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    Summary
    EudraCT Number:2009-017950-11
    Sponsor's Protocol Code Number:ING113086
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-08-23
    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 number2009-017950-11
    A.3Full title of the trial
    A Phase III, randomized, double blind study of the safety and efficacy of GSK1349572 50 mg once daily to raltegravir 400 mg twice daily both administered with fixed-dose dual nucleoside reverse transcriptase inhibitor therapy over 96 weeks in HIV-1 infected antiretroviral therapy naïve adult subjects.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test a new drug dolutegravir vs. raltegravir for HIV
    patients who have never taken HIV medication.
    A.3.2Name or abbreviated title of the trial where available
    Dolutegravir vs. raltegravir
    A.4.1Sponsor's protocol code numberING113086
    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 Ltd
    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 supportGlaxoSmithKline Research and Development Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research and Development Ltd
    B.5.2Functional name of contact pointClinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressIron Bridge Road
    B.5.3.2Town/ cityUxbridge
    B.5.3.3Post codeUB11 1BU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+442089904466
    B.5.5Fax number+442089901234
    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 nameDolutegravir
    D.3.2Product code GSK1349572
    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.3.9.1CAS number 1051375-19-9
    D.3.9.2Current sponsor codeGSK1349572
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Isentress
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dhome Ltd
    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 nameIsentress
    D.3.2Product code Not applicable
    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 INNRALTEGRAVIR
    D.3.9.1CAS number 518048-05-0
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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
    D.8 Placebo: 2
    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-1 infected antiretroviral (ART) - naïve adult subjects
    E.1.1.1Medical condition in easily understood language
    HIV-1 infection in adults who have never taken HIV medication previously
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10008922
    E.1.2Term Chronic infection with HIV
    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
    To demonstrate the antiviral activity of GSK1349572 50 mg administered once daily compared to RAL 400 mg twice daily over 48 weeks in HIV-1 infected therapy naïve subjects.
    E.2.2Secondary objectives of the trial
    To demonstrate the antiviral activity of GSK1349572 compared to RAL over 96 weeks.
    To compare the tolerability, long-term safety and antiviral and immunologic activity of GSK1349572 to RAL over time.
    To assess the development of viral resistance in subjects experiencing virological failure.
    To characterize the pharmacokinetics (PK) of GSK1349572 using a sparse PK sampling strategy and a population modelling approach.
    To explore exposure-response relationships of GSK1349572.
    To evaluate the effect of patient characteristics and concurrent medications on PK parameters of GSK1349572.
    To evaluate the incidence of HIV-associated conditions in subjects treated with GSK1349572 compared to RAL over time.
    To explore the impact of gender, race and/or HIV-1 subtype on response GSK1349572 and RAL over time.
    To explore the change in utility and health related quality of life for subjects treated with GSK1349572 and RAL.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Eligible subjects must
    •be able to understand and comply with protocol requirements, instructions, and restrictions.
    •be likely to complete the study as planned.
    •be considered appropriate candidates for participation in an investigative clinical trial with oral medication (e.g., no active substance abuse, acute major organ disease).
    Laboratory results from the central laboratory services provided by this trial will be used to assess eligibility. If results from the central laboratory (e.g., genotype results) will delay screening beyond the defined 28-day period, use of local laboratory results may be used only after consultation and agreement with GSK.
    Subjects eligible for enrolment in this study must meet all of the following criteria:
    1.HIV-1 infected adults > 18 years of age.
    2.A female may be eligible to enter and participate in the study if she:
    a)is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and >45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or
    b)is of child-bearing potential with a negative pregnancy test at both Screening and Day 1 and agrees to use one of the following methods of contraception to avoid pregnancy:
    •Complete abstinence from intercourse from 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all study medications.
    •Double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide).
    •Approved hormonal contraception (see the SPM for a listing of examples of approved hormonal contraception).
    •Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year (not all IUDs meet this criterion, see the SPM for a listing of example approved IUDs).
    •Any other method with published data showing that the expected failure rate is <1% per year.
    Any contraception method must be used consistently and in accordance with the approved product label.
    All subjects participating in the study should be counselled on safer sexual practices including the use of effective barrier methods (e.g., male condom/spermicide).
    3.HIV-1 infection as documented by Screening plasma HIV-1 RNA >1000 c/mL;
    4.Antiretroviral-naïve (< 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection).
    5.Signed and dated written informed consent is obtained from the subject or the subject’s legal representative prior to screening.
    6.For subjects enrolled in France: a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
    Note: subjects starting abacavir as part of the NRTI backbone must be or have been screened and be negative for the HLA-B*5701 allele.
    E.4Principal exclusion criteria
    Subjects meeting any of the following criteria must not be enrolled in the study:
    Exclusionary medical conditions
    1.Women who are breastfeeding;
    2.Any evidence of an active Center for Disease and Prevention Control (CDC) Category C disease [CDC, 1992], except cutaneous Kaposi’s sarcoma not requiring systemic therapy or historic or current CD4+ cell levels <200cells/mm3;
    3.Subjects with moderate to severe hepatic impairment as determined by Child-Pugh classification (see Appendix 1);
    4.Anticipated need for HCV therapy during the study;
    5.History or presence of allergy or intolerance to the study drugs or their components or drugs of their class;
    6.History of malignancy within the past 5 years or ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma; other localized malignancies require agreement between the investigator and GSK medical monitor for inclusion of the subject;
    Exclusionary Treatments prior to Screening or Day 1
    7.Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening;
    8.Treatment with any of the following agents within 28 days of Screening;
    • radiation therapy;
    • cytotoxic chemotherapeutic agents;
    • any immunomodulator;
    9.Treatment with any agent, except recognized ART as allowed above (Section 4.2), with documented activity against HIV-1 in vitro within 28 days of first dose of IP;
    10.Exposure to an experimental drug or experimental vaccine within either 28 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP;
    11.French subjects recruited at sites in France will be excluded if the subject has participated in any study using an investigational agent during the previous 60 days or 5 half-lives, or twice the duration of the biological effect of the experimental drug or vaccine, whichever is longer, prior to screening for the study or the subject will participate simultaneously in another clinical study;
    Exclusionary Lab Values or Clinical Assessments at Screening
    12.Any evidence of primary viral resistance in the Screening result or, if known, any historical resistance test result. Note: retests of Screening genotypes are not allowed;
    13.Any verified Grade 4 laboratory abnormality (a single repeat test is allowed during the Screening period to verify a result). Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject’s participation in the study of an investigational compound is exclusionary;
    14.Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN);
    15.ALT > 3xULN and bilirubin > 1.5xULN (with >35% direct bilirubin);
    16.Subject has estimated creatinine clearance <50 mL/min via Cockroft-Gault method;
    17.Recent history (<3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding.
    Notwithstanding these minimum inclusion and exclusion criteria, Investigators must also follow country specific guidelines where they exist when making decisions about subjects who are eligible for study participation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for this study will be the proportion of subjects with HIV-1 RNA <50 c/mL through Week 48 using a Missing, Switch or Discontinuation = Failure (MSDF) algorithm as codified by the FDA’s “snapshot” algorithm.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 48
    E.5.2Secondary end point(s)
    • Proportion of subjects with detectable virus that has genotypic or phenotypic evidence of INI resistance by Week 48 at Weeks 48 and 96
    • Proportion of subjects with plasma HIV-1 RNA <50 c/mL at Week 96
    • Proportion of subjects with plasma HIV-1 RNA <400 c/mL at Weeks 48 and 96
    • Absolute values and change from baseline in plasma HIV-1 RNA over time
    • Absolute values and changes from baseline in CD4+ and CD8+ cell counts over time
    • Incidence of disease progression (HIV-associated conditions, AIDS and death)

    • Incidence and severity of AEs and laboratory abnormalities;
    • Absolute values and changes over time in laboratory parameters;
    • Proportion of subjects who discontinue treatment due to AEs;
    • Incidence of any clinically significant changes in ECG profiles;
    • Change from Baseline in vital signs.

    • Plasma GSK1349572 PK parameters (AUC(0-τ), Cmax, and Cτ) estimated by population PK modelling based on sparse PK sampling.
    • Relationship between plasma GSK1349572 PK parameters and plasma HIV-1 RNA, CD4+ cell counts and/or occurrence of AEs.
    • Effect of demographic factors (e.g., weight, age, gender, and race), patient characteristics, and concurrent medications on GSK1349572 PK parameters.

    • Incidence of treatment emergent genotypic and phenotypic resistance to GSK1349572, RAL and other on-study ART.
    E.5.2.1Timepoint(s) of evaluation of this end point
    See protocol
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    96 week randomised phase followed by open label phase
    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 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA45
    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
    Canada
    France
    Germany
    Italy
    Russian Federation
    Spain
    United Kingdom
    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
    see protocol
    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) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 395
    F.4.2.2In the whole clinical trial 788
    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)
    Following Week 96 subjects randomised to GSK1349572 will continue to receive drug according to the protocol. Subjects randomised to raltegravir need to have alternative arrangements in place to access antiretroviral therapy (ART). All subjects will need to have made alternative arrangements for independent access to all other ART (e.g., dual NRTI).
    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 Decision2010-09-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-12-27
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