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    Clinical Trial Results:
    A feasibility study to assess the effects of AntiretroViral Intensification with Cenicriviroc for the management of HIV-associated Cognitive Impairment. The AVICCI study

    Summary
    EudraCT number
    		 2015-002955-85
    Trial protocol
    		 GB  
    Global end of trial date
    06 Jan 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Oct 2018
    First version publication date
    14 Oct 2018
    Other versions
    Summary report(s)
    		 Cenicriviroc cerebrospinal fluid exposure abstract

    Trial information

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    Trial identification
    Sponsor protocol code
    AVICCI001
    Additional study identifiers
    ISRCTN number
    		 ISRCTN18166185
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 The AVICCI study: AVICCI01
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    Praed Street, London, United Kingdom,
    Public contact
    Legg, Imperial College London, 44 02033121464, k.legg@imperial.ac.uk
    Scientific contact
    Legg, Imperial College London, 44 02033121464, k.legg@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
    05 Jul 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jan 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Jan 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the acceptability, safety and tolerability of cART intensification with cenicriviroc in PLWH with cognitive impairment
    Protection of trial subjects
    Cerebral magnetic resonance imaging to ensure no imaging contraindications to cerebrospinal fluid examination
    Background therapy
    		 On cART comprising of BHIVA guideline recommended therapies (2015 guidelines) with the exception of elvitegravir/cobicistat and rilpivirine
    Evidence for comparator
    		 No comparator
    Actual start date of recruitment
    29 Jan 2016
    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: 7
    Worldwide total number of subjects
    7
    EEA total number of subjects
    7
    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)
    7
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Of seven subjects enrolled, four completed all study procedures.

    Pre-assignment
    Screening details
    		 Screening period lasted 28 days prior to the baseline visit.

    Pre-assignment period milestones
    Number of subjects started
    		 7
    Intermediate milestone: Number of subjects
    Baseline visit: 7
    Number of subjects completed
    		 7

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open label

    Arms
    Arm title
    		 Treatment
    Arm description
    		 Addition of cenicriviroc
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cenicriviroc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    ART with enzyme inhibition properties Cenicriviroc dose Darunavir/ritonavir 800/100 mg daily, Darunavir / ritonavir 600/100 mg twice daily Atazanavir 300/100 mg daily Total dose 50 mg in morning with food 2 x 25 mg tablet Administration with ART agents with minimal effects on hepatic iso-enzymes: ART Cenicriviroc dose Dolutegravir 50 mg daily, Dolutegravir 50 mg twice daily, Raltegravir 400 mg twice daily Total dose 150 mg in morning with food 1 x 150 mg tablet Administration with ART agents with enzyme induction properties: ART Cenicriviroc dose Efavirenz 600 mg daily Total dose 300 mg in morning with food 2 x 150mg tablet

    Number of subjects in period 1
    		Treatment
    Started
    7
    Baseline visit
    7
    Completed
    4
    Not completed
    3
         Adverse event, non-fatal
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 7 7
    Age categorical
    Male median age 45
    Units: Subjects
    Age continuous
    Median 45 IQR 42-49
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 45 (42 to 49) -
    Gender categorical
    All male
    Units: Subjects
        Female
    		 0 0
        Male
    		 7 7

    End points

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    End points reporting groups
    Reporting group title
    Treatment
    Reporting group description
    		 Addition of cenicriviroc

    Primary: CSF Cenicriviroc concentration

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    End point title
    		 CSF Cenicriviroc concentration [1]
    End point description
    Lumber puncture performed for CSF collection
    End point type
    Primary
    End point timeframe
    8 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive endpoint only.
    End point values
    		 Treatment
    Number of subjects analysed
    4
    Units: ng/ml
    geometric mean (confidence interval 95%)
        CSF Cenicriviroc exposure
    0.43 (0.28 to 0.68)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From first participant first visit to last participant last visit
    Adverse event reporting additional description
    Fatigue, headache, nausea
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SNOMED CT
    Dictionary version
    RF2
    Reporting groups
    Reporting group title
    Participants
    Reporting group description
    		 Participants enrolled on the study

    Serious adverse events
    		 Participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 7 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 7 (42.86%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 7 (14.29%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Fatigue
         subjects affected / exposed
    3 / 7 (42.86%)
         occurrences all number
    3

    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.
    All results are descriptive only.
    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.

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