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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

    Results information
    Results version number
    		 v1
    This version publication date
    09 Aug 2017
    First version publication date
    09 Aug 2017
    Other versions
    		 v2

    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
    Interim
    Date of interim/final analysis
    16 Jun 2017
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 May 2016
    Global end of trial reached?
    No
    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
    		 -

    Pre-assignment
    Screening details
    		 A total of 305 participants were enrolled, of which 210 were randomized to 1 of 4 treatment arms. Of 210 participants only 206 received randomized treatment. The study was originally designed for 96 weeks of treatment, but it was terminated early. Study results through the primary completion achieved at Week 24 were presented.

    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
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-955176/GSK3532795 60mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    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
    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
    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
    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
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-955176/GSK3532795 120 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    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
    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
    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
    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
    		 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    BMS-955176/GSK3532795 60mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    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
    BMS-955176/GSK3532795 120 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    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 EFV 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    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
    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
    		 EFV 600 mg + TDF/FTC
    Arm 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.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Placebo to match BMS-955176/GSK3532795 60 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    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 BMS-955176/GSK3532795 120 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    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
    EFV 600 mg
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    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
    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.

    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
    3
    -
    1
    -
         Adverse event, non-fatal
    1
    3
    5
    9
         Study terminated by sponsor
    42
    42
    42
    43
         Poor/Non-compliance
    -
    -
    1
    -
         Lost to follow-up
    -
    1
    -
    -
         Subject no longer meets study criteria
    -
    1
    1
    -
         Lack of efficacy
    3
    4
    -
    -
         Participant request to discontinue study treatment
    1
    -
    -
    1
         Concerns about the safety of treatment
    -
    1
    -
    -
         Discontinuation due to NRTI resistance
    -
    -
    1
    -
    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
    		 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.

    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
    Treated Subjects Population, also known as the modified intent-to-treat (mITT) population, comprised of all subjects who received at least one dose of study treatment, was used to present baseline characteristics
    Units: years
        arithmetic mean (standard deviation)
    		 31.8 ± 8.26 34.7 ± 11.29 35.5 ± 11.34 32.9 ± 9.35 -
    Gender categorical
    Treated Subjects Population was used to present Baseline characteristics
    Units:
        Male
    		 42 44 44 46 176
        Female
    		 8 8 7 7 30
    Race/Ethnicity, Customized
    Treated Subjects Population was used to present Baseline characteristics
    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
    		 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.

    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
    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 to determine response. Plasma samples were collected for HIV-1 RNA at Week 0 (Day 1), Week 2 (Day 12 to 16), Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84 and 96. The analysis was based on a modified Intent-to-Treat (mITT) approach. The Treated Subjects Population includes 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: 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 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] - Treated Subjects Population
    [3] - Treated Subjects Population
    [4] - Treated Subjects Population
    [5] - Treated Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants with plasma HIV-1 RNA < 40 c/mL at Week 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 Week 48 and 96 using FDA snapshot algorithm
    End point description
    The antiviral efficacy was planned to be determined by the number of participants with plasma HIV 1 RNA < 40 c/mL at Week 48 and 96 using the FDA snapshot algorithm. This would use the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. Plasma samples were to be collected for HIV-1 RNA at Week 0 (Day 1), Week 2 (Day 12 to 16), Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84 and 96. The analysis was based on a modified Intent-to-Treat (mITT) . As the study was terminated early, this outcome was not analyzed.
    End point type
    Secondary
    End point timeframe
    Week 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
    0 [6]
    0 [7]
    0 [8]
    0 [9]
    Units: Participants
    Notes
    [6] - The study was terminated early, this outcome was not analyzed.
    [7] - The study was terminated early, this outcome was not analyzed.
    [8] - The study was terminated early, this outcome was not analyzed.
    [9] - The study was terminated early, this outcome was not analyzed.
    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
    The antiviral efficacy was to be determined by the number of participants with plasma HIV 1 RNA < 40 c/mL at Week 24, 48 and 96 using the FDA snapshot algorithm. This use the last on-treatment plasma HIV-1 RNA measurement within an FDA-specified visit window to determine response. Plasma samples were to be collected for HIV-1 RNA at Week 0 (Day 1), Week 2 (Day 12 to 16), Week 4, 8, 12, 16, 24, 32, 40, 48, 60, 72, 84 and 96. Positive response was defined as HIV-1 RNA < 200 c/mL. The analysis was based on a modified Intent-to-Treat (mITT) approach. The Treated Subjects Population includes randomized participants who received at least 1 dose of BMS-955176/GSK3532795 or EFV
    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
    40
    44
    43
    44
    Notes
    [10] - Treated Subjects Population
    [11] - Treated Subjects Population
    [12] - Treated Subjects Population
    [13] - Treated Subjects Population
    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 HIV drug resistance among samples selected for drug resistance testing were assessed using the most recent version of the international acquired immunodeficiency syndrome (AIDS) society United States of America (IAS-USA) list of HIV-1 drug resistance mutations. Samples for emergent drug resistance testing (genotypic) were collected at Week 4, 8, 12, 16 and 24. Treated participants with on-treatment genotypic resistance sequenced were summarized. 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. Outcome results through Week 24 were presented. Treated Subjects 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 [14]
    5 [15]
    2 [16]
    1 [17]
    Units: Participants
        Protease inhibitor substitution
    1
    0
    0
    0
        Reverse transcriptase substitution
    3
    5
    2
    0
    Notes
    [14] - Treated Subjects Population
    [15] - Treated Subjects Population
    [16] - Treated Subjects Population
    [17] - Treated Subjects 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
    The emergence of HIV drug resistance among samples selected for drug resistance testing were assessed using the most recent version of the international AIDS IAS-USA list of HIV-1 drug resistance mutations. Samples for emergent drug resistance testing (phenotypic) were collected at Week 4, 8, 12, 16 and 24. Emergent phenotypic resistance to BMS-955176/GSK3532795 was defined as a Baseline fold change half maximal inhibitory concentration (IC50)<= 3 and an on-treatment fold change IC50>3. Treated participants with on-treatment phenotypic resistance tested were summarized. 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. Outcome results through Week 24 were presented.
    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 [18]
    3 [19]
    0 [20]
    1 [21]
    Units: Participants
    1
    0
    0
    Notes
    [18] - Treated Subjects Population who had Baseline and on-treatment phenotypic resistance testing.
    [19] - Treated Subjects Population who had Baseline and on-treatment phenotypic resistance testing.
    [20] - Treated Subjects Population who had Baseline and on-treatment phenotypic resistance testing.
    [21] - Treated Subjects Population who had Baseline and on-treatment phenotypic resistance testing.
    No statistical analyses for this end point

    Secondary: Changes from Baseline in log10 HIV-1 RNA over time

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    End point title
    		 Changes from Baseline in log10 HIV-1 RNA over time
    End point description
    Plasma samples were collected for HIV-1 RNA at Week 0 (Day 1), Week 2 (Day 12 to 16), Week 4, 8, 12, 16, 24, 32, 40 and 48. Values obtained at Day 1 were considered as Baseline value. Change from Baseline over time in log 10 HIV-1 RNA overall was presented from on-treatment laboratory results and pre-specified visit windows. Change from Baseline was calculated as value at indicated time point minus Baseline value. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 48 as the study was terminated early. Outcome results through Week 48 were presented.Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and at Week 2 (Day 12 to 16), 4, 8, 12, 16, 24, 32, 40 and 48
    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 [22]
    52 [23]
    51 [24]
    53 [25]
    Units: log 10 c/mL
    arithmetic mean (standard deviation)
        Week 4, n=50, 51, 51, 48
    -2.082 ± 0.587
    -2.074 ± 0.5382
    -2.143 ± 0.5093
    -2.315 ± 0.4597
        Week 8, n=49, 51, 49, 48
    -2.308 ± 0.6995
    -2.254 ± 0.7096
    -2.335 ± 0.6041
    -2.515 ± 0.6402
        Week 12, n=49, 50, 47, 47
    -2.372 ± 0.8221
    -2.343 ± 0.7584
    -2.442 ± 0.6373
    -2.73 ± 0.6252
        Week 16, n=47, 50, 46, 45
    -2.503 ± 0.8656
    -2.423 ± 0.7964
    -2.514 ± 0.6426
    -2.876 ± 0.6909
        Week 24, n=46, 47, 45, 44
    -2.506 ± 0.8103
    -2.548 ± 0.7937
    -2.507 ± 0.7279
    -2.919 ± 0.7586
        Week 32, n=41, 38, 34, 37
    -2.517 ± 0.8039
    -2.66 ± 0.7349
    -2.582 ± 0.6551
    -2.878 ± 0.7542
        Week 40, n=8, 7, 9, 10
    -2.913 ± 0.5622
    -2.846 ± 0.5992
    -2.673 ± 0.5465
    -2.829 ± 0.7215
        Week 48, n=5, 4, 3, 6
    -2.408 ± 0.6076
    -2.538 ± 0.5144
    -2.767 ± 0.678
    -2.97 ± 0.5908
    Notes
    [22] - Treated Subjects Population
    [23] - Treated Subjects Population
    [24] - Treated Subjects Population
    [25] - Treated Subjects Population
    No statistical analyses for this end point

    Secondary: Changes from Baseline in cluster designation (CD)4+ thymus (T)-cell counts over time

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    End point title
    		 Changes from Baseline in cluster designation (CD)4+ thymus (T)-cell counts over time
    End point description
    Plasma samples were collected for CD4+ T-cell counts at Week 0 (Day 1) and at Week 4, 8, 12, 16, 24, 32, 40 and 48. Values obtained at Day 1 were considered as Baseline value. Change from Baseline over time in CD4+ T-cell counts overall was assessed using flow cytometry. Change from Baseline was calculated as value at indicated time point minus Baseline value. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 48 as the study was terminated early. Outcome results through Week 48 were presented. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and at Week 4, 8, 12, 16, 24, 32, 40 and 48
    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: Cells per uL
    arithmetic mean (standard deviation)
        Week 4, n=50, 51, 50, 48
    41.6 ± 148.92
    71.5 ± 169.22
    52.9 ± 149.54
    71.1 ± 145.01
        Week 8, n=48, 49, 49, 47
    59.1 ± 219.64
    80.4 ± 127.52
    88.4 ± 177.68
    117.4 ± 230.74
        Week 12, n=49, 49, 47, 47
    110.4 ± 170.87
    118.6 ± 179.42
    129.7 ± 175.73
    142.5 ± 118.39
        Week 16, n=46, 50, 46, 46
    90.8 ± 200.76
    98.4 ± 173.53
    128 ± 212.09
    140.5 ± 179.7
        Week 24, n=46, 46, 44, 44
    94.3 ± 175
    79.7 ± 199.46
    92.5 ± 144.04
    134.7 ± 151.7
        Week 32, n=42, 39, 38, 41
    114.8 ± 190.12
    96.2 ± 167.77
    97.7 ± 174.75
    171.5 ± 148.97
        Week 40, n=9, 7, 9, 11
    176.1 ± 161.74
    342.3 ± 250.51
    152.8 ± 219.04
    199.3 ± 161.07
        Week 48, n=5, 4, 3, 6
    94.6 ± 105.21
    194.5 ± 130.27
    28.7 ± 90.61
    289 ± 244.9
    Notes
    [26] - Treated Subjects Population
    [27] - Treated Subjects Population
    [28] - Treated Subjects Population
    [29] - Treated Subjects Population
    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
    Plasma samples were collected for CD4+ T-cell counts at Week 0 (Day 1) and at Week 4, 8, 12, 16, 24, 32, 40 and 48. Values obtained at Day 1 were considered as Baseline value. Change in the percentage of CD4+ T-cell counts overall was assessed using flow cytometry. Change from Baseline was calculated as value at indicated time point minus Baseline value. The outcome was originally designed to be assessed up to 96 weeks of treatment, but it was analyzed up to Week 48 as the study was terminated early. Outcome results through Week 48 were presented. Only those participants with data available at the specified time points were analyzed (represented by n=X, X in the category titles).
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1) and at Week 4, 8, 12, 16, 24, 32, 40 and 48
    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: Percentage
    arithmetic mean (standard deviation)
        Week 4, n=50, 51, 50, 48
    4.56 ± 3.195
    3.54 ± 4.077
    3.93 ± 3.21
    3.84 ± 4.339
        Week 8, n=48, 49, 49, 47
    5.02 ± 4.65
    4.27 ± 4.116
    5.15 ± 3.943
    5.09 ± 4.257
        Week 12, n=49, 49, 47, 47
    5.47 ± 4.57
    5.51 ± 4.643
    6.22 ± 4.45
    6.29 ± 4.557
        Week 16, n=46, 50, 46, 46
    6.2 ± 6.163
    5.77 ± 4.117
    6.95 ± 4.019
    6.87 ± 4.763
        Week 24, n=46, 46, 44, 44
    7.68 ± 5.834
    5.84 ± 4.457
    6.96 ± 4.761
    5.94 ± 5.73
        Week 32, n=42, 39, 38, 41
    7.46 ± 6.578
    7.63 ± 5.334
    7.07 ± 6.756
    8.31 ± 6.447
        Week 40, n=9, 7, 9, 11
    9.56 ± 8.395
    11.01 ± 7.421
    10.32 ± 6.567
    10.5 ± 5.415
        Week 48, n=5, 4, 3, 6
    6.82 ± 6.9
    7.8 ± 3.057
    13.9 ± 7.545
    11.77 ± 4.238
    Notes
    [30] - Treated Subjects Population
    [31] - Treated Subjects Population
    [32] - Treated Subjects Population
    [33] - Treated Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants with at least one adverse event (AE) and with AE leading to discontinuation (AELD)

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    End point title
    		 Number of participants with at least one adverse event (AE) and with AE leading to discontinuation (AELD)
    End point description
    An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, 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 at least one AE or SAE or with AELD up to Week 24 was summarized. 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. Outcome results through Week 24 were presented.
    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
    50 [34]
    52 [35]
    51 [36]
    53 [37]
    Units: Participants
        At least one AE
    41
    45
    45
    48
        AELD
    1
    3
    4
    9
    Notes
    [34] - Treated Subjects Population
    [35] - Treated Subjects Population
    [36] - Treated Subjects Population
    [37] - Treated Subjects Population
    No statistical analyses for this end point

    Secondary: Number of participants with at least one centers for disease control (CDC) class C AIDS event

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    End point title
    		 Number of participants with at least one centers for disease control (CDC) class C AIDS event
    End point description
    Number of participants with at least one CDC class C AIDS event was summarized. 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. Outcome results through Week 24 were presented.
    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
    50 [38]
    52 [39]
    51 [40]
    53 [41]
    Units: Participants
    0
    1
    0
    0
    Notes
    [38] - Treated Subjects Population
    [39] - Treated Subjects Population
    [40] - Treated Subjects Population
    [41] - Treated Subjects 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 [42]
    End point description
    Cmax, C0 and Ctau was evaluated from the blood samples collected at pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 and 24 hours after administration of BMS-955176/GSK3532795 60 mg or 120 mg or 180 mg with TDF/ FTC on study Week 2 (Days 12 to 16). The evaluable pharmacokinetic (PK) Population was a sub-population including 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 and 24 hours on study Week 2 (Days 12 to 16)
    Notes
    [42] - 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 [43]
    6 [44]
    10 [45]
    Units: Nanogram per milliliter
    geometric mean (geometric coefficient of variation)
        Cmax
    1945.342 ± 16
    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
    [43] - Evaluable PK Population
    [44] - Evaluable PK Population
    [45] - 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 [46]
    End point description
    Tmax was evaluated from the blood samples collected at pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 and 24 hours after administration of BMS-955176/GSK3532795 60 mg or 120 mg or 180 mg with TDF/ FTC on study Week 2 (Days 12 to 16).
    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 and 24 hours on study 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: There are no statistical data to report.
    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: Hour
        median (full range (min-max))
    4 (1.6 to 8.2)
    4.29 (4 to 5.1)
    5.5 (1 to 12)
    Notes
    [47] - Evaluable PK Population
    [48] - Evaluable PK Population
    [49] - 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 [50]
    End point description
    AUC (tau) was evaluated from the blood samples collected at pre-dose (morning) and at 0.5, 1, 1.5, 2, 4, 4.5, 5, 6, 8, 12 and 24 hours after administration of BMS-955176/GSK3532795 mg or 120 mg or 180 mg with TDF/ FTC on study Week 2 (Days 12 to 16).
    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 and 24 hours on study 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*ng/ mL
        geometric mean (geometric coefficient of variation)
    34226.751 ± 18.73
    55251.956 ± 32.88
    87128.359 ± 20.79
    Notes
    [51] - Evaluable PK Population
    [52] - Evaluable PK Population
    [53] - Evaluable PK Population
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    On-treatment SAEs and non-serious AEs were collected from the start of the study treatment up to 24 weeks. They were planned to be assessed up to 96 weeks, but it was analyzed up to Week 24 as the study was terminated.
    Adverse event reporting additional description
    On treatment SAEs and non-serious AEs were reported for the Treated Subjects Population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    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
    1 / 50 (2.00%)
    2 / 52 (3.85%)
    1 / 51 (1.96%)
    5 / 53 (9.43%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Investigations
    HEPATIC ENZYME INCREASED
    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
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    OVERDOSE
    alternative dictionary used: MedDRA 19.0
         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
    Cardiac disorders
    VENTRICULAR EXTRASYSTOLES
    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
    Gastrointestinal disorders
    ABDOMINAL PAIN
    alternative dictionary used: MedDRA 19.0
         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
    alternative dictionary used: MedDRA 19.0
         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
    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
    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
    Infections and infestations
    INTERVERTEBRAL DISCITIS
    alternative dictionary used: MedDRA 19.0
         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
    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
    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
    34 / 50 (68.00%)
    38 / 52 (73.08%)
    41 / 51 (80.39%)
    41 / 53 (77.36%)
    Nervous system disorders
    Dizziness
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 52 (3.85%)
    2 / 51 (3.92%)
    19 / 53 (35.85%)
         occurrences all number
    0
    2
    2
    22
    Headache
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 50 (0.00%)
    3 / 52 (5.77%)
    5 / 51 (9.80%)
    6 / 53 (11.32%)
         occurrences all number
    0
    3
    6
    7
    General disorders and administration site conditions
    Fatigue
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    1 / 53 (1.89%)
         occurrences all number
    3
    1
    3
    1
    Pyrexia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    2 / 53 (3.77%)
         occurrences all number
    1
    1
    3
    2
    Ear and labyrinth disorders
    Vertigo
    alternative dictionary used: MedDRA 19.0
         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
    Gastrointestinal disorders
    Diarrhoea
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    19 / 50 (38.00%)
    20 / 52 (38.46%)
    32 / 51 (62.75%)
    6 / 53 (11.32%)
         occurrences all number
    25
    28
    52
    7
    Nausea
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 50 (6.00%)
    4 / 52 (7.69%)
    6 / 51 (11.76%)
    8 / 53 (15.09%)
         occurrences all number
    3
    4
    7
    9
    Abdominal pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    4 / 50 (8.00%)
    5 / 52 (9.62%)
    11 / 51 (21.57%)
    0 / 53 (0.00%)
         occurrences all number
    5
    7
    15
    0
    Vomiting
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 50 (4.00%)
    5 / 52 (9.62%)
    3 / 51 (5.88%)
    1 / 53 (1.89%)
         occurrences all number
    2
    6
    4
    1
    Abdominal pain upper
    alternative dictionary used: MedDRA 19.0
         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
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 50 (0.00%)
    5 / 52 (9.62%)
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    0
    5
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 50 (4.00%)
    1 / 52 (1.92%)
    0 / 51 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    2
    1
    0
    3
    Skin and subcutaneous tissue disorders
    Rash
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 50 (0.00%)
    2 / 52 (3.85%)
    1 / 51 (1.96%)
    3 / 53 (5.66%)
         occurrences all number
    0
    2
    1
    3
    Rash macular
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 50 (2.00%)
    0 / 52 (0.00%)
    1 / 51 (1.96%)
    3 / 53 (5.66%)
         occurrences all number
    1
    0
    1
    3
    Psychiatric disorders
    Insomnia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 52 (1.92%)
    8 / 51 (15.69%)
    2 / 53 (3.77%)
         occurrences all number
    1
    1
    8
    2
    Abnormal dreams
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 50 (0.00%)
    4 / 52 (7.69%)
    1 / 51 (1.96%)
    5 / 53 (9.43%)
         occurrences all number
    0
    5
    1
    5
    Anxiety
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    3 / 53 (5.66%)
         occurrences all number
    2
    1
    1
    3
    Musculoskeletal and connective tissue disorders
    Back pain
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 52 (1.92%)
    4 / 51 (7.84%)
    2 / 53 (3.77%)
         occurrences all number
    1
    1
    4
    2
    Muscle spasms
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    1 / 50 (2.00%)
    1 / 52 (1.92%)
    3 / 51 (5.88%)
    0 / 53 (0.00%)
         occurrences all number
    1
    1
    3
    0
    Arthralgia
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    0 / 50 (0.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    3 / 53 (5.66%)
         occurrences all number
    0
    0
    0
    3
    Infections and infestations
    Nasopharyngitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    4 / 50 (8.00%)
    3 / 52 (5.77%)
    5 / 51 (9.80%)
    2 / 53 (3.77%)
         occurrences all number
    6
    4
    6
    2
    Pharyngitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    5 / 50 (10.00%)
    3 / 52 (5.77%)
    3 / 51 (5.88%)
    3 / 53 (5.66%)
         occurrences all number
    5
    4
    5
    3
    Upper respiratory tract infection
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 50 (6.00%)
    6 / 52 (11.54%)
    2 / 51 (3.92%)
    1 / 53 (1.89%)
         occurrences all number
    6
    7
    2
    2
    Influenza
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 50 (4.00%)
    5 / 52 (9.62%)
    1 / 51 (1.96%)
    3 / 53 (5.66%)
         occurrences all number
    2
    5
    1
    3
    Bronchitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    2 / 50 (4.00%)
    3 / 52 (5.77%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    2
    3
    0
    1
    Sinusitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 50 (6.00%)
    1 / 52 (1.92%)
    1 / 51 (1.96%)
    0 / 53 (0.00%)
         occurrences all number
    4
    1
    1
    0
    Conjunctivitis
    alternative dictionary used: MedDRA 19.0
         subjects affected / exposed
    3 / 50 (6.00%)
    0 / 52 (0.00%)
    0 / 51 (0.00%)
    1 / 53 (1.89%)
         occurrences all number
    3
    0
    0
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    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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