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    Summary
    EudraCT Number:2009-010270-37
    Sponsor's Protocol Code Number:ING112961
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-07-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2009-010270-37
    A.3Full title of the trial
    A Phase IIb pilot study to assess the antiviral activity of GSK1349572 containing regimen in antiretroviral therapy (ART)-experienced, HIV-1-infected adult subjects with raltegravir resistance
    A.3.2Name or abbreviated title of the trial where available
    VIKING
    A.4.1Sponsor's protocol code numberING112961
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGlaxoSmithKline Research and Development 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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.2Product code GSK1349572
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 number25
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 antiretroviral therapy experienced adults with raltegravir resistance
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10008922
    E.1.2Term Chronic infection with HIV
    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 short-term antiviral activity of GSK1349572 + failing background regimen.
    E.2.2Secondary objectives of the trial
    • To assess the short-term safety and tolerability of GSK1349572 + failing background regimen
    • To examine the incidence of Day 1 genotypic and phenotypic cross-resistance to GSK1349572 and the impact of resistance on treatment response
    • To evaluate the effect of GSK1349572 and OBR on selected virologic and immunologic markers of HIV-1 infection over time
    • To evaluate the safety and tolerability of GSK1349572 + OBR over time
    • To assess steady-state plasma GSK1349572 PK at Day 10, Week 4 and Week 24
    • To explore the relationship between GSK1349572 PK measures and antiviral activity and/or adverse events (AEs) and assess the effect of patient characteristics (e.g. demographics, baseline HIV RNA, baseline resistance to GSK1349572, and phenotypic sensitivity score of OBR) on PK, PD, and PK/PD relationship.
    • To assess treatment emergent viral resistance patterns and potential relationship with treatment outcome
    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 > 1,000 copies/mL at Screening.
    2. Subject is ART-experienced (defined as on stable ART for at least the last 2 months) and is either currently experiencing virologic failure to RAL or experienced virologic failure to RAL >8 weeks prior to Screening (with documented genotypic and/or phenotypic RAL resistance at time of failure) and is currently experiencing treatment failure on a subsequent regimen
    3. Subject has documented RAL genotypic resistance on Screening genotype
    4. Subject has documented genotypic or phenotypic resistance to at least one drug from each of three or more of all approved classes of ART based on Screening genotype/phenotype and/or historical genotype/phenotype data.
    5. Subject is >18 years of age. A female is eligible to enter and participate in the study if she falls into one of the following categories:
    a. Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal defined as 24 months of spontaneous amenorrhea;
    or,
    b. Child-bearing potential, with a negative pregnancy test at screen and a negative pregnancy test at Day 1, who agrees to use one of the methods of contraception listed below. Premenarchal females who develop child-bearing potential while on study will be expected to follow one of the methods of contraception listed below.
    • 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).
    • Any intrauterine device (IUD) with published data showing that the expected failure rate is <1% per year
    • Any other method with published data showing that the lowest expected failure rate for that method is less than 1% per year.
    6. Subject or the subject’s legal representative is willing and able to understand and provide signed and dated written informed consent prior to screening.
    7. 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.
    E.4Principal exclusion criteria
    1. Any pre-existing mental, physical, or substance abuse disorder which, in the opinion of the investigator, may interfere with the subject’s ability to comply with the dosing schedule and/or protocol evaluations (including alcohol or drug abuse) or which may compromise the safety of the subject.
    2. Pregnant women and women who are breastfeeding.
    3. Any evidence of an active Centres for Disease Control and Prevention Category C disease except cutaneous Kaposi’s sarcoma not requiring systemic therapy at the Screening visit. Subjects may be enrolled provided they are on a stable, anti-infective treatment or prophylaxis regimen and are clinically improving at the Baseline visit.
    4. Current use and/or anticipated need for EFV, NVP, FPV/RTV or TPV/RTV during the Functional Monotherapy or Combination Phases of the study.
    5. Subjects who require treatment with any of the following medications within 15 days of commencement of investigational product, or anticipated need during the study: Etravirine (unless co-administered with LPV/RTV or DRV/RTV), rifampin, rifabutin, phenytoin, pheonobarbital, barbiturates, glucocorticoids, modafinil, oxcarbazepine, pioglitazone, troglitazone, carbamazepine, St. Johns wort.
    6. Previous participation in an experimental drug and/or vaccine trials (s) as defined in the protocol, prior to the first dose of study medication.
    7. History of ongoing or clinically relevant pancreatitis or hepatitis within the previous 6 months. Asymptomatic individuals with chronic hepatitis B and hepatitis C virus (HBV, HCV) infection will not be excluded, but should be carefully assessed if therapy specific for HCV infection is required; subjects who are anticipated to require such therapy during the first 24 weeks of the study should be excluded. Any subjects with evidence of cirrhosis with or without hepatitis viral co-infection should be excluded.
    8. History of upper gastrointestinal bleed (unless in the opinion of the Investigator and Sponsor the primary cause was reversible and has been adequately treated) and/or subjects with active peptic ulcer disease
    9. Screening haemoglobin <10g/dL (100g/L).
    10. Subject suffers from a serious medical condition which in the opinion of the Investigator would compromise the safety of the subject.
    11. Any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the subject unable to take oral medication.
    12. Screening lipase > 3 x upper limit of normal (ULN)
    13. 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. Any verified Grade 4 laboratory abnormality at Screening would exclude a subject from study participation unless the investigator can provide a compelling explanation for the laboratory result(s) and has the assent of the Sponsor.
    14. Screening alanine aminotransferase (ALT) >5 x ULN. Subjects with ALT > 2xULN but <5xULN may participate in the study, if in the opinion of the Investigator and Sponsor the lab abnormality will not interfere with the study procedures or compromise subject safety.
    15. Screening ALT >3xULN and bilirubin >1.5xULN (with 35% direct bilirubin).
    16. Personal or family history of prolonged QT syndrome.
    17. Any clinically significant finding on screening or baseline electrocardiograph (ECG) as specified in the protocol.
    18. History or presence of allergy or intolerance to the study drugs or their components or drugs of their class, as defined in the protocol.
    19. Treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to screening, or has an anticipated need for these agents during the study.
    20. Requires treatment with immunomodulators within 28 days prior to screening or subject has received an HIV-1 immunotherapeutic vaccine within 90 days prior to screening.
    21. Immunization within 30 days prior to first dose of investigational product.
    22. French subjects: the French subject has participated in a recent clinical study as defined in the protocol.
    Notwithstanding these minimum inclusion and exclusion criteria, investigators are urged to 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)
    Proportion of subjects with Day 11 plasma HIV-1 RNA <400 copies/mL or at least 0.7 log10 copies/mL below their Baseline value
    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 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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months6
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    F.4.2.2In the whole clinical trial 30
    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 successfully remain on IMP when the last subject completes 24 weeks on study may continue to receive GSK1349572 until it becomes commercially available, the subject is no longer deriving clinical benefit or development of GSK1349572 is discontinued. Should an adverse event require a change in investigational product or the subject experience virologic failure after Week 24, they will be managed as noted per the Withdrawal Criteria.
    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 Decision2009-08-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-22
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-01-23
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