001 in treatment-naive HIV-1 infected subjects by measuring numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuations through Weeks 48 and 96, as reported on case report forms
    • To assess the antiretroviral activity of BMS-986001 based on change from baseline in CD4+ T-cell count through Weeks 24, 48, and 96
    • To assess the number of subjects with virologic failure who exhibit genotypic drug resistance substitutions in viral RNA through Weeks 24, 48, and 96;
    • To assess the steady-state plasma PK of BMS-986001 when co-administered with EFV and 3TC in treatment-naive HIV-1 infected subjects
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Protocol AI467003: A Phase IIb Randomized, Controlled, partially Blinded Clinical Trial to Investigate Safety, Efficacy and Dose-response of BMS-986001 in Treatment-naive HIV-1-infected Subjects, Followed by an Open-label Period on the Recommended Dose Pharmacogenetics Blood Sample Amendment Number 01 - Site Specific
    Site All
    E.3Principal inclusion criteria
    1) Signed Written Informed Consent:
    Freely given informed consent must be obtained from subjects prior to clinical trial participation, including informed consent for any screening procedures conducted to establish subject eligibility for the study.
    2) Target Population:
    a) Men and women at least 18 years of age, (or minimum age as determined by local regulatory or as legal requirements dictate, whichever is higher),
    b) Plasma HIV-1 RNA > 5000 copies/mL,
    c) Antiretroviral treatment-naive; defined as no current or previous exposure to > 1 week of an antiretroviral drug,
    d) CD4 + T-cell count > 200 cells/mm3.
    3) Age and Reproductive Status:
    a) Women of childbearing potential (WOCBP) and men must be using at least 2 acceptable methods of contraception, including at least one barrier method, to
    avoid pregnancy throughout the study, for up to 12 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized,
    b) 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 investigational product,
    c) Women must not be breastfeeding,
    d) Sexually active fertile men must use effective birth control if their partners are WOCBP.
    E.4Principal exclusion criteria
    1) Target Disease Exceptions:
    a) History of genotypic and/or phenotypic drug resistance testing showing resistance to EFV, TDF, or 3TC.
    b) Screening HIV-1 genotypic drug resistance testing showing resistance to EFV, TDF, or 3TC, as defined by the presence of any in the following:
    EFV RT: A98G, L100I, K101E/Q/R/P, K103N, V106M, V108I, V179D, Y181C/I, Y188L, G190S/A/T, P225H, F227L, M230I/L;
    TDF RT: M41L, K65R, D67N, K70R/E, T69 insertion, L74V, L210W, Y115F, Q151M, T215Y/F, K219Q/E/N;
    3TC RT: M184V/I, K65R.
    c) Screening HIV-1 genotypic drug resistance testing showing primary protease inhibitor resistance mutations as defined by the presence of any of the following:
    PR: D30N, M46I/L, I47V/A, G48V, I50L, I54M/L, Q58E, T74P, L76V, V82A/F/L/T/S, N83D, I84V, N88S, L90M.
    2) Medical History and Concurrent Diseases:
    a) Any gastrointestinal disease or surgical procedure that may impact absorption of study drug,
    b) Presence of a newly diagnosed HIV-related opportunistic infection (OI) or any medical condition requiring acute therapy at the time of enrollment; suspected primary (acute) HIV infection,
    c) History of or current presence of clinically relevant cardiac disease, defined by presence of arrhythmias, ischemic disease, or a conduction abnormality including
    2nd/3rd degree atrioventricular block (AVB), or any cardiac abnormality deemed clinically relevant by investigator,
    d) Personal or family history of long QT syndrome,
    e) History of seizures or other clinically relevant CNS disorders,
    f) History of diagnosed and uncontrolled mental illness,
    g) History of suicidal ideation or attempt,
    h) History of Idiopathic Thrombocytopenia Purpura or clinically relevant diagnosis of thrombocytopenia,
    i) Active alcohol or substance use which in the investigator’s opinion is sufficient,
    to prevent adequate adherence with study therapy or make participation in the study not in the best interest of the subject.
    3) Physical and Laboratory Test Findings:
    a) Liver enzymes (ALT/AST) > 3 times the upper limit of normal,
    b) Alkaline phosphatase > 5 times the upper limit of normal,
    c) Creatinine clearance < 60 cc/min,
    d) Hemoglobin < 8.0 g/dL,
    e) Platelets < 75,000 cells/mm3,
    f) Positive blood screen for HBsAg,
    g) Positive blood screen for HCV Ab and HCV RNA,
    h) Confirmed QT value > 500 msec at Screening or Day -1,
    i) Confirmed QTc value > 470 msec for women and > 450 msec for men at Screening or Day -1,
    j) Confirmed PR Interval > 260 msec (severe first degree AV block),
    k) Confirmed second or third degree heart block at Screening or Day -1,
    4) Allergies and Adverse Drug Reaction,
    a) History of allergy to TDF, EFV, or 3TC,
    b) History of clinically relevant severe drug reaction (such as anaphylaxis or hepatotoxicity.
    5) Other Exclusion Criteria:
    a) Prisoners or subjects who are involuntarily incarcerated
    b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness,
    c) Contraindications to any of the study drugs.
    E.5 End points
    E.5.1Primary end point(s)
    • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses at Week 24
    • Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuations through Week 24, as reported on case report forms.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Timepoint of evaluation of primary end point is Week 24.
    E.5.2Secondary end point(s)
    • Proportion of subjects with plasma HIV-1 RNA < 50 c/mL as measured by polymerase chain reaction (PCR) analyses through Weeks 48 and 96;
    • Safety as measured by numbers of subjects with SAEs and numbers of subjects with AEs leading to discontinuations through Weeks 48 and 96, as reported on case report forms;
    • Changes from baseline in CD4 + T-cell counts through Weeks 24, 48, and 96;
    • Numbers of subjects with virologic failure who exhibit drug resistance genotypic substitutions in viral RNA through Weeks 24, 48, and 96;
    • Steady-state plasma PK of BMS-986001 when co-administered with EFV and 3TC.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Timepoints of evaluation of secondat end points are Weeks 24, 48 and 96, as explained in section E.5.2.
    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 Yes
    E.6.10Pharmacogenetic Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    partially blind
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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
    Argentina
    Australia
    Brazil
    Canada
    Chile
    Colombia
    Mexico
    Peru
    South Africa
    Thailand
    United States
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    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: 270
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 300
    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 conclusion of the study, subjects who continue to demonstrate clinical benefit will be eligible to receive study drug up to 12 months after the approval of study drug by the responsible health authority or until the study drug becomes commercially available within the country, whichever occurs sooner.
    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 Decision2012-04-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2014-08-05
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