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    Clinical Trial Results:
    A phase IV study to determine the oral and genital tract concentration of Maraviroc required for ex vivo protection from HIV-1 using Maraviroc 300mg stat

    Summary
    EudraCT number
    		 2012-003778-16
    Trial protocol
    		 GB  
    Global end of trial date
    01 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    06 Dec 2018
    First version publication date
    06 Dec 2018
    Other versions
    Summary report(s)
    		 FINAL STUDY REPORT

    Trial information

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    Trial identification
    Sponsor protocol code
    J005
    Additional study identifiers
    ISRCTN number
    		 -
    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 & St. Thomas' NHS Foundation Trust, 44 02071882643, julie.fox@gstt.nhs.uk
    Scientific contact
    Dr Julie Fox, Guy's & St. Thomas' NHS Foundation Trust, 44 02071882643, julie.fox@gstt.nhs.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 Jul 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Jul 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Jul 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine concentration of Maraviroc in directly aspirated fluid and tissue from the genital tract and rectal compartments at different time periods following a single oral administration of Maraviroc 300mg in HIV-1-negative healthy volunteers
    Protection of trial subjects
    Patients must refrain from drinking grapefruit juice during the study as very large quantities can affect the pharmacokinetics of Maraviroc. Patients are asked to refrain from caffeine and alcohol for 48 hours prior to dosing (if applicable) and until after biopsy.
    Background therapy
    		 None
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    18 Dec 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: 58
    Worldwide total number of subjects
    58
    EEA total number of subjects
    58
    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)
    58
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Healthy adult volunteers were recruited through information presented in community organisations, hospitals, colleges, other institutions and/or advertisements, including email responses to expressed interest. 58 participants were recruited from two centres in London between 2013 and 2015.

    Pre-assignment
    Screening details
    		 Inclusion Criteria Male or non-pregnant, non-lactating females Age between 18 to 50 years, inclusive. Body Mass Index (BMI) of 16 to 35 kg/m2, inclusive. Negative antibody/antigen combined test for HIV-1 and HIV-2. Absence of any significant health problems (in the opinion of the investigator)

    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
    N/A

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 ARM A - CONTROL
    Arm description
    		 1st sampling at end of V2 (baseline) 2nd sampling 4 weeks post V2 No IMP administration
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 ARM B - MARAVIROC 300mg
    Arm description
    		 1st sampling 2 hours post 1stMaraviroc 300g stat dose 2nd sampling 24 hours post 2nd Maraviroc 300mg stat dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    MARAVIROC
    Investigational medicinal product code
    Other name
    CELSENTRI
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg single dose administered at two timepoints one month apart.

    Arm title
    		 ARM C - MARAVIROC 300mg
    Arm description
    		 1st sampling 4 hours post 1stMaraviroc 300g stat dose 2nd sampling 36 hours post 2ndMaraviroc 300mg stat dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    MARAVIROC
    Investigational medicinal product code
    Other name
    CELSENTRI
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg single dose administered at two timepoints one month apart.

    Arm title
    		 ARM D - MARAVIROC 300mg
    Arm description
    		 1st sampling 6 hours post 1stMaraviroc 300mg stat dose 2nd sampling 48 hours post 2ndMaraviroc 300mg stat dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    MARAVIROC
    Investigational medicinal product code
    Other name
    CELSENTRI
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg single dose administered at two timepoints one month apart.

    Arm title
    		 ARM E - MARAVIROC 300mg
    Arm description
    		 1st sampling 12 hours post 1stMaraviroc 300mg stat dose 2nd sampling 72 hours post 2ndMaraviroc 300mg stat dose
    Arm type
    		 Experimental

    Investigational medicinal product name
    MARAVIROC
    Investigational medicinal product code
    Other name
    CELSENTRI
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg single dose administered at two timepoints one month apart.

    Number of subjects in period 1
    		ARM A - CONTROL ARM B - MARAVIROC 300mg ARM C - MARAVIROC 300mg ARM D - MARAVIROC 300mg ARM E - MARAVIROC 300mg
    Started
    10
    12
    12
    12
    12
    Completed
    10
    12
    12
    12
    12

    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
    		 58 58
    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)
    		 58 58
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 28 28
        Male
    		 30 30

    End points

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    End points reporting groups
    Reporting group title
    ARM A - CONTROL
    Reporting group description
    		 1st sampling at end of V2 (baseline) 2nd sampling 4 weeks post V2 No IMP administration

    Reporting group title
    ARM B - MARAVIROC 300mg
    Reporting group description
    		 1st sampling 2 hours post 1stMaraviroc 300g stat dose 2nd sampling 24 hours post 2nd Maraviroc 300mg stat dose

    Reporting group title
    ARM C - MARAVIROC 300mg
    Reporting group description
    		 1st sampling 4 hours post 1stMaraviroc 300g stat dose 2nd sampling 36 hours post 2ndMaraviroc 300mg stat dose

    Reporting group title
    ARM D - MARAVIROC 300mg
    Reporting group description
    		 1st sampling 6 hours post 1stMaraviroc 300mg stat dose 2nd sampling 48 hours post 2ndMaraviroc 300mg stat dose

    Reporting group title
    ARM E - MARAVIROC 300mg
    Reporting group description
    		 1st sampling 12 hours post 1stMaraviroc 300mg stat dose 2nd sampling 72 hours post 2ndMaraviroc 300mg stat dose

    Primary: Concentration of Maraviroc in fluid and tissue

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    End point title
    		 Concentration of Maraviroc in fluid and tissue [1]
    End point description
    Concentration of Maraviroc in fluid and tissue from the genital tract and rectal compartments at different time periods following a single oral administration of Maraviroc 300mg in HIV-1-negative healthy volunteers
    End point type
    Primary
    End point timeframe
    Duration of trial maximum 6 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: See attached document for results
    End point values
    		 ARM A - CONTROL ARM B - MARAVIROC 300mg ARM C - MARAVIROC 300mg ARM D - MARAVIROC 300mg ARM E - MARAVIROC 300mg
    Number of subjects analysed
    10
    12
    12
    12
    12
    Units: whole
    10
    12
    12
    12
    12
    Attachments
    		 Untitled (Filename: MVC PREP RESULTS TABLES.pdf)
    No statistical analyses for this end point

    Secondary: Secondary Enpoint

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    End point title
    		 Secondary Enpoint
    End point description
    Level of Maraviroc required in the plasma, vagina, rectum and urethra for 100% ex vivo protection from HIV-1(this will inform on dosing of intermittent PrEP).
    End point type
    Secondary
    End point timeframe
    0-6 weeks Follow up
    End point values
    		 ARM A - CONTROL ARM B - MARAVIROC 300mg ARM C - MARAVIROC 300mg ARM D - MARAVIROC 300mg ARM E - MARAVIROC 300mg
    Number of subjects analysed
    10
    12
    12
    12
    12
    Units: whole
    10
    12
    12
    12
    12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    0 to 6 weeks follow up visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    ARM B
    Reporting group description
    		 -

    Reporting group title
    ARM C
    Reporting group description
    		 -

    Reporting group title
    ARM A
    Reporting group description
    		 -

    Reporting group title
    ARM D
    Reporting group description
    		 -

    Serious adverse events
    		 ARM B ARM C ARM A ARM D
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 ARM B ARM C ARM A ARM D
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 12 (0.00%)
    2 / 12 (16.67%)
    0 / 10 (0.00%)
    1 / 12 (8.33%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    Post Exposure Prop (PEP). from sexual exposure
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 12 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Gastrointestinal disorders
    Abdominal Pain
         subjects affected / exposed
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    02 Oct 2013
    * Change in CI to Julie Fox * Label update to reflect change in CI
    15 May 2014
    Removal of Hep A from exclusion criteria
    29 Apr 2015
    Additional Control group included

    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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