Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43932   clinical trials with a EudraCT protocol, of which   7307   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    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.

    Summary
    EudraCT number
    2017-003430-85
    Trial protocol
    FI  
    Global end of trial date
    02 Nov 2019

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Aug 2021
    First version publication date
    26 Aug 2021
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    OBERAL
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Helsinki University Hospital Infectious Disease Clinic
    Sponsor organisation address
    Kolmiosairaala Haartmaninkatu 4, Helsinki, Finland, 00290
    Public contact
    Dr. Jussi Sutinen, Helsinki University Hospital, jussi.sutinen@hus.fi
    Scientific contact
    Dr. Jussi Sutinen, Helsinki University Hospital, 358 407480437, jussi.sutinen@hus.fi
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    30 Sep 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Nov 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Nov 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the effect of switching from a protease inhibitor or efavirenz to raltegravir on liver fat content.
    Protection of trial subjects
    Subjects had direct phone numbers to the investigators and could contact them 24/7. Local anesthesia was used with invasive procedures.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    04 Dec 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 45
    Worldwide total number of subjects
    45
    EEA total number of subjects
    45
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    43
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    All subjects were recruited from Finland during the period of Oct 2017 - April 2019.

    Pre-assignment
    Screening details
    HIV-infected patients who were overweight or obese and had at least one metabolic syndrome component, or who had fatty liver diagnosed by imaging studies .

    Pre-assignment period milestones
    Number of subjects started
    45
    Number of subjects completed
    45

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Not blinded
    Blinding implementation details
    This is an open label randomized controlled study.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Raltegravir
    Arm description
    Those subjects who switched their earlier protease inhibitor or efavirenz to raltegravir.
    Arm type
    Experimental

    Investigational medicinal product name
    raltegravir
    Investigational medicinal product code
    J05AJ01
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Raltegravir was taken 1200 mg once a day.

    Arm title
    Control
    Arm description
    Subjects who continued their protease inhibitor or efavirenz containing antiretroviral regimen unchanged.
    Arm type
    Active comparator

    Investigational medicinal product name
    efavirenz
    Investigational medicinal product code
    J05AG03
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The control subjects continued their efavirenz (600mg QD) or protease inhibitor containing regimen unchanged.

    Number of subjects in period 1
    Raltegravir Control
    Started
    21
    24
    Completed
    19
    23
    Not completed
    2
    1
         Consent withdrawn by subject
    2
    -
         Adverse event, non-fatal
    -
    1

    Baseline characteristics

    Close Top of page

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Raltegravir
    Reporting group description
    Those subjects who switched their earlier protease inhibitor or efavirenz to raltegravir.

    Reporting group title
    Control
    Reporting group description
    Subjects who continued their protease inhibitor or efavirenz containing antiretroviral regimen unchanged.

    Primary: Change in liver fat content from baseline to 24 weeks.

    Close Top of page
    End point title
    Change in liver fat content from baseline to 24 weeks.
    End point description
    End point type
    Primary
    End point timeframe
    The change in liver fat between baseline and 24 weeks.
    End point values
    Raltegravir Control
    Number of subjects analysed
    18
    21
    Units: liver fat fraction (%)
        median (inter-quartile range (Q1-Q3))
    0.6 (-0.3 to 1.6)
    0.3 (-0.5 to 2.7)
    Statistical analysis title
    Comparison
    Statistical analysis description
    The change from baseline and 24 weeks within the study groups and between the study groups were analyzed
    Comparison groups
    Raltegravir v Control
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    other [1]
    P-value
    > 0.05 [2]
    Method
    Wilcoxon (Mann-Whitney)
    Parameter type
    Median difference (net)
    Confidence interval
    Notes
    [1] - Within group changes were analyzed using Wilcoxon signed rank test and differences between the groups were analyzed Mann-Whitney test.
    [2] - non significant in all comparisons

    Adverse events

    Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    8 Feb 2018 - 2 Nov 2019.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Raltegravir
    Reporting group description
    -

    Reporting group title
    Control
    Reporting group description
    -

    Serious adverse events
    Raltegravir Control
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 24 (4.17%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    Gastrointestinal disorders
    Pancreatitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 24 (4.17%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    Raltegravir Control
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    16 / 19 (84.21%)
    20 / 24 (83.33%)
    Nervous system disorders
    dizzyness
         subjects affected / exposed
    5 / 19 (26.32%)
    8 / 24 (33.33%)
         occurrences all number
    16
    20
    Headache
         subjects affected / exposed
    9 / 19 (47.37%)
    8 / 24 (33.33%)
         occurrences all number
    16
    20
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    9 / 19 (47.37%)
    7 / 24 (29.17%)
         occurrences all number
    16
    20

    More information

    Close Top of page

    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)

    Were there any global interruptions to the trial? No

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA