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    Clinical Trial Results:
    A Phase 2b Randomized, Active-Controlled, Double-Blind Trial to Investigate Safety, Efficacy and Dose-response of BMS-955176/GSK3532795, Given on a Backbone of Tenofovir/Emtricitabine, in Treatment-Naive HIV-1 Infected Adults

    Summary
    EudraCT number
    		 2013-005487-26
    Trial protocol
    		 DE   ES   GB   IT  
    Global end of trial date
    21 Aug 2017

    Results information
    Results version number
    		 v2(current)
    This version publication date
    02 Sep 2018
    First version publication date
    09 Aug 2017
    Other versions
    		 v1
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    205891
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    ViiV Healthcare
    Sponsor organisation address
    980 Great West Road, Brentford, Middlesex, United Kingdom,
    Public contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1 866-435-7343,
    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
    13 Jul 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    21 Aug 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate antiviral efficacy of 3 doses (60, 120 and 180 mg) of BMS-955176/GSK3532795, and EFV, each when given in combination with TDF/FTC in treatment-naive subjects by determining the proportion of treatment-naive subjects with plasma HIV-1 RNA < 40 c/mL at Week 24
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    12 May 2015
    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
    Argentina: 41
    Country: Number of subjects enrolled
    Canada: 24
    Country: Number of subjects enrolled
    Chile: 20
    Country: Number of subjects enrolled
    France: 11
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Italy: 17
    Country: Number of subjects enrolled
    Mexico: 40
    Country: Number of subjects enrolled
    Poland: 15
    Country: Number of subjects enrolled
    Puerto Rico: 7
    Country: Number of subjects enrolled
    South Africa: 45
    Country: Number of subjects enrolled
    Spain: 20
    Country: Number of subjects enrolled
    United Kingdom: 4
    Country: Number of subjects enrolled
    United States: 38
    Worldwide total number of subjects
    305
    EEA total number of subjects
    90
    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)
    302
    From 65 to 84 years
    3
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This study was originally designed for 96 weeks of treatment in treatment naïve human immunodeficiency virus-1 (HIV-1) infected adults; however, it was terminated early due to gastrointestinal intolerability and treatment emergent resistance. The study was conducted at 58 centers in 12 countries.

    Pre-assignment
    Screening details
    		 A total of 305 participants were screened, of which 210 were randomized to 1 of 4 treatment arms. Of 210 participants, only 206 received study treatment. Four participants were randomized but not treated as: 2 participants were randomized in error, 1 participant was lost to follow-up and 1 participant withdrew consent.

    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, Carer

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC
    Arm description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-955176/GSK3532795 60mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing BMS-955176/GSK3532795 60 mg active dose.

    Investigational medicinal product name
    Placebo to match BMS-955176/GSK3532795 120 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing BMS-955176/GSK3532795 placebo matching 120 mg.

    Investigational medicinal product name
    Placebo to match EFV 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At bed time, on an empty stomach, without food, participants took one pill once daily from the bottle containing EFV placebo matching 600 mg.

    Investigational medicinal product name
    TDF/FTC 300 mg/ 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing open-label TDF/FTC 300 mg/ 200 mg.

    Arm title
    		 BMS-955176/GSK3532795 120 mg + TDF/FTC
    Arm description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-955176/GSK3532795 120 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing BMS-955176/GSK3532795 120 mg active dose.

    Investigational medicinal product name
    Placebo to match BMS-955176/GSK3532795 60 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing BMS-955176/GSK3532795 placebo matching 60 mg.

    Investigational medicinal product name
    Placebo to match EFV 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At bed time, on an empty stomach, without food, participants took one pill once daily from the bottle containing EFV placebo matching 600 mg.

    Investigational medicinal product name
    TDF/FTC 300 mg/ 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing open-label TDF/FTC 300 mg/ 200 mg.

    Arm title
    		 BMS-955176/GSK3532795 180 mg + TDF/FTC
    Arm description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-955176/GSK3532795 60mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing BMS-955176/GSK3532795 60 mg active dose.

    Investigational medicinal product name
    Placebo to match EFV 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At bed time, on an empty stomach, without food, participants took one pill once daily from the bottle containing EFV placebo matching 600 mg.

    Investigational medicinal product name
    TDF/FTC 300 mg/ 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing open-label TDF/FTC 300 mg/ 200 mg.

    Investigational medicinal product name
    BMS-955176/GSK3532795 120 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing BMS-955176/GSK3532795 120 mg active dose.

    Arm title
    		 EFV 600 mg + TDF/FTC
    Arm description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo to match BMS-955176/GSK3532795 60 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing BMS-955176/GSK3532795 placebo matching 60 mg.

    Investigational medicinal product name
    EFV 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    At bed time, on an empty stomach, without food, participants took one pill once daily from the bottle containing EFV 600 mg.

    Investigational medicinal product name
    TDF/FTC 300 mg/ 200 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing open-label TDF/FTC 300 mg/ 200 mg.

    Investigational medicinal product name
    Placebo to match BMS-955176/GSK3532795 120 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    In the morning, with a meal, participants took one pill once daily from the bottle containing BMS-955176/GSK3532795 placebo matching 120 mg.

    Number of subjects in period 1 [1]
    		BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Started
    50
    52
    51
    53
    Completed
    0
    0
    0
    0
    Not completed
    50
    52
    51
    53
         Consent withdrawn by subject
    4
    -
    1
    3
         Subject reached protocol-defined stopping criteria
    -
    1
    1
    -
         Adverse event, non-fatal
    1
    3
    5
    10
         Unknown
    -
    1
    1
    -
         Poor/Non-compliance
    1
    -
    1
    -
         Lost to follow-up
    1
    3
    1
    1
         Lack of efficacy
    4
    4
    -
    -
         Administrative reason by sponsor
    39
    40
    41
    39
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: A total of 305 participants were enrolled, of which 210 were randomized and only 206 received randomized treatment.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    BMS-955176/GSK3532795 60 mg + TDF/FTC
    Reporting group description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.

    Reporting group title
    BMS-955176/GSK3532795 120 mg + TDF/FTC
    Reporting group description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.

    Reporting group title
    BMS-955176/GSK3532795 180 mg + TDF/FTC
    Reporting group description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.

    Reporting group title
    EFV 600 mg + TDF/FTC
    Reporting group description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.

    Reporting group values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC Total
    Number of subjects
    		 50 52 51 53
    Age categorical
    Units: Subjects
    Age continuous
    Baseline characteristics is presented for Treated Subjects Population, also known as the modified intent-to-treat (mITT) Population which comprised of all participants who received at least one dose of BMS-955176 or EFV.
    Units: years
        arithmetic mean (standard deviation)
    		 31.8 ( 8.26 ) 34.7 ( 11.29 ) 35.5 ( 11.34 ) 32.9 ( 9.35 ) -
    Gender categorical
    Units:
        Male
    		 42 44 44 46 176
        Female
    		 8 8 7 7 30
    Race/Ethnicity, Customized
    Units: Subjects
        White
    		 39 38 41 40 158
        Black or African American
    		 8 10 6 9 33
        American Indian or Alaska Native
    		 0 0 1 0 1
        Unknown
    		 3 4 3 4 14

    End points

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    End points reporting groups
    Reporting group title
    BMS-955176/GSK3532795 60 mg + TDF/FTC
    Reporting group description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label tenofovir/emtricitabine (TDF/FTC) 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg at bed time on an empty stomach, without food from Day 1 to Week 96.

    Reporting group title
    BMS-955176/GSK3532795 120 mg + TDF/FTC
    Reporting group description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg at bed time on an empty stomach, without food, from Day 1 to Week 96.

    Reporting group title
    BMS-955176/GSK3532795 180 mg + TDF/FTC
    Reporting group description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill once daily from the bottle containing EFV placebo matching 600 mg once daily at bed time on an empty stomach, without food from Day 1 to Week 96.

    Reporting group title
    EFV 600 mg + TDF/FTC
    Reporting group description
    		 Participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 96. The doses were administered in the morning with a meal. Participants took one pill containing EFV 600 mg active dose once daily at bed time on an empty stomach, without food from Day 1 to Week 96.

    Primary: Number of participants with plasma HIV-1 ribonucleic acid (RNA) <40 copies per milliliter (c/mL) at Week 24 using Food and Drug Administration (FDA) snapshot algorithm

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    End point title
    		 Number of participants with plasma HIV-1 ribonucleic acid (RNA) <40 copies per milliliter (c/mL) at Week 24 using Food and Drug Administration (FDA) snapshot algorithm [1]
    End point description
    Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window (18 to 30 weeks) to determine response. Analysis was performed on mITT Population, which comprised of randomized participants who received at least 1 dose of BMS-955176/GSK3532795 or EFV.
    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: No statistical analysis were performed.
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Number of subjects analysed
    50 [2]
    52 [3]
    51 [4]
    53 [5]
    Units: Participants
    38
    43
    42
    41
    Notes
    [2] - mITT Population
    [3] - mITT Population
    [4] - mITT Population
    [5] - mITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 using FDA snapshot algorithm

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    End point title
    		 Number of participants with plasma HIV-1 RNA < 40 c/mL at Weeks 48 and 96 using FDA snapshot algorithm
    End point description
    Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV 1 RNA <40 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). 99999 indicates data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Weeks 48 and 96
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Number of subjects analysed
    50 [6]
    52 [7]
    51 [8]
    53 [9]
    Units: Participants
        Week 48; n=40, 42, 40, 43
    35
    41
    40
    40
        Week 96; n=0, 0, 0, 0
    99999
    99999
    99999
    99999
    Notes
    [6] - mITT Population (observed)
    [7] - mITT Population (observed)
    [8] - mITT Population (observed)
    [9] - mITT Population (observed)
    No statistical analyses for this end point

    Secondary: Number of participants with plasma HIV-1 RNA < 200 c/mL at Week 24 using FDA snapshot algorithm

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    End point title
    		 Number of participants with plasma HIV-1 RNA < 200 c/mL at Week 24 using FDA snapshot algorithm
    End point description
    Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Week 24 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Number of subjects analysed
    50 [10]
    52 [11]
    51 [12]
    53 [13]
    Units: Participants
        Week 24; n=50, 52, 51, 53
    40
    44
    43
    44
    Notes
    [10] - mITT Population
    [11] - mITT Population
    [12] - mITT Population
    [13] - mITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96

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    End point title
    		 Number of participants with plasma HIV-1 RNA < 200 c/mL at Weeks 48 and 96
    End point description
    Blood samples were collected for quantitative analysis of plasma HIV-1 RNA. The antiviral efficacy was determined by the number of participants with plasma HIV-1 RNA <200 c/mL at Weeks 48 and 96 using the FDA snapshot algorithm. This used the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. The analysis was performed using mITT Population (observed), which consisted of participants in the mITT Population excluding participants who had no HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). 99999 indicates data was not collected for Week 96 analysis; as the study was terminated early. Only those participants with data available at the specified time points were analyzed (represented by n=X in category titles).
    End point type
    Secondary
    End point timeframe
    Weeks 48 and 96
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Number of subjects analysed
    50 [14]
    52 [15]
    51 [16]
    53 [17]
    Units: Participants
        Week 48; n=40, 42, 40, 43
    38
    42
    40
    40
        Week 96; n=0, 0, 0, 0
    99999
    99999
    99999
    99999
    Notes
    [14] - mITT Population (observed)
    [15] - mITT Population (observed)
    [16] - mITT Population (observed)
    [17] - mITT Population (observed)
    No statistical analyses for this end point

    Secondary: Number of participants with newly emergent genotypic resistance using all on-treatment isolates

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    End point title
    		 Number of participants with newly emergent genotypic resistance using all on-treatment isolates
    End point description
    The emergence of genotypic resistance among samples selected for drug resistance testing were assessed by searching for all reverse transcriptase substitutions and protease inhibitor substitutions listed in the International Acquired Immunodeficiency Syndrome (AIDS) Society-United States of America (IAS-USA) list of HIV-1 drug resistance mutations. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early. The emergence of genotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment genotypic resistance testing and who had successful sequencing.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Number of subjects analysed
    5 [18]
    5 [19]
    2 [20]
    1 [21]
    Units: Participants
        Protease inhibitor substitution
    1
    0
    0
    0
        Reverse transcriptase substitution
    3
    5
    2
    0
    Notes
    [18] - mITT Population
    [19] - mITT Population
    [20] - mITT Population
    [21] - mITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with newly emergent phenotypic resistance using all on-treatment isolates

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    End point title
    		 Number of participants with newly emergent phenotypic resistance using all on-treatment isolates
    End point description
    Phenotypic resistance to a drug is defined as a fold change (i.e., ratio of the 50% inhibitory concentration (IC50) of the clinical isolate to the IC50 of the reference strain) which is greater than the cut-off for reduced susceptibility. Emergent phenotypic resistance to BMS-955176/GSK3532795 was defined as a Baseline fold change IC50<= 3 and an on-treatment fold change IC50>3. The number of participants with newly emergent phenotypic resistance is presented for participants in the mITT Population who had Baseline and on-treatment phenotypic resistance testing. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 24 as the study was terminated early.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Number of subjects analysed
    3 [22]
    3 [23]
    0 [24]
    1 [25]
    Units: Participants
    1
    0
    0
    Notes
    [22] - mITT Population
    [23] - mITT Population
    [24] - mITT Population
    [25] - mITT Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in logarithm to the base 10 (log10) HIV-1 RNA over time

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    End point title
    		 Change from Baseline in logarithm to the base 10 (log10) HIV-1 RNA over time
    End point description
    Blood samples were collected for analysis of HIV-1 RNA. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in plasma HIV-1 RNA (log10) is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). 99999 indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Weeks 2, 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Number of subjects analysed
    50 [26]
    52 [27]
    51 [28]
    53 [29]
    Units: Log 10 c/mL
    arithmetic mean (standard deviation)
        Week 2, n=8, 6, 10, 8
    -1.927 ( 0.3726 )
    -1.930 ( 0.4785 )
    -2.006 ( 0.3783 )
    -2.003 ( 0.3662 )
        Week 4, n=50, 51, 51, 50
    -2.083 ( 0.5870 )
    -2.082 ( 0.5480 )
    -2.142 ( 0.5092 )
    -2.305 ( 0.4554 )
        Week 8, n=49, 51, 49, 48
    -2.308 ( 0.6989 )
    -2.262 ( 0.7152 )
    -2.334 ( 0.6046 )
    -2.516 ( 0.6408 )
        Week 12, n=49, 50, 47, 47
    -2.372 ( 0.8215 )
    -2.351 ( 0.7622 )
    -2.441 ( 0.6372 )
    -2.730 ( 0.6254 )
        Week 16, n=47, 50, 46, 46
    -2.502 ( 0.8650 )
    -2.432 ( 0.7991 )
    -2.513 ( 0.6429 )
    -2.862 ( 0.6903 )
        Week 24, n=46, 47, 45, 44
    -2.506 ( 0.8094 )
    -2.557 ( 0.7956 )
    -2.505 ( 0.7284 )
    -2.919 ( 0.7584 )
        Week 32, n=44, 42, 42, 44
    -2.497 ( 0.8045 )
    -2.642 ( 0.7408 )
    -2.528 ( 0.7392 )
    -2.920 ( 0.7488 )
        Week 40, n=40, 42, 41, 43
    -2.605 ( 0.7096 )
    -2.640 ( 0.7391 )
    -2.581 ( 0.6803 )
    -2.949 ( 0.7665 )
        Week 48, n=40, 42, 40, 43
    -2.650 ( 0.6824 )
    -2.649 ( 0.7388 )
    -2.557 ( 0.6711 )
    -2.935 ( 0.7415 )
        Week 60; n=22, 24, 19, 20
    -2.705 ( 0.6379 )
    -2.810 ( 0.5765 )
    -2.703 ( 0.7455 )
    -2.906 ( 0.5646 )
        Week 72; n=5, 5, 5, 6
    -2.586 ( 0.4682 )
    -2.733 ( 0.6809 )
    -2.725 ( 0.5025 )
    -2.780 ( 0.6598 )
        Week 84; n= 2, 1, 2, 2
    -0.993 ( 3.4142 )
    -3.032 ( 99999 )
    -3.155 ( 0.1218 )
    -3.257 ( 0.5700 )
    Notes
    [26] - mITT Population (observed)
    [27] - mITT Population (observed)
    [28] - mITT Population (observed)
    [29] - mITT Population (observed)
    No statistical analyses for this end point

    Secondary: Change from Baseline in cluster of differentiation (CD)4+ thymus (T)-cell counts over time

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    End point title
    		 Change from Baseline in cluster of differentiation (CD)4+ thymus (T)-cell counts over time
    End point description
    CD4+ T-cell counts was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). 99999 indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Number of subjects analysed
    50 [30]
    52 [31]
    51 [32]
    53 [33]
    Units: Cells per microliter
    arithmetic mean (standard deviation)
        Week 4, n=50, 51, 50, 50
    41.6 ( 148.92 )
    72.9 ( 167.53 )
    52.9 ( 149.54 )
    64.7 ( 145.51 )
        Week 8, n=48, 49, 49, 47
    59.1 ( 219.64 )
    81.8 ( 126.79 )
    88.4 ( 177.68 )
    117.4 ( 230.74 )
        Week 12, n=49, 49, 47, 47
    110.4 ( 170.87 )
    120.0 ( 178.04 )
    129.7 ( 175.73 )
    142.5 ( 118.39 )
        Week 16, n=46, 50, 46, 46
    90.8 ( 200.76 )
    99.7 ( 171.16 )
    128.0 ( 212.09 )
    140.5 ( 179.70 )
        Week 24, n=46, 46, 44, 44
    94.3 ( 175.00 )
    81.2 ( 195.39 )
    92.5 ( 144.04 )
    134.7 ( 151.70 )
        Week 32, n=44, 42, 42, 44
    131.5 ( 207.69 )
    103.5 ( 172.15 )
    99.7 ( 171.95 )
    175.6 ( 152.48 )
        Week 40, n=41, 42, 41, 43
    175.9 ( 235.99 )
    194.4 ( 235.14 )
    167.3 ( 215.23 )
    222.5 ( 191.99 )
        Week 48, n=40, 41, 39, 43
    158.3 ( 228.90 )
    152.0 ( 204.56 )
    161.4 ( 221.65 )
    232.4 ( 207.71 )
        Week 60; n=22, 23, 19, 20
    168.4 ( 148.63 )
    156.5 ( 301.91 )
    198.3 ( 137.51 )
    204.7 ( 154.86 )
        Week 72; n=5, 5, 5, 7
    176.2 ( 98.50 )
    336.8 ( 329.32 )
    240.4 ( 240.48 )
    209.7 ( 97.79 )
        Week 84; n=2, 1, 2, 2
    -4.0 ( 173.95 )
    203.0 ( 99999 )
    97.0 ( 285.67 )
    165.5 ( 70.00 )
    Notes
    [30] - mITT Population (observed)
    [31] - mITT Population (observed)
    [32] - mITT Population (observed)
    [33] - mITT Population (observed)
    No statistical analyses for this end point

    Secondary: Change from Baseline in the percentage of CD4+ T-cells over time

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    End point title
    		 Change from Baseline in the percentage of CD4+ T-cells over time
    End point description
    CD4+ T-cell counts overall was assessed using flow cytometry. Values obtained at Day 1 were considered as Baseline value. Change from Baseline was calculated as value at indicated time point minus Baseline value. Change from Baseline in percentage of CD4+T- cell counts is summarized over time for the mITT Population using observed values, which excluded participants without HIV-1 RNA result data in the assessment visit windows due to discontinuation and who discontinued on or after the date of site notification of study termination by the sponsor (10 October 2016). Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). 99999 indicates standard deviation could not be calculated as only one participant was analyzed at the specified time point.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and Weeks 4, 8, 12, 16, 24, 32, 40, 48, 60, 72 and 84
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Number of subjects analysed
    50 [34]
    52 [35]
    51 [36]
    53 [37]
    Units: Percentage of CD4+T- cells
    arithmetic mean (standard deviation)
        Week 4, n=50, 51, 50, 50
    4.56 ( 3.195 )
    3.43 ( 3.982 )
    3.93 ( 3.210 )
    3.87 ( 4.284 )
        Week 8, n=48, 49, 49, 47
    5.02 ( 4.650 )
    4.15 ( 4.047 )
    5.15 ( 3.943 )
    5.09 ( 4.257 )
        Week 12, n=49, 49, 47, 47
    5.47 ( 4.570 )
    5.39 ( 4.577 )
    6.22 ( 4.450 )
    6.29 ( 4.557 )
        Week 16, n=46, 50, 46, 46
    6.20 ( 6.163 )
    5.65 ( 4.179 )
    6.95 ( 4.019 )
    6.87 ( 4.763 )
        Week 24, n=46, 46, 44, 44
    7.68 ( 5.834 )
    5.71 ( 4.542 )
    6.96 ( 4.761 )
    5.94 ( 5.730 )
        Week 32, n=44, 42, 42, 44
    7.75 ( 6.559 )
    7.36 ( 5.457 )
    6.90 ( 6.498 )
    8.37 ( 6.253 )
        Week 40, n=41, 42, 41, 43
    7.90 ( 6.612 )
    6.97 ( 8.253 )
    7.94 ( 5.601 )
    9.06 ( 5.538 )
        Week 48, n=40, 41, 39, 43
    9.07 ( 6.311 )
    7.62 ( 6.218 )
    9.59 ( 4.828 )
    10.16 ( 6.262 )
        Week 60; n=22, 23, 19, 20
    9.41 ( 6.290 )
    8.44 ( 7.788 )
    11.36 ( 6.568 )
    10.73 ( 7.098 )
        Week 72; n=5, 5, 5, 7
    8.56 ( 3.436 )
    9.92 ( 4.147 )
    12.46 ( 9.557 )
    9.67 ( 3.982 )
        Week 84; n=2, 1, 2, 2
    -0.75 ( 8.839 )
    4.60 ( 99999 )
    19.50 ( 11.314 )
    12.90 ( 4.950 )
    Notes
    [34] - mITT Population (observed)
    [35] - mITT Population (observed)
    [36] - mITT Population (observed)
    [37] - mITT Population (observed)
    No statistical analyses for this end point

    Secondary: Number of participants with serious adverse events (SAEs) and adverse events leading to discontinuation (AELD)

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    End point title
    		 Number of participants with serious adverse events (SAEs) and adverse events leading to discontinuation (AELD)
    End point description
    Any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention were categorized as SAE. Number of participants with SAEs and AELDs is summarized.
    End point type
    Secondary
    End point timeframe
    Up to Week 96
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Number of subjects analysed
    50 [38]
    52 [39]
    51 [40]
    53 [41]
    Units: Participants
        SAEs
    3
    5
    2
    5
        AELD
    1
    4
    5
    10
    Notes
    [38] - mITT Population
    [39] - mITT Population
    [40] - mITT Population
    [41] - mITT Population
    No statistical analyses for this end point

    Secondary: Number of participants with at least one Centers for Disease Control (CDC) class C event

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    End point title
    		 Number of participants with at least one Centers for Disease Control (CDC) class C event
    End point description
    The occurrence of new AIDS defining events, that is CDC class C events is presented.
    End point type
    Secondary
    End point timeframe
    Up to Week 96
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Number of subjects analysed
    50 [42]
    52 [43]
    51 [44]
    53 [45]
    Units: Participants
    0
    2
    0
    0
    Notes
    [42] - mITT Population
    [43] - mITT Population
    [44] - mITT Population
    [45] - mITT Population
    No statistical analyses for this end point

    Secondary: Maximum observed plasma concentration (Cmax), observed pre-dose plasma concentration (C0) and observed plasma concentration at the end of a dosing interval (Ctau) of BMS-955176/GSK3532795

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    End point title
    		 Maximum observed plasma concentration (Cmax), observed pre-dose plasma concentration (C0) and observed plasma concentration at the end of a dosing interval (Ctau) of BMS-955176/GSK3532795 [46]
    End point description
    Serial blood samples were collected at indicated time points for intensive pharmacokinetic (PK) assessment. The PK assessments were performed on evaluable PK Population, a sub-population which included all treated participants who had adequate PK profiles.
    End point type
    Secondary
    End point timeframe
    Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
    Notes
    [46] - 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: This endpoint is only reporting on a subset of the arms that are contained in the baseline period.
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC
    Number of subjects analysed
    8 [47]
    6 [48]
    10 [49]
    Units: Nanogram per milliliter
    geometric mean (geometric coefficient of variation)
        Cmax
    1945.342 ( 16.0 )
    3162.161 ( 28.8 )
    4645.266 ( 16.2 )
        C0
    1065.102 ( 25.2 )
    1800.952 ( 33.4 )
    2728.671 ( 17.8 )
        Ctau
    1100.138 ( 15.1 )
    1656.578 ( 39.7 )
    2705.751 ( 26.8 )
    Notes
    [47] - Evaluable PK Population
    [48] - Evaluable PK Population
    [49] - Evaluable PK Population
    No statistical analyses for this end point

    Secondary: Time of maximum observed plasma concentration (Tmax) of BMS-955176/GSK3532795

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    End point title
    		 Time of maximum observed plasma concentration (Tmax) of BMS-955176/GSK3532795 [50]
    End point description
    Serial blood samples were collected at indicated time points for intensive PK assessment.
    End point type
    Secondary
    End point timeframe
    Pre-dose (morning) and 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
    Notes
    [50] - 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: This endpoint is only reporting on a subset of the arms that are contained in the baseline period.
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC
    Number of subjects analysed
    8 [51]
    6 [52]
    10 [53]
    Units: Hour
        median (full range (min-max))
    4.00 (1.6 to 8.2)
    4.29 (4.0 to 5.1)
    5.50 (1.0 to 12.0)
    Notes
    [51] - Evaluable PK Population
    [52] - Evaluable PK Population
    [53] - Evaluable PK Population
    No statistical analyses for this end point

    Secondary: Area under the concentration-time curve in one dosing interval (AUC [tau]) of BMS-955176/GSK3532795

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    End point title
    		 Area under the concentration-time curve in one dosing interval (AUC [tau]) of BMS-955176/GSK3532795 [54]
    End point description
    Serial blood samples were collected at indicated time points for intensive PK assessment.
    End point type
    Secondary
    End point timeframe
    Pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 (evening pre-dose) and 24 hours (morning pre-dose) at Week 2 (Days 12 to 16)
    Notes
    [54] - 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: This endpoint is only reporting on a subset of the arms that are contained in the baseline period.
    End point values
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC
    Number of subjects analysed
    8 [55]
    6 [56]
    10 [57]
    Units: Hour*nanograms per milliliter
        geometric mean (geometric coefficient of variation)
    34226.751 ( 18.73 )
    55251.956 ( 32.88 )
    87128.359 ( 20.79 )
    Notes
    [55] - Evaluable PK Population
    [56] - Evaluable PK Population
    [57] - Evaluable PK Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Non-serious adverse events and serious adverse events (SAEs) were collected from the start of study treatment until Week 96.
    Adverse event reporting additional description
    Non-SAEs and SAEs were collected in the mITT Population, which comprised of all participants who received at least one dose of BMS-955176/GSK3532795 or EFV.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    BMS-955176/GSK3532795 60 mg + TDF/FTC
    Reporting group description
    		 In the morning, with a meal, participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 milligrams (mg) active dose, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 48. At bed time, on an empty stomach, without food, participants took one pill once daily from the bottle containing efavirenz (EFV) placebo matching 600 mg from Day 1 to Week 48.

    Reporting group title
    BMS-955176/GSK3532795 120 mg + TDF/FTC
    Reporting group description
    		 In the morning, with a meal, participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 120 mg active dose, BMS-955176/GSK3532795 placebo matching 60 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 48. At bed time, on an empty stomach, without food, participants took one pill once daily from the bottle containing EFV placebo matching 600 mg from Day 1 to Week 48.

    Reporting group title
    BMS-955176/GSK3532795 180 mg + TDF/FTC
    Reporting group description
    		 In the morning, with a meal, participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 60 mg active dose, BMS-955176/GSK3532795 120 mg active dose and open-label TDF/FTC 300/200 mg from Day 1 to Week 48. At bed time, on an empty stomach, without food, participants took one pill once daily from the bottle containing EFV placebo matching 600 mg from Day 1 to Week 48.

    Reporting group title
    EFV 600 mg + TDF/FTC
    Reporting group description
    		 In the morning, with a meal, participants took one pill once daily from each of the three blinded bottles provided to them, containing BMS-955176/GSK3532795 placebo matching 60 mg, BMS-955176/GSK3532795 placebo matching 120 mg and open-label TDF/FTC 300/200 mg from Day 1 to Week 48. At bed time, on an empty stomach, without food, participants took one pill once daily from the bottle containing EFV 600 mg active dose from Day 1 to Week 48.

    Serious adverse events
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 50 (6.00%)
    5 / 52 (9.62%)
    2 / 51 (3.92%)
    5 / 53 (9.43%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    HEPATIC ENZYME INCREASED
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         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
    Injury, poisoning and procedural complications
    OVERDOSE
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 53 (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
    Gastrointestinal injury
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (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
    Cardiac disorders
    VENTRICULAR EXTRASYSTOLES
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         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
    Nervous system disorders
    Orthostatic intolerance
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (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
    Gastrointestinal disorders
    ABDOMINAL PAIN
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    COLITIS ULCERATIVE
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    0 / 53 (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
    TOOTHACHE
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         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
    Respiratory, thoracic and mediastinal disorders
    PNEUMOTHORAX SPONTANEOUS
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         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
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 53 (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
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 53 (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
    Infections and infestations
    INTERVERTEBRAL DISCITIS
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 53 (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
    URINARY TRACT INFECTION
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         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 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 53 (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
    Metapneumovirus infection
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    0 / 53 (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
    Pelvic infection
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 53 (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
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 BMS-955176/GSK3532795 60 mg + TDF/FTC BMS-955176/GSK3532795 120 mg + TDF/FTC BMS-955176/GSK3532795 180 mg + TDF/FTC EFV 600 mg + TDF/FTC
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    41 / 50 (82.00%)
    46 / 52 (88.46%)
    45 / 51 (88.24%)
    48 / 53 (90.57%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 52 (5.77%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    0
    3
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 52 (3.85%)
    2 / 51 (3.92%)
    21 / 53 (39.62%)
         occurrences all number
    0
    2
    2
    27
    Headache
         subjects affected / exposed
    1 / 50 (2.00%)
    6 / 52 (11.54%)
    7 / 51 (13.73%)
    6 / 53 (11.32%)
         occurrences all number
    1
    8
    8
    8
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    2 / 53 (3.77%)
         occurrences all number
    3
    1
    3
    2
    Pyrexia
         subjects affected / exposed
    2 / 50 (4.00%)
    0 / 52 (0.00%)
    4 / 51 (7.84%)
    2 / 53 (3.77%)
         occurrences all number
    2
    0
    4
    2
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    4 / 53 (7.55%)
         occurrences all number
    1
    0
    0
    4
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    20 / 50 (40.00%)
    22 / 52 (42.31%)
    31 / 51 (60.78%)
    8 / 53 (15.09%)
         occurrences all number
    30
    33
    58
    9
    Nausea
         subjects affected / exposed
    4 / 50 (8.00%)
    4 / 52 (7.69%)
    6 / 51 (11.76%)
    7 / 53 (13.21%)
         occurrences all number
    4
    4
    7
    8
    Abdominal pain
         subjects affected / exposed
    5 / 50 (10.00%)
    6 / 52 (11.54%)
    10 / 51 (19.61%)
    1 / 53 (1.89%)
         occurrences all number
    6
    8
    14
    1
    Vomiting
         subjects affected / exposed
    2 / 50 (4.00%)
    5 / 52 (9.62%)
    3 / 51 (5.88%)
    2 / 53 (3.77%)
         occurrences all number
    2
    6
    4
    2
    Abdominal pain upper
         subjects affected / exposed
    3 / 50 (6.00%)
    3 / 52 (5.77%)
    4 / 51 (7.84%)
    0 / 53 (0.00%)
         occurrences all number
    4
    5
    5
    0
    Dyspepsia
         subjects affected / exposed
    0 / 50 (0.00%)
    5 / 52 (9.62%)
    2 / 51 (3.92%)
    0 / 53 (0.00%)
         occurrences all number
    0
    6
    2
    0
    Abdominal distension
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    3 / 51 (5.88%)
    0 / 53 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Irritable bowel syndrome
         subjects affected / exposed
    0 / 50 (0.00%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    0 / 53 (0.00%)
         occurrences all number
    0
    1
    3
    0
    Toothache
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    1
    1
    0
    3
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    3 / 51 (5.88%)
    0 / 53 (0.00%)
         occurrences all number
    0
    0
    3
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    3 / 53 (5.66%)
         occurrences all number
    3
    1
    1
    3
    Cough
         subjects affected / exposed
    1 / 50 (2.00%)
    3 / 52 (5.77%)
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    1
    3
    1
    0
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    1
    0
    0
    3
    Drug eruption
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    3 / 53 (5.66%)
         occurrences all number
    0
    0
    1
    3
    Pruritus
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    3
    1
    0
    1
    Psychiatric disorders
    Insomnia
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 52 (1.92%)
    7 / 51 (13.73%)
    3 / 53 (5.66%)
         occurrences all number
    3
    1
    9
    3
    Abnormal dreams
         subjects affected / exposed
    1 / 50 (2.00%)
    4 / 52 (7.69%)
    1 / 51 (1.96%)
    6 / 53 (11.32%)
         occurrences all number
    1
    5
    1
    6
    Anxiety
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    4 / 53 (7.55%)
         occurrences all number
    1
    1
    1
    4
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    1 / 53 (1.89%)
         occurrences all number
    2
    1
    3
    1
    Muscle spasms
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    0 / 53 (0.00%)
         occurrences all number
    2
    1
    3
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    5 / 50 (10.00%)
    4 / 52 (7.69%)
    6 / 51 (11.76%)
    4 / 53 (7.55%)
         occurrences all number
    8
    5
    8
    4
    Pharyngitis
         subjects affected / exposed
    6 / 50 (12.00%)
    3 / 52 (5.77%)
    2 / 51 (3.92%)
    3 / 53 (5.66%)
         occurrences all number
    7
    4
    4
    4
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 50 (6.00%)
    8 / 52 (15.38%)
    6 / 51 (11.76%)
    1 / 53 (1.89%)
         occurrences all number
    7
    11
    8
    2
    Influenza
         subjects affected / exposed
    1 / 50 (2.00%)
    6 / 52 (11.54%)
    1 / 51 (1.96%)
    3 / 53 (5.66%)
         occurrences all number
    1
    6
    1
    4
    Bronchitis
         subjects affected / exposed
    2 / 50 (4.00%)
    4 / 52 (7.69%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    2
    5
    0
    1
    Sinusitis
         subjects affected / exposed
    4 / 50 (8.00%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    1 / 53 (1.89%)
         occurrences all number
    5
    1
    1
    1
    Conjunctivitis
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    2 / 53 (3.77%)
         occurrences all number
    3
    0
    1
    2
    Urethritis
         subjects affected / exposed
    4 / 50 (8.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    0 / 53 (0.00%)
         occurrences all number
    5
    1
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    29 Apr 2015
    This amendment served to clarify inclusion/exclusion criteria, clarify virologic failure, clarify resistance testing, correct Sparse PK sample collection time, provide additional details on dosage forms, and modify references to discontinuation due to pregnancy to ensure consistency.
    22 May 2015
    This amendment served to clearly define most contraception methods, incorporate a post-dosing safety follow-up visit, require women of childbearing potential (WOCBP) to follow study instructions, add a time to loss of virologic response (TLOVR) analysis and define virologic rebound, add information on laboratory assessments, update the division of AIDS (DAIDS) toxicity table as appendices, and clarify that AIDS history will be taken at screening.

    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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