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    Clinical Trial Results:
    A Randomized, Open Label, Phase 4 Study Evaluating the Renal Effect of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF or other Tenofovir DF-containing Regimens (Ritonavir-boosted Atazanavir plus Emtricitabine/Tenofovir DF or Efavirenz /Emtricitabine/Tenofovir DF) compared to Ritonavir boosted Atazanavir plus Abacavir/Lamivudine in Antiretroviral Treatment-naïve HIV-1 Infected Adults with eGFR ≥70 mL/min

    Summary
    EudraCT number
    		 2014-002095-93
    Trial protocol
    		 GB   BE   ES   IE  
    Global end of trial date
    17 Feb 2016

    Results information
    Results version number
    		 v3(current)
    This version publication date
    21 Aug 2017
    First version publication date
    06 Mar 2017
    Other versions
    		 v1 , v2
    Version creation reason
    • Correction of full data set
    Updated description for 3 endpoints for clarification regarding the data.

    Trial information

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    Trial identification
    Sponsor protocol code
    GS-US-236-0140
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02246998
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Gilead Sciences
    Sponsor organisation address
    333 Lakeside Drive, Foster City, United States, 94404
    Public contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Scientific contact
    Clinical Trials Mailbox, Gilead Sciences International Ltd, ClinicalTrialDisclosures@gilead.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    17 Feb 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    17 Feb 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/ cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR; efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and estimated (calculated) glomerular filtration rate (eGFR).
    Protection of trial subjects
    The protocol and consent/assent forms were submitted by each investigator to a duly constituted Independent Ethics Committee (IEC) or Institutional Review Board (IRB) for review and approval before study initiation. All revisions to the consent/assent forms (if applicable) after initial IEC/IRB approval were submitted by the investigator to the IEC/IRB for review and approval before implementation in accordance with regulatory requirements. This study was conducted in accordance with recognized international scientific and ethical standards, including but not limited to the International Conference on Harmonization guideline for Good Clinical Practice (ICH GCP) and the original principles embodied in the Declaration of Helsinki.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Dec 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 16
    Country: Number of subjects enrolled
    United Kingdom: 37
    Country: Number of subjects enrolled
    Belgium: 14
    Country: Number of subjects enrolled
    Ireland: 5
    Worldwide total number of subjects
    72
    EEA total number of subjects
    72
    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)
    72
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at study sites in Belgium, Ireland, Spain, and the United Kingdom. The first participant was screened on 15 Dec 2014. The last study visit occurred on 17 February 2016.

    Pre-assignment
    Screening details
    		 93 participants were screened.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Stribild (STB)
    Arm description
    		 Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STB; Stribild®; EVG/COBI/FTC/TDF; 150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Arm type
    		 Experimental

    Investigational medicinal product name
    Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate
    Investigational medicinal product code
    Other name
    Stribild®; EVG/COBI/FTC/TDF
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    150/150/200/300 mg FDC orally with food once daily for 24 weeks

    Investigational medicinal product name
    Iohexol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1500 mg solution at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Arm title
    		 TVD + ATV/r
    Arm description
    		 FTC/TDF (TVD; Truvada®; 200/300 mg) FDC tablet + Atazanavir (ATV) 300 mg capsule + Ritonavir (RTV) 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24
    Arm type
    		 Experimental

    Investigational medicinal product name
    FTC/TDF
    Investigational medicinal product code
    Other name
    TVD; Truvada®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200/300 mg FDC with food once daily for 24 weeks

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    ATV
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    300 mg orally with food once daily for 24 weeks

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    RTV
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg orally with food once daily for 24 weeks

    Investigational medicinal product name
    Iohexol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1500 mg solution at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Arm title
    		 Atripla (ATR)
    Arm description
    		 EFV/FTC/TDF (ATR; Atripla® 600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Arm type
    		 Experimental

    Investigational medicinal product name
    EFV/FTC/TDF
    Investigational medicinal product code
    Other name
    ATR; Atripla®
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600/200/300 mg FDC once daily on an empty stomach for 24 weeks

    Investigational medicinal product name
    Iohexol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    1500 mg solution at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Arm title
    		 ABC/3TC + ATV/r
    Arm description
    		 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABC/3TC
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    600/300 mg FDC with food once daily for 24 weeks

    Investigational medicinal product name
    RTV
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    100 mg with food once daily for 24 weeks

    Investigational medicinal product name
    Iohexol
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    1500 mg solution at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Number of subjects in period 1 [1]
    		Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Started
    17
    16
    16
    17
    Completed
    16
    15
    15
    16
    Not completed
    1
    1
    1
    1
         Adverse event, non-fatal
    -
    1
    1
    -
         Lost to follow-up
    1
    -
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 6 participants who were randomized but not treated is are not included in the subject disposition table.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Stribild (STB)
    Reporting group description
    		 Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STB; Stribild®; EVG/COBI/FTC/TDF; 150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Reporting group title
    TVD + ATV/r
    Reporting group description
    		 FTC/TDF (TVD; Truvada®; 200/300 mg) FDC tablet + Atazanavir (ATV) 300 mg capsule + Ritonavir (RTV) 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24

    Reporting group title
    Atripla (ATR)
    Reporting group description
    		 EFV/FTC/TDF (ATR; Atripla® 600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Reporting group title
    ABC/3TC + ATV/r
    Reporting group description
    		 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Reporting group values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r Total
    Number of subjects
    		 17 16 16 17 66
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36 ± 8.1 34 ± 8.4 34 ± 9.6 34 ± 7.5 -
    Gender categorical
    Units: Subjects
        Female
    		 0 1 1 0 2
        Male
    		 17 15 15 17 64
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 0 0 1
        Asian
    		 1 0 0 1 2
        Black
    		 2 1 2 1 6
        White
    		 13 15 13 15 56
        Other
    		 0 0 1 0 1
    Ethinicity
    Units: Subjects
        Hispanic or Latino
    		 2 3 2 0 7
        Not Hispanic or Latino
    		 15 13 14 17 59
    Actual Glomerular Filtration Rate
    Units: mL/min
        arithmetic mean (standard deviation)
    		 111.8 ± 31.07 112 ± 19.17 105.4 ± 38.22 96.6 ± 34.52 -
    Estimated Glomerular Filtration Rate by Cockcroft- Gault
    Units: mL/min
        arithmetic mean (standard deviation)
    		 120.8 ± 13.94 121.2 ± 24.34 119.5 ± 20.36 122.6 ± 20.25 -
    Estimated Glomerular Filtration Rate by MDRD Formula
    Units: mL/ min/1.73m^2
        arithmetic mean (standard deviation)
    		 103.8 ± 14.06 110.6 ± 18.47 108.4 ± 21.42 105.5 ± 12.59 -
    CD4 Cell Count
    Units: cells/µL
        arithmetic mean (standard deviation)
    		 552 ± 177.8 600 ± 217.9 553 ± 215.8 524 ± 190 -

    End points

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    End points reporting groups
    Reporting group title
    Stribild (STB)
    Reporting group description
    		 Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (STB; Stribild®; EVG/COBI/FTC/TDF; 150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Reporting group title
    TVD + ATV/r
    Reporting group description
    		 FTC/TDF (TVD; Truvada®; 200/300 mg) FDC tablet + Atazanavir (ATV) 300 mg capsule + Ritonavir (RTV) 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24

    Reporting group title
    Atripla (ATR)
    Reporting group description
    		 EFV/FTC/TDF (ATR; Atripla® 600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Reporting group title
    ABC/3TC + ATV/r
    Reporting group description
    		 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Primary: Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24

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    End point title
    		 Actual Glomerular Filtration Rate (aGFR) Using Iohexol Plasma Clearance (CLiohexol) at Week 24 [1]
    End point description
    Participants in the pharmacodynamics (PD) analysis Set (all treated participants in each group, who have evaluable baseline and at least 1 postbaseline aGFR and /or eGFR at any visit) with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Week 24
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    17
    15
    15
    17
    Units: mL/min
        arithmetic mean (standard deviation)
    103.6 ± 23.28
    104.9 ± 27.16
    111.1 ± 23.23
    101 ± 27.01
    No statistical analyses for this end point

    Primary: Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24

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    End point title
    		 Estimated GFR (eGFR) Calculated by Cockcroft-Gault Formula at Week 24 [2]
    End point description
    GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFR = (140 - age) * (mass in kg) * (0.85 if female) divided by 72 * serum creatinine in mg/dL. Participants in the PD Analysis Set with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Week 24
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    16
    15
    15
    16
    Units: mL/min
        arithmetic mean (standard deviation)
    116.9 ± 17.06
    122.4 ± 31.71
    120 ± 20.52
    123 ± 25.74
    No statistical analyses for this end point

    Primary: Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24

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    End point title
    		 Estimated GFR Calculated by Modification of Diet in Renal Disease (MDRD) Formula at Week 24 [3]
    End point description
    MDRD is an equation (calculation) used to estimate GFR in participants with impaired renal function based on serum creatinine, age, race, and gender. eGFR (mL/min/1.73 m^2) = 186 * (Scr)^-1.154 * (Age)^(-0.203) * (0.742 if female) * (1.212 if black). Scr = serum creatinine in mg/dL. Participants in the PD Analysis Set with available data were analyzed.
    End point type
    Primary
    End point timeframe
    Week 24
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No statistical comparison was planned or performed.
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    16
    15
    15
    16
    Units: mL/min/1.73m^2
        arithmetic mean (standard deviation)
    99.3 ± 17.07
    110.2 ± 23.98
    109.2 ± 20.9
    104.9 ± 12.59
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)

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    End point title
    		 Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Urine Glucose (by Dipstick)
    End point description
    Safety Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks plus 30 days
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    17
    16
    16
    17
    Units: Participants
        Grade 1
    0
    0
    0
    0
        Grade 2
    0
    0
    0
    0
        Grade 3
    0
    0
    0
    0
        Grade 4
    0
    0
    0
    0
        Any Grade
    0
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)

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    End point title
    		 Percentage of Participants Experiencing Treatment-Emergent Graded Laboratory Abnormality: Serum Glucose (Fasting)
    End point description
    Participants in the Safety Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Up to 24 weeks plus 30 days
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    17
    16
    15
    17
    Units: percentage of participants
    number (not applicable)
        Grade 1 (Hyperglycemia)
    11.8
    12.5
    20
    0
        Grade 1 (Hypoglycemia)
    0
    0
    0
    0
        Grade 2 (Hyperglycemia)
    0
    0
    0
    0
        Grade 2 (Hypoglycemia)
    0
    6.3
    0
    0
        Grade 3 (Hyperglycemia)
    0
    0
    0
    0
        Grade 3 (Hypoglycemia)
    0
    0
    0
    0
        Grade 4 (Hyperglycemia)
    0
    0
    0
    0
        Grade 4 (Hypoglycemia)
    0
    0
    0
    0
        Any grade (Hyperglycemia)
    11.8
    12.5
    20
    0
        Any grade (Hypoglycemia)
    0
    6.3
    0
    0
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24

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    End point title
    		 Percentage Change From Baseline in Urine Albumin to Creatinine Ratio (mg/g) at Week 24
    End point description
    Participants in the PD Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    16
    14
    13
    17
    Units: percentage change
        median (inter-quartile range (Q1-Q3))
    0 (-23.6 to 50)
    -18.3 (-57.1 to 50)
    50 (-25 to 100)
    -16.7 (-37.5 to 0)
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24

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    End point title
    		 Percentage Change From Baseline in Urine Protein to Creatinine Ratio (mg/g) at Week 24
    End point description
    Participants in the PD Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    16
    14
    15
    17
    Units: percentage change
        median (inter-quartile range (Q1-Q3))
    5.7 (-11 to 22.5)
    17.5 (0 to 45.7)
    -10.5 (-41.9 to 69.8)
    7.1 (-24.3 to 13.3)
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (μg/g) at Week 24

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    End point title
    		 Percentage Change From Baseline in Urine β2-microglobulin to Creatinine Ratio (μg/g) at Week 24
    End point description
    Participants in the PD Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline ; Week 24
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    16
    14
    13
    17
    Units: percentage change
        median (inter-quartile range (Q1-Q3))
    -5.1 (-48.2 to 22.8)
    197.3 (21.7 to 328.7)
    -1.1 (-33.1 to 36.7)
    -22.7 (-60.8 to -6)
    No statistical analyses for this end point

    Secondary: Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Week 24

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    End point title
    		 Percentage Change From Baseline in Urine Retinol Binding Protein (RBP) to Creatinine Ratio (μg/g) at Week 24
    End point description
    Participants in the PD Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    16
    14
    13
    17
    Units: percentage change
        median (inter-quartile range (Q1-Q3))
    38.1 (-1.1 to 51.1)
    52.2 (5.9 to 147.6)
    52.1 (-33.8 to 92.8)
    4.8 (-13.6 to 15.5)
    No statistical analyses for this end point

    Secondary: Pharmacokinetic (PK) Parameter: Cmax for COBI

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    End point title
    		 Pharmacokinetic (PK) Parameter: Cmax for COBI [4]
    End point description
    Cmax is defined as the maximum observed concentration of drug in plasma. Participants in the COBI PK Analysis Set (all treated participants who have respective, evaluable PK profiles of COBI) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
    Notes
    [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: COBI was not administered in arms: TVD + ATV/ r, ATR (Atripla) and ABC/3TC + ATV/r
    End point values
    		 Stribild (STB)
    Number of subjects analysed
    17
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 4
    1189.1 ± 377.88
        Week 8
    1017.8 ± 388.09
        Week 16
    1197.3 ± 656.33
        Week 24 (N= 16)
    1123.4 ± 430.41
    No statistical analyses for this end point

    Secondary: PK Parameter: Tmax for COBI

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    End point title
    		 PK Parameter: Tmax for COBI [5]
    End point description
    Tmax is defined as the time of Cmax. Participants in the COBI PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
    Notes
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: COBI was not administered in arms: TVD + ATV/ r, ATR (Atripla), and ABC/3TC + ATV/r
    End point values
    		 Stribild (STB)
    Number of subjects analysed
    17
    Units: hours
    median (inter-quartile range (Q1-Q3))
        Week 4
    3.3 (3 to 4.1)
        Week 8
    3.1 (3 to 4.1)
        Week 16
    3.1 (2.1 to 4)
        Week 24 (N= 16)
    3 (2.1 to 4)
    No statistical analyses for this end point

    Secondary: PK Parameter: Clast for COBI

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    End point title
    		 PK Parameter: Clast for COBI [6]
    End point description
    Clast is defined as the last observable concentration of drug. Participants in the COBI PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
    Notes
    [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: COBI was not administered in arms: TVD + ATV/ r, ATR (Atripla), and ABC/3TC + ATV/r
    End point values
    		 Stribild (STB)
    Number of subjects analysed
    17
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 4
    85 ± 126.69
        Week 8
    54.5 ± 59.58
        Week 16
    214 ± 693.66
        Week 24 (N=16)
    162.7 ± 299.48
    No statistical analyses for this end point

    Secondary: PK Parameter: Tlast for COBI

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    End point title
    		 PK Parameter: Tlast for COBI [7]
    End point description
    Tlast is defined as the time of Clast. Participants in the COBI PK Analysis Set with available data were analyzed. Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
    Notes
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: COBI was not administered in arms: TVD + ATV/ r, ATR (Atripla), and ABC/3TC + ATV/r
    End point values
    		 Stribild (STB)
    Number of subjects analysed
    17
    Units: hours
    median (inter-quartile range (Q1-Q3))
        Week 4
    24 (24 to 24)
        Week 8
    24 (24 to 24)
        Week 16
    24 (24 to 24)
        Week 24 (N=16)
    24 (10.1 to 24)
    No statistical analyses for this end point

    Secondary: PK Parameter: Ctau for COBI

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    End point title
    		 PK Parameter: Ctau for COBI [8]
    End point description
    Ctau is defined as the observed drug concentration at the end of the dosing interval. Participants in the COBI PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: COBI was not administered in arms: TVD + ATV/ r, ATR (Atripla), and ABC/3TC + ATV/r
    End point values
    		 Stribild (STB)
    Number of subjects analysed
    17
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 4
    59.7 ± 113.31
        Week 8
    26 ± 28.79
        Week 16
    198.3 ± 697.06
        Week 24
    82.7 ± 285.81
    No statistical analyses for this end point

    Secondary: PK Parameter: λz for COBI

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    End point title
    		 PK Parameter: λz for COBI [9]
    End point description
    λz is defined as the terminal elimination rate constant. Participants in the COBI PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
    Notes
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: COBI was not administered in arms: TVD + ATV/ r, ATR (Atripla), and ABC/3TC + ATV/r
    End point values
    		 Stribild (STB)
    Number of subjects analysed
    16
    Units: 1/hour
    arithmetic mean (standard deviation)
        Week 4
    0.179 ± 0.0598
        Week 8 ( N= 15)
    0.192 ± 0.0481
        Week 16 (N= 16)
    0.206 ± 0.061
        Week 24 (N=15)
    0.211 ± 0.0844
    No statistical analyses for this end point

    Secondary: PK Parameter: AUCtau for COBI

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    End point title
    		 PK Parameter: AUCtau for COBI [10]
    End point description
    AUCtau is defined as the concentration of drug over time (area under the plasma concentration versus time curve over the dosing interval). Participants in the COBI PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
    Notes
    [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: COBI was not administered in arms: TVD + ATV/ r, ATR (Atripla), and ABC/3TC + ATV/r
    End point values
    		 Stribild (STB)
    Number of subjects analysed
    17
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        Week 4 (N=16)
    9225.8 ± 2786.6
        Week 8 (N=15)
    8127.4 ± 3217.12
        Week 16 (N=17)
    10684.8 ± 12567.09
        Week 24 (N=15)
    8391.3 ± 6132.5
    No statistical analyses for this end point

    Secondary: PK Parameter: t1/2 for COBI

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    End point title
    		 PK Parameter: t1/2 for COBI [11]
    End point description
    t1/2 is defined as the estimate of the terminal elimination half-life of the drug. Participants in the COBI PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: COBI was not administered in arms: TVD + ATV/ r, ATR (Atripla), and ABC/3TC + ATV/r
    End point values
    		 Stribild (STB)
    Number of subjects analysed
    17
    Units: hours
    median (inter-quartile range (Q1-Q3))
        Week 4 (N= 16)
    3.8 (3.24 to 4.63)
        Week 8 (N= 15)
    4.09 (2.89 to 4.75)
        Week 16 (N= 16)
    3.42 (2.91 to 4.18)
        Week 24 (N= 15)
    3.24 (2.57 to 4.39)
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax for RTV

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    End point title
    		 PK Parameter: Cmax for RTV [12]
    End point description
    Participants in the RTV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of RTV) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: ATV boosted with RTV (ATV/r) was not administered in arms: Stribild (STB) and Atripla (ATR)
    End point values
    		 TVD + ATV/r ABC/3TC + ATV/r
    Number of subjects analysed
    16
    17
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 4
    1260 ± 453.58
    1352.1 ± 513.74
        Week 8
    1142.3 ± 489.18
    1326.2 ± 493.47
        Week 16 (TVD+ATV/r: N= 15; ABC/3TC + ATV/r: N=17)
    1144.8 ± 416.41
    1557.6 ± 555.87
        Week 24 (TVD+ATV/r: N= 15; ABC/3TC + ATV/r: N=17)
    1217.7 ± 445.18
    1485.4 ± 662.49
    No statistical analyses for this end point

    Secondary: PK Parameter: Tmax for RTV

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    End point title
    		 PK Parameter: Tmax for RTV [13]
    End point description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: ATV boosted with RTV (ATV/r) was not administered in arms: Stribild (STB) and Atripla (ATR)
    End point values
    		 TVD + ATV/r ABC/3TC + ATV/r
    Number of subjects analysed
    16
    17
    Units: hours
    median (inter-quartile range (Q1-Q3))
        Week 4
    4 (3.2 to 4.6)
    4 (2.1 to 4.1)
        Week 8
    4 (2.5 to 5.1)
    4 (3 to 4.1)
        Week 16 (TVD+ATV/r: N= 15; ABC/3TC + ATV/r: N=17)
    4.1 (3 to 5.1)
    4 (2.2 to 4.1)
        Week 24 (TVD+ATV/r: N= 15; ABC/3TC + ATV/r: N=17)
    4 (3 to 5)
    4 (3 to 4.1)
    No statistical analyses for this end point

    Secondary: PK Parameter: Clast for RTV

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    End point title
    		 PK Parameter: Clast for RTV [14]
    End point description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: ATV boosted with RTV (ATV/r) was not administered in arms: Stribild (STB) and Atripla (ATR)
    End point values
    		 TVD + ATV/r ABC/3TC + ATV/r
    Number of subjects analysed
    16
    17
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 4
    59.5 ± 57.85
    61 ± 56.51
        Week 8
    71 ± 91.24
    85.5 ± 99.68
        Week 16 (TVD+ATV/r: N= 15; ABC/3TC + ATV/r: N=17)
    69.2 ± 49.85
    99.1 ± 92.42
        Week 24 (TVD+ATV/r: N= 15; ABC/3TC + ATV/r: N=17)
    102.5 ± 182.16
    187.9 ± 258.53
    No statistical analyses for this end point

    Secondary: PK Parameter: Tlast for RTV

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    End point title
    		 PK Parameter: Tlast for RTV [15]
    End point description
    Participants in the RTV PK Analysis Set with available data were analyzed. Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: ATV boosted with RTV (ATV/r) was not administered in arms: Stribild (STB) and Atripla (ATR)
    End point values
    		 TVD + ATV/r ABC/3TC + ATV/r
    Number of subjects analysed
    16
    17
    Units: hours
    median (inter-quartile range (Q1-Q3))
        Week 4
    24 (24 to 24)
    24 (24 to 24)
        Week 8
    24 (24 to 24)
    24 (24 to 24)
        Week 16 (TVD+ATV/r: N= 15)
    24 (24 to 24)
    24 (24 to 24)
        Week 24 (TVD+ATV/r: N= 15)
    24 (24 to 24)
    24 (24 to 24)
    No statistical analyses for this end point

    Secondary: PK Parameter: Ctau for RTV

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    End point title
    		 PK Parameter: Ctau for RTV [16]
    End point description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: ATV boosted with RTV (ATV/r) was not administered in arms: Stribild (STB) and Atripla (ATR)
    End point values
    		 TVD + ATV/r ABC/3TC + ATV/r
    Number of subjects analysed
    16
    17
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 4
    59.5 ± 57.85
    61 ± 56.51
        Week 8
    71 ± 91.24
    85.5 ± 99.68
        Week 16 (TVD+ATV/r: N= 15)
    69.2 ± 49.85
    99.1 ± 92.42
        Week 24 (TVD+ATV/r: N= 15)
    102.5 ± 182.16
    157 ± 246.75
    No statistical analyses for this end point

    Secondary: PK Parameter: AUCtau for RTV

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    End point title
    		 PK Parameter: AUCtau for RTV [17]
    End point description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [17] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: ATV boosted with RTV (ATV/r) was not administered in arms: Stribild (STB) and Atripla (ATR)
    End point values
    		 TVD + ATV/r ABC/3TC + ATV/r
    Number of subjects analysed
    16
    17
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        Week 4
    8259.6 ± 3166.47
    9649.1 ± 3713.87
        Week 8
    8362 ± 3544.53
    9702.2 ± 3391.68
        Week 16 (TVD+ATV/r: N= 15)
    8102.6 ± 3392
    11148 ± 4482.33
        Week 16 (TVD+ATV/r: N= 15; ABC/3TC + ATV/r: N=16)
    8907 ± 5182.65
    12039.3 ± 6792.06
    No statistical analyses for this end point

    Secondary: PK Parameter: λz for RTV

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    End point title
    		 PK Parameter: λz for RTV [18]
    End point description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
    Notes
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: ATV boosted with RTV (ATV/r) was not administered in arms: Stribild (STB) and Atripla (ATR)
    End point values
    		 TVD + ATV/r ABC/3TC + ATV/r
    Number of subjects analysed
    16
    17
    Units: 1/hour
    arithmetic mean (standard deviation)
        Week 4 (TVD+ATV/r: N= 14; ABC/3TC + ATV/r: N=15)
    0.156 ± 0.0386
    0.151 ± 0.0346
        Week 8 (TVD+ATV/r: N= 13; ABC/3TC + ATV/r: N=15)
    0.144 ± 0.0474
    0.142 ± 0.0281
        Week 16 (TVD+ATV/r: N= 12; ABC/3TC + ATV/r: N=17)
    0.138 ± 0.0382
    0.131 ± 0.0291
        Week 24 (TVD+ATV/r: N= 15; ABC/3TC + ATV/r: N=15)
    0.133 ± 0.0347
    0.128 ± 0.0469
    No statistical analyses for this end point

    Secondary: PK Parameter: t1/2 for RTV

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    End point title
    		 PK Parameter: t1/2 for RTV [19]
    End point description
    Participants in the RTV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: ATV boosted with RTV (ATV/r) was not administered in arms: Stribild (STB) and Atripla (ATR)
    End point values
    		 TVD + ATV/r ABC/3TC + ATV/r
    Number of subjects analysed
    16
    17
    Units: hours
    arithmetic mean (full range (min-max))
        Week 4 (TVD+ATV/r: N= 14; ABC/3TC + ATV/r: N=15)
    4.56 (3.77 to 4.99)
    4.53 (3.83 to 6.01)
        Week 8 (TVD+ATV/r: N= 13; ABC/3TC + ATV/r: N=15)
    4.85 (3.75 to 5.34)
    4.68 (4.31 to 5.69)
        Week 16 (TVD+ATV/r: N= 12; ABC/3TC + ATV/r: N=17)
    5.39 (4.22 to 6.22)
    5.57 (4.68 to 6)
        Week 24 (TVD+ATV/r: N= 15; ABC/3TC + ATV/r: N=15)
    5.08 (4.49 to 5.78)
    4.82 (4.25 to 6.41)
    No statistical analyses for this end point

    Secondary: PK Parameter: Cmax for TFV

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    End point title
    		 PK Parameter: Cmax for TFV [20]
    End point description
    Participants in the TFV PK Analysis Set (all treated participants who have respective, evaluable PK profiles of TFV) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: TDF (which is metabolized to TFV) was not administered in arm: ABC/3TC + ATV/r
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR)
    Number of subjects analysed
    17
    16
    15
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 4
    371.2 ± 94.46
    301.6 ± 116.36
    298.3 ± 100.36
        Week 8 (ATR: N= 14)
    379.8 ± 87.44
    343 ± 133.97
    325.5 ± 149.48
        Week 16 (TVD + ATV/r: N= 15; ATR: N= 15)
    399.5 ± 169.51
    319.4 ± 146.41
    298.6 ± 107.11
        Week 24(STB: N= 16; TVD + ATV/r: N= 15; ATR: N=15)
    394.4 ± 131.09
    350.7 ± 126.91
    305.9 ± 106.24
    No statistical analyses for this end point

    Secondary: PK Parameter: Tmax for TFV

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    End point title
    		 PK Parameter: Tmax for TFV [21]
    End point description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: TDF (which is metabolized to TFV) was not administered in arm: ABC/3TC + ATV/r
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR)
    Number of subjects analysed
    17
    16
    15
    Units: hours
    median (inter-quartile range (Q1-Q3))
        Week 4
    2 (1.3 to 3.1)
    3 (1.5 to 3.1)
    1.1 (0.6 to 2)
        Week 8 (ATR: N=14)
    2 (2 to 2.1)
    3 (2 to 3.1)
    1 (0.6 to 1.1)
        Week 16 (TVD + ATV/r: N= 15)
    2.1 (1.1 to 3.1)
    2.1 (1 to 3.1)
    1.2 (1 to 2.1)
        Week 24 (STB: N= 16; TVD + ATV/r: N= 15)
    2 (1.1 to 3)
    2.1 (1.1 to 3.2)
    1.1 (0.6 to 2)
    No statistical analyses for this end point

    Secondary: PK Parameter: Clast for TFV

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    End point title
    		 PK Parameter: Clast for TFV [22]
    End point description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: TDF (which is metabolized to TFV) was not administered in arm: ABC/3TC + ATV/r
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR)
    Number of subjects analysed
    17
    16
    15
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 4
    81.1 ± 32.41
    73.1 ± 23.74
    55.4 ± 15.52
        Week 8 (ATR: N=14)
    80.9 ± 35.12
    78.2 ± 31.27
    53.4 ± 18.83
        Week 16 (TVD + ATV/r: N= 15; ATR: N= 15)
    128.5 ± 184.17
    74.5 ± 26.01
    63 ± 19.25
        Week 24 (STB: N= 16; TVD+ATV/r: N= 15; ATR: N=15)
    78.5 ± 53.04
    87.3 ± 41.2
    58.5 ± 16.45
    No statistical analyses for this end point

    Secondary: PK Parameter: Tlast for TFV

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    End point title
    		 PK Parameter: Tlast for TFV [23]
    End point description
    Participants in the TFV PK Analysis Set with available data were analyzed. Plasma samples for PK analysis were collected out to 10 hours postdose, and the predose concentration was used as a surrogate for the 24 hour concentration for PK parameter generation.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: TDF (which is metabolized to TFV) was not administered in arm: ABC/3TC + ATV/r
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR)
    Number of subjects analysed
    17
    16
    15
    Units: hours
    median (inter-quartile range (Q1-Q3))
        Week 4
    24 (24 to 24)
    24 (24 to 24)
    24 (24 to 24)
        Week 8 (ATR: N= 14)
    24 (24 to 24)
    24 (24 to 24)
    24 (24 to 24)
        Week 16 (TVD + ATV/r: N= 15; ATR: N= 15)
    24 (24 to 24)
    24 (24 to 24)
    24 (24 to 24)
        Week 24 (STB: N= 16; TVD+ATV/r: N= 15; ATR: N=15)
    24 (24 to 24)
    24 (24 to 24)
    24 (24 to 24)
    No statistical analyses for this end point

    Secondary: PK Parameter: Ctau for TFV

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    End point title
    		 PK Parameter: Ctau for TFV [24]
    End point description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: TDF (which is metabolized to TFV) was not administered in arm: ABC/3TC + ATV/r
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR)
    Number of subjects analysed
    17
    16
    15
    Units: ng/mL
    arithmetic mean (standard deviation)
        Week 4
    74.6 ± 36.88
    73.1 ± 23.74
    55.4 ± 15.52
        Week 8 (ATR: N= 14)
    75.8 ± 40.16
    78.2 ± 31.27
    48.8 ± 23.27
        Week 16 (TVD + ATV/r: N= 15; ATR: N= 15)
    128.5 ± 184.17
    74.5 ± 26.01
    57.5 ± 24.41
        Week 24 (TVD + ATV/r: N= 15; ATR: N= 15)
    71.7 ± 57.06
    77.3 ± 43.06
    54.2 ± 22.17
    No statistical analyses for this end point

    Secondary: PK Parameter: λz for TFV

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    End point title
    		 PK Parameter: λz for TFV [25]
    End point description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Weeks 4, 8, 16, and 24
    Notes
    [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: TDF (which is metabolized to TFV) was not administered in arm: ABC/3TC + ATV/r
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR)
    Number of subjects analysed
    17
    16
    15
    Units: 1/hour
    arithmetic mean (standard deviation)
        Week 4 (TVD + ATV/r: N= 15)
    0.045 ± 0.0148
    0.048 ± 0.0059
    0.037 ± 0.0133
        Week 8 (TVD + ATV/r: N= 15; ATR: N= 13)
    0.051 ± 0.0167
    0.048 ± 0.0158
    0.041 ± 0.0197
        Week 16 (STB: N= 16; TVD+ATV/r: N= 14; ATR: N=15)
    0.047 ± 0.0173
    0.047 ± 0.0115
    0.033 ± 0.0166
        Week 24 (STB: N= 16; TVD+ATV/r: N= 15; ATR: N=15)
    0.051 ± 0.0195
    0.046 ± 0.0184
    0.035 ± 0.0138
    No statistical analyses for this end point

    Secondary: PK Parameter: AUCtau for TFV

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    End point title
    		 PK Parameter: AUCtau for TFV [26]
    End point description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
    Notes
    [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: TDF (which is metabolized to TFV) was not administered in arm: ABC/3TC + ATV/r
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR)
    Number of subjects analysed
    17
    16
    15
    Units: h*ng/mL
    arithmetic mean (standard deviation)
        Week 4
    3370.2 ± 1000.75
    3151.2 ± 1107.18
    2244.8 ± 572.09
        Week 8 (ATR: N= 14)
    3549.7 ± 1238.03
    3361.9 ± 1152.04
    2250.8 ± 555.79
        Week 16 (TVD + ATV/r: N= 15; ATR: N= 15)
    3939.7 ± 2499.63
    3234.7 ± 1207.58
    2326.4 ± 494.24
        Week 24 (STB: N= 16; TVD+ATV/r: N= 15; ATR: N=15)
    3307 ± 1387.97
    3451.5 ± 1075.47
    2265.7 ± 412.87
    No statistical analyses for this end point

    Secondary: PK Parameter: t1/2 for TFV

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    End point title
    		 PK Parameter: t1/2 for TFV [27]
    End point description
    Participants in the TFV PK Analysis Set with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" at Weeks 4, 8, 16, and 24
    Notes
    [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: TDF (which is metabolized to TFV) was not administered in arm: ABC/3TC + ATV/r
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR)
    Number of subjects analysed
    17
    16
    15
    Units: hours
    median (inter-quartile range (Q1-Q3))
        Week 4 (TVD + ATV/r: N= 15)
    15.73 (12.49 to 18.9)
    14.1 (13.28 to 16.81)
    20.65 (15.3 to 26.75)
        Week 8 (TVD + ATV/r: N= 16; ATR: N= 13)
    14.4 (12.07 to 16.83)
    15.82 (11.94 to 19.53)
    18.81 (13.08 to 25.14)
        Week 16 (STB: N= 16; TVD+ATV/r: N= 14; ATR: N=15)
    14.41 (13.11 to 19.87)
    14.72 (12.76 to 16.73)
    22.78 (16.88 to 32.15)
        Week 24 (STB: N= 16; TVD+ATV/r: N= 15; ATR: N=15)
    13.99 (11.91 to 18.52)
    16.17 (13.18 to 21.37)
    21.54 (19.39 to 27.32)
    No statistical analyses for this end point

    Secondary: PK Parameter: AUCinf for Iohexol

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    End point title
    		 PK Parameter: AUCinf for Iohexol
    End point description
    AUC inf is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time). Participants in the iohexol PK Analysis Set (all treated participants who have respective, evaluable PK profiles of iohexol) with available data were analyzed.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0, 0.5, 1, 2, 3, 4, 5, 6, and 10 hours post "time zero" on Day 1 and Weeks 4, 8, 16, and 24
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    17
    16
    16
    17
    Units: h*μg/mL
    arithmetic mean (standard deviation)
        Day 1
    511.2 ± 172.71
    486.8 ± 108.28
    706.9 ± 647.25
    695.2 ± 523.33
        Week 4 (ATR: N= 14)
    521.8 ± 121.67
    496.2 ± 153.05
    512.6 ± 163.89
    720.5 ± 657.95
        Week 8 (ATR: N= 15; ABC/3TC + ATV/r: N= 16))
    517.8 ± 170.24
    574.8 ± 382.63
    510.6 ± 136.4
    667 ± 559.06
        Week 16 (TVD + ATV/r: N= 15; ATR: N= 15)
    494.3 ± 113.6
    509.5 ± 156.98
    504.8 ± 95.07
    725.9 ± 843.22
        Week 24 (TVD + ATV/r: N= 15; ATR: N= 15)
    545.8 ± 127.34
    561.2 ± 214.26
    507.1 ± 113.45
    606.5 ± 321.4
    No statistical analyses for this end point

    Secondary: Percentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm

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    End point title
    		 Percentage of Participants With HIV-1 RNA < 50 Copies/mL Week 24 as Determined by Snapshot Algorithm
    End point description
    Full Analysis Set (FAS): all participants who (1) are randomized into the study and (2) have received at least one dose of study drug.
    End point type
    Secondary
    End point timeframe
    Week 24
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    17
    16
    13
    15
    Units: percentage of participants
        number (not applicable)
    88.2
    81.3
    81.3
    88.2
    No statistical analyses for this end point

    Secondary: Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24

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    End point title
    		 Change From Baseline in Cluster of Differentiation 4 Positive (CD4+) Cell Count at Week 24
    End point description
    Full Analysis Set
    End point type
    Secondary
    End point timeframe
    Baseline; Week 24
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    16
    15
    15
    17
    Units: cell/µL
        arithmetic mean (standard deviation)
    139.63 ± 142.196
    217.6 ± 195.375
    204.33 ± 194.653
    237.29 ± 201.222
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Adverse Events (AEs)

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    End point title
    		 Percentage of Participants Experiencing Adverse Events (AEs)
    End point description
    Safety Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    17
    16
    16
    17
    Units: percentage of participants
    number (not applicable)
        Any Treatment-Emergent Adverse Events (TEAE)
    70.6
    87.5
    87.5
    88.2
        Any Grade 3 or 4 Treatment-Emergent Adverse Event
    5.9
    12.5
    12.5
    5.9
        Any Treatment-Emergent Study-Drug-Related AEs
    11.8
    50
    68.8
    23.5
        Any TEAE Leading to Study Drug Discontinuation
    5.9
    6.3
    6.3
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities

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    End point title
    		 Percentage of Participants Experiencing Treatment Emergent (TE) Grade 3 or 4 Laboratory Abnormalities
    End point description
    Graded laboratory abnormalities were defined as values that increased at least one toxicity grade from predose at any postdose up to the last dose date of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant. Safety Analysis Set
    End point type
    Secondary
    End point timeframe
    Up to the last dose date plus 30 days (Up to 24 weeks plus 30 days)
    End point values
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Number of subjects analysed
    17
    16
    16
    17
    Units: Percentage of participants
    number (not applicable)
        Any Grade 3 or 4 TE Laboratory Abnormality
    5.9
    25
    12.5
    52.9
        Grade 3 or 4 Neutrophils
    0
    6.3
    0
    0
        Grade 3 or 4 Amylase
    0
    0
    6.3
    0
        Grade 3 or 4 AST
    0
    6.3
    0
    0
        Grade 3 or 4 CK
    5.9
    18.8
    6.3
    5.9
        Grade 3 or 4 Total Bilirubin
    0
    12.5
    0
    52.9
        Grade 3 or 4 Urine RBC
    0
    7.7
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline to 30 days after last dose of study drug (up to 24 weeks plus 30 days)
    Adverse event reporting additional description
    Safety Analysis Set
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Stribild (STB)
    Reporting group description
    		 STB (150/150/200/300 mg) FDC tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Reporting group title
    TVD + ATV/r
    Reporting group description
    		 TVD (200/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day 1), and Weeks 4, 8, 16, and 24

    Reporting group title
    Atripla (ATR)
    Reporting group description
    		 ATR (600/200/300 mg) FDC tablet orally once daily on an empty stomach for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Reporting group title
    ABC/3TC + ATV/r
    Reporting group description
    		 ABC/3TC (600/300 mg) FDC tablet + ATV 300 mg capsule + RTV 100 mg tablet orally with food once daily for 24 weeks + iohexol 1500 mg solution administered intravenously at Baseline (Day1), and Weeks 4, 8, 16, and 24

    Serious adverse events
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    2 / 17 (11.76%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Upper limb fracture
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Liver injury
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Psychiatric disorders
    Intentional self-injury
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pneumonia bacterial
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Stribild (STB) TVD + ATV/r Atripla (ATR) ABC/3TC + ATV/r
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    11 / 17 (64.71%)
    14 / 16 (87.50%)
    13 / 16 (81.25%)
    14 / 17 (82.35%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Vascular disorders
    Haematoma
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Hot flush
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Hypotension
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Spider vein
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Fatigue
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    2
    1
    0
    0
    Influenza like illness
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    1
    1
    Pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Pyrexia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Catarrh
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Cough
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    2
    0
    Nasal congestion
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    2
    Oropharyngeal pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Psychiatric disorders
    Abnormal behaviour
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Abnormal dreams
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Depressed mood
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Disorientation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Indifference
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Insomnia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    2 / 17 (11.76%)
         occurrences all number
    1
    0
    1
    2
    Nightmare
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Sleep disorder
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Terminal insomnia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    0
    0
    Liver function test abnormal
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    2
    0
    Traumatic haematoma
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    7 / 16 (43.75%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    7
    0
    Head discomfort
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Headache
         subjects affected / exposed
    2 / 17 (11.76%)
    1 / 16 (6.25%)
    2 / 16 (12.50%)
    3 / 17 (17.65%)
         occurrences all number
    2
    2
    2
    5
    Hypoaesthesia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Lethargy
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Nervous system disorder
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Eye disorders
    Eye pain
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ocular icterus
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 16 (18.75%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    0
    0
    Gastrointestinal disorders
    Anal fissure
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Constipation
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Diarrhoea haemorrhagic
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Dry mouth
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Dyspepsia
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    1
    Flatulence
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    0
    0
    1
    Haemorrhoids
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Nausea
         subjects affected / exposed
    1 / 17 (5.88%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    1
    2
    0
    1
    Toothache
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    4
    1
    Vomiting
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    2 / 16 (12.50%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    4
    1
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    2
    0
    1
    Skin and subcutaneous tissue disorders
    Dermatitis allergic
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Erythema
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Ingrowing nail
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Rash
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    2 / 16 (12.50%)
    0 / 17 (0.00%)
         occurrences all number
    0
    2
    2
    0
    Rash erythematous
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Neck pain
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Infections and infestations
    Acute hepatitis C
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Anal chlamydia infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Cystitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Ear infection
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Eye abscess
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Eyelid boil
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Fungal skin infection
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Furuncle
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Gonorrhoea
         subjects affected / exposed
    0 / 17 (0.00%)
    3 / 16 (18.75%)
    1 / 16 (6.25%)
    1 / 17 (5.88%)
         occurrences all number
    0
    3
    1
    1
    Laryngitis
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    0
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 17 (5.88%)
    3 / 16 (18.75%)
    3 / 16 (18.75%)
    2 / 17 (11.76%)
         occurrences all number
    1
    3
    3
    2
    Onychoclasis
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Otitis externa
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Respiratory tract infection
         subjects affected / exposed
    1 / 17 (5.88%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Syphilis
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Tinea cruris
         subjects affected / exposed
    2 / 17 (11.76%)
    0 / 16 (0.00%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Tinea versicolour
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 16 (6.25%)
    0 / 17 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Upper respiratory tract infection
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    1 / 17 (5.88%)
         occurrences all number
    0
    1
    0
    1
    Metabolism and nutrition disorders
    Increased appetite
         subjects affected / exposed
    0 / 17 (0.00%)
    1 / 16 (6.25%)
    0 / 16 (0.00%)
    0 / 17 (0.00%)
         occurrences all number
    0
    1
    0
    0

    More information

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

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

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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