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    Summary
    EudraCT Number:2010-018532-40
    Sponsor's Protocol Code Number:SGN113399
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-09-02
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2010-018532-40
    A.3Full title of the trial
    A Phase 2b study to select a once daily oral dose of GSK2248761 in HIV-1 infected antiretroviral therapy experienced adults with non-nucleoside reverse transcriptase
    inhibitor (NNRTI) resistance
    A.4.1Sponsor's protocol code numberSGN113399
    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 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 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.3.1Product nameGSK2248761
    D.3.2Product code GSK2248761
    D.3.4Pharmaceutical form Capsule*
    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 1018450-26-4
    D.3.9.2Current sponsor codeGSK2248761
    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) 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.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 Intelence
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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.3.4Pharmaceutical form 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.3.8INN - Proposed INNETRAVIRINE
    D.3.9.1CAS number 269055-15-4
    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) 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
    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
    HIV-1 infected antiretroviral therapy experienced adult subjects
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    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 select a once daily dose of GSK2248761 for further evaluation in Phase 3 based on a comparison of the Week 16 antiviral activity and tolerability of two oral doses of
    GSK2248761 in treatment-experienced HIV-1 infected subjects who have documented NNRTI-resistant virus.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of GSK2248761 on virologic and immunologic markers of HIV infection through week 48;
    To evaluate the safety and tolerability of GSK2248761 through week 48;
    To characterize GSK2248761 PK and identify potential covariates that influence the PK, also to evaluate the effect of GSK2248761 on darunavir and ritonavir exposures
    To confirm the optimal GSK2248761 dose at Week 24 based on antiviral activity in conjunction with immunologic, safety and PK measures;
    To explore exposure-response relationships of GSK2248761 and predict clinical PK and PD outcome to assist with dose selection for Phase 3 trials;
    To assess the development of viral resistance in subjects experiencing protocol-defined virologic failure;
    To evaluate the effect of subject characteristics on exposure-response parameters of GSK2248761;
    To evaluate the antiviral activity, safety, tolerability and development of viral
    resistance of the selected dose of GSK2248761 relative to ETV over 48 weeks
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) HIV-1 infected adults ≥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; or, b. Child-bearing potential, with a negative pregnancy test at screen and Day 1 and agrees to one of the methods of contraception listed below. Premenarchal females who develop child-bearing potential while on study will also be expected to follow one of the methods of contraception listed below:
    - 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. Should a subject of child-bearing potential decide to
    become sexually active during the course of the study, she must be counseled
    and be willing to use one of the other contraception methods listed below:
    - 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 (not all IUDs meet this criterion).
    - Any other method with published data showing that the lowest expected
    failure rate for that method is <1% per year.
    Note: Since no data is currently available on interactions between hormonal
    contraceptives and GSK2248761, hormonal contraceptives are excluded medications in this study unless supportive drug interaction data becomes available.
    Note:Non-child-bearing potential is defined as pre-menopausal with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or post-menopausal defined as 24 months of spontaneous amenorrhea.
    Any contraception method must be used consistently and in accordance with the
    approved product label.
    All study subjects should be counseled on the practice of safer sexual practices including
    the use of effective barrier methods (e.g. male condom/spermicide).
    2) HIV-1 infection with a screening plasma HIV-1 RNA ≥400copies/mL;
    3) Previously received or current treatment with antiretroviral therapy (HAART) for
    HIV-1 infection (patient may be off ART at time of screening);
    4) HIV-1 harboring NNRTI resistance by screening genotype (defined as the presence
    of ≥1 NNRTI resistance-associated mutations
    E.4Principal exclusion criteria
    1. Any pre-existing physical or mental condition (including substance abuse disorder) which, may interfere with the subject’s ability to comply with the study requirements or which may compromise the safety of the subject;
    2. 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;
    3. Women who are currently breastfeeding;
    4. Any evidence of an active Centers for Disease and Prevention Control (CDC) Category C disease, except cutaneous Kaposi’s sarcoma not requiring systemic therapy;
    5. History of ongoing or clinically relevant hepatitis within the previous 6 months, including chronic hepatitis B virus (HBV) infection (HBsAg positive). Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded
    6. History of liver cirrhosis with or without hepatitis viral co-infection;
    7. Ongoing or clinically relevant pancreatitis;
    8. History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia;
    9. Personal or known family history of prolonged QT syndrome;
    10. History or presence of allergy or intolerance to the study drugs or their components, or a history of drug or other allergy that, in the opinion of the Principal Investigator, contraindicates their participation. In addition, if heparin is used during PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled;
    11. HIV-1 genotype results with any of the following will be excluded:
    • Any screening genotype with virus showing a Y181 mutation in combination with any other NNRTI resistance-associated mutations;
    • Any screening genotype with virus showing a Y181I or Y188L alone or in combination with any other NNRTI resistance-associated mutations;
    12. HIV-1 phenotype results with any of the following will be excluded:
    • Any screening phenotype with virus showing etravirine fold change >10;
    • Any screening phenotype with virus showing darunavir fold change >20;
    • Any screening phenotype with virus showing raltegravir fold change >1.5;
    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 medical monitor;
    14. Any of the following laboratory values at screening:
    • Creatinine clearance <50 mL/min via Cockroft-Gault method;
    • Alanine aminotransferase (ALT) ≥5 times ULN. Subjects with ALT > 2xULN but <5xULN may participate in the study, if in the opinion of the Investigator and GSK medical monitor the lab abnormality will not interfere with the study procedures or compromise subject safety;
    • Alanine aminotransferase (ALT) ≥3xULN and bilirubin ≥1.5xULN (with >35% direct bilirubin);
    15. Any clinically significant finding on screening electrocardiograph (ECG), specifically (a single repeat is allowed to determine eligibility):
    • Heart rate <45 and >100bpm (males), <50 and >100bpm (females); Note: A heart rate from 100 to 110 BPM can be rechecked within 30 minutes to verify eligibility.
    • QRS duration >120msec;
    • QTc interval > 450msec;
    • Non-sustained (≥ 3 consecutive beats) or sustained ventricular tachycardia;
    • Sinus pauses >2.5 seconds;
    • 2nd degree (Type II) or higher AV (Atrioventricular) block;
    • Evidence of WPW (Wolff-Parkinson-White) syndrome (ventricular preexcitation);
    • Pathologic Q waves (defined as Q wave > 40msec OR depth >0.4 mV;
    • Any other abnormality which in the opinion of the investigator would interfere with the safety of the subject;
    16. Treatment with any of the following agents within 28 days prior to screening, or has an anticipated need for these agents during the study:
    • radiation therapy or cytotoxic chemotherapeutic agents;
    • immunomodulators (such as systemic corticosteroids, interleukins, or interferons); Note: Subjects using short-term (<7 day) steroid tapers and inhaled corticosteroids are eligible for enrollment.
    • Any non-protocol-specified agent with documented activity against HIV-1 in vitro;
    17. Treatment with an HIV-1 immunotherapeutic vaccine within 90 days prior to screening;
    18. Receipt of an experimental drug and/or vaccine within 28 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;
    19. Immunization within 28 days prior to first dose of IP.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects with HIV-1 RNA <50copies/mL at Week 16. Dose selection
    will be based primarily on antiviral activity and tolerability in conjunction with
    immunologic, safety, virologic resistance and PK measures. Data from the Week 24
    analysis will be used to confirm dose selection.
    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 Yes
    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 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 No
    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.8.3 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 EEA33
    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 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
    SGN113399 is a 48 week study. However, in order to provide for continuity of care, subjects who successfully complete 48 weeks of randomized therapy with GSK2248761 will have the opportunity to continue to receive GSK2248761 until commercialization, unless development of GSK2248761 is terminated or the subject meets a protocol-defined criterion requiring discontinuation. Data from these subjects will provide long term descriptive information on safety, tolerability and durability of response.
    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 months7
    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 months7
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    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 75
    F.4.2.2In the whole clinical trial 150
    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)
    Subjects randomized to receive GSK2248761 and who have successfully completed Week 48 of treatment will be given the opportunity to continue to receive SK2248761
    until one of the following occurs:
    • GSK2248761 is locally approved and commercially available
    • The development of GSK2248761 is discontinued
    Refer to protocol (p44)
    • The subject no longer derives clinical benefit from the receipt of GSK2248761
    • The subject meets a protocol-defined reason for discontinuation
    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 Decision2010-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-07-19
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