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    Summary
    EudraCT Number:2009-017951-87
    Sponsor's Protocol Code Number:ING112574
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-04-20
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2009-017951-87
    A.3Full title of the trial
    A Phase III study to demonstrate the antiviral activity and safety
    of dolutegravir in HIV-1-infected adult subjects with treatment
    failure on an integrase inhibitor containing regimen.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to test a new drug dolutegravir for HIV patients with raltegravir or elvitegravir failure
    A.4.1Sponsor's protocol code numberING112574
    A.5.4Other Identifiers
    Name:VIKING-3Number:VIKING-3
    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
    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 number442089904466
    B.5.5Fax number442089901234
    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 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.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-1-infected adult subjects with treatment failure on an integrase inhibitor containing regimen
    E.1.1.1Medical condition in easily understood language
    HIV 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 18.1
    E.1.2Level LLT
    E.1.2Classification code 10008922
    E.1.2Term Chronic infection with HIV
    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 assess the antiviral activity of DTG 50mg twice daily (BID) administered failing background therapy to Day 8 and thereafter with with optimised background ART (OBR) consisting of at least one fully active agent through Week 24 in HIV-infected adult subjects with virological failure on a prior INI containing regimen.
    • To evaluate the safety and tolerability of DTG 50mg BID with background ART over time
    E.2.2Secondary objectives of the trial
    • To assess the antiviral and immunologic activity of DTG over time
    • To assess the impact of different baseline INI genotypic resistant patterns and phenotype on treatment response (short and long term) to DTG
    • To characterise treatment emergent viral resistance in subjects experiencing virological failure
    • To characterise the pharmacokinetics (PK) of using a sparse PK sampling strategy and a population modeling approach
    • To evaluate the effect of patient characteristics (eg demographic factors) and concurrent medications (as covariates) on PK parameters of DTG
    • To explore, using multivariate models, the impact of Day 1 covariates (e.g. demographics, HIV RNA, resistance to DTG, overall susceptibility score of background ART) and PK on treatment response (e.g. antiviral activity, development of resistance, and/or AEs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Subject has documented HIV-1 infection with a plasma HIV-1 RNA >=500 copies/mL at Screening.
    2.Subject is ART-experienced and on stable ART for at least one month prior to Screening and through Day 1(with exceptions for ETV, EFV and NVP as detailed in Exclusion Criterion 11).
    3.Subject is INI-experienced, but naïve to DTG, and either:
    •currently experiencing virologic failure to RAL or ELV or
    •experienced virologic failure while on therapy containing RAL or ELV (with documented genotypic and/or phenotypic INI resistance at time of failure) and is currently experiencing treatment failure on a subsequent regimen.
    4.Subject harbours virus with :
    •Evidence of genotypic resistance to RAL and/or ELV on Screening resistance testing.
    •Evidence of phenotypic resistance to RAL on Screening resistance testing,
    OR
    •No evidence of resistance at Screening but documented historical genotypic and/or phenotypic resistance to RAL and/or ELV at time of prior INI virological failure,
    Phenotypic resistance is defined as the IC50 above the biological cut-off of the Phenosense assay for RAL (>1.5 FC versus wild type IC50). For ELV phenotypic resistance is defined as >2.5 FC above WT IC50. If assays other than the Monogram PhenoSense have been used to provide historical evidence of resistance, please discuss eligibility with the Study Virologist as specified in the Study Procedures Manual.
    5.Subject harbours virus with documented genotypic or phenotypic resistance to at least one drug from each of two or more of all other approved classes of ART –N(t)RTIs, NNRTIs, PIs, fusion inhibitors, co-receptor inhibitors, based on Screening genotype/phenotype and/or historical genotype/phenotype data.
    6.Subject must be able to receive at least one fully active drug in the OBR (to ensure an OSS 1) from Day 8 onwards based on the subject’s Screening Monogram resistance test Net Assessment results.
    7.Subject is >=18 years of age.
    8.A female is eligible to enter and participate in the study if she:
    a.is of non-childbearing 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 Screen and Day 1, and agrees to use one of the methods of contraception listed below to avoid pregnancy:
    •Complete abstinence from intercourse from 2 weeks prior to administration of the investigational products, 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 may be administered with DTG (see the SPM for a listing of examples of approved hormonal contraception, and Section 5.7.1),
    •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 an example listing of approved IUDs),
    •Any other method with published data showing that the lowest expected failure rate for that method is less than 1% per year.
    Any contraception method must be used consistently and in accordance with the approved product label and the instruction of a physician.
    The potential for drug interaction with background ARTs should also be considered (see Section 5.7.1)
    All subjects in this study should also be counselled on the practice of safe/safer sex, including the use of effective barrier methods (eg. male condom/spermicide).
    9.Subject or the subject’s legal representative is willing and able to understand and provide signed and dated written informed consent prior to screening.
    10.French subjects: 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.
    11.Subject is able to understand and comply with protocol requirements, instructions, and protocol-stated restrictions and is likely to complete the study as planned (please see protocol)
    E.4Principal exclusion criteria
    Deviations from exclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
    A single repeat test (re-test) per analyte is allowed during the screening period.
    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, 1993; See Appendix 2]. This definition excludes cutaneous Kaposi’s sarcoma (KS) not requiring systemic therapy or current CD4+ cell levels <200cells/mm3 (i.e. subjects with cutaneous KS or <200 CD4+cells/mm3 are eligible for inclusion).
    3.Subjects with moderate to severe hepatic impairment as determined by Child-Pugh classification (see Appendix 3).
    4.Anticipated need for HCV therapy during the first 24 weeks of the study.
    5.Recent history (<=3 months) of any upper or lower gastrointestinal bleed, with the exception of anal or rectal bleeding.
    6.History or presence of allergy or intolerance to the study drugs or their components or drugs of their class.
    7.History of malignancy within the past 6 months 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 Study medical monitor for inclusion of the subject. Subjects with a history of anal intraepithelial neoplasia (AIN) or cervical intraepithelial neoplasia (CIN) may be included in the study.
    Exclusionary Treatments prior to Screening or Day 1
    8.Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening.
    9.Treatment with any of the following agents within 28 days of Screening:
    •radiation therapy,
    •cytotoxic chemotherapeutic agents,
    •any immunomodulator.
    10.Treatment with any agent, other than licensed ART, with documented activity against HIV-1 in vitro within 28 days of first dose of IP.
    11.Treatment with etravirine, efavirenz or nevirapine within 14 days of first dose of IP (etravirine only may be used if co-administered with LPV/RTV or DRV/RTV).
    12.Treatment with tipranavir/ritonavir (TPV/RTV), fosamprenavir (FPV) or FPV/RTV within 28 days prior to Screening.
    13.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.
    14.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
    15.Any verified Grade 4 laboratory abnormality, with the exception of Grade 4 lipid (total cholesterol, triglycerides, HDL cholesterol, LDL cholesterol) abnormalities. A single repeat test is allowed during the Screening period to verify a result.
    16.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.
    17.Alanine aminotransferase (ALT) >5 times the upper limit of normal (ULN).
    18.ALT >= 3xULN and bilirubin >= 1.5xULN (with >35% direct bilirubin).
    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 efficacy endpoint for hypothesis testing in this study will be the mean change from baseline in plasma HIV-1 RNA (log10 copies/mL) at Day 8, using a last observation carried forward (discontinuation equals baseline) (LOCFDB) dataset.
    The study’s primary objective is the characterisation of antiviral activity at both Day 8 and Week 24. The primary endpoint for assessment of Week 24 response will be the proportion of subjects with plasma HIV-1 RNA <50 copies/mL at Week 24 using a Missing, Switch or Discontinuation = Failure (MSDF) algorithm as codified by the FDA’s “snapshot” algorithm (see Section 8.3.2).
    (Please review Protocol Section 6.3.2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 8 and Week 24
    E.5.2Secondary end point(s)
    •Proportion of subjects with plasma HIV-1 RNA <400 copies/mL and <50 copies/mL over time
    •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 HIV-1 disease progression (AIDS and death)
    (Please review Protocol Section 6.3.3)
    E.5.2.1Timepoint(s) of evaluation of this end point
    overtime through Weeks 24 and 48
    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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA34
    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
    Belgium
    Canada
    France
    Italy
    Portugal
    Spain
    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
    All subjects who derive clinical benefit and remain on IP when the last subject completes 24 weeks on study, may continue to receive DTG. GSK will provide IP until it becomes commercially available unless the subject is no longer deriving clinical benefit or development is discontinued. During this time, subjects will be monitored every 8 weeks to Week 48 and every 12 weeks thereafter, to ensure they continue to derive clinical benefit from DTG.
    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.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    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 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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 200
    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)
    All subjects who derive clinical benefit and remain on IP when the last subject completes 24 weeks on study, may continue to receive DTG. GSK will provide IP until it becomes commercially available unless the subject is no longer deriving clinical benefit or development is discontinued. During this time, subjects will be monitored every 8 weeks to Week 48 and every 12 weeks thereafter, to ensure they continue to derive clinical benefit from DTG.
    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 Decision2011-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-05-25
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