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    Clinical Trial Results:
    A Phase IIb, randomized, partially blind, active controlled, dose-range finding study of GSK3640254 compared to a reference arm of dolutegravir, each in combination with nucleoside reverse transcriptase inhibitors, in HIV-1 infected antiretroviral treatment-naive adults

    Summary
    EudraCT number
    		 2019-004435-23
    Trial protocol
    		 PT   FR   DE   IT  
    Global end of trial date
    29 May 2023

    Results information
    Results version number
    		 v3(current)
    This version publication date
    14 Jun 2024
    First version publication date
    21 Sep 2023
    Other versions
    		 v1 , v2
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    208379
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04493216
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ViiV Healthcare
    Sponsor organisation address
    980 GreatWest Road, Brentford,Middlesex, United Kingdom, TW8 9GS
    Public contact
    GSK Response Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com
    Scientific contact
    GSK Response Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com
    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
    Interim
    Date of interim/final analysis
    21 Oct 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    05 Sep 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    29 May 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate antiviral efficacy of GSK3640254 relative to DTG, each given in combination with 2 NRTIs, enabling the selection of an optimal dose for GSK3640254
    Protection of trial subjects
    Not Applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    18 Nov 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Argentina: 36
    Country: Number of subjects enrolled
    Canada: 4
    Country: Number of subjects enrolled
    France: 2
    Country: Number of subjects enrolled
    Germany: 6
    Country: Number of subjects enrolled
    Italy: 11
    Country: Number of subjects enrolled
    Portugal: 8
    Country: Number of subjects enrolled
    Russian Federation: 20
    Country: Number of subjects enrolled
    South Africa: 16
    Country: Number of subjects enrolled
    Spain: 41
    Country: Number of subjects enrolled
    United States: 17
    Worldwide total number of subjects
    161
    EEA total number of subjects
    68
    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)
    160
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was terminated by the sponsor at Week 48 as the sponsor determined further development of GSK3640254-containing daily oral regimen would not be differentiated enough from existing 2-drug daily oral regimens. Thus, secondary analyses at Week 96 and Week 144 were not evaluated.

    Pre-assignment
    Screening details
    		 The changes from the planned subsequent analyses were presented as pre-specified in Statistical Analysis Plan. Safety analysis is presented based on the Entire Duration of Treatment Exposure period, which was defined from Day 1 up to end of continued access to treatment post-study termination (Day 922).

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
    Arm description
    		 Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual nucleoside reverse transcriptase inhibitors (NRTIs) background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABC/3TC or FTC/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.

    Investigational medicinal product name
    100 mg GSK3640254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with human immunodeficiency virus type 1 (HIV-1) infected antiretroviral treatment-naive adults orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo as blinded.

    Arm title
    		 GSK3640254 150 mg + ABC/3TC or FTC/TAF
    Arm description
    		 Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABC/3TC or FTC/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.

    Investigational medicinal product name
    150 mg GSK3640254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with HIV-1 infected antiretroviral treatment-naive adults orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 as blinded.

    Arm title
    		 GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
    Arm description
    		 Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABC/3TC or FTC/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.

    Investigational medicinal product name
    200 mg GSK3640254
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with HIV-1 infected antiretroviral treatment-naive adults orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo as blinded.

    Arm title
    		 Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Arm description
    		 Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ABC/3TC or FTC/TAF
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Open label dual NRTI background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.

    Investigational medicinal product name
    50 mg DTG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants with HIV-1 infected antiretroviral treatment-naive adults orally received one 50 mg tablet per day of DTG in an open label setting.

    Number of subjects in period 1
    		GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Started
    40
    43
    42
    36
    Completed
    0
    0
    0
    0
    Not completed
    40
    43
    42
    36
         Consent withdrawn by subject
    2
    1
    1
    2
         Physician decision
    -
    -
    1
    -
         Subject reached protocol-defined stopping criteria
    4
    2
    7
    2
         Adverse event, non-fatal
    1
    4
    5
    2
         Study terminated by sponsor
    30
    33
    28
    27
         Lost to follow-up
    2
    1
    -
    1
         Protocol deviation
    1
    2
    -
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual nucleoside reverse transcriptase inhibitors (NRTIs) background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.

    Reporting group title
    GSK3640254 150 mg + ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

    Reporting group title
    GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

    Reporting group title
    Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

    Reporting group values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF Total
    Number of subjects
    		 40 43 42 36 161
    Age categorical
    Units: Subjects
        19-64 years
    		 40 42 42 36 160
        >=65 years
    		 0 1 0 0 1
    Sex: Female, Male
    Units: Participants
        Female
    		 7 9 12 10 38
        Male
    		 33 34 30 26 123
    Race/Ethnicity, Customized
    Units: Subjects
        AMERICAN INDIAN OR ALASKA NATIVE
    		 1 2 1 0 4
        ASIAN
    		 0 2 2 1 5
        BLACK OR AFRICAN AMERICAN
    		 6 8 6 6 26
        WHITE
    		 32 31 32 29 124
        MIXED RACE
    		 1 0 0 0 1
        MISSING
    		 0 0 1 0 1
    Age, Continuous
    Units: YEARS
        arithmetic mean (standard deviation)
    		 32.8 ( 6.20 ) 38.1 ( 12.54 ) 33.7 ( 10.59 ) 35.3 ( 9.85 ) -

    End points

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    End points reporting groups
    Reporting group title
    GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual nucleoside reverse transcriptase inhibitors (NRTIs) background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.

    Reporting group title
    GSK3640254 150 mg + ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

    Reporting group title
    GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

    Reporting group title
    Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

    Primary: Percentage of participants with plasma HIV-1 ribonucleic acid (RNA) less than (<)50 copies per milliliter (c/mL) at Week 24

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    End point title
    		 Percentage of participants with plasma HIV-1 ribonucleic acid (RNA) less than (<)50 copies per milliliter (c/mL) at Week 24
    End point description
    Percentage of participants with plasma HIV-1 RNA <50 c/mL at week 24 was assessed using the Food and Drug Administration (FDA) snapshot algorithm to demonstrate the antiviral activity of GSK3640254 given in combination with either ABC/3TC or FTC/TAF compared to the reference treatment of DTG given in combination with either ABC/3TC or FTC/TAF. The analysis was performed on the Intent-to-Treat Exposed (ITT-E) population which included all randomized participants who received at least one dose of study intervention.
    End point type
    Primary
    End point timeframe
    At Week 24
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    40
    43
    42
    36
    Units: Percentage of participants
        number (confidence interval 95%)
    82.5 (68.1 to 91.3)
    90.7 (78.4 to 96.3)
    76.2 (61.5 to 86.5)
    91.7 (78.2 to 97.1)
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Differences in percentage of participant = Percentage of participant in GSK3640254 150 mg+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF
    Comparison groups
    GSK3640254 150 mg + ABC/3TC or FTC/TAF v Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects included in analysis
    79
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Differences in percentage of participant
    Point estimate
    -1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -13.5
         upper limit
    		 11.6
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Differences in percentage of participant = Percentage of participant in GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ABC/3TC or FTC/TAF
    Comparison groups
    GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF v Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects included in analysis
    76
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Differences in percentage of participant
    Point estimate
    -9.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -24
         upper limit
    		 5.7
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Differences in percentage of participant = Percentage of participant in GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF - Percentage of participant in DTG+ ABC/3TC or FTC/TAF
    Comparison groups
    GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF v Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects included in analysis
    78
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Differences in percentage of participant
    Point estimate
    -15.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -31.2
         upper limit
    		 0.3

    Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48

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    End point title
    		 Percentage of participants with plasma HIV-1 RNA <50 c/mL at Week 48
    End point description
    Percentage of participants with plasma HIV-1 RNA <50 c/mL at week 48 was assessed using the FDA snapshot algorithm to demonstrate the antiviral activity of GSK3640254 given in combination with either ABC/3TC or FTC/TAF compared to the reference treatment of DTG given in combination with either ABC/3TC or FTC/TAF. The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention.
    End point type
    Secondary
    End point timeframe
    At Week 48
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    40
    43
    42
    36
    Units: Percentage of participants
        number (confidence interval 95%)
    85.0 (70.9 to 92.9)
    83.7 (70.0 to 91.9)
    76.2 (61.5 to 86.5)
    77.8 (61.9 to 88.3)
    No statistical analyses for this end point

    Secondary: Absolute values of HIV-1 RNA at Weeks 24 and 48

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    End point title
    		 Absolute values of HIV-1 RNA at Weeks 24 and 48
    End point description
    Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and at Weeks 24 and 48
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    40
    43
    42
    36
    Units: Log 10 copies per milliliter
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    4.351 ( 0.5712 )
    4.353 ( 0.6705 )
    4.165 ( 0.6505 )
    4.247 ( 0.6765 )
        Week 24
    1.619 ( 0.1260 )
    1.607 ( 0.0663 )
    1.610 ( 0.0679 )
    1.592 ( 0.0126 )
        Week 48
    1.602 ( 0.0536 )
    1.605 ( 0.0647 )
    1.594 ( 0.0233 )
    1.590 ( 0.0000 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in plasma HIV-1 RNA at Weeks 24 and 48

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    End point title
    		 Change from Baseline in plasma HIV-1 RNA at Weeks 24 and 48
    End point description
    Plasma samples were collected for quantitative analysis of HIV-1 RNA. log10 values for plasma HIV-1 RNA have been presented. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and at Weeks 24 and 48
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    40
    43
    42
    36
    Units: Log 10 copies per milliliter
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    4.351 ( 0.5712 )
    4.353 ( 0.6705 )
    4.165 ( 0.6505 )
    4.247 ( 0.6765 )
        Change from Baseline to Week 24
    -2.718 ( 0.5501 )
    -2.784 ( 0.6615 )
    -2.565 ( 0.6513 )
    -2.629 ( 0.6835 )
        Change from Baseline to Week 48
    -2.675 ( 0.5640 )
    -2.762 ( 0.6784 )
    -2.580 ( 0.6941 )
    -2.717 ( 0.6672 )
    No statistical analyses for this end point

    Secondary: Absolute values of Cluster of differentiation 4 plus (CD4+) cell counts at Weeks 24 and 48

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    End point title
    		 Absolute values of Cluster of differentiation 4 plus (CD4+) cell counts at Weeks 24 and 48
    End point description
    Blood samples were collected and CD4+ cell count was assessed using flow cytometry. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and at Weeks 24 and 48
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    40
    43
    42
    36
    Units: Cells per cubic millimeter
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    480.3 ( 171.72 )
    509.7 ( 207.13 )
    478.7 ( 204.04 )
    514.1 ( 240.88 )
        Week 24
    717.5 ( 222.91 )
    643.5 ( 202.27 )
    689.8 ( 316.64 )
    724.8 ( 403.99 )
        Week 48
    749.9 ( 328.28 )
    702.6 ( 258.65 )
    747.3 ( 313.15 )
    705.2 ( 221.18 )
    No statistical analyses for this end point

    Secondary: Change from Baseline in CD4+ cell counts at Weeks 24 and 48

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    End point title
    		 Change from Baseline in CD4+ cell counts at Weeks 24 and 48
    End point description
    Blood samples were collected and CD4+ cell count was assessed using flow cytometry. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. The analysis was performed on the ITT-E population which included all randomized participants who received at least one dose of study intervention. Only those participants with data available at specified time points have been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and at Weeks 24 and 48
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    40
    43
    42
    36
    Units: Cells per cubic millimeter
    arithmetic mean (standard deviation)
        Baseline (Day 1)
    480.3 ( 171.72 )
    509.7 ( 207.13 )
    478.7 ( 204.04 )
    514.1 ( 240.88 )
        Change from Baseline to Week 24
    241.3 ( 191.26 )
    129.3 ( 233.07 )
    202.3 ( 271.98 )
    198.5 ( 285.00 )
        Change from Baseline to Week 48
    292.4 ( 264.16 )
    189.2 ( 216.10 )
    243.0 ( 233.24 )
    190.6 ( 180.19 )
    No statistical analyses for this end point

    Secondary: Number of participants with serious adverse events (SAEs) and deaths

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    End point title
    		 Number of participants with serious adverse events (SAEs) and deaths
    End point description
    An SAE was defined as any serious adverse event that, at any dose resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or any other situation according to medical or scientific judgment. The analysis was performed on the Safety Population, which included all randomized participants who were exposed to study intervention with the exception of any participants with documented evidence of not having consumed any amount of study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to end of continued access to treatment post-study termination (Day 922)
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    40
    43
    42
    36
    Units: Participants
        Serious Adverse Events
    2
    7
    2
    2
        Deaths
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with adverse events (AEs) leading to treatment discontinuation

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    End point title
    		 Number of participants with adverse events (AEs) leading to treatment discontinuation
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants who discontinued study treatment due to AEs are presented. The analysis was performed on the Safety Population, which included all randomized participants who were exposed to study intervention with the exception of any participants with documented evidence of not having consumed any amount of study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to end of continued access to treatment post-study termination (Day 922)
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    40
    43
    42
    36
    Units: Participants
        AEs leading to treatment discontinuation
    2
    4
    5
    2
    No statistical analyses for this end point

    Secondary: Number of participants with AE based on maximum severity grades

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    End point title
    		 Number of participants with AE based on maximum severity grades
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The severity of AEs was defined as per the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events and was categorized into grades: Grade 1 - mild, Grade 2 - moderate, Grade 3 - severe, Grade 4 - Potentially life threatening, Grade 5 - Fatal. The analysis was performed on the Safety Population, which included all randomized participants who were exposed to study intervention except for any participants with documented evidence of not having consumed any amount of study intervention. The data presented here is not cumulative data but the number of participants experiencing the adverse event based on maximum grade at the indicated timepoints.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to end of continued access to treatment post-study termination (Day 922)
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    40
    43
    42
    36
    Units: Participants
        Grade 1
    12
    14
    17
    15
        Grade 2
    19
    17
    17
    10
        Grade 3
    5
    5
    3
    3
        Grade 4
    1
    2
    1
    0
        Grade 5
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with AEs of special interest (AESI)

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    End point title
    		 Number of participants with AEs of special interest (AESI)
    End point description
    An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. Number of participants with AESI in (gastrointestinal (GI), nervous system, and psychiatric AEs) are presented. The analysis was performed on the Safety Population, which included all randomized participants who were exposed to study intervention with the exception of any participants with documented evidence of not having consumed any amount of study intervention.
    End point type
    Secondary
    End point timeframe
    From Day 1 up to end of continued access to treatment post-study termination (Day 922)
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    40
    43
    42
    36
    Units: Participants
        AESI (Gastrointestinal)
    15
    18
    14
    14
        AESI (Nervous system)
    7
    5
    7
    3
        AESI (Psychiatric)
    4
    3
    4
    4
    No statistical analyses for this end point

    Secondary: Number of participants with genotypic resistance

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    End point title
    		 Number of participants with genotypic resistance
    End point description
    Plasma samples were collected for resistance testing. Genotypic testing was conducted in participants meeting protocol-defined virologic failure (PDVF) criteria. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The analysis was performed on the PDVF Population, which included participants with A. virologic non-response (Decrease from Baseline [Day 1] in plasma HIV-1 RNA of ˂1.0 log10 c/mL unless plasma HIV-1 RNA is <200 c/mL by Week 12; confirmed plasma HIV-1 RNA levels ≥200 c/mL at or after Week 24; plasma HIV-1 RNA ≥50 c/mL on repeat testing of Week 24 results and prior to Week 28) and B. virologic rebound (confirmed plasma HIV-1 RNA ≥200 c/mL after confirmed consecutive plasma HIV-1 RNA <50 c/mL).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and at Weeks 24 and 48
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    3
    2
    5
    1
    Units: Participants
        Baseline (Day 1)
    0
    0
    0
    0
        Weeks 24
    0
    0
    0
    0
        Weeks 48
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Number of participants with phenotypic resistance

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    End point title
    		 Number of participants with phenotypic resistance
    End point description
    Plasma samples were collected to for resistance testing. Phenotypic testing was conducted in participants meeting PDVF criteria. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. The analysis was performed on the PDVF Population. Only those participants with data available at specified time points have been analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and at Weeks 24 and 48
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Number of subjects analysed
    3
    2
    5
    1
    Units: Participants
        Baseline (Day 1)
    0
    0
    0
    0
        Weeks 24
    0
    0
    0
    0
        Weeks 48
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Observed plasma concentration at the end of the dosing interval (Ctau) of GSK3640254 at steady state - Week 2

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    End point title
    		 Observed plasma concentration at the end of the dosing interval (Ctau) of GSK3640254 at steady state - Week 2 [1]
    End point description
    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254. Observed plasma concentration at the end of the dosing interval was determined directly from the concentration-time data. The analysis was performed on the Intensive PK Population, which included all participants who received at least one dose of GSK3640254, had evaluable drug concentrations reported and where samples were collected according to the intensive PK sampling scheme. Only those participants who received GSK3640254 have been analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per objective of this endpoint, only analysis of GSK3640254 was planned to present.
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
    Number of subjects analysed
    14
    13
    18
    Units: Nanogram/ milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Week 2
    430.5361 ( 56.5 )
    604.8387 ( 44.2 )
    805.2209 ( 43.7 )
    No statistical analyses for this end point

    Secondary: Observed plasma concentration at the end of the dosing interval (Ctau) of GSK3640254 at steady state - Week 24 and 48

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    End point title
    		 Observed plasma concentration at the end of the dosing interval (Ctau) of GSK3640254 at steady state - Week 24 and 48 [2]
    End point description
    Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of GSK3640254. Observed plasma concentration at the end of the dosing interval was determined directly from the concentration-time data. The analysis was performed on the Sparse PK Population, which included all participants who received at least one dose of GSK3640254, had evaluable drug concentrations reported and had samples collected according to the sparse PK sampling scheme. Only those participants who received GSK3640254 and had data available at specified time points have been analyzed.
    End point type
    Secondary
    End point timeframe
    At Weeks 24 and 48
    Notes
    [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per objective of this endpoint, only analysis of GSK3640254 was planned to present.
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
    Number of subjects analysed
    12
    10
    13
    Units: Nanogram/ milliliter (ng/mL)
    geometric mean (geometric coefficient of variation)
        Week 24
    396.5117 ( 62.5 )
    519.6041 ( 84.9 )
    922.9638 ( 51.6 )
        Week 48
    310.9877 ( 135.4 )
    568.0656 ( 13.4 )
    812.4745 ( 49.1 )
    No statistical analyses for this end point

    Secondary: Area under the plasma drug concentration-time curve from pre-dose to the end of the dosing interval (AUC [0-tau]) of GSK3640254 at steady state

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    End point title
    		 Area under the plasma drug concentration-time curve from pre-dose to the end of the dosing interval (AUC [0-tau]) of GSK3640254 at steady state [3]
    End point description
    Blood samples were collected at indicated time points for PK analysis of GSK3640254. The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 and had data available at specified time points have been analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
    Notes
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per objective of this endpoint, only analysis of GSK3640254 was planned to present.
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
    Number of subjects analysed
    14
    13
    18
    Units: Hour*nanogram/ milliliter (h*ng/mL)
        geometric mean (geometric coefficient of variation)
    14995.7576 ( 49.8 )
    21212.2480 ( 44.5 )
    30708.2546 ( 40.1 )
    No statistical analyses for this end point

    Secondary: Maximum observed concentration (Cmax) of GSK3640254 at steady state

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    End point title
    		 Maximum observed concentration (Cmax) of GSK3640254 at steady state [4]
    End point description
    Blood samples were collected at indicated time points for PK analysis of GSK3640254. The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 have been analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per objective of this endpoint, only analysis of GSK3640254 was planned to present.
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
    Number of subjects analysed
    15
    13
    18
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    929.8 ( 45.9 )
    1337.3 ( 47.7 )
    2094.5 ( 39.2 )
    No statistical analyses for this end point

    Secondary: Observed pre-dose plasma concentration (C0) of GSK3640254 at steady state

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    End point title
    		 Observed pre-dose plasma concentration (C0) of GSK3640254 at steady state [5]
    End point description
    Blood samples were collected at indicated time points for PK analysis of GSK3640254. Observed pre-dose plasma concentration was determined directly from the concentration-time data. The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 have been analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per objective of this endpoint, only analysis of GSK3640254 was planned to present.
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
    Number of subjects analysed
    15
    13
    18
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    435.9 ( 54.6 )
    603.2 ( 59.5 )
    865.2 ( 43.4 )
    No statistical analyses for this end point

    Secondary: Time to Cmax (Tmax) of GSK3640254 at steady state

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    End point title
    		 Time to Cmax (Tmax) of GSK3640254 at steady state [6]
    End point description
    Blood samples were collected at indicated time points for PK analysis of GSK3640254. Tmax was determined directly from the concentration-time data. The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 have been analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per objective of this endpoint, only analysis of GSK3640254 was planned to present.
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
    Number of subjects analysed
    15
    13
    18
    Units: Hour
        median (full range (min-max))
    3.0000 (1.900 to 9.017)
    3.4167 (1.000 to 9.000)
    3.4583 (1.917 to 5.000)
    No statistical analyses for this end point

    Secondary: Steady state oral clearance (CLt/F) of GSK3640254

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    End point title
    		 Steady state oral clearance (CLt/F) of GSK3640254 [7]
    End point description
    Blood samples were collected at indicated time points for PK analysis of GSK3640254. The analysis was performed on the Intensive PK Population. Only those participants who received GSK3640254 and had data available at specified time points have been analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 1, 2, 3, 3.5, 4, 4.5, 5, 6, 10, and 24 hours post-dose at Week 2
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: As per objective of this endpoint, only analysis of GSK3640254 was planned to present.
    End point values
    		 GSK3640254 100 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
    Number of subjects analysed
    14
    13
    18
    Units: Liter/ hour
        geometric mean (geometric coefficient of variation)
    6.6686 ( 49.8 )
    7.0714 ( 44.5 )
    6.5129 ( 40.1 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected from Day 1 up to end of continued access to treatment post-study termination (Day 922).
    Adverse event reporting additional description
    The study was terminated by the sponsor after primary analysis (at week 48). As prespecified in Statistical analysis plan, AEs were collected up to end of continued access to treatment post-study termination (Day 922).
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    26.0
    Reporting groups
    Reporting group title
    GSK3640254 100 milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with human immunodeficiency virus type 1 (HIV-1), orally received one 100 mg tablet per day of GSK3640254 and two tablets per day of matching placebo in a blinded setting. Open label dual nucleoside reverse transcriptase inhibitors (NRTIs) background therapies were given as one tablet per day of 600 mg abacavir (ABC) / 300 mg lamivudine (3TC) OR 200 mg emtricitabine (FTC) / 25 mg tenofovir alafenamide (TAF) orally.

    Reporting group title
    Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with HIV-1, orally received one 50 mg tablet per day of DTG in an open label setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

    Reporting group title
    GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with HIV-1, orally received two 100 mg tablets (200 mg) per day of GSK3640254 and one tablet per day of matching placebo in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

    Reporting group title
    GSK3640254 150 mg + ABC/3TC or FTC/TAF
    Reporting group description
    		 Participants with HIV-1, orally received 150 mg (one 100 mg tablet + two 25 mg tablets per day) of GSK3640254 in a blinded setting. Open label dual NRTI background therapies were given as one tablet per day combination of 600 mg ABC / 300 mg 3TC OR 200 mg FTC / 25 mg TAF orally.

    Serious adverse events
    		 GSK3640254 100 milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 36 (5.56%)
    2 / 42 (4.76%)
    7 / 43 (16.28%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 36 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 36 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Limb fracture
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 36 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 36 (0.00%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Colitis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pancreatitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 36 (0.00%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis acute
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Pulmonary embolism
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 36 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pulmonary hypertension
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 36 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 36 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Substance dependence
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Suicidal ideation
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    0 / 40 (0.00%)
    1 / 36 (2.78%)
    0 / 42 (0.00%)
    0 / 43 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Necrotising fasciitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 36 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Appendicitis
         subjects affected / exposed
    0 / 40 (0.00%)
    0 / 36 (0.00%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 GSK3640254 100 milligram(mg)+ Placebo+ ABC/3TC or FTC/TAF Dolutegravir (DTG) 50 mg + ABC/3TC or FTC/TAF GSK3640254 200 mg+ Placebo+ ABC/3TC or FTC/TAF GSK3640254 150 mg + ABC/3TC or FTC/TAF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    37 / 40 (92.50%)
    28 / 36 (77.78%)
    38 / 42 (90.48%)
    38 / 43 (88.37%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 36 (2.78%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    3
    1
    1
    0
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
    1 / 42 (2.38%)
    2 / 43 (4.65%)
         occurrences all number
    1
    0
    1
    2
    Injury, poisoning and procedural complications
    Limb injury
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
    2 / 42 (4.76%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    2
    1
    Vascular disorders
    Hypertension
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
    1 / 42 (2.38%)
    2 / 43 (4.65%)
         occurrences all number
    2
    0
    1
    2
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
    2 / 42 (4.76%)
    3 / 43 (6.98%)
         occurrences all number
    2
    1
    3
    3
    Headache
         subjects affected / exposed
    6 / 40 (15.00%)
    3 / 36 (8.33%)
    7 / 42 (16.67%)
    4 / 43 (9.30%)
         occurrences all number
    6
    4
    10
    4
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    4 / 40 (10.00%)
    1 / 36 (2.78%)
    1 / 42 (2.38%)
    4 / 43 (9.30%)
         occurrences all number
    5
    1
    1
    4
    Asthenia
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
    3 / 42 (7.14%)
    0 / 43 (0.00%)
         occurrences all number
    2
    2
    3
    0
    Gastrointestinal disorders
    Food poisoning
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Dyspepsia
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
    2 / 42 (4.76%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    3
    1
    Diarrhoea
         subjects affected / exposed
    5 / 40 (12.50%)
    9 / 36 (25.00%)
    6 / 42 (14.29%)
    7 / 43 (16.28%)
         occurrences all number
    5
    10
    7
    8
    Abdominal pain upper
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 36 (8.33%)
    3 / 42 (7.14%)
    3 / 43 (6.98%)
         occurrences all number
    1
    3
    3
    3
    Abdominal pain
         subjects affected / exposed
    2 / 40 (5.00%)
    2 / 36 (5.56%)
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    2
    2
    3
    1
    Vomiting
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
    0 / 42 (0.00%)
    3 / 43 (6.98%)
         occurrences all number
    2
    0
    0
    3
    Toothache
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 36 (5.56%)
    2 / 42 (4.76%)
    3 / 43 (6.98%)
         occurrences all number
    0
    2
    2
    3
    Nausea
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
    3 / 42 (7.14%)
    6 / 43 (13.95%)
         occurrences all number
    2
    1
    3
    8
    Haemorrhoids
         subjects affected / exposed
    0 / 40 (0.00%)
    2 / 36 (5.56%)
    0 / 42 (0.00%)
    2 / 43 (4.65%)
         occurrences all number
    0
    2
    0
    2
    Respiratory, thoracic and mediastinal disorders
    Rhinitis allergic
         subjects affected / exposed
    3 / 40 (7.50%)
    1 / 36 (2.78%)
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences all number
    3
    1
    1
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    2 / 40 (5.00%)
    3 / 36 (8.33%)
    2 / 42 (4.76%)
    2 / 43 (4.65%)
         occurrences all number
    2
    4
    2
    3
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 40 (2.50%)
    3 / 36 (8.33%)
    1 / 42 (2.38%)
    1 / 43 (2.33%)
         occurrences all number
    1
    3
    1
    1
    Infections and infestations
    COVID-19
         subjects affected / exposed
    10 / 40 (25.00%)
    10 / 36 (27.78%)
    6 / 42 (14.29%)
    12 / 43 (27.91%)
         occurrences all number
    12
    13
    7
    12
    Chlamydial infection
         subjects affected / exposed
    2 / 40 (5.00%)
    1 / 36 (2.78%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    2
    1
    2
    0
    Gastroenteritis
         subjects affected / exposed
    1 / 40 (2.50%)
    0 / 36 (0.00%)
    2 / 42 (4.76%)
    2 / 43 (4.65%)
         occurrences all number
    1
    0
    2
    2
    Gonorrhoea
         subjects affected / exposed
    2 / 40 (5.00%)
    0 / 36 (0.00%)
    2 / 42 (4.76%)
    0 / 43 (0.00%)
         occurrences all number
    2
    0
    2
    0
    Influenza
         subjects affected / exposed
    3 / 40 (7.50%)
    4 / 36 (11.11%)
    3 / 42 (7.14%)
    4 / 43 (9.30%)
         occurrences all number
    3
    5
    3
    4
    Respiratory tract infection
         subjects affected / exposed
    3 / 40 (7.50%)
    0 / 36 (0.00%)
    1 / 42 (2.38%)
    0 / 43 (0.00%)
         occurrences all number
    3
    0
    1
    0
    Pharyngitis
         subjects affected / exposed
    4 / 40 (10.00%)
    3 / 36 (8.33%)
    1 / 42 (2.38%)
    4 / 43 (9.30%)
         occurrences all number
    4
    3
    1
    5
    Nasopharyngitis
         subjects affected / exposed
    4 / 40 (10.00%)
    3 / 36 (8.33%)
    3 / 42 (7.14%)
    3 / 43 (6.98%)
         occurrences all number
    5
    6
    5
    4
    Monkeypox
         subjects affected / exposed
    1 / 40 (2.50%)
    1 / 36 (2.78%)
    2 / 42 (4.76%)
    1 / 43 (2.33%)
         occurrences all number
    1
    1
    2
    1
    Syphilis
         subjects affected / exposed
    3 / 40 (7.50%)
    5 / 36 (13.89%)
    3 / 42 (7.14%)
    1 / 43 (2.33%)
         occurrences all number
    3
    6
    3
    1
    Upper respiratory tract infection
         subjects affected / exposed
    4 / 40 (10.00%)
    1 / 36 (2.78%)
    3 / 42 (7.14%)
    3 / 43 (6.98%)
         occurrences all number
    5
    1
    5
    3
    Urethritis
         subjects affected / exposed
    1 / 40 (2.50%)
    2 / 36 (5.56%)
    0 / 42 (0.00%)
    1 / 43 (2.33%)
         occurrences all number
    1
    2
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    25 Sep 2020
    This is a global amendment and was created primarily to replace details of the internal Safety Review Committee to reflect the use instead of an Independent Data Monitoring Committee (IDMC). The decision to switch was based on feedback received from several health authorities and ethics committees, with advice and approval by VH guidance committee. This amendment also includes corrections, clarifications and minor administrative errors. In addition, details from 2 prior country-specific amendments (Canada amendment CAN-1 and Portugal amendment POR-1) were incorporated into this global amendment.
    09 Apr 2021
    This is a global amendment. This amendment was created primarily to make non-substantial changes generally related to inclusion/exclusion criteria and the screening period, esophagogastroduodenoscopy (EGD) biopsy-based stopping criteria for individual participants and the study overall. The other changes exist for further detail, clarity, and current information.
    10 May 2021
    Study 208379 is undergoing this  substantial amendment to reduce the sample size from approximately 210 participants to approximately 150 participants. This reduction of 60 participants will occur equally among the 3 experimental arms. There is no change to the Dolutegravir (DTG) reference arm. Thus, the number of participants will be as follows (each arm in combination with open-label Nucleoside Reverse Transcriptase Inhibitor [NRTI] backbone as originally described): 

    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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