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    Summary
    EudraCT Number:2017-003430-85
    Sponsor's Protocol Code Number:OBERAL
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-29
    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 ConcernedFinland - Fimea
    A.2EudraCT number2017-003430-85
    A.3Full title of the trial
    A randomized, open, parallel design study to evaluate the effect on liver fat, adipose tissue and metabolic parameters when switching a protease inhibitor or efavirenz to once daily raltegravir in HIV-infected patients with body mass index over 25 kg/m2 and with at least one metabolic syndrome component.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate the effect of changing HIV medication (from a protease inhibitor or efavirenz to raltegravir) on liver fat, fat tissue and metabolic parameters (blood sugar and cholesterol, etc) in overweight or obese patients with metabolic problems.
    A.3.2Name or abbreviated title of the trial where available
    OBERAL
    A.4.1Sponsor's protocol code numberOBERAL
    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 SponsorHelsinki University Hospital
    B.1.3.4CountryFinland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck Sharp & Dohme
    B.4.2CountryFinland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHelsinki University Hospital
    B.5.2Functional name of contact pointDr. Jussi Sutinen
    B.5.3 Address:
    B.5.3.1Street AddressNordenskiöldinkatu 20
    B.5.3.2Town/ cityHelsinki
    B.5.3.3Post code00250
    B.5.3.4CountryFinland
    B.5.6E-mailjussi.sutinen@hus.fi
    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 Yes
    D.2.1.1.1Trade name Isentress
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme 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.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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
    Study subjects are HIV infected patients with BMI>25kg/m2 and who have at least one metabolic syndrome component or a fatty liver disease.
    E.1.1.1Medical condition in easily understood language
    Study subjects are overweight or obese HIV infected patients, who have metabolic syndrome components or a fatty liver disease.
    E.1.1.2Therapeutic area Body processes [G] - Metabolic Phenomena [G03]
    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 evaluate the effect of switching from a protease inhibitor or efavirenz to raltegravir on liver fat content.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of ART switch (a protease inhibitor or efavirenz to raltegravir) on
    1. Liver Stiffness
    2. Body Composition including subcutaneous and visceral adipose tissue volume
    3. Glucose Metabolism
    4. Lipid Profile
    5. Metabolic and Inflammatory Biomarkers
    6. Subcutaneous adipose tissue metabolic gene expression
    7.Stool microbiome, saliva and urine
    10. Basal metabolic rate.
    In addition,
    8. To collect safety and tolerability data related to the switch to raltegravir.
    9. To analyze the fatty liver adipose allele (B-PNPLA3) in this study group.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent (IC) obtained

    • HIV-positive adult (over 18 years) subjects currently on stable ART, with no changes in the ART regimens during the past 6 months

    • Current ART includes either a protease inhibitor or efavirenz

    • No documented or suspected resistance to integrase inhibitors or to NRTIs

    • No prior history of virologic failure. Failure is defined as a confirmed plasma viral load > 200 cop/ml measured no less than six months after initiation or modification of therapy

    • Virological blips accepted only if a single viral load measurement has been between 50-200 cop/ml followed by VL < 50 cop/ml without the need to initiate a change in ART and no blip within 12 month window period prior to screening

    • Documented evidence of at least two HIV VL < 50 cop/ml measurements conducted during the past 12 months prior to inclusion: one within 6 months prior to screening

    • HIV VL < 50 cop/ml at screening

    • BMI>25 kg/m2 and at least one metabolic syndrome condition, which are
    o BP ≥ 130/≥ 85 mmHg or hypertension medication currently in use or
    o fasting glucose ≥ 5.6 mmol/l or B-HbA1C > 42 mmol/mol or diabetes medication currently in use or
    o HDL < 1.0 mmol/l in men and < 1.3 mmol/l in women or triglycerides ≥ 1.7 mmol/l or a cholesterol-lowering regimen currently in use or
    o waist circumference > 94 cm in men and >80 cm in women (or respective cut off values for non-European ethnic groups as defined by International Diabetes Federation)

    OR

    • ultrasound or biopsy proven hepatosteatosis
    E.4Principal exclusion criteria
    • Within 12 month window period prior to screening, one or more HIV VL measurement of >50 cop/ml
    • More than one consecutive HIV VL measurements of > 50 cop/ml in the treatment history after initial viral suppression with ART
    • Chronic hepatitis B or C
    • Daily alcohol consumption ≥ 30 g for men and ≥ 20 g for women
    • Pregnancy or planned pregnancy during the study period
    • Lipid or glucose lowering regimen or hormonal supplement started within 3 months before the planned study start
    • Psychiatric disorder, which prevents a study subject to understand the study protocol
    • Other serious disease, which prevents a study subject to participate in the study
    • For MRI/spectroscopy imaging: metal objects in the body or claustrophobia
    E.5 End points
    E.5.1Primary end point(s)
    The change in liver fat content measurered by the proton magnetic resonance spectroscopy after 24 weeks of changing a protease inhibitor or efavirenz to raltegravir versus continuing a protease inhibitor or efavirenz -containing regimen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline and 24 weeks.
    E.5.2Secondary end point(s)
    1.Baseline to 24-week Change in Body Composition (subcutaneous and visceral adipose tissue volume measured by magnetic resonance imaging), total body fat and lean tissue mass measured by Bioelectrical Impedance Analysis

    2.Baseline to 24-week Change in Liver Stiffness measured by transient elastography (Fibroscan ®)

    3.Baseline to 24-week Change in Glucose Metabolism including fasting glucose, insulin, 2-h oral glucose tolerance test

    4.Baseline to 24-week Change in Lipid Profile (LDL and HDL cholesterol, Triglyceride)

    5.Baseline to 24-week Change in Metabolic and Inflammatory Biomarkers (e.g. high-sensitivity C-reactive protein (hsCRP), adiponectin, etc)

    6.Baseline to 24-week Change in subcutaneous adipose tissue gene expression (focusing in metabolic and inflammatory gene expression panels)

    7.Baseline to 24-week Change in stool and saliva microbiomes

    8. Determination of basal metabolic rate by indirect calorimetry at screening and at the end of study

    9. Monitoring safety and tolerability throughout the study

    10. Determination of the fatty liver adipose allele (B-PNPLA3)

    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline and 24 weeks.
    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 No
    E.6.6Pharmacokinetic No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state50
    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)
    The treatment of the study subjects will continue after the trial as standard of care with a possibility to continue their study drugs.
    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 Decision2017-10-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-29
    P. End of Trial
    P.End of Trial StatusCompleted
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