Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43873   clinical trials with a EudraCT protocol, of which   7292   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women

    Summary
    EudraCT number
    		 2012-005823-34
    Trial protocol
    		 GB   IT   ES   PT   FR  
    Global end of trial date

    Results information
    Results version number
    		 v1
    This version publication date
    10 Aug 2016
    First version publication date
    10 Aug 2016
    Other versions
    		 v2

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ING117172
    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 4357343,
    Scientific contact
    GSK Response Center, GlaxoSmithKline, 1-866 4357343,
    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
    15 Jan 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Sep 2015
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To demonstrate the non-inferior antiviral activity of DTG/ABC/3TC FDC once daily compared to ATV+RTV+TDF/FTC FDC each administered once daily over 48 weeks in HIV-1 infected ART naïve women.
    Protection of trial subjects
    Not applicable
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    22 Aug 2013
    Long term follow-up planned
    Yes
    Long term follow-up rationale
    		 Ethical reason
    Long term follow-up duration
    		 4 Years
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 134
    Country: Number of subjects enrolled
    South Africa: 66
    Country: Number of subjects enrolled
    Russian Federation: 50
    Country: Number of subjects enrolled
    Argentina: 44
    Country: Number of subjects enrolled
    Thailand: 40
    Country: Number of subjects enrolled
    Canada: 20
    Country: Number of subjects enrolled
    Puerto Rico: 2
    Country: Number of subjects enrolled
    Mexico: 11
    Country: Number of subjects enrolled
    Portugal: 9
    Country: Number of subjects enrolled
    Spain: 54
    Country: Number of subjects enrolled
    United Kingdom: 25
    Country: Number of subjects enrolled
    France: 16
    Country: Number of subjects enrolled
    Italy: 28
    Worldwide total number of subjects
    499
    EEA total number of subjects
    132
    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)
    493
    From 65 to 84 years
    6
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study consists of a Screening (14-28 days), Randomized (48 weeks) and Continuation (Cont.) Phase. Participants were said to have completed the study if they completed the Randomized phase and did not enter the Cont. Phase. Participants entering the Cont. Phase were said to have completed the study if they completed both phases of the study.

    Pre-assignment
    Screening details
    		 A total of 499 participants were randomized to receive dolutegravir (DTG)/ abacavir (ABC)/ lamivudine (3TC) fixed dose combination (FDC) or combination of atazanavir (ATV), Ritonavir (RTV) and FDC of tenofovir disoproxil fumarate/emtricitabine (TDF/FTC). A total of 495 participants received at least single dose of investigational products (IP).

    Period 1
    Period 1 title
    Randomized phase
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD
    Arm description
    		 Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir (DTG)/ abacavir (ABC)/ lamivudine (3TC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received Dolutegravir (DTG)/ abacavir (ABC)/ lamivudine (3TC) 50 mg/600 mg/300 mg tablet once daily orally for 48 weeks.

    Arm title
    		 ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Arm description
    		 Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Atazanavir (ATV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received ATV 300 mg capsule along with RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.

    Investigational medicinal product name
    Ritonavir (RTV)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received RTV 100 mg tablet along with ATV 300 mg capsule and TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks

    Investigational medicinal product name
    Disoproxil fumarate/ emtricitabine (TDF/FTC).
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received TDF/FTC FDC 300 mg/200 mg tablet along with ATV 300 mg capsule and RTV 100 mg tablet once daily orally for 48 weeks

    Number of subjects in period 1 [1]
    		DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Started
    248
    247
    Completed
    206
    192
    Not completed
    42
    55
         Adverse event, serious fatal
    1
    -
         Physician decision
    1
    -
         Consent withdrawn by subject
    5
    7
         Adverse event, non-fatal
    9
    18
         Lost to follow-up
    11
    13
         Lack of efficacy
    5
    4
         Protocol deviation
    10
    13
    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: Justification for difference in the number of enrolled and the number of patients who received drugs: 1 participant withdrew consent, 1 participant was excluded at the investigator's discretion, 2 participants were entered in error (1 pregnant, 1 had resistance mutations).
    Period 2
    Period 2 title
    Continuation phase
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD
    Arm description
    		 Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Dolutegravir (DTG)/ abacavir (ABC)/ lamivudine (3TC)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants received Dolutegravir (DTG)/ abacavir (ABC)/ lamivudine (3TC), 50 mg/600 mg/300 mg tablet once daily orally for 48 weeks.

    Number of subjects in period 2 [2]
    		DTG 50 mg/ABC 600 mg/3TC 300 mg QD
    Started
    120
    Ongoing
    84
    Completed
    30
    Not completed
    90
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    2
         Ongoing
    84
         Protocol deviation
    3
    Notes
    [2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
    Justification: As per protocol, subjects are entered into the Continuation Phase only if i) the subject is randomized to the DTG/ABC/3TC FDC group, ii) the subject successfully completes 48 weeks of treatment, iii) DTG/ABC/3TC FDC is not locally approved or commercially available, and iii) the subject continues to derives clinical benefit, and does not meet a protocol-defined reason for discontinuation.

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD
    Reporting group description
    		 Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.

    Reporting group title
    ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Reporting group description
    		 Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.

    Reporting group values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD Total
    Number of subjects
    		 248 247 495
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.1 ( 11.15 ) 37.8 ( 10.14 ) -
    Gender categorical
    Units: Subjects
        Female
    		 248 247 495
        Male
    		 0 0 0
    Race
    Units: Subjects
        African American/African Heritage
    		 102 108 210
        American Indian Or Alaskan Native
    		 6 7 13
        Asian - Central/South Asian Heritage
    		 2 0 2
        Asian - East Asian Heritage
    		 0 1 1
        Asian - South East Asian Heritage
    		 20 22 42
        Native Hawaiian Or Other Pacific Islander
    		 1 0 1
        White - Arabic/North African Heritage
    		 3 3 6
        White - White/Caucasian/European Heritage
    		 112 104 216
        Mixed Race
    		 2 2 4

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD
    Reporting group description
    		 Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.

    Reporting group title
    ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Reporting group description
    		 Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
    Reporting group title
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD
    Reporting group description
    		 Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.

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

    		 Close Top of page
    End point title
    		 Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48
    End point description
    Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) <50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells per millimetre cube (cells/mm^3) or >350 cells/mm^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication.
    End point type
    Primary
    End point timeframe
    Week 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [1]
    247 [2]
    Units: Percentage of Participants
        number (not applicable)
    82
    71
    Notes
    [1] - ITT-E population
    [2] - ITT-E Population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Hypothesis was to show that the antiviral effect of the DTG/ABC/3TC FDC administered QD was non-inferior to QD ATV+RTV+TDF/FTC FDC. Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -12%.
    Comparison groups
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD v ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.005 [3]
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 Adjusted difference in proportion
    Point estimate
    10.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 3.1
         upper limit
    		 17.8
    Notes
    [3] - If the primary and PP analyses both demonstrated non-inferiority, then as per pre-specified analysis, superiority of DTG/ABC/3TC FDC versus ATV+RTV+TDF/FTC FDC was tested in the ITT-E population at the 2-sided 5% level of significance.

    Secondary: Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL over time

    		 Close Top of page
    End point title
    		 Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL over time
    End point description
    Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL were assessed at Baseline, Week 4, 12, 24 , 36 and Week 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. A value of "99999" indicates where no data is available or not able to determine the value.
    End point type
    Secondary
    End point timeframe
    Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [4]
    247 [5]
    Units: Percentage of Participants
    number (not applicable)
        HIV-1 RNA <50 c/mL, Baseline
    0
    0
        HIV-1 RNA <50 c/mL, Week 4
    64
    13
        HIV-1 RNA <50 c/mL, Week 12
    81
    49
        HIV-1 RNA <50 c/mL, Week 24
    85
    77
        HIV-1 RNA <50 c/mL, Week 36
    85
    77
        HIV-1 RNA <50 c/mL, Week 48
    82
    71
        HIV-1 RNA <400 c/mL, Baseline
    0.8
    0.8
        HIV-1 RNA <400 c/mL, Week 4
    90
    54
        HIV-1 RNA <400 c/mL, Week 12
    91
    84
        HIV-1 RNA <400 c/mL, Week 24
    88
    82
        HIV-1 RNA <400 c/mL, Week 36
    86
    81
        HIV-1 RNA <400 c/mL, Week 48
    83
    76
    Notes
    [4] - ITT-E Population
    [5] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in Plasma HIV-1 RNA at indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in Plasma HIV-1 RNA at indicated time points
    End point description
    Change from the Baseline in plasma HIV-1 RNA were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants 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), Week 4, Week 12, Week 24, Week 36 and Week 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [6]
    247 [7]
    Units: Log10 copies/mL
    arithmetic mean (standard deviation)
        Baseline, n=248, 247
    4.481 ( 0.8111 )
    4.441 ( 0.8023 )
        Week 4, n=245, 238
    -2.646 ( 0.7971 )
    -1.932 ( 0.5303 )
        Week 12, n=236, 226
    -2.831 ( 0.8945 )
    -2.585 ( 0.7321 )
        Week 24, n=225, 212
    -2.868 ( 0.9196 )
    -2.801 ( 0.892 )
        Week 36, n=221, 204
    -2.922 ( 0.8611 )
    -2.851 ( 0.847 )
        Week 48, n=207, 192
    -2.96 ( 0.8033 )
    -2.834 ( 0.8462 )
    Notes
    [6] - ITT-E Population
    [7] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in CD4+ cell count at indicated timepoints

    		 Close Top of page
    End point title
    		 Change from Baseline in CD4+ cell count at indicated timepoints
    End point description
    Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants 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), Week 4, Week 12, Week 24, Week 36 and Week 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [8]
    247 [9]
    Units: Cells per millimeter cube
    arithmetic mean (standard deviation)
        Baseline, n=248, 247
    369.7 ( 225.67 )
    380.3 ( 223.6 )
        Week 4, n=245, 237
    94.9 ( 140.02 )
    73.7 ( 108.15 )
        Week 12, n=236, 224
    143.8 ( 142.19 )
    124.4 ( 133.6 )
        Week 24, n=226, 210
    200.6 ( 162.37 )
    163 ( 126.67 )
        Week 36, n=219, 204
    230.7 ( 163.61 )
    191.4 ( 167.24 )
        Week 48, n=208, 191
    248.8 ( 172.01 )
    230.7 ( 189.59 )
    Notes
    [8] - ITT-E Population
    [9] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in carbon dioxide, electrolytes, lipids, glucose, urea at indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in carbon dioxide, electrolytes, lipids, glucose, urea at indicated time points
    End point description
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol [CHLS], high density lipoprotein [HDL] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). A value of "99999" indicates where no data is available or not able to determine the value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 12, 24, 36, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [10]
    247 [11]
    Units: Millimoles per liter
    arithmetic mean (standard deviation)
        Carbon Dioxide, Baseline, n= 248, 247
    22.1 ( 2.37 )
    21.5 ( 2.28 )
        Carbon Dioxide, Week 4, n= 244, 237
    -0.4 ( 2.29 )
    0.6 ( 2.2 )
        Carbon Dioxide, Week 12, n= 236, 226
    -0.2 ( 2.2 )
    0.8 ( 2.19 )
        Carbon Dioxide, Week 24, n= 224, 212
    -0.5 ( 2.31 )
    0.3 ( 2.38 )
        Carbon Dioxide, Week 36, n= 219, 204
    0 ( 2.34 )
    0.6 ( 2.5 )
        Carbon Dioxide, Week 48, n= 208, 192
    -0.6 ( 2.55 )
    0.4 ( 2.46 )
        Chloride, Baseline, n= 248, 247
    104 ( 2.49 )
    104.6 ( 2.63 )
        Chloride, Week 4, n= 245, 237
    0.6 ( 2.42 )
    -0.5 ( 2.68 )
        Chloride, Week 12, n= 236, 226
    1 ( 2.51 )
    0.2 ( 2.58 )
        Chloride, Week 24, n= 225, 212
    0.7 ( 2.71 )
    -0.1 ( 2.58 )
        Chloride, Week 36, n= 219, 204
    0.9 ( 2.65 )
    0 ( 2.96 )
        Chloride, Week 48, n= 208, 192
    0.7 ( 2.42 )
    0 ( 2.63 )
        CHLS, Baseline, n= 230, 232
    4.351 ( 0.9389 )
    4.324 ( 0.9766 )
        CHLS, Week 4, n= 1, 3
    -0.1 ( 99999 )
    -0.017 ( 0.446 )
        CHLS, Week 12, n= 224, 221
    0.298 ( 0.7492 )
    -0.058 ( 0.7137 )
        CHLS, Week 24, n= 218, 201
    0.317 ( 0.7254 )
    -0.001 ( 0.7456 )
        CHLS, Week 36, n= 205, 191
    0.33 ( 0.7328 )
    0 ( 0.7509 )
        CHLS, Week 48, n= 195, 175
    0.447 ( 0.7441 )
    0.109 ( 0.7647 )
        Glucose, Baseline, n= 231, 234
    4.91 ( 1.003 )
    4.88 ( 1.41 )
        Glucose, Week 12, n= 226, 224
    0.3 ( 1.359 )
    0.22 ( 1.234 )
        Glucose, Week 24, n= 219, 204
    0.17 ( 0.811 )
    0.26 ( 1.248 )
        Glucose, Week 36, n= 211, 196
    0.17 ( 1.24 )
    0.34 ( 1.753 )
        Glucose, Week 48, n= 197, 180
    0.18 ( 1.01 )
    0.24 ( 1.377 )
        HDL CHLS, Direct, Baseline, n= 230, 232
    1.23 ( 0.3717 )
    1.235 ( 0.3953 )
        HDL CHLS, Direct, Week 4, n= 1, 3
    -0.1 ( 99999 )
    0 ( 0.0529 )
        HDL CHLS, Direct, Week 12, n= 224, 221
    0.182 ( 0.3407 )
    0.005 ( 0.2316 )
        HDL CHLS, Direct, Week 24, n= 218, 201
    0.201 ( 0.2962 )
    0.053 ( 0.2819 )
        HDL CHLS, Direct, Week 36, n= 205, 191
    0.204 ( 0.2943 )
    0.036 ( 0.2848 )
        HDL CHLS, Direct, Week 48, n= 195, 175
    0.231 ( 0.2911 )
    0.081 ( 0.2964 )
        Hyperglycaemia, Baseline, n= 231, 234
    4.91 ( 1.003 )
    4.88 ( 1.41 )
        Hyperglycaemia, Week 12, n= 226, 224
    0.3 ( 1.359 )
    0.22 ( 1.234 )
        Hyperglycaemia, Week 24, n= 219, 204
    0.17 ( 0.811 )
    0.26 ( 1.248 )
        Hyperglycaemia, Week 36, n= 211, 196
    0.17 ( 1.24 )
    0.34 ( 1.753 )
        Hyperglycaemia, Week 48, n= 197, 180
    0.18 ( 1.01 )
    0.24 ( 1.377 )
        Hyperkalemia, Baseline, n= 248, 247
    4.11 ( 0.304 )
    4.08 ( 0.33 )
        Hyperkalemia, Week 4, n= 244, 237
    -0.01 ( 0.344 )
    0.12 ( 0.367 )
        Hyperkalemia, Week 12, n= 236, 226
    0.03 ( 0.355 )
    0.1 ( 0.39 )
        Hyperkalemia, Week 24, n= 224, 212
    -0.04 ( 0.339 )
    0.06 ( 0.372 )
        Hyperkalemia, Week 36, n= 219, 204
    0.03 ( 0.332 )
    0.13 ( 0.387 )
        Hyperkalemia, Week 48, n= 208, 192
    -0.04 ( 0.346 )
    0.04 ( 0.372 )
        Hypernatremia, Baseline, n= 248, 247
    137.6 ( 2.25 )
    137.8 ( 2.48 )
        Hypernatremia, Week 4, n= 245, 237
    0 ( 2.11 )
    -0.5 ( 2.4 )
        Hypernatremia, Week 12, n= 236, 226
    0.7 ( 2.3 )
    0.1 ( 2.51 )
        Hypernatremia, Week 24, n= 225, 212
    0.6 ( 2.3 )
    0.2 ( 2.11 )
        Hypernatremia, Week 36, n= 219, 204
    0.9 ( 2.32 )
    0.2 ( 2.5 )
        Hypernatremia, Week 48, n= 208, 192
    0.6 ( 2.24 )
    0.5 ( 2.39 )
        Hypoglycaemia, Baseline, n= 231, 234
    4.91 ( 1.003 )
    4.88 ( 1.41 )
        Hypoglycaemia, Week 12, n= 226, 224
    0.3 ( 1.359 )
    0.22 ( 1.234 )
        Hypoglycaemia, Week 24, n= 219, 204
    0.17 ( 0.811 )
    0.26 ( 1.248 )
        Hypoglycaemia, Week 36, n= 211, 196
    0.17 ( 1.24 )
    0.34 ( 1.753 )
        Hypoglycaemia, Week 48, n= 197, 180
    0.18 ( 1.01 )
    0.24 ( 1.377 )
        Hypokalemia, Baseline, n= 248, 247
    4.11 ( 0.304 )
    4.08 ( 0.33 )
        Hypokalemia, Week 4, n= 244, 237
    -0.01 ( 0.344 )
    0.12 ( 0.367 )
        Hypokalemia, Week 12, n= 236, 226
    0.03 ( 0.355 )
    0.1 ( 0.39 )
        Hypokalemia, Week 24, n= 224, 212
    -0.04 ( 0.339 )
    0.06 ( 0.372 )
        Hypokalemia, Week 36, n= 219, 204
    0.03 ( 0.332 )
    0.13 ( 0.387 )
        Hypokalemia, Week 48, n= 208, 192
    -0.04 ( 0.346 )
    0.04 ( 0.372 )
        Hyponatremia, Baseline, n= 248, 247
    137.6 ( 2.25 )
    137.8 ( 2.48 )
        Hyponatremia, Week 4, n= 245, 237
    0 ( 2.11 )
    -0.5 ( 2.4 )
        Hyponatremia, Week 12, n= 236, 226
    0.7 ( 2.3 )
    0.1 ( 2.51 )
        Hyponatremia, Week 24, n= 225, 212
    0.6 ( 2.3 )
    0.2 ( 2.11 )
        Hyponatremia, Week 36, n= 219, 204
    0.9 ( 2.32 )
    0.2 ( 2.5 )
        Hyponatremia, Week 48, n= 208, 192
    0.6 ( 2.24 )
    0.5 ( 2.39 )
        LDL CHLS Calculation, Baseline, n= 229, 231
    2.513 ( 0.7912 )
    2.537 ( 0.8016 )
        LDL CHLS Calculation, Week 4, n= 1, 3
    0.08 ( 99999 )
    -0.123 ( 0.5255 )
        LDL CHLS Calculation, Week 12, n= 221, 219
    0.125 ( 0.6045 )
    -0.14 ( 0.6114 )
        LDL CHLS Calculation, Week 24, n= 213, 201
    0.111 ( 0.6209 )
    -0.111 ( 0.6188 )
        LDL CHLS Calculation, Week 36, n= 201, 188
    0.112 ( 0.6385 )
    -0.099 ( 0.6049 )
        LDL CHLS Calculation, Week 48, n= 190, 175
    0.213 ( 0.6499 )
    -0.021 ( 0.6227 )
        LDL CHLS, Direct, Baseline, n= 13, 7
    2.522 ( 0.7586 )
    2.993 ( 0.7707 )
        LDL CHLS, Direct, Week 12, n= 0, 1
    99999 ( 99999 )
    -0.44 ( 99999 )
        LDL CHLS, Direct, Week 24, n= 1, 0
    -0.64 ( 99999 )
    99999 ( 99999 )
        LDL CHLS, Direct, Week 36, n= 1, 0
    -0.23 ( 99999 )
    99999 ( 99999 )
        LDL CHLS, Direct, Week 48, n= 0, 0
    99999 ( 99999 )
    99999 ( 99999 )
        Phosphate, Baseline, n= 248, 247
    1.15 ( 0.1695 )
    1.142 ( 0.1732 )
        Phosphate, Week 4, n= 245, 237
    0 ( 0.1461 )
    -0.032 ( 0.1726 )
        Phosphate, Week 12, n= 236, 226
    0.02 ( 0.1694 )
    0.026 ( 0.1634 )
        Phosphate, Week 24, n= 225, 212
    0.021 ( 0.1628 )
    0.026 ( 0.1701 )
        Phosphate, Week 36, n= 219, 204
    0.029 ( 0.1736 )
    0.009 ( 0.1675 )
        Phosphate, Week 48, n= 208, 192
    0.016 ( 0.1736 )
    0 ( 0.1673 )
        Potassium, Baseline, n= 248, 247
    4.11 ( 0.304 )
    4.08 ( 0.33 )
        Potassium, Week 4, n= 244, 237
    -0.01 ( 0.344 )
    0.12 ( 0.367 )
        Potassium, Week 12, n= 236, 226
    0.03 ( 0.355 )
    0.1 ( 0.39 )
        Potassium, Week 24, n= 224, 212
    -0.04 ( 0.339 )
    0.06 ( 0.372 )
        Potassium, Week 36, n= 219, 204
    0.03 ( 0.332 )
    0.13 ( 0.387 )
        Potassium, Week 48, n= 208, 192
    -0.04 ( 0.346 )
    0.04 ( 0.372 )
        Sodium, Baseline, n= 248, 247
    137.6 ( 2.25 )
    137.8 ( 2.48 )
        Sodium, Week 4, n= 245, 237
    0 ( 2.11 )
    -0.5 ( 2.4 )
        Sodium, Week 12, n= 236, 226
    0.7 ( 2.3 )
    0.1 ( 2.51 )
        Sodium, Week 24, n= 225, 212
    0.6 ( 2.3 )
    0.2 ( 2.11 )
        Sodium, Week 36, n= 219, 204
    0.9 ( 2.32 )
    0.2 ( 2.5 )
        Sodium, Week 48, n= 208, 192
    0.6 ( 2.24 )
    0.5 ( 2.39 )
        Triglycerides, Baseline, n= 230, 232
    1.335 ( 0.8261 )
    1.217 ( 0.6642 )
        Triglycerides, Week 4, n= 1, 3
    -0.18 ( 99999 )
    0.237 ( 0.2491 )
        Triglycerides, Week 12, n= 224, 221
    -0.04 ( 0.6861 )
    0.167 ( 0.7074 )
        Triglycerides, Week 24, n= 218, 201
    0.036 ( 0.7108 )
    0.125 ( 0.6132 )
        Triglycerides, Week 36, n= 205, 191
    0.037 ( 0.6732 )
    0.157 ( 0.6785 )
        Triglycerides, Week 48, n= 195, 175
    0.018 ( 0.8158 )
    0.107 ( 0.5527 )
        Urea, Baseline, n= 248, 247
    4.28 ( 1.329 )
    4.43 ( 1.518 )
        Urea, Week 4, n= 245, 237
    -0.04 ( 1.085 )
    0.1 ( 1.313 )
        Urea, Week 12, n= 236, 226
    0.08 ( 1.097 )
    0.16 ( 1.409 )
        Urea, Week 24, n= 225, 212
    0.03 ( 1.187 )
    0.12 ( 1.283 )
        Urea, Week 36, n= 219, 204
    0.08 ( 1.236 )
    -0.03 ( 1.256 )
        Urea, Week 48, n= 208, 192
    0.1 ( 1.162 )
    0.02 ( 1.179 )
    Notes
    [10] - Safety population
    [11] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in bilirubin and creatinine at indicated timepoints

    		 Close Top of page
    End point title
    		 Change from Baseline in bilirubin and creatinine at indicated timepoints
    End point description
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants 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, Week 4, 12, 24, 36, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [12]
    247 [13]
    Units: Micromoles per liter
    arithmetic mean (standard deviation)
        Bilirubin, Baseline, n= 248, 247
    7.4 ( 3.2 )
    7.5 ( 3.11 )
        Bilirubin, Week 4, n= 244, 237
    -0.8 ( 2.59 )
    27.2 ( 23.15 )
        Bilirubin, Week 12, n= 236, 226
    -0.6 ( 2.65 )
    22.8 ( 16.49 )
        Bilirubin, Week 24, n= 225, 212
    -0.2 ( 3.06 )
    25 ( 18.38 )
        Bilirubin, Week 36, n= 219, 204
    -0.2 ( 3.01 )
    23.8 ( 16.31 )
        Bilirubin, Week 48, n= 208, 192
    -0.3 ( 3.08 )
    23.7 ( 17 )
        Creatinine, Baseline, n= 248, 247
    58.29 ( 12.035 )
    61.56 ( 15.43 )
        Creatinine, Week 4, n= 245, 237
    8.4 ( 7.057 )
    4.89 ( 7.109 )
        Creatinine, Week 12, n= 236, 226
    9.2 ( 8.288 )
    5.83 ( 8.357 )
        Creatinine, Week 24, n= 225, 212
    9.16 ( 9.983 )
    5.8 ( 8.063 )
        Creatinine, Week 36, n= 219, 204
    10.08 ( 10.473 )
    5.37 ( 9.013 )
        Creatinine, Week 48, n= 208, 192
    9.29 ( 8.614 )
    5.86 ( 10.252 )
    Notes
    [12] - Safety population
    [13] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in albumin at indicated timepoints

    		 Close Top of page
    End point title
    		 Change from Baseline in albumin at indicated timepoints
    End point description
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants 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, Week 4, 12, 24, 36, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [14]
    247 [15]
    Units: grams per liter
    arithmetic mean (standard deviation)
        Baseline, n= 248, 247
    41.3 ( 4.39 )
    41.5 ( 3.88 )
        Week 4, n= 245, 237
    0.1 ( 2.36 )
    -0.5 ( 2.59 )
        Week 12, n= 236, 226
    0.5 ( 2.95 )
    0.1 ( 2.59 )
        Week 24, n= 225, 212
    1.4 ( 3.2 )
    0.8 ( 2.95 )
        Week 36, n= 219, 204
    1.4 ( 3.09 )
    0.6 ( 2.96 )
        Week 48, n= 208, 192
    1.7 ( 3.17 )
    1.3 ( 3.04 )
    Notes
    [14] - Safety Population
    [15] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase at indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase at indicated time points
    End point description
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants 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, Week 4, 12, 24, 36, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [16]
    247 [17]
    Units: International units per liter
    arithmetic mean (standard deviation)
        Alanine aminotransferase, Baseline, n= 248, 247
    22.5 ( 26.69 )
    22.3 ( 20.47 )
        Alanine aminotransferase, Week 4, n= 245, 237
    -3.3 ( 27.54 )
    -3.4 ( 15.86 )
        Alanine aminotransferase, Week 12, n= 236, 226
    -5.2 ( 27.51 )
    -2.3 ( 20.26 )
        Alanine aminotransferase, Week 24, n= 225, 212
    -5.4 ( 27.92 )
    -3.7 ( 20.7 )
        Alanine aminotransferase, Week 36, n= 219, 204
    -4.9 ( 36.11 )
    -5.3 ( 20.08 )
        Alanine aminotransferase, Week 48, n= 208, 192
    -5.7 ( 28.54 )
    -1.5 ( 31.53 )
        Alkaline phosphatase, Baseline, n= 248, 247
    72.7 ( 22.75 )
    72 ( 30.26 )
        Alkaline phosphatase, Week 4, n= 245, 237
    -1.5 ( 14.56 )
    9.4 ( 28.69 )
        Alkaline phosphatase, Week 12, n= 236, 226
    -2.1 ( 17.1 )
    15.1 ( 30.82 )
        Alkaline phosphatase, Week 24, n= 225, 212
    0.5 ( 17.86 )
    22.4 ( 41.59 )
        Alkaline phosphatase, Week 36, n= 219, 204
    0.6 ( 19.19 )
    20.4 ( 30.7 )
        Alkaline phosphatase, Week 48, n= 208, 192
    2.9 ( 28.05 )
    21.9 ( 25.35 )
        Aspartate aminotransferase, Baseline, n= 248, 247
    28.7 ( 22.11 )
    28.3 ( 19.77 )
        Aspartate aminotransferase, Week 4, n= 244, 237
    -3.3 ( 29.8 )
    -3.6 ( 18.83 )
        Aspartate aminotransferase, Week 12, n= 236, 226
    -6.2 ( 21.11 )
    -4 ( 13.79 )
        Aspartate aminotransferase, Week 24, n= 224, 212
    -6.3 ( 22.44 )
    -5.1 ( 13.8 )
        Aspartate aminotransferase, Week 36, n= 219, 204
    -6.4 ( 31.42 )
    -6.5 ( 16.63 )
        Aspartate aminotransferase, Week 48, n= 208, 192
    -7.5 ( 22.19 )
    -3.7 ( 25.28 )
        Creatine Kinase, Baseline, n= 248, 247
    97.4 ( 88.55 )
    105.5 ( 100.51 )
        Creatine Kinase, Week 4, n= 245, 237
    -0.3 ( 68.72 )
    35.6 ( 549.1 )
        Creatine Kinase, Week 12, n= 236, 226
    6.9 ( 73.7 )
    7.3 ( 90.39 )
        Creatine Kinase, Week 24, n= 225, 212
    10.3 ( 88.66 )
    5.8 ( 77.12 )
        Creatine Kinase, Week 36, n= 219, 204
    11.9 ( 155.68 )
    7.2 ( 132.74 )
        Creatine Kinase, Week 48, n= 208, 192
    23.8 ( 242.66 )
    3.8 ( 98.58 )
    Notes
    [16] - Safety population
    [17] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in creatinine clearance at indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in creatinine clearance at indicated time points
    End point description
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants 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, Week 4, 12, 24, 36, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [18]
    247 [19]
    Units: Milliliter per minute
    arithmetic mean (standard deviation)
        Baseline, n= 248, 247
    132.1 ( 42.95 )
    128.7 ( 45.96 )
        Week 4, n= 245, 237
    -16.3 ( 15.03 )
    -7.5 ( 12.91 )
        Week 12, n= 236, 226
    -17.3 ( 17.01 )
    -7 ( 23.14 )
        Week 24, n= 225, 212
    -16.2 ( 20.36 )
    -9.1 ( 16.88 )
        Week 36, n= 219, 204
    -16.8 ( 22.35 )
    -7.5 ( 17.67 )
        Week 48, n= 208, 192
    -15.9 ( 19.62 )
    -7.7 ( 18.42 )
    Notes
    [18] - Safety population
    [19] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in lipase at indicated timepoints

    		 Close Top of page
    End point title
    		 Change from Baseline in lipase at indicated timepoints
    End point description
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants 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, Week 4, 12, 24, 36, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [20]
    247 [21]
    Units: Units per liter
    arithmetic mean (standard deviation)
        Baseline, n= 248, 247
    32.9 ( 24.67 )
    32.3 ( 22.14 )
        Week 4, n= 245, 237
    -1.2 ( 15.06 )
    -1.3 ( 15.81 )
        Week 12, n= 236, 226
    -2.2 ( 22.74 )
    -2.1 ( 29 )
        Week 24, n= 225, 212
    -6 ( 21.05 )
    -6 ( 18.57 )
        Week 36, n= 219, 204
    -6.3 ( 25.62 )
    -6.3 ( 21.36 )
        Week 48, n= 208, 192
    -6.5 ( 29.63 )
    -7.8 ( 20.72 )
    Notes
    [20] - Safety Population
    [21] - Safety Population
    No statistical analyses for this end point

    Secondary: Change from Baseline in total CHLS/HDL CHLS ratio at indicated timepoints

    		 Close Top of page
    End point title
    		 Change from Baseline in total CHLS/HDL CHLS ratio at indicated timepoints
    End point description
    Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). A value of "99999" indicates where no data is available or not able to determine the value.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4, 12, 24, 36, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [22]
    247 [23]
    Units: Ratio
    arithmetic mean (standard deviation)
        Baseline, n= 247, 245
    3.78841 ( 1.33327 )
    3.84622 ( 2.6556 )
        Week 4, n= 1, 4
    0.1264 ( 99999 )
    0.21588 ( 0.60727 )
        Week 12, n= 233, 223
    -0.2736 ( 1.0283 )
    -0.1092 ( 0.73776 )
        Week 24, n= 224, 209
    -0.3098 ( 1.11093 )
    -0.1922 ( 0.79848 )
        Week 36, n= 212, 198
    -0.3286 ( 1.01181 )
    -0.1433 ( 0.79498 )
        Week 48, n= 207, 186
    -0.2886 ( 1.01415 )
    -0.1444 ( 1.23362 )
    Notes
    [22] - Safety population
    [23] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in basophils, eosinophils, lymphocytes, monocytes at indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in basophils, eosinophils, lymphocytes, monocytes at indicated time points
    End point description
    Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants 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, Week 4, 12, 24, 36, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [24]
    247 [25]
    Units: 10^9 per liter
    arithmetic mean (standard deviation)
        Basophils, Baseline, n= 248, 247
    0.017 ( 0.0139 )
    0.017 ( 0.0127 )
        Basophils, Week 4, n= 241, 234
    0.003 ( 0.0182 )
    0.003 ( 0.0198 )
        Basophils, Week 12, n= 228, 216
    0.002 ( 0.0174 )
    0.003 ( 0.0162 )
        Basophils, Week 24, n= 221, 208
    0.004 ( 0.0187 )
    0.003 ( 0.0155 )
        Basophils, Week 36, n= 214, 203
    0.004 ( 0.0182 )
    0.003 ( 0.0158 )
        Basophils, Week 48, n= 206, 189
    0.005 ( 0.0199 )
    0.006 ( 0.0146 )
        Eosinophils, Baseline, n= 248, 247
    0.139 ( 0.179 )
    0.146 ( 0.258 )
        Eosinophils, Week 4, n= 241, 234
    0.04 ( 0.1486 )
    0.021 ( 0.1648 )
        Eosinophils, Week 12, n= 228, 216
    0.037 ( 0.1982 )
    -0.001 ( 0.161 )
        Eosinophils, Week 24, n= 221, 208
    0.028 ( 0.1927 )
    0.005 ( 0.1973 )
        Eosinophils, Week 36, n= 214, 203
    0.048 ( 0.2244 )
    0.014 ( 0.2139 )
        Eosinophils, Week 48, n= 206, 189
    0.03 ( 0.1744 )
    0.007 ( 0.2274 )
        Lymphocytes, Baseline, n= 248, 247
    1.538 ( 0.6092 )
    1.573 ( 0.7895 )
        Lymphocytes, Week 4, n= 241, 234
    0.208 ( 0.4914 )
    0.119 ( 0.5493 )
        Lymphocytes, Week 12, n= 228, 216
    0.257 ( 0.55 )
    0.156 ( 0.669 )
        Lymphocytes, Week 24, n= 221, 208
    0.317 ( 0.4889 )
    0.192 ( 0.591 )
        Lymphocytes, Week 36, n= 214, 203
    0.362 ( 0.5199 )
    0.178 ( 0.6441 )
        Lymphocytes, Week 48, n= 206, 189
    0.359 ( 0.5235 )
    0.261 ( 0.7098 )
        Monocytes, Baseline, n= 248, 247
    0.315 ( 0.1491 )
    0.326 ( 0.1606 )
        Monocytes, Week 4, n= 241, 234
    -0.001 ( 0.1558 )
    -0.015 ( 0.1391 )
        Monocytes, Week 12, n= 228, 216
    -0.01 ( 0.1412 )
    -0.031 ( 0.1369 )
        Monocytes, Week 24, n= 221, 208
    0.008 ( 0.1498 )
    -0.015 ( 0.1581 )
        Monocytes, Week 36, n= 214, 203
    -0.006 ( 0.1448 )
    -0.028 ( 0.15 )
        Monocytes, Week 48, n= 206, 189
    0.001 ( 0.1379 )
    -0.024 ( 0.1638 )
    Notes
    [24] - Safety population
    [25] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in erythrocytes at indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in erythrocytes at indicated time points
    End point description
    Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants 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, Week 4, 12, 24, 36, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [26]
    247 [27]
    Units: 10^12 per liter
    arithmetic mean (standard deviation)
        Baseline, n= 248, 247
    4.27 ( 0.467 )
    4.28 ( 0.44 )
        Week 4, n= 243, 234
    -0.04 ( 0.244 )
    -0.07 ( 0.239 )
        Week 12, n= 233, 220
    -0.07 ( 0.351 )
    -0.09 ( 0.308 )
        Week 24, n= 225, 211
    -0.08 ( 0.373 )
    -0.09 ( 0.329 )
        Week 36, n= 218, 203
    -0.1 ( 0.384 )
    -0.08 ( 0.358 )
        Week 48, n= 207, 190
    -0.1 ( 0.365 )
    -0.05 ( 0.318 )
    Notes
    [26] - Safety population
    [27] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in hematocrit count at indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in hematocrit count at indicated time points
    End point description
    Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants 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, Week 4, 12, 24, 36, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [28]
    247 [29]
    Units: Fraction of 1
    arithmetic mean (standard deviation)
        Baseline, n= 248, 247
    0.3757 ( 0.03978 )
    0.3766 ( 0.03675 )
        Week 4, n= 243, 234
    0.0003 ( 0.02176 )
    -0.0042 ( 0.02238 )
        Week 12, n= 233, 220
    0.0081 ( 0.03157 )
    0 ( 0.02646 )
        Week 24, n= 225, 211
    0.0157 ( 0.03209 )
    0.0051 ( 0.03083 )
        Week 36, n= 218, 203
    0.0167 ( 0.03451 )
    0.0062 ( 0.03379 )
        Week 48, n= 207, 190
    0.0212 ( 0.03293 )
    0.0107 ( 0.032 )
    Notes
    [28] - Safety population
    [29] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in erythrocyte mean corpuscular volume at indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in erythrocyte mean corpuscular volume at indicated time points
    End point description
    Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants 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, Week 4, 12, 24, 36, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [30]
    247 [31]
    Units: Femtoliter
    arithmetic mean (standard deviation)
        Baseline, n= 248, 247
    88.4 ( 6.45 )
    88.4 ( 7.01 )
        Week 4, n= 243, 234
    0.9 ( 1.81 )
    0.5 ( 1.83 )
        Week 12, n= 233, 220
    3.4 ( 2.98 )
    1.9 ( 2.94 )
        Week 24, n= 225, 211
    5.5 ( 4.03 )
    3.1 ( 4.33 )
        Week 36, n= 218, 203
    6 ( 4.04 )
    3.1 ( 5.22 )
        Week 48, n= 207, 190
    7.1 ( 4.31 )
    3.7 ( 5.15 )
    Notes
    [30] - Safety population
    [31] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in Triglycerides at Week 48

    		 Close Top of page
    End point title
    		 Change from Baseline in Triglycerides at Week 48
    End point description
    Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    226 [32]
    214 [33]
    Units: Millimoles per liter
        least squares mean (standard error)
    0.045 ( 0.0477 )
    0.07 ( 0.0477 )
    Notes
    [32] - Safety population
    [33] - Safety population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD v ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.7053
    Method
    		 Multiple Imputed Dataset - MAR
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.026
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.159
         upper limit
    		 0.107

    Secondary: Change from Baseline in TC/HDL Ratio at Week 48

    		 Close Top of page
    End point title
    		 Change from Baseline in TC/HDL Ratio at Week 48
    End point description
    Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Subjects on lipid lowering therapy at baseline were excluded from analysis. Measurements collected after a subject initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    226 [34]
    214 [35]
    Units: Ratio
        arithmetic mean (standard deviation)
    -0.264 ( 0.0707 )
    -0.158 ( 0.0784 )
    Notes
    [34] - Safety population
    [35] - Safety population
    Statistical analysis title
    		 Statistical analysis 1
    Comparison groups
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD v ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects included in analysis
    440
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.3165
    Method
    		 Multiple Imputed Dataset - MAR
    Parameter type
    		 Mean difference (final values)
    Point estimate
    -0.106
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.313
         upper limit
    		 0.101

    Secondary: Change from Baseline in urine albumin creatinine ratio at indicated time points

    		 Close Top of page
    End point title
    		 Change from Baseline in urine albumin creatinine ratio at indicated time points
    End point description
    Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 are summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, Week 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [36]
    247 [37]
    Units: milligrams per millimole
    arithmetic mean (standard deviation)
        Baseline, n= 221, 231
    5.69 ( 27.277 )
    3.44 ( 8.52 )
        Week 24, n= 179, 186
    -1.15 ( 16.557 )
    -1.03 ( 9.091 )
        Week 48, n= 170, 164
    -0.68 ( 20.597 )
    -0.1 ( 9.393 )
    Notes
    [36] - Safety population
    [37] - Safety population
    No statistical analyses for this end point

    Secondary: Summary of AE's by maximum toxicity as per DAIDS AE Grading Table

    		 Close Top of page
    End point title
    		 Summary of AE's by maximum toxicity as per DAIDS AE Grading Table
    End point description
    Number of participants with Grade 1-4 AEs were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Acquired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.
    End point type
    Secondary
    End point timeframe
    Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [38]
    247 [39]
    Units: Participants
    number (not applicable)
        Grade 1
    79
    60
        Grade 2
    94
    91
        Grade 3
    18
    37
        Grade 4
    3
    9
    Notes
    [38] - Safety population
    [39] - Safety population
    No statistical analyses for this end point

    Secondary: Number of participants with any adverse events (AEs), and serious adverse events (SAEs)

    		 Close Top of page
    End point title
    		 Number of participants with any adverse events (AEs), and serious adverse events (SAEs)
    End point description
    An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. A serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.
    End point type
    Secondary
    End point timeframe
    From start of IP through the Study Phase (average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC)
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [40]
    247 [41]
    Units: Participants
    number (not applicable)
        Any AEs
    132
    160
        Any SAEs
    16
    20
    Notes
    [40] - Safety population
    [41] - Safety population
    No statistical analyses for this end point

    Secondary: Summary of maximum post-Baseline emergent chemistry toxicities

    		 Close Top of page
    End point title
    		 Summary of maximum post-Baseline emergent chemistry toxicities
    End point description
    Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and until the follow up contact. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.
    End point type
    Secondary
    End point timeframe
    Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [42]
    247 [43]
    Units: Participants
    number (not applicable)
        Hyperglycaemia, Grade 1
    23
    15
        Hyperglycaemia, Grade 2
    21
    15
        Hyperglycaemia, Grade 3
    4
    3
        Hyperglycaemia, Grade 4
    1
    0
        Hyperkalemia, Grade 1
    1
    0
        Hyperkalemia, Grade 2
    0
    1
        Hyperkalemia, Grade 3
    0
    0
        Hyperkalemia, Grade 4
    0
    0
        Hypernatremia, Grade 1
    1
    0
        Hypernatremia, Grade 2
    0
    0
        Hypernatremia, Grade 3
    0
    0
        Hypernatremia, Grade 4
    0
    0
        Hypoglycaemia, Grade 1
    9
    7
        Hypoglycaemia, Grade 2
    4
    1
        Hypoglycaemia, Grade 3
    1
    0
        Hypoglycaemia, Grade 4
    0
    0
        Hypokalemia, Grade 1
    18
    21
        Hypokalemia, Grade 2
    1
    0
        Hypokalemia, Grade 3
    0
    0
        Hypokalemia, Grade 4
    0
    0
        Hyponatremia, Grade 1
    79
    82
        Hyponatremia, Grade 2
    1
    0
        Hyponatremia, Grade 3
    0
    0
        Hyponatremia, Grade 4
    0
    0
        Alanine aminotransferase, Grade 1
    7
    11
        Alanine aminotransferase, Grade 2
    8
    5
        Alanine aminotransferase, Grade 3
    1
    2
        Alanine aminotransferase, Grade 4
    1
    0
        Albumin, Grade 1
    6
    2
        Albumin, Grade 2
    1
    4
        Albumin, Grade 3
    0
    0
        Albumin, Grade 4
    0
    0
        Alkaline phosphatase, Grade 1
    4
    17
        Alkaline phosphatase, Grade 2
    2
    1
        Alkaline phosphatase, Grade 3
    0
    0
        Alkaline phosphatase, Grade 4
    0
    0
        Aspartate aminotransferase, Grade 1
    17
    14
        Aspartate aminotransferase, Grade 2
    8
    5
        Aspartate aminotransferase, Grade 3
    1
    2
        Aspartate aminotransferase, Grade 4
    1
    0
        Bilirubin, Grade 1
    2
    52
        Bilirubin, Grade 2
    0
    86
        Bilirubin, Grade 3
    0
    57
        Bilirubin, Grade 4
    0
    5
        Carbon dioxide, Grade 1
    94
    74
        Carbon dioxide, Grade 2
    5
    4
        Carbon dioxide, Grade 3
    0
    0
        Carbon dioxide, Grade 4
    0
    0
        Cholesterol, Grade 1
    74
    47
        Cholesterol, Grade 2
    32
    13
        Cholesterol, Grade 3
    4
    2
        Cholesterol, Grade 4
    0
    0
        Creatine kinase, Grade 1
    4
    7
        Creatine kinase, Grade 2
    1
    1
        Creatine kinase, Grade 3
    4
    0
        Creatine kinase, Grade 4
    0
    1
        Creatinine, Grade 1
    5
    8
        Creatinine, Grade 2
    0
    3
        Creatinine, Grade 3
    1
    0
        Creatinine, Grade 4
    0
    0
        LDL cholesterol calculation, Grade 1
    53
    31
        LDL cholesterol calculation, Grade 2
    15
    11
        LDL cholesterol calculation, Grade 3
    7
    3
        LDL cholesterol calculation, Grade 4
    0
    0
        LDL cholesterol direct, Grade 1
    3
    1
        LDL cholesterol direct, Grade 2
    1
    0
        LDL cholesterol direct, Grade 3
    0
    0
        LDL cholesterol direct, Grade 4
    0
    0
        Lipase, Grade 1
    16
    11
        Lipase, Grade 2
    11
    5
        Lipase, Grade 3
    3
    2
        Lipase, Grade 4
    0
    1
        Phosphate, Grade 1
    5
    12
        Phosphate, Grade 2
    9
    13
        Phosphate, Grade 3
    1
    2
        Phosphate, Grade 4
    0
    0
        Potassium, Grade 1
    19
    21
        Potassium, Grade 2
    1
    1
        Potassium, Grade 3
    0
    0
        Potassium, Grade 4
    0
    0
        Sodium, Grade 1
    80
    82
        Sodium, Grade 2
    1
    0
        Sodium, Grade 3
    0
    0
        Sodium, Grade 4
    0
    0
        Triglycerides, Grade 1
    0
    0
        Triglycerides, Grade 2
    5
    2
        Triglycerides, Grade 3
    2
    0
        Triglycerides, Grade 4
    0
    0
        Glucose, Grade 1
    28
    21
        Glucose, Grade 2
    24
    14
        Glucose, Grade 3
    4
    3
        Glucose, Grade 4
    1
    0
    Notes
    [42] - Safety population
    [43] - Safety population
    No statistical analyses for this end point

    Secondary: Summary of maximum post-Baseline emergent hematology toxicities

    		 Close Top of page
    End point title
    		 Summary of maximum post-Baseline emergent hematology toxicities
    End point description
    Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and until the follow up contact. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe Grade 4- potentially life-threatening.
    End point type
    Secondary
    End point timeframe
    Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [44]
    247 [45]
    Units: Participants
    number (not applicable)
        Hemoglobin, Grade 1
    21
    30
        Hemoglobin, Grade 2
    4
    3
        Hemoglobin, Grade 3
    1
    1
        Hemoglobin, Grade 4
    0
    0
        Leukocytes, Grade 1
    6
    6
        Leukocytes, Grade 2
    1
    2
        Leukocytes, Grade 3
    0
    0
        Leukocytes, Grade 4
    0
    0
        Neutrophils, Grade 1
    19
    14
        Neutrophils, Grade 2
    7
    9
        Neutrophils, Grade 3
    0
    3
        Neutrophils, Grade 4
    1
    1
        Platelets, Grade 1
    9
    1
        Platelets, Grade 2
    0
    4
        Platelets, Grade 3
    1
    0
        Platelets, Grade 4
    0
    0
    Notes
    [44] - Safety population
    [45] - Safety population
    No statistical analyses for this end point

    Secondary: Number of participants who withdrew from treatment due to AEs

    		 Close Top of page
    End point title
    		 Number of participants who withdrew from treatment due to AEs
    End point description
    An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.
    End point type
    Secondary
    End point timeframe
    Average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [46]
    247 [47]
    Units: Participants
        number (not applicable)
    11
    17
    Notes
    [46] - Safety population
    [47] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in bone specific alkaline phosphatase, osteocalcin and procollagen 1 N-terminal propeptide at indicated timepoints

    		 Close Top of page
    End point title
    		 Change from Baseline in bone specific alkaline phosphatase, osteocalcin and procollagen 1 N-terminal propeptide at indicated timepoints
    End point description
    Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. A value of "99999" indicates where no data is available or not able to determine the value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [48]
    247 [49]
    Units: Micrograms per liter
    arithmetic mean (standard deviation)
        BSAP, Baseline, n=244, 243
    11.52 ( 3.837 )
    11.67 ( 5.287 )
        BSAP, Week 24, n=219, 207
    1.33 ( 3.934 )
    6 ( 5.962 )
        BSAP, Week 48, n=202, 184
    2.64 ( 5.746 )
    7.6 ( 7.144 )
        Osteocalcin, Baseline, n=235, 235
    16.6 ( 8.551 )
    18.27 ( 19.891 )
        Osteocalcin, Week 24, n=209, 197
    3.73 ( 7.484 )
    14.38 ( 22.205 )
        Osteocalcin, Week 48, n=194, 178
    5.15 ( 9.018 )
    16.3 ( 25.043 )
        PTP, Baseline, n=246, 240
    49.4 ( 24.48 )
    49.5 ( 23.01 )
        PTP, Week 24, n=223, 206
    10.1 ( 20.11 )
    32 ( 27.89 )
        PTP, Week 48, n=205, 186
    11.2 ( 23.05 )
    34.1 ( 27.28 )
    Notes
    [48] - Safety population
    [49] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in Type I collagen C-telopeptides at indicated timepoints

    		 Close Top of page
    End point title
    		 Change from Baseline in Type I collagen C-telopeptides at indicated timepoints
    End point description
    Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. A value of "99999" indicates where no data is available or not able to determine the value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 24, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [50]
    247 [51]
    Units: Nanograms per liter
    arithmetic mean (standard deviation)
        Baseline, n=245, 243
    312.9 ( 183.68 )
    329.7 ( 190.02 )
        Week 24, n=221, 207
    89.8 ( 173.09 )
    272.4 ( 205.22 )
        Week 48, n=202, 185
    75.9 ( 173.73 )
    267.9 ( 200.82 )
    Notes
    [50] - Safety population
    [51] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline in vitamin D, vitamin D2 and vitamin D3 at Week 24 and Week 48

    		 Close Top of page
    End point title
    		 Change from Baseline in vitamin D, vitamin D2 and vitamin D3 at Week 24 and Week 48
    End point description
    Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D and vitamin D2 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. A value of "99999" indicates where no data is available or not able to determine the value.
    End point type
    Secondary
    End point timeframe
    Baseline, Weeks 24, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [52]
    247 [53]
    Units: Nanomoles per liter
    arithmetic mean (standard deviation)
        Vitamin D, Baseline, n=247, 244
    58.6 ( 30.15 )
    56.9 ( 22.43 )
        Vitamin D, Week 24, n=223, 208
    1.8 ( 24.95 )
    16.3 ( 31.66 )
        Vitamin D, Week 48, n=206, 186
    -1.9 ( 20.63 )
    8.9 ( 23.78 )
        Vitamin D2, Baseline, n=247, 244
    9.3 ( 3.16 )
    9.5 ( 3.79 )
        Vitamin D2, Week 24, n=223, 208
    0.3 ( 6.04 )
    1 ( 7.88 )
        Vitamin D2, Week 48, n=206, 186
    0.1 ( 4.71 )
    0.9 ( 11 )
        Vitamin D3, Baseline, n=247, 244
    58.1 ( 30.07 )
    56.1 ( 22.59 )
        Vitamin D3, Week 24, n=223, 208
    1.5 ( 24.33 )
    15.2 ( 31.39 )
        Vitamin D3, Week 48, n=206, 186
    -1.9 ( 20.56 )
    7.9 ( 21.72 )
    Notes
    [52] - Safety population
    [53] - Safety population
    No statistical analyses for this end point

    Secondary: Change from Baseline at Week 48 in SF-12 Total Score, MCS and PCS

    		 Close Top of page
    End point title
    		 Change from Baseline at Week 48 in SF-12 Total Score, MCS and PCS
    End point description
    The SF-12 is the 12 item abbreviated form of SF-36 survey. It provides information about how participants feel, and how well they have been able to perform their usual activities. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health . Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using all the 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline and Week 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [54]
    247 [55]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Total Score, Baseline, n=245, 240
    38.6 ( 4.33 )
    38.5 ( 4.47 )
        Total Score, Week 48, n=205, 192
    0 ( 5.15 )
    0.1 ( 5.66 )
        MCS, Baseline, n=245, 240
    48.31 ( 10.3025 )
    47.67 ( 10.4284 )
        MCS, Week 48, n=205, 192
    2.397 ( 10.5232 )
    2.329 ( 9.9782 )
        PCS, Baseline, n=245, 240
    50.663 ( 8.4227 )
    50.374 ( 8.0038 )
        PCS, Week 48, n=205, 192
    1.905 ( 8.6309 )
    1.444 ( 8.3938 )
    Notes
    [54] - ITT-E population
    [55] - ITT-E population
    No statistical analyses for this end point

    Secondary: Assessment of HIVTSQs Total Score at indicated timepoints.

    		 Close Top of page
    End point title
    		 Assessment of HIVTSQs Total Score at indicated timepoints.
    End point description
    The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed.
    End point type
    Secondary
    End point timeframe
    Week 4, 12, 24, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [56]
    247 [57]
    Units: Score on a scale
    arithmetic mean (standard deviation)
        Week 4, n=243, 239
    54 ( 6.37 )
    51.9 ( 8.53 )
        Week 12, n=236, 226
    56.1 ( 5.38 )
    53.6 ( 7.67 )
        Week 24, n=225, 211
    56.8 ( 4.55 )
    54.3 ( 7.27 )
        Week 48, n=206, 191
    57 ( 4.38 )
    55.4 ( 6 )
    Notes
    [56] - ITT-E population
    [57] - ITT-E population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison of HIV treatment satisfaction questionnaire (HIVTSQ) between two groups at week 4
    Comparison groups
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD v ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.016 [58]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [58] - Week 4
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison of HIV treatment satisfaction questionnaire (HIVTSQ) between two groups at week 12
    Comparison groups
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD v ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001 [59]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [59] - Week 12
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Comparison of HIV treatment satisfaction questionnaire (HIVTSQ) between two groups at week 24
    Comparison groups
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD v ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.002 [60]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [60] - Week 24
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Comparison of HIV treatment satisfaction questionnaire (HIVTSQ) between two groups at week 48
    Comparison groups
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD v ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects included in analysis
    495
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.007 [61]
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Notes
    [61] - Week 48

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

    		 Close Top of page
    End point title
    		 Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups
    End point description
    Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA (BPHR), Baseline CD4+ cell count (BCCC), Baseline Centers for Disease Control and Prevention (CDC) category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =<vs. >100,000 c/mL) and CD4+ cell count (=<350 cells/mm^3 or >350 cells/mm^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
    End point type
    Secondary
    End point timeframe
    Week 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [62]
    247 [63]
    Units: Percentage of Participants
    number (not applicable)
        Age, <50 Years, n=212, 212
    80
    71
        Age, >=50 Years, n=36, 35
    92
    74
        Race, White, n=115, 107
    86
    80
        Race, Non-White, n=133,140
    78
    64
        Race, African-American/African Heritage, n=102,108
    74
    67
        Non-African-American/African Heritage, n=146, 139
    88
    75
        BPHR, <1000, n=5, 10
    60
    80
        BPHR, 1000 to <10,000, n=66, 62
    83
    77
        BPHR, 10,000 to <50,000, n=83, 81
    84
    74
        BPHR, 50,000 to <=100,000, n=25, 28
    80
    64
        BPHR, >100,000, n=69, 66
    80
    64
        BCCC, <200, n=64, 49
    81
    69
        BCCC, >=200, n=184, 198
    82
    72
        BCCC, <50, n=9, 15
    67
    60
        BCCC, 50 to <200, n=55, 34
    84
    74
        BCCC, 200 to <350, n=66, 74
    89
    73
        BCCC, 350 to <500, n=56, 65
    79
    74
        BCCC, >=500, n=62, 59
    77
    68
        CDC category, A, n=210, 208
    81
    71
        CDC category, B, n=27, 30
    81
    77
        CDC category, C, n=11, 9
    91
    56
        HIV-1 subtype: B vs Non-B, B, n=95, 111
    80
    69
        IV-1 subtype: B vs Non-B, non-B, n=140, 131
    84
    73
    Notes
    [62] - ITT-E Population
    [63] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Number of participants with post-Baseline HIV-1disease progression

    		 Close Top of page
    End point title
    		 Number of participants with post-Baseline HIV-1disease progression
    End point description
    Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    7 [64]
    7 [65]
    Units: Participants
    number (not applicable)
        CDC Class A to CDC Class C
    5
    4
        CDC Class B to CDC Class C
    1
    2
        CDC Class C to new CDC Class C
    0
    0
        CDC Class A, B or C to Death
    1
    1
    Notes
    [64] - ITT-E Population
    [65] - ITT-E Population
    No statistical analyses for this end point

    Secondary: Number of Participants with treatment emergent resistances

    		 Close Top of page
    End point title
    		 Number of Participants with treatment emergent resistances
    End point description
    Number of participants, who met confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to INI, NNRTI, NRTI, PI are summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITT-E population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.
    End point type
    Secondary
    End point timeframe
    Up to Week 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    6 [66]
    4 [67]
    Units: Participants
    number (not applicable)
        Any mutation
    0
    1
        INSTI
    0
    0
        NRTI
    0
    1
        M184M/I/V
    0
    1
        PI
    0
    1
    Notes
    [66] - On-treatment Genotypic Resistance Population
    [67] - On-treatment Genotypic Resistance Population
    No statistical analyses for this end point

    Post-hoc: Bone specific alkaline phosphatase, osteocalcin, procollagen 1 N-terminal propeptide, Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline

    		 Close Top of page
    End point title
    		 Bone specific alkaline phosphatase, osteocalcin, procollagen 1 N-terminal propeptide, Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline
    End point description
    Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analysed based on log transformed data. Only those participants available at the specified time points (represented by n=X, X in the category titles) were analyzed. Estimates of adjusted mean and difference were calculated from an ANCOVA model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.
    End point type
    Post-hoc
    End point timeframe
    Baseline, Weeks 24, 48
    End point values
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects analysed
    248 [68]
    247 [69]
    Units: Ratio
    number (confidence interval 95%)
        BSAP, n=202, 183
    1.188 (1.135 to 1.243)
    1.629 (1.553 to 1.708)
        PTP, n=202, 184
    1.214 (1.158 to 1.272)
    1.752 (1.668 to 1.84)
        Osteocalcin, n=194, 178
    1.282 (1.214 to 1.354)
    2.039 (1.926 to 2.159)
        Type 1 Collagen C-Telopeptide, n=202, 184
    1.257 (1.195 to 1.323)
    1.918 (1.819 to 2.023)
        Vitamin D, n=206, 186
    0.987 (0.94 to 1.036)
    1.158 (1.101 to 1.219)
    Notes
    [68] - Safety population
    [69] - Safety population
    Statistical analysis title
    		 Statistical analysis 1
    Statistical analysis description
    Comparison of Bone specific alkaline phosphatase (BSAP) ratio between 2 groups
    Comparison groups
    ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD v DTG 50 mg/ABC 600 mg/3TC 300 mg QD
    Number of subjects included in analysis
    495
    Analysis specification
    Post-hoc
    Analysis type
    		 other [70]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of ratio
    Point estimate
    0.729
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.683
         upper limit
    		 0.779
    Notes
    [70] - BSAP ratio of Week 48 result over Baseline
    Statistical analysis title
    		 Statistical analysis 2
    Statistical analysis description
    Comparison of procollagen 1 N-terminal propeptide (PTP) ratio between 2 groups
    Comparison groups
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD v ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects included in analysis
    495
    Analysis specification
    Post-hoc
    Analysis type
    		 other [71]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of ratio
    Point estimate
    0.693
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.647
         upper limit
    		 0.741
    Notes
    [71] - PTP ratio of Week 48 result over Baseline
    Statistical analysis title
    		 Statistical analysis 3
    Statistical analysis description
    Comparison of Osteocalcin ratio between 2 groups
    Comparison groups
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD v ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects included in analysis
    495
    Analysis specification
    Post-hoc
    Analysis type
    		 other [72]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of ratio
    Point estimate
    0.629
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.581
         upper limit
    		 0.68
    Notes
    [72] - Osteocalcin ratio of Week 48 result over Baseline
    Statistical analysis title
    		 Statistical analysis 4
    Statistical analysis description
    Comparison of Type 1 Collagen C-Telopeptide ratio between 2 groups
    Comparison groups
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD v ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Number of subjects included in analysis
    495
    Analysis specification
    Post-hoc
    Analysis type
    		 other [73]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of ratio
    Point estimate
    0.655
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.609
         upper limit
    		 0.706
    Notes
    [73] - Type 1 Collagen C-Telopeptide ratio of Week 48 result over Baseline
    Statistical analysis title
    		 Statistical analysis 5
    Statistical analysis description
    Comparison of Vitamin D ratio between 2 groups
    Comparison groups
    ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD v DTG 50 mg/ABC 600 mg/3TC 300 mg QD
    Number of subjects included in analysis
    495
    Analysis specification
    Post-hoc
    Analysis type
    		 other [74]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio of ratio
    Point estimate
    0.852
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.794
         upper limit
    		 0.914
    Notes
    [74] - Vitamin D ratio of Week 48 result over Baseline

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    AEs and SAEs were collected from start of study treatment until end of study treatment (average of 354 days for DTG/ABC/3TC, and average of 336 days for ATV+RTV+TDF/FTC)
    Adverse event reporting additional description
    On-treatment SAEs and non-serious AEs are reported for the Safety Population, which comprises of all randomized participants who received at least one dose of study treatment. AEs were identified post-hoc for two ATV+RTV+TDF/FTC FDC subjects at one site. These AEs are not included and are not considered to affect the overall safety findings.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    DTG 50 mg/ABC 600 mg/3TC 300 mg QD
    Reporting group description
    		 Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.

    Reporting group title
    ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Reporting group description
    		 Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.

    Serious adverse events
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Total subjects affected by serious adverse events
         subjects affected / exposed
    16 / 248 (6.45%)
    20 / 247 (8.10%)
         number of deaths (all causes)
    2
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Hypertensive emergency
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Peripheral artery stenosis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Reproductive system and breast disorders
    Endometriosis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Rectocele
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Asthma
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Acute psychosis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Intentional self-injury
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Panic attack
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Investigations
    Blood creatinine increased
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Ankle fracture
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thermal burn
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Toxicity to various agents
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Cardiac disorders
    Acute coronary syndrome
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute myocardial infarction
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Amnesia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cerebrovascular accident
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Seizure
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Transient ischaemic attack
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 248 (0.40%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nausea
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vomiting
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatitis acute
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin and subcutaneous tissue disorders
    Angioedema
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Diabetic foot
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Skin ulcer
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Chronic kidney disease
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Musculoskeletal and connective tissue disorders
    Osteonecrosis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Scleroderma
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pneumonia
         subjects affected / exposed
    1 / 248 (0.40%)
    2 / 247 (0.81%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Arthritis infective
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bacteraemia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cellulitis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infected skin ulcer
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Malaria
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Mastoiditis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Meningitis viral
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Otitis media chronic
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumocystis jirovecii pneumonia
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Salpingitis
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Diabetic ketoacidosis
         subjects affected / exposed
    0 / 248 (0.00%)
    1 / 247 (0.40%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Electrolyte imbalance
         subjects affected / exposed
    1 / 248 (0.40%)
    0 / 247 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 DTG 50 mg/ABC 600 mg/3TC 300 mg QD ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    132 / 248 (53.23%)
    160 / 247 (64.78%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    29 / 248 (11.69%)
    32 / 247 (12.96%)
         occurrences all number
    50
    38
    Dizziness
         subjects affected / exposed
    13 / 248 (5.24%)
    15 / 247 (6.07%)
         occurrences all number
    16
    15
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    8 / 248 (3.23%)
    14 / 247 (5.67%)
         occurrences all number
    10
    15
    Eye disorders
    Ocular icterus
         subjects affected / exposed
    0 / 248 (0.00%)
    18 / 247 (7.29%)
         occurrences all number
    0
    21
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    47 / 248 (18.95%)
    48 / 247 (19.43%)
         occurrences all number
    55
    62
    Diarrhoea
         subjects affected / exposed
    24 / 248 (9.68%)
    32 / 247 (12.96%)
         occurrences all number
    25
    37
    Dyspepsia
         subjects affected / exposed
    9 / 248 (3.63%)
    25 / 247 (10.12%)
         occurrences all number
    17
    29
    Vomiting
         subjects affected / exposed
    17 / 248 (6.85%)
    17 / 247 (6.88%)
         occurrences all number
    18
    41
    Abdominal pain
         subjects affected / exposed
    8 / 248 (3.23%)
    17 / 247 (6.88%)
         occurrences all number
    8
    20
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    10 / 248 (4.03%)
    26 / 247 (10.53%)
         occurrences all number
    11
    27
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 248 (0.00%)
    14 / 247 (5.67%)
         occurrences all number
    0
    14
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 248 (0.00%)
    13 / 247 (5.26%)
         occurrences all number
    0
    16
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    12 / 248 (4.84%)
    20 / 247 (8.10%)
         occurrences all number
    13
    22
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    13 / 248 (5.24%)
    17 / 247 (6.88%)
         occurrences all number
    13
    18
    Infections and infestations
    Upper respiratory tract infection
         subjects affected / exposed
    19 / 248 (7.66%)
    20 / 247 (8.10%)
         occurrences all number
    23
    23
    Nasopharyngitis
         subjects affected / exposed
    16 / 248 (6.45%)
    14 / 247 (5.67%)
         occurrences all number
    19
    16
    Urinary tract infection
         subjects affected / exposed
    13 / 248 (5.24%)
    16 / 247 (6.48%)
         occurrences all number
    14
    16

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Tue May 07 01:01:09 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA