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    Clinical Trial Results:
    The Central Nervous System Effects of Two Different HIV-Integrase Inhibitor Containing Antiretroviral Regimens.

    Summary
    EudraCT number
    		 2014-003710-84
    Trial protocol
    		 GB  
    Global end of trial date
    02 Aug 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Oct 2019
    First version publication date
    28 Oct 2019
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    CIIS
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    South Kensingston Campus, London, United Kingdom, SW7 2AZ
    Public contact
    Prof Alan Winston, Imperial College London, +44 020 3312 1603, a.winston@imperial.ac.uk
    Scientific contact
    Prof Alan Winston, Imperial College London, +44 020 3312 1603, a.winston@imperial.ac.uk
    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
    31 Aug 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    02 Aug 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    02 Aug 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of the study is to compare cerebral function parameters in HIV-infected subjects receiving two different integrase-inhibitor containing antiretroviral regimens by assessing the following questions: -Principal research question: • Changes in neurocognitive function between study treatment arms.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 2015
    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
    United Kingdom: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    22
    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)
    20
    From 65 to 84 years
    2
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Study was conducted at St. Mary’s Hospital (Imperial College Healthcare NHS Trust, London, UK) from July 2015 to August 2016.

    Pre-assignment
    Screening details
    		 Of 28 participants screened, 22 were randomised and 20 completed study. Individuals were randomised on a 2:1 basis to either switch integrase inhibitor from raltegravir to dolutegravir 50 mg once daily (Switch Arm) or to remain on raltegravir (Control Arm).

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Switch Arm
    Arm description
    		 Switch integrase inhibitor from Raltegravir to Dolutegravir 50 mg once daily
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg once daily

    Investigational medicinal product name
    Truvada
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    tenofovir/emtricitabine 245/200 mg

    Arm title
    		 Control Arm
    Arm description
    		 Remain on raltegravir treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Raltegravir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    400 mg twice daily

    Investigational medicinal product name
    Truvada
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    tenofovir/emtricitabine 245/200 mg

    Number of subjects in period 1
    		Switch Arm Control Arm
    Started
    13
    9
    Completed
    12
    8
    Not completed
    1
    1
         Consent withdrawn by subject
    -
    1
         Death not related to drug
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Switch Arm
    Reporting group description
    		 Switch integrase inhibitor from Raltegravir to Dolutegravir 50 mg once daily

    Reporting group title
    Control Arm
    Reporting group description
    		 Remain on raltegravir treatment

    Reporting group values
    		 Switch Arm Control Arm Total
    Number of subjects
    		 13 9 22
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 12 8 20
        From 65-84 years
    		 1 1 2
    Age continuous
    Units: years
        geometric mean (inter-quartile range (Q1-Q3))
    		 43 (30 to 56) 39.5 (24 to 55) -
    Gender categorical
    Units: Subjects
        Female
    		 0 2 2
        Male
    		 13 7 20
    BMI
    Units: kg/m2
        geometric mean (standard deviation)
    		 27.4 ( 3.4 ) 25.4 ( 2.9 ) -
    Baseline absolute CD4+ count
    Units: cells/µL
        geometric mean (standard deviation)
    		 736 ( 237 ) 688 ( 395 ) -

    End points

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    End points reporting groups
    Reporting group title
    Switch Arm
    Reporting group description
    		 Switch integrase inhibitor from Raltegravir to Dolutegravir 50 mg once daily

    Reporting group title
    Control Arm
    Reporting group description
    		 Remain on raltegravir treatment

    Primary: Change in PHQ-9 questionnaires score from baseline

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    End point title
    		 Change in PHQ-9 questionnaires score from baseline
    End point description
    End point type
    Primary
    End point timeframe
    120 days
    End point values
    		 Switch Arm Control Arm
    Number of subjects analysed
    12
    8
    Units: score
        median (full range (min-max))
    -0.5 (-5 to 3)
    0 (-5 to 1)
    Statistical analysis title
    		 PHQ-9
    Comparison groups
    Switch Arm v Control Arm
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.57
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in Beck’s depression questionnaire score from baseline

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    End point title
    		 Change in Beck’s depression questionnaire score from baseline
    End point description
    End point type
    Primary
    End point timeframe
    120 days
    End point values
    		 Switch Arm Control Arm
    Number of subjects analysed
    12
    8
    Units: score
        median (full range (min-max))
    -1 (-15 to 9)
    -1.5 (-10 to 2)
    Statistical analysis title
    		 Beck’s depression questionnaire
    Comparison groups
    Switch Arm v Control Arm
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.38
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Primary: Change in cognitive function from baseline

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    End point title
    		 Change in cognitive function from baseline
    End point description
    End point type
    Primary
    End point timeframe
    120 days
    End point values
    		 Switch Arm Control Arm
    Number of subjects analysed
    12
    8
    Units: score
        geometric mean (standard deviation)
    0.14 ( 0.4 )
    0.14 ( 0.37 )
    Statistical analysis title
    		 Cognitive Function
    Comparison groups
    Switch Arm v Control Arm
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.98
    Method
    		 t-test, 2-sided
    Confidence interval

    Primary: Change in cerebral metabolite from baseline (NAA/Cr frontal grey matter)

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    End point title
    		 Change in cerebral metabolite from baseline (NAA/Cr frontal grey matter)
    End point description
    End point type
    Primary
    End point timeframe
    120 days
    End point values
    		 Switch Arm Control Arm
    Number of subjects analysed
    12
    8
    Units: ng/mL
        geometric mean (standard deviation)
    0.08 ( 00.14 )
    -0.06 ( 0.16 )
    Statistical analysis title
    		 Metabolites
    Comparison groups
    Switch Arm v Control Arm
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.07
    Method
    		 Regression, Linear
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    120 days
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    10
    Reporting groups
    Reporting group title
    Switch group
    Reporting group description
    		 -

    Reporting group title
    Control group
    Reporting group description
    		 -

    Serious adverse events
    		 Switch group Control group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    1
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Switch group Control group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 13 (0.00%)
    0 / 8 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No study related non serious AE

    More information

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    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
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    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.

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