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    Clinical Trial Results:
    Investigating the effect of Maraviroc on microbial translocation in HIV-1 infected individuals who are receiving antiretroviral therapy

    Summary
    EudraCT number
    		 2010-023625-38
    Trial protocol
    		 GB  
    Global end of trial date
    01 Oct 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 Feb 2019
    First version publication date
    09 Feb 2019
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    JF003
    Additional study identifiers
    ISRCTN number
    		 ISRCTN81045654
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Guy's and St Thomas' NHS Foundation Trust
    Sponsor organisation address
    Great Maze Pond, London, United Kingdom, SE19RT
    Public contact
    Dr Julie Fox, Guy's and St Thomas' NHS Foundation Trust, 0044 02071887188, julie.fox@kcl.ac.uk
    Scientific contact
    Dr Julie Fox, Guy's and St Thomas' NHS Foundation Trust, 0044 02071887188, julie.fox@kcl.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
    01 Oct 2014
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Oct 2014
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Oct 2014
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine whether the addition of a CCR5 inhibitor to a stable ART regimen reduces microbial translocation (as determined by plasma bacterial 16s DNA)
    Protection of trial subjects
    Patients will be given information regarding which symptoms should alert them to the possibility of a serious adverse event following their biopsies, in particular perforation or bleeding,. In the event of these symptoms they will be advised to attend their local Accident & Emergency Department directly and to take with them their Patient Information Card and/or inform the medical staff that they are participating in a clinical trial and that the research unit needs to be informed of their admission.
    Background therapy
    		 Participants must be stable on antiretroviral therapy for at least 12 months.
    Evidence for comparator
    		 n/a
    Actual start date of recruitment
    01 May 2012
    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: 10
    Worldwide total number of subjects
    10
    EEA total number of subjects
    10
    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)
    10
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were recruited from one clinical site in London during 2014.

    Pre-assignment
    Screening details
    		 Inclusion Criteria:- Males and females aged between 18-64 stable on antiretroviral therapy for at least 12 months. Screening CD4+ T cell count below 500 cells/mm.3 Screening plasma HIV RNA levels below 100 copies RNA/mL. Ability and willingness of subject to give provide informed consent.

    Period 1
    Period 1 title
    Whole Group (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Open label proof of concept trial.

    Arms
    Arm title
    		 Full study
    Arm description
    		 All participants as this is a single arm proof of concept trial.
    Arm type
    		 Pilot

    Investigational medicinal product name
    MARAVIROC
    Investigational medicinal product code
    Other name
    CELCENTRI
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Maraviroc is marketed as CELSENTRI ® by ViiV Healthcare in film-coated tablets either 150mg or 300 mg in 60 tab pack. Maraviroc dose based on each participants current medications in regimen as per SmPC.

    Number of subjects in period 1
    		Full study
    Started
    10
    Completed
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Whole Group
    Reporting group description
    		 -

    Reporting group values
    		 Whole Group Total
    Number of subjects
    		 10 10
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 10 10
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 10 10

    End points

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    End points reporting groups
    Reporting group title
    Full study
    Reporting group description
    		 All participants as this is a single arm proof of concept trial.

    Primary: Microbial Translocation

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    End point title
    		 Microbial Translocation [1]
    End point description
    Level of Microbial translocation as quantified by bacterial 16s DNA PCR at week 24
    End point type
    Primary
    End point timeframe
    Week 24 of participation.
    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: See attached document for all results data.
    End point values
    		 Full study
    Number of subjects analysed
    10
    Units: whole
    10
    Attachments
    		 Results
    No statistical analyses for this end point

    Secondary: Secondary Endpoints

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    End point title
    		 Secondary Endpoints
    End point description
    - Level of gut permeability: changes in level of CD14a - Immune activation: changes in levels of CD8+CD38+ - Clinical outcome: CD4+ T cell count change and HIV plasma viral load change. - Biomarkers of inflammation: levels of D-dimer - Low copy HIV viral quantification - Neurocognitive function: memory tests - Gut immune reconstitution : Immunohistochemistry
    End point type
    Secondary
    End point timeframe
    Week 24 of Participation
    End point values
    		 Full study
    Number of subjects analysed
    10
    Units: whole
    10
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Duration of trial
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Whole Trial
    Reporting group description
    		 -

    Serious adverse events
    		 Whole Trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Whole Trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    5 / 10 (50.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    General disorders and administration site conditions
    Rectal spotting post biopsy
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Bursitis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    pain on palpation at sterno-costo-clavicular joint associated with signs of sternochondritis
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Severe chest pain
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Infections and infestations
    Eye Infection left eye
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Gonorrhea throat
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Skin Irritation associated with fungal skin infection
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    Syphillis (re-infection)
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1
    tooth infection
         subjects affected / exposed
    1 / 10 (10.00%)
         occurrences all number
    1

    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.
    This is a proof of concept unpowered study involving 10 volunteers. The results of which will be used to provide information about the feasibility of conducting a large scale randomised control study. There is currently no pilot data on the effect of

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27917639
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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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