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    Clinical Trial Results:
    Bictegravir concentrations and antiviral activity in genital fluids and rectal compartment in HIV-1 infected individuals (“BIGER Study”).

    Summary
    EudraCT number
    		 2018-002310-12
    Trial protocol
    		 ES  
    Global end of trial date
    03 Dec 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    17 Oct 2021
    First version publication date
    17 Oct 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    IN-ES-380-4663
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Fight AIDS and Infectious diseases foundation
    Sponsor organisation address
    Ctra Canyet s/n, Badalona/Barcelona, Spain, 08916
    Public contact
    Unidad de VIH, Hospital Universitari de Bellvitge, 0034 9333590112876, dpodzamczer@bellvitgehospital.cat
    Scientific contact
    Unidad de VIH, Hospital Universitari de Bellvitge, 0034 9333590112876, anavarroa@bellvitgehospital.cat
    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
    03 Mar 2020
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    03 Dec 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    -To evaluate HIV viral kinetics in seminal plasma and rectal fluid, and cervicovaginal fluid in HIV-1 infected ART naïve male and female individuals, respectively, initiating Bictegravir/FTC/TAF. - To determine Bictegravir concentrations in fluid and tissue from the male and female genital tract (seminal plasma and cervicovaginal fluid) and rectal compartment (rectal tissue and rectal fluid) in HIV-1 infected male and female individuals receiving ART with Bictegravir/FTC/TAF.
    Protection of trial subjects
    Although assessed treatment is approved and is used in routine care, the sponsor contracted an insurance as a mandatory aspect defined in the legal framework of the country site due a different procedures performed during the clinical trial out of routine clinical practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Oct 2018
    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
    Spain: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Subjects who met inclusion criteria and accepted to sign the informed consent to participate will be cited for a screening visit. A total of 25 HIV-infected patients were selected at the screening phase, and 1 patient was screening failure. Recruitment was started 01-feb-2019 and the last patient recruited was 28-may-2019. First

    Pre-assignment
    Screening details
    		 25 patient were screened. 1 patient was screening failure.

    Pre-assignment period milestones
    Number of subjects started
    		 25 [1]
    Number of subjects completed
    		 24

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Screening failure: 1
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 25 patients were screened. 1 patient was screening failure
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 BIC/TAF/FTC
    Arm description
    		 Bictegravir/Tenofovir Alafenamide Fumarate/Emtricitabine treatment
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bictegravir/Emtricitabine/Tenofovir alafenamide fumarate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg Bictegravir /200 mg Emtracitibine/Tenofovir alafenamide fumarate 25 mg

    Number of subjects in period 1
    		BIC/TAF/FTC
    Started
    24
    Completed
    23
    Not completed
    1
         Protocol deviation
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial (overall period) Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 30 (20 to 57) -
    Gender categorical
    Units: Subjects
        Female
    		 8 8
        Male
    		 16 16
    Subject analysis sets

    Subject analysis set title
    Overall analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients were included in this analysis. Full analysis assessed the differences in viral suppression efficacy on the different reservoirs evaluated

    Subject analysis sets values
    		 Overall analysis
    Number of subjects
    23
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    Gender categorical
    Units: Subjects
        Female
    8
        Male
    15

    End points

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    End points reporting groups
    Reporting group title
    BIC/TAF/FTC
    Reporting group description
    		 Bictegravir/Tenofovir Alafenamide Fumarate/Emtricitabine treatment

    Subject analysis set title
    Overall analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All patients were included in this analysis. Full analysis assessed the differences in viral suppression efficacy on the different reservoirs evaluated

    Primary: HIV-1 RNA decay in seminal plasma from baseline and up to 24 weeks

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    End point title
    		 HIV-1 RNA decay in seminal plasma from baseline and up to 24 weeks [1]
    End point description
    End point type
    Primary
    End point timeframe
    week 24
    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: Data reported has been a descriptive analysis, which shows the Bictegravir concentration in different anatomical reservoirs
    End point values
    		 BIC/TAF/FTC Overall analysis
    Number of subjects analysed
    15 [2]
    15
    Units: log10 copies/ml
        median (inter-quartile range (Q1-Q3))
    -2.23 (-2.49 to -1.11)
    -2.23 (-2.49 to -1.11)
    Notes
    [2] - Only male participants were assessed on this endpoint
    No statistical analyses for this end point

    Primary: Concentration of Bictegravir in seminal plasma, at week4 after initiation a first ART regimen with Bictegravir/FTC/TAF.

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    End point title
    		 Concentration of Bictegravir in seminal plasma, at week4 after initiation a first ART regimen with Bictegravir/FTC/TAF. [3]
    End point description
    End point type
    Primary
    End point timeframe
    week 4
    Notes
    [3] - 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: Data reported has been a descriptive analysis, which shows the Bictegravir concentration in different anatomical reservoirs
    End point values
    		 BIC/TAF/FTC Overall analysis
    Number of subjects analysed
    15 [4]
    15
    Units: ng/ml or ng/g
        median (inter-quartile range (Q1-Q3))
    65.5 (20.1 to 923)
    65.5 (20.1 to 923)
    Notes
    [4] - Only male participants were assessed on this endpoint
    No statistical analyses for this end point

    Primary: HIV-1 RNA decay in rectal fluid from baseline and up to 24 weeks

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    End point title
    		 HIV-1 RNA decay in rectal fluid from baseline and up to 24 weeks [5]
    End point description
    End point type
    Primary
    End point timeframe
    week 24
    Notes
    [5] - 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: Data reported has been a descriptive analysis, which shows the HIV-1 RNA decay in different anatomical reservoirs
    End point values
    		 BIC/TAF/FTC Overall analysis
    Number of subjects analysed
    15 [6]
    15
    Units: log10 copies/mL
        median (inter-quartile range (Q1-Q3))
    -2.89 (-3.4 to -1.68)
    -2.89 (-3.4 to -1.68)
    Notes
    [6] - Only male participants were assessed on this endpoint
    No statistical analyses for this end point

    Primary: Concentration of Bictegravir in rectal fluid at weeks 4 after initiation a first ART regimen with Bictegravir/FTC/TAF.

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    End point title
    		 Concentration of Bictegravir in rectal fluid at weeks 4 after initiation a first ART regimen with Bictegravir/FTC/TAF. [7]
    End point description
    End point type
    Primary
    End point timeframe
    weeks 4.
    Notes
    [7] - 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: Data reported has been a descriptive analysis, which shows the Bictegravir concentration in different anatomical reservoirs
    End point values
    		 BIC/TAF/FTC Overall analysis
    Number of subjects analysed
    15 [8]
    15
    Units: ng/g
        median (inter-quartile range (Q1-Q3))
    74.1 (6 to 478.5)
    74.1 (6 to 478.5)
    Notes
    [8] - Only male participants were assessed on this endpoint
    No statistical analyses for this end point

    Primary: Concentration of Bictegravir in cervicovaginal fluid at weeks 12 after initiation a first ART regimen with Bictegravir/FTC/TAF.

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    End point title
    		 Concentration of Bictegravir in cervicovaginal fluid at weeks 12 after initiation a first ART regimen with Bictegravir/FTC/TAF. [9]
    End point description
    End point type
    Primary
    End point timeframe
    Bictegravir concentration was assessed at week 12
    Notes
    [9] - 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: Data reported has been a descriptive analysis, which shows the Bictegravir concentration in different anatomical reservoirs
    End point values
    		 BIC/TAF/FTC
    Number of subjects analysed
    8 [10]
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    61.6 (14.4 to 1760.2)
    Notes
    [10] - Only female participants were assessed on this endpoint
    No statistical analyses for this end point

    Secondary: HIV-1 RNA decay in blood plasma from baseline and up to 24 weeks

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    End point title
    		 HIV-1 RNA decay in blood plasma from baseline and up to 24 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    HIV RNA decay in blood plasma was assessed at: Day 3, Day 7, Day 14, week 4, week 12 and week 24
    End point values
    		 Overall analysis
    Number of subjects analysed
    23
    Units: log10 copies/mL
        median (inter-quartile range (Q1-Q3))
    -3.48 (-3.68 to -3.17)
    No statistical analyses for this end point

    Secondary: Concentration of Bictegravir in blood plasma at week 12 after initiation a first ART regimen with Bictegravir/FTC/TAF in male participants

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    End point title
    		 Concentration of Bictegravir in blood plasma at week 12 after initiation a first ART regimen with Bictegravir/FTC/TAF in male participants
    End point description
    End point type
    Secondary
    End point timeframe
    week 12
    End point values
    		 BIC/TAF/FTC
    Number of subjects analysed
    15 [11]
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    2640 (424 to 10300)
    Notes
    [11] - Male participants data
    No statistical analyses for this end point

    Secondary: Concentration of Bictegravir in blood plasma at week 12 after initiation a first ART regimen with Bictegravir/FTC/TAF in female participants

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    End point title
    		 Concentration of Bictegravir in blood plasma at week 12 after initiation a first ART regimen with Bictegravir/FTC/TAF in female participants
    End point description
    End point type
    Secondary
    End point timeframe
    week 12
    End point values
    		 BIC/TAF/FTC
    Number of subjects analysed
    8 [12]
    Units: ng/ml
        median (inter-quartile range (Q1-Q3))
    2320 (834 to 5770)
    Notes
    [12] - Female participants
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse event were reported since baseline visit to w24 and follow-up visit
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Frequency threshold for reporting non-serious adverse events: 1%
    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: Non-serious adverse event were reported during the 24 weeks of follow up

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/32945851
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