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    Clinical Trial Results:
    A phase IV, open-label three-arm study investigating the impact of a combination of tenofovir disoproxil fumarate/emtricitabine with raltegravir or dolutegravir or elvitegravir/cobicistat on renal tubular function and renal transporters in HIV-1 antiretroviral naïve patients

    Summary
    EudraCT number
    		 2014-004578-40
    Trial protocol
    		 GB  
    Global end of trial date
    06 Apr 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Apr 2018
    First version publication date
    22 Apr 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    SSAT066
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02351908
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 REC ref: 15/LO/0031, MHRA CTA no.: 21918/0042/001-0001
    Sponsors
    Sponsor organisation name
    St Stephen's AIDS Trust
    Sponsor organisation address
    Chelsea Chambers, 262a Fulham Road, London, United Kingdom, SW10 9EL
    Public contact
    Marita Marshall, St Stephen's Clinical Research, +44 203 828 0567, marita.marshall@ststcr.com
    Scientific contact
    Dr Greame Moyle, Chelsea and Westminster Hosptial NHS FT, geylom@gmail.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
    22 Jan 2018
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Apr 2017
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Apr 2017
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To describe the change in retinol-binding protein/creatinine ratio with each regimen over 24 weeks.
    Protection of trial subjects
    The protocol was written, and the study was conducted according to the ICH Harmonized Tripartite Guideline on Good Clinical Practice, E6 and the principles of the Declaration of Helsinki. The protocol was approved by the National Regulator and an Independent Ethics Committee as required by national legislation. Written informed consent was obtained from each subject prior to evaluations being performed for eligibility. Subjects were given adequate time to review the information in the informed consent and were encouraged to ask questions concerning all portions of the conduct of the study to ensure understanding. The purpose of the study together with the procedures benefits and risks of the study; any discomforts and the precautions taken was described during the consent process; allowing subject to make an informed decision about participation. Subjects were also informed of their right to discontinue from the study at any time without any detriment. The inclusion/exclusion criteria were designed to eliminate subjects who may have been put at risk by participating in the study. Women of childbearing potential were required to have a negative pregnancy test at screening in order to exclude any participants who may have been pregnant, and these participants (along with heterosexually active males) were required to use effective birth control for the duration of the study. Safety and tolerability of medications were assessed by questions, physical examination (as required) and laboratory parameters. Any changes in health status during the study were recorded and followed up by the clinical team.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Feb 2015
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 60
    Worldwide total number of subjects
    60
    EEA total number of subjects
    60
    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)
    60
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 60 patients were enrolled to this study, out of the 68 patients screened. All patients were recruited from Chelsea and Westminster Hospital NHS Foundation Trust, screening began 7th Apr 2015 and continued until 17th March 2016. Their virus has to show full genetic susceptibility to NRTI class antiretrovirals, and EGFR>60ml/min

    Pre-assignment
    Screening details
    		 Patients with untreated HIV and a measured viral load >1000 copies/ml were approached for this study. They required no previous exposure to an anti-retrovrial drug (with the exception of PrEP or PEP use that is not associated with the HIV acquisition).

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Raltegravir + Truvada
    Arm description
    		 Truvada® (200mg/245mg film coated tablets) one tablet once daily + Raltegravir 400mg (one tablet) twice daily
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Truvada
    Investigational medicinal product code
    J05AR03
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir). Taken once daily.

    Investigational medicinal product name
    Raltegravir
    Investigational medicinal product code
    J05AX08
    Other name
    Isentress
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each film-coated tablet contains 400 mg of raltegravir (as potassium). Taken twice daily.

    Arm title
    		 Dolutegravir + Truvada
    Arm description
    		 Truvada® + Tivicay® (Dolutegravir) 50mg OD
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Truvada
    Investigational medicinal product code
    J05AR03
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each film-coated tablet contains 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir). Taken once daily.

    Investigational medicinal product name
    Dolutegravir
    Investigational medicinal product code
    J05AX12
    Other name
    Tivicay
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    50 mg (one tablet) orally once daily

    Arm title
    		 Stribild
    Arm description
    		 Stribild®(150mg Elvitegravir, 150mg Cobicistat, 200mg TenofovirDF, 245mg Emtricitabine) film coated tablet, once daily.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Stribild
    Investigational medicinal product code
    J05AR09
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Each film-coated tablet contains 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil (equivalent to 300 mg of tenofovir disoproxil fumarate or 136 mg of tenofovir). One tablet taken once daily.

    Number of subjects in period 1
    		Raltegravir + Truvada Dolutegravir + Truvada Stribild
    Started
    20
    20
    20
    Week 4
    19
    20
    20
    Week 12
    19
    20
    20
    Week 24
    19
    20
    20
    Week 36
    18
    20
    20
    Week 48
    18
    20
    19
    Completed
    18
    20
    19
    Not completed
    2
    0
    1
         Physician decision
    1
    -
    -
         Lost to follow-up
    1
    -
    1

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Raltegravir + Truvada
    Reporting group description
    		 Truvada® (200mg/245mg film coated tablets) one tablet once daily + Raltegravir 400mg (one tablet) twice daily

    Reporting group title
    Dolutegravir + Truvada
    Reporting group description
    		 Truvada® + Tivicay® (Dolutegravir) 50mg OD

    Reporting group title
    Stribild
    Reporting group description
    		 Stribild®(150mg Elvitegravir, 150mg Cobicistat, 200mg TenofovirDF, 245mg Emtricitabine) film coated tablet, once daily.

    Reporting group values
    		 Raltegravir + Truvada Dolutegravir + Truvada Stribild Total
    Number of subjects
    		 20 20 20 60
    Age categorical
    Units: Subjects
        In utero
    		 0
        Preterm newborn infants (gestational age < 37 wks)
    		 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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.0 ( 10.0 ) 32.2 ( 8.2 ) 36.8 ( 10.0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 1 0 2 3
        Male
    		 19 20 18 57
    Ethnicity
    Units: Subjects
        White
    		 15 16 15 46
        Black
    		 2 1 1 4
        Asian
    		 1 2 1 4
        Mixed race
    		 1 0 1 2
        Other
    		 1 1 2 4
    BMI
    Body Mass Index
    Units: kg/m^2
        median (inter-quartile range (Q1-Q3))
    		 24.4 (22.0 to 26.6) 23.3 (19.1 to 23.3) 22.8 (22.4 to 26.4) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Raltegravir + Truvada
    Reporting group description
    		 Truvada® (200mg/245mg film coated tablets) one tablet once daily + Raltegravir 400mg (one tablet) twice daily

    Reporting group title
    Dolutegravir + Truvada
    Reporting group description
    		 Truvada® + Tivicay® (Dolutegravir) 50mg OD

    Reporting group title
    Stribild
    Reporting group description
    		 Stribild®(150mg Elvitegravir, 150mg Cobicistat, 200mg TenofovirDF, 245mg Emtricitabine) film coated tablet, once daily.

    Subject analysis set title
    Baseline RTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline time-point Raltegravir + Truvada arm

    Subject analysis set title
    Week 4 RTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 4 Raltegravir + Truvada arm

    Subject analysis set title
    Week 12 RTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 12 time-point Raltegravir + Truvada arm

    Subject analysis set title
    Week 24 RTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 24 time-point Raltegravir + Truvada arm

    Subject analysis set title
    Week 36 RTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 36 time-point Raltegravir + Truvada Arm

    Subject analysis set title
    Week 48 RTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 48 time-point Ralegravir + Truvada arm

    Subject analysis set title
    Baseline DTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline time-point Dolutegravir + Truvada arm

    Subject analysis set title
    Week 4 DTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 4 time-point Dolutegravir + Truvada arm

    Subject analysis set title
    Week 12 DTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 12 time-point Dolutegravir + Truvada arm

    Subject analysis set title
    Week 24 DTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 24 time-point Dolutegravir + Truvada arm

    Subject analysis set title
    Week 36 DTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 36 time-point Dolutegravir + Truvada arm

    Subject analysis set title
    Week 48 DTG Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 48 time-point Dolutegravir + Truvada arm

    Subject analysis set title
    Baseline Str Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Baseline time-point Stribild arm

    Subject analysis set title
    Week 4 Str Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 4 time-point Stribild arm

    Subject analysis set title
    Week 12 Str Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 12 time-point Stribild arm

    Subject analysis set title
    Week 24 Str Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 24 time-point Stribild arm

    Subject analysis set title
    Week 36 Str Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 36 time-point Stribild arm

    Subject analysis set title
    Week 48 Str Arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Week 48 time-point Stribild arm

    Primary: Change in retinol-binding protein/creatinine ratio (PCR) with each regimen over time.

    		 Close Top of page
    End point title
    		 Change in retinol-binding protein/creatinine ratio (PCR) with each regimen over time.
    End point description
    Change in The change in retinol-binding protein/creatinine ratio (PCR) with each regimen over time (measured via nephelometric assay run on Siemens BNII nephelometer).
    End point type
    Primary
    End point timeframe
    Baseline, Week 4, Week 12, Week 24 & Week 48
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    19
    18
    17
    19
    19
    19
    19
    18
    19
    18
    19
    17
    19
    Units: μg/mmol
    median (inter-quartile range (Q1-Q3))
        Value
    7 (6 to 10)
    6 (5 to 8)
    8 (6 to 10)
    10 (9 to 12)
    9 (6 to 15)
    7 (6 to 11)
    8 (6 to 13)
    9 (7 to 14)
    9 (6 to 13)
    12 (8 to 17)
    7 (5 to 11)
    9 (6 to 13)
    10 (6 to 19)
    11 (8 to 12)
    12 (6 to 22)
        Change from baseline
    0 (0 to 0)
    0 (-1 to 2)
    1 (-1 to 4)
    3 (1 to 6)
    2 (1 to 6)
    0 (0 to 0)
    1 (-1 to 5)
    1.5 (-1 to 4)
    1 (-2 to 8)
    3 (0 to 7)
    0 (0 to 0)
    1 (-2 to 3)
    1 (-1 to 6)
    4 (1.5 to 8)
    2 (0 to 9)
    Attachments
    		 Untitled (Filename: SSAT066 Stats RBP.pdf)
    Statistical analysis title
    		 RTG Baseline to W4 Wilcoxon
    Comparison groups
    Baseline RTG Arm v Week 4 RTG Arm
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.773
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 RTG Baseline to W12 Wilcoxon
    Comparison groups
    Baseline RTG Arm v Week 12 RTG Arm
    Number of subjects included in analysis
    39
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.109
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 RTG Baseline to W24 Wilcoxon
    Comparison groups
    Baseline RTG Arm v Week 24 RTG Arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 RTG Baseline to W48 Wilcoxon
    Comparison groups
    Baseline RTG Arm v Week 48 RTG Arm
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.007
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 DTG Baseline to W4 Wilcoxon
    Comparison groups
    Baseline DTG Arm v Week 4 DTG Arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.109
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 DTG Baseline to W12 Wilcoxon
    Comparison groups
    Baseline DTG Arm v Week 12 DTG Arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.024
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 DTG Baseline to W24 Wilcoxon
    Comparison groups
    Baseline DTG Arm v Week 24 DTG Arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.169
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 DTG Baseline to W48 Wilcoxon
    Comparison groups
    Baseline DTG Arm v Week 48 DTG Arm
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.006
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Str Baseline to W4 Wilcoxon
    Comparison groups
    Baseline Str Arm v Week 4 Str Arm
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.324
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Str Baseline to W12 Wilcoxon
    Comparison groups
    Baseline Str Arm v Week 12 Str Arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.022
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Str Baseline to W12 Wilcoxon
    Comparison groups
    Baseline Str Arm v Week 24 Str Arm
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 < 0.001
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval
    Statistical analysis title
    		 Str Baseline to W48 Wilcoxon
    Comparison groups
    Baseline Str Arm v Week 48 Str Arm
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.004
    Method
    		 Wilcoxon (Mann-Whitney)
    Confidence interval

    Secondary: Variation from baseline of eGFR using Cockcroft Gault formula

    		 Close Top of page
    End point title
    		 Variation from baseline of eGFR using Cockcroft Gault formula
    End point description
    The Cockcroft and Gault formula (1973) Weight measured over time.
    End point type
    Secondary
    End point timeframe
    From baseline to Weeks 4,12,24,36 and 48
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    17
    18
    17
    19
    17
    18
    20
    19
    18
    17
    17
    17
    20
    18
    18
    19
    19
    20
    Units: mL/min
        median (inter-quartile range (Q1-Q3))
    129.5 (113.3 to 145.8)
    115.7 (105.5 to 143.4)
    124.1 (102.6 to 140.0)
    124.3 (109.3 to 137.3)
    118.1 (104.3 to 138.5)
    115.9 (97.5 to 141.2)
    124.6 (111.4 to 141.2)
    100.1 (94.1 to 118.8)
    104.2 (93.8 to 115.9)
    104.7 (98.8 to 119.8)
    106.2 (95.2 to 110.2)
    99.0 (89.1 to 117.9)
    127.8 (117.0 to 143.8)
    113.4 (101.9 to 133.8)
    113.1 (98.2 to 141.1)
    121.0 (88.2 to 140.7)
    120.6 (96.0 to 134.1)
    114.2 (103.0 to 131.1)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - CG.pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of eGFR - MDRD with creatinine

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    End point title
    		 Variation from baseline of eGFR - MDRD with creatinine
    End point description
    GFR = 186 x SerumCr-1.154 * age-0.203 * 1.212 (if patient is black) * 0.742 (if female) Source: http://www.mdcalc.com/mdrd-gfr-equation/
    End point type
    Secondary
    End point timeframe
    Change from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    18
    19
    18
    18
    20
    19
    20
    17
    19
    19
    20
    18
    18
    19
    19
    20
    Units: mL/min/1.73m^2
        median (inter-quartile range (Q1-Q3))
    109.8 (97.7 to 118.3)
    105.1 (95.5 to 116.8)
    103.9 (92.6 to 117.9)
    105.1 (96.7 to 117.1)
    100.9 (88.4 to 111.1)
    103.0 (70.6 to 129.0)
    114.6 (98.9 to 122.5)
    98.1 (79.0 to 105.3)
    89.9 (78.3 to 104.5)
    94.8 (87.1 to 105.6)
    89.0 (77.8 to 100.0)
    90.5 (71.2 to 107.0)
    115.7 (103.6 to 122.6)
    102.3 (97.2 to 109.9)
    101.7 (87.6 to 116.9)
    92.5 (84.1 to 112.4)
    101.5 (85.1 to 113.0)
    99.6 (88.2 to 109.0)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - Creatinine.pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of eGFR - CKD-EPI with creatinine / cystatin-C

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    End point title
    		 Variation from baseline of eGFR - CKD-EPI with creatinine / cystatin-C
    End point description
    Inker LA, Schmid CH, Tighiouart H, et al. Estimating glomerular filtration rate from serum creatinine and cystatin C. N Engl J Med. 2012;367(1):20-29. The CKD-EPI creatinine–cystatin C equation (2012) can be expressed as a single equation: 135 × min(Scr/κ, 1)α × max(Scr/κ, 1)−0.601 × min(Scys/0.8, 1)−0.375 × max(Scys/0.8, 1)−0.711 × 0.995Age [× 0.969 if female] [× 1.08 if black], where Scr is serum creatinine, Scys is serum cystatin C, κ is 0.7 for females and 0.9 for males, α is −0.248 for females and −0.207 for males, min indicates the minimum of Scr/κ or 1, and max indicates the maximum of Scr/κ or 1. Change from baseline & P values are include in attached chart.
    End point type
    Secondary
    End point timeframe
    Change from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    19
    19
    19
    19
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    Units: mL/min/1.73m^2
        median (inter-quartile range (Q1-Q3))
    92.0 (83.7 to 102.6)
    95.0 (86.2 to 102.8)
    97.9 (89.6 to 105.2)
    102.2 (97.3 to 110.7)
    111.8 (105.2 to 113.8)
    101.3 (88.6 to 107.4)
    101.7 (93.8 to 107.2)
    88.9 (82.9 to 99.5)
    91.1 (85.1 to 95.8)
    95.0 (89.6 to 103.7)
    106.5 (97.2 to 110.7)
    100.7 (89.0 to 105.4)
    109.1 (97.3 to 115.6)
    103.2 (91.4 to 113.0)
    104.1 (87.1 to 110.3)
    96.9 (90.0 to 112.3)
    111.4 (103.5 to 118.4)
    104.3 (94.6 to 114.8)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - CKD-EPI Creatinine & cystatin C.pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of eGFR - CKD-EPI with Creatinine

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    End point title
    		 Variation from baseline of eGFR - CKD-EPI with Creatinine
    End point description
    eGFR = 141 x min(SCr/κ, 1)α x max(SCr /κ, 1)-1.209 x 0.993Age x 1.018 [if female] x 1.159 [if Black] Source: https://www.kidney.org/content/ckd-epi-creatinine-equation-2009
    End point type
    Secondary
    End point timeframe
    Change from baseline at weeks 4, 12, 24, 36, 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    19
    19
    19
    19
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    20
    Units: mL/min/1.73m^2
        median (inter-quartile range (Q1-Q3))
    111.4 (100.6 to 115.3)
    108.2 (99.3 to 115.0)
    109.3 (99.2 to 115.6)
    108.8 (99.4 to 115.6)
    106.3 (97.7 to 109.4)
    107.4 (96.7 to 111.1)
    112.4 (103.6 to 120.3)
    101.4 (83.5 to 110.9)
    95.2 (83.2 to 103.9)
    103.4 (93.9 to 111.4)
    96.3 (83.5 to 106.0)
    97.9 (79.9 to 108.7)
    117.5 (110.7 to 122.5)
    108.6 (105.3 to 116.8)
    111.0 (94.7 to 118.1)
    102.9 (93.5 to 119.0)
    106.2 (93.7 to 118.9)
    106.9 (96.1 to 112.1)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - CKD-EPI Creatinine.pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of eGFR - β2-Microglobulin excretion

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    End point title
    		 Variation from baseline of eGFR - β2-Microglobulin excretion
    End point description
    β2-Microglobulin excretion in urine.
    End point type
    Secondary
    End point timeframe
    Change from baseline at weeks 4, 12, 28, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    16
    16
    11
    14
    10
    17
    10
    14
    12
    12
    13
    12
    14
    11
    13
    Units: ug/L
        median (inter-quartile range (Q1-Q3))
    101 (63 to 399)
    137 (74 to 218)
    98 (40 to 310)
    131 (40 to 302)
    105 (40 to 269)
    117 (96 to 228)
    115 (56 to 280)
    146 (84 to 255)
    114 (46 to 242)
    145 (90 to 307)
    72 (58 to 103)
    101 (50 to 139)
    105 (76 to 146)
    172 (40 to 561)
    130 (64 to 187)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - Beta-2-microglobulin excretion.pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of eGFR - alpha-1-Microglobulin excretion

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    End point title
    		 Variation from baseline of eGFR - alpha-1-Microglobulin excretion
    End point description
    Alpha-1-Microglobulin excretion in urine.
    End point type
    Secondary
    End point timeframe
    Changed from baseline at weeks 4, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    19
    19
    18
    20
    19
    20
    20
    19
    20
    19
    19
    20
    20
    Units: mg/L
        median (inter-quartile range (Q1-Q3))
    6 (2 to 13)
    7 (3 to 13)
    9 (3 to 17)
    11 (3 to 18)
    9 (4 to 17)
    5 (2 to 9)
    5 (4 to 11)
    11 (6 to 17)
    7 (5 to 17)
    9 (5 to 16)
    3 (2 to 7)
    4 (2 to 16)
    7 (3 to 19)
    6 (3 to 26)
    10 (2 to 19)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - alpha-1-microglobulin excretion.pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of eGFR - urinary microalbumin/creatinine ratio

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    End point title
    		 Variation from baseline of eGFR - urinary microalbumin/creatinine ratio
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    16
    12
    12
    13
    13
    17
    12
    17
    14
    14
    13
    11
    13
    14
    15
    Units: mg/mmol
        median (inter-quartile range (Q1-Q3))
    0.6 (0.5 to 2.2)
    0.6 (0.4 to 1.1)
    0.7 (0.4 to 2.1)
    0.6 (0.3 to 1.6)
    0.5 (0.4 to 0.6)
    0.5 (0.4 to 1.1)
    0.7 (0.5 to 1.5)
    0.9 (0.3 to 1.2)
    0.7 (0.4 to 1.2)
    0.4 (0.4 to 0.9)
    0.6 (0.5 to 1.0)
    0.6 (0.4 to 1.0)
    0.6 (0.4 to 1.0)
    0.7 (0.4 to 1.7)
    0.9 (0.4 to 1.9)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - Urinary albumin & creatinine ratio.pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of eGFR - protein/creatinine ratio

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    End point title
    		 Variation from baseline of eGFR - protein/creatinine ratio
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    17
    17
    18
    17
    15
    20
    15
    18
    18
    17
    19
    14
    17
    17
    16
    Units: mg/mmol
        median (inter-quartile range (Q1-Q3))
    9 (6 to 10)
    8 (6 to 9)
    8 (6 to 11)
    9 (7 to 12)
    8 (6 to 9)
    7 (5 to 8)
    7 (5 to 8)
    8 (6 to 9)
    7 (5 to 9)
    7 (6 to 9)
    6 (5 to 8)
    8 (6 to 9)
    9 (8 to 10)
    8 (7 to 11)
    7 (6 to 12)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - Urinary protien & creatinine ratio.pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of eGFR - Fractional phosphate excretion (fasted plasma PO4)

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    End point title
    		 Variation from baseline of eGFR - Fractional phosphate excretion (fasted plasma PO4)
    End point description
    Fractional phosphate excretion (fasted plasma phosphate and urinary spot phosphate) From the protocol: Fractional phosphate excretion (FEPi): {[PO4 (U) x Cr (S)] /[PO4 (S) x Cr (U)]} x100 http://www.scymed.com/en/smnxps/pshpb390.htm Our Lab uses phosphate in mmol/L instead of mEq/L, so if that is the case you can use for Creatinine in the serum umol/L and for Creatinine in the urine mmol/L. Serum creatinine unit in SSAT 066 database is in umol/L.
    End point type
    Secondary
    End point timeframe
    Changed from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    18
    19
    18
    20
    18
    20
    16
    19
    20
    16
    16
    19
    20
    Units: percent
        median (inter-quartile range (Q1-Q3))
    7 (6.0 to 9.5)
    9.7 (5.2 to 15.3)
    11.2 (9.3 to 13.5)
    9.3 (6.7 to 14.9)
    9.8 (7.7 to 13.3)
    8.5 (5.5 to 9.9)
    11.6 (7.1 to 14.7)
    12.0 (9.2 to 17.0)
    11.2 (7.1 to 12.9)
    9.5 (6.8 to 13.1)
    9.1 (7.3 to 14.5)
    12.0 (9.3 to 17.3)
    13.2 (7.5 to 16.2)
    10.8 (7.1 to 16.0)
    10.5 (8.6 to 17.7)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - Fractional phosphate excretion (fasted plasma PO4).pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of eGFR - Fractional phosphate excretion (urine spot phosphate)

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    End point title
    		 Variation from baseline of eGFR - Fractional phosphate excretion (urine spot phosphate)
    End point description
    Fractional phosphate excretion (fasted plasma phosphate and urinary spot phosphate) From the protocol: Fractional phosphate excretion (FEPi): {[PO4 (U) x Cr (S)] /[PO4 (S) x Cr (U)]} x100 http://www.scymed.com/en/smnxps/pshpb390.htm Our Lab uses phosphate in mmol/L instead of mEq/L, so if that is the case you can use for Creatinine in the serum umol/L and for Creatinine in the urine mmol/L. Serum creatinine unit in SSAT 066 database is in umol/L.
    End point type
    Secondary
    End point timeframe
    Changed from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    19
    19
    18
    20
    19
    20
    20
    19
    20
    19
    19
    20
    20
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    17.9 (7.9 to 22.7)
    15.4 (8.5 to 22.9)
    20.1 (9.4 to 27.5)
    20.9 (10.9 to 33.8)
    17.3 (9.6 to 27.7)
    16.4 (8.7 to 19.2)
    15.9 (7.7 to 25.6)
    19.5 (11.4 to 34.8)
    16.9 (8.0 to 25.9)
    11.8 (6.7 to 19.4)
    13.2 (9.0 to 29.0)
    18.8 (9.6 to 22.0)
    19.6 (5.8 to 27.3)
    19.6 (7.1 to 28.5)
    17.5 (6.5 to 22.4)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - Fractional phosphate excretion (urinary spot phosphate).pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of eGFR - Plasma urate

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    End point title
    		 Variation from baseline of eGFR - Plasma urate
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline at week 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    18
    19
    18
    18
    19
    20
    19
    19
    19
    19
    20
    20
    19
    18
    18
    20
    Units: µmol/L
        median (inter-quartile range (Q1-Q3))
    366 (296 to 438)
    371 (326 to 413)
    365 (330 to 416)
    342 (320 to 379)
    389 (284 to 413)
    367 (324 to 412)
    354 (344 to 387)
    376 (345 to 407)
    378 (358 to 430)
    366 (348 to 379)
    360 (297 to 393)
    357 (297 to 390)
    308 (294 to 390)
    324 (288 to 367)
    311 (275 to 347)
    315 (277 to 358)
    320 (267 to 367)
    329 (264 to 391)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - Plasma Urate.pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of eGFR - glycosuria

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    End point title
    		 Variation from baseline of eGFR - glycosuria
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    19
    19
    18
    20
    19
    20
    20
    19
    20
    19
    19
    20
    20
    Units: mmol/FL
        median (inter-quartile range (Q1-Q3))
    0.4 (0.2 to 0.5)
    0.3 (0.2 to 0.4)
    0.3 (0.2 to 0.4)
    0.4 (0.1 to 0.5)
    0.4 (0.2 to 0.4)
    0.3 (0.2 to 0.4)
    0.3 (0.2 to 0.5)
    0.4 (0.3 to 0.5)
    0.3 (0.2 to 0.5)
    0.3 (0.1 to 0.4)
    0.3 (0.2 to 0.4)
    0.3 (0.1 to 0.3)
    0.3 (0.1 to 0.4)
    0.4 (0.1 to 0.5)
    0.3 (0.1 to 0.4)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - Urine Glucose.pdf)
    No statistical analyses for this end point

    Secondary: Proportion of patients achieving virologic response

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    End point title
    		 Proportion of patients achieving virologic response
    End point description
    Virologic response was measured as HIV RNA < 40 cp/mL. All patients had >40cp/ml at baesline (inclusion criteria)
    End point type
    Secondary
    End point timeframe
    The proportion of patients achieving virologic response at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    18
    18
    19
    18
    18
    20
    20
    20
    19
    18
    19
    20
    20
    20
    18
    17
    20
    Units: Patients
    0
    11
    17
    19
    16
    17
    0
    15
    19
    18
    17
    17
    0
    15
    20
    16
    14
    17
    Attachments
    		 Untitled (Filename: SSAT 066 Proportion of patients HIV less than 40cp per mL.pdf)
    No statistical analyses for this end point

    Secondary: Variation in immunologic markers - CD4+

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    End point title
    		 Variation in immunologic markers - CD4+
    End point description
    End point type
    Secondary
    End point timeframe
    Changes in immunological markers at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    18
    19
    19
    18
    18
    20
    20
    20
    19
    20
    18
    19
    20
    20
    20
    19
    20
    Units: cells/μL
        median (inter-quartile range (Q1-Q3))
    450 (412 to 541)
    559 (448 to 676)
    587 (450 to 742)
    604 (479 to 859)
    611 (499 to 725)
    614 (473 to 833)
    488 (353 to 622)
    554 (471 to 617)
    607 (561 to 809)
    648 (578 to 799)
    600 (489 to 847)
    629 (566 to 761)
    548 (444 to 800)
    671 (455 to 776)
    682 (452 to 887)
    652 (512 to 861)
    688 (542 to 978)
    664 (511 to 960)
    Attachments
    		 Untitled (Filename: SSAT 066 immological markers - CD4.pdf)
    No statistical analyses for this end point

    Secondary: Variation in immunologic markers - CD8+

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    End point title
    		 Variation in immunologic markers - CD8+
    End point description
    End point type
    Secondary
    End point timeframe
    Changes in immunologic markers at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    18
    19
    19
    18
    18
    20
    20
    20
    19
    20
    18
    19
    20
    20
    20
    19
    20
    Units: cells/μL
        median (inter-quartile range (Q1-Q3))
    900 (730 to 1144)
    888 (668 to 1091)
    818 (675 to 981)
    842 (695 to 946)
    747 (669 to 838)
    734 (556 to 840)
    1187 (907 to 1456)
    998 (749 to 1269)
    1157 (968 to 1522)
    1151 (849 to 1402)
    977 (678 to 1303)
    911 (717 to 1125)
    996 (584 to 1184)
    794 (596 to 1055)
    747 (600 to 994)
    635 (497 to 910)
    694 (491 to 1010)
    744 (492 to 861)
    Attachments
    		 Untitled (Filename: SSAT 066 immological markers - CD8.pdf)
    No statistical analyses for this end point

    Secondary: Variation in immunologic markers - CD4:CD8 Ratio

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    End point title
    		 Variation in immunologic markers - CD4:CD8 Ratio
    End point description
    A normal CD4/CD8 ratio is 2.0, with CD4 lymphocytes equal to or greater than 400/mm3 and CD8 lymphocytes equal to 200 to 800/mm3.
    End point type
    Secondary
    End point timeframe
    Changes at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    18
    19
    19
    18
    18
    20
    20
    20
    19
    20
    18
    19
    20
    20
    20
    19
    20
    Units: CD4:CD8 ratio
        median (inter-quartile range (Q1-Q3))
    0.5 (0.4 to 0.7)
    0.7 (0.5 to 0.7)
    0.7 (0.5 to 1.0)
    0.7 (0.6 to 1.0)
    0.8 (0.7 to 1.2)
    0.9 (0.8 to 1.1)
    0.5 (0.3 to 0.6)
    0.6 (0.4 to 0.7)
    0.6 (0.4 to 0.8)
    0.6 (0.5 to 0.9)
    0.7 (0.5 to 0.9)
    0.7 (0.5 to 0.9)
    0.7 (0.4 to 1.0)
    0.9 (0.6 to 1.1)
    0.9 (0.7 to 1.1)
    0.9 (0.7 to 1.2)
    0.9 (0.7 to 1.5)
    1.1 (0.8 to 1.3)
    Attachments
    		 Untitled (Filename: SSAT 066 immological markers - CD4-CD8 Ratio.pdf)
    No statistical analyses for this end point

    Secondary: Variation in inflammatory markers - hsCRP

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    End point title
    		 Variation in inflammatory markers - hsCRP
    End point description
    End point type
    Secondary
    End point timeframe
    At weeks 4, 12 ,24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    19
    19
    18
    20
    20
    20
    20
    19
    20
    20
    20
    20
    20
    Units: mg/L
        median (inter-quartile range (Q1-Q3))
    1.2 (0.8 to 1.2)
    1.4 (0.8 to 2.8)
    1.0 (0.7 to 2.4)
    0.9 (0.6 to 3.1)
    0.9 (0.6 to 1.4)
    1.2 (0.8 to 2.1)
    0.9 (0.6 to 1.6)
    1.9 (1.1 to 3.6)
    1.5 (0.9 to 3.2)
    1.2 (0.8 to 2.6)
    1.2 (0.7 to 2.9)
    1.5 (0.7 to 3.2)
    1.9 (0.6 to 3.6)
    1.7 (0.7 to 3.9)
    1.4 (0.7 to 2.0)
    Attachments
    		 Untitled (Filename: SSAT 066 Inflammatory markers - hsCRP.pdf)
    No statistical analyses for this end point

    Secondary: Variation in inflammatory markers - IL-6

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    End point title
    		 Variation in inflammatory markers - IL-6
    End point description
    End point type
    Secondary
    End point timeframe
    Change at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    19
    19
    18
    20
    20
    19
    20
    19
    20
    20
    20
    20
    20
    Units: pg/mL
        median (inter-quartile range (Q1-Q3))
    2.6 (1.5 to 3.5)
    3.1 (1.8 to 3.7)
    2.6 (1.5 to 3.6)
    2.5 (1.7 to 5.5)
    1.5 (1.5 to 1.9)
    2.0 (1.5 to 2.8)
    2.1 (1.5 to 3.4)
    2.3 (1.5 to 3.4)
    2.5 (1.5 to 2.9)
    1.5 (1.5 to 2.8)
    1.9 (1.5 to 2.6)
    2.9 (1.6 to 4.7)
    1.8 (1.5 to 3.7)
    1.5 (1.5 to 4.0)
    1.5 (1.5 to 2.7)
    Attachments
    		 Untitled (Filename: SSAT 066 Inflammatory markers - IL-6.pdf)
    No statistical analyses for this end point

    Secondary: Variation in inflammatory markers - d-dimer

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    End point title
    		 Variation in inflammatory markers - d-dimer
    End point description
    End point type
    Secondary
    End point timeframe
    Change at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    19
    19
    18
    20
    20
    20
    20
    19
    20
    20
    20
    20
    20
    Units: ng/mL
        median (inter-quartile range (Q1-Q3))
    215 (190 to 370)
    190 (190 to 330)
    190 (190 to 330)
    190 (190 to 250)
    190 (190 to 230)
    190 (190 to 325)
    190 (190 to 215)
    210 (190 to 290)
    205 (190 to 255)
    205 (190 to 2550)
    200 (190 to 310)
    190 (190 to 190)
    190 (190 to 200)
    190 (190 to 210)
    190 (190 to 205)
    Attachments
    		 Untitled (Filename: SSAT 066 Inflammatory markers - d-dimer.pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of metabolic markers - Lipids (Total Cholesterol)

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    End point title
    		 Variation from baseline of metabolic markers - Lipids (Total Cholesterol)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    17
    18
    18
    18
    19
    20
    20
    18
    20
    19
    20
    20
    17
    18
    19
    19
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    4.7 (3.8 to 5.5)
    4.2 (3.6 to 5.5)
    4.5 (3.6 to 5.3)
    4.0 (3.7 to 5.0)
    4.4 (3.3 to 4.8)
    4.6 (3.9 to 5.2)
    4.3 (3.6 to 5.1)
    4.1 (3.6 to 5.0)
    4.1 (3.5 to 4.8)
    4.4 (3.3 to 4.9)
    4.1 (3.7 to 4.8)
    4.3 (3.8 to 4.9)
    4.1 (3.9 to 5.1)
    4.2 (3.8 to 5.3)
    4.3 (4.1 to 5.0)
    4.5 (4.3 to 5.6)
    4.3 (3.8 to 5.2)
    4.4 (3.9 to 4.8)
    Attachments
    		 Untitled (Filename: SSAT 066 metabolic markers - Lipids (Total Cholesterol).pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of metabolic markers - Lipids (LDL)

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    End point title
    		 Variation from baseline of metabolic markers - Lipids (LDL)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    17
    18
    18
    18
    19
    19
    20
    18
    20
    19
    20
    20
    17
    17
    18
    19
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    2.9 (2.2 to 3.5)
    2.7 (2.3 to 3.9)
    2.6 (2.4 to 3.6)
    2.5 (2.3 to 3.3)
    2.9 (2.2 to 3.1)
    2.9 (2.4 to 3.5)
    2.7 (2.2 to 3.1)
    2.5 (2.0 to 3.3)
    2.5 (2.0 to 3.2)
    2.7 (2.0 to 3.2)
    2.5 (2.1 to 3.0)
    2.7 (2.2 to 3.1)
    2.7 (2.2 to 3.3)
    2.7 (2.1 to 3.3)
    2.8 (2.5 to 3.5)
    3.1 (2.6 to 3.8)
    2.6 (2.3 to 3.4)
    2.7 (2.2 to 3.0)
    Attachments
    		 Untitled (Filename: SSAT 066 metabolic markers - Lipids (LDL).pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of metabolic markers - Lipids (HDL)

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    End point title
    		 Variation from baseline of metabolic markers - Lipids (HDL)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    17
    18
    18
    18
    19
    20
    20
    18
    20
    19
    20
    20
    17
    18
    19
    19
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    1.2 (0.9 to 1.5)
    1.0 (0.9 to 1.3)
    1.0 (1.0 to 1.2)
    1.2 (1.0 to 1.3)
    1.1 (0.9 to 1.3)
    1.3 (1.1 to 1.5)
    1.1 (0.8 to 1.3)
    1.0 (0.9 to 1.2)
    1.0 (0.9 to 1.2)
    1.0 (0.8 to 1.3)
    1.1 (1.0 to 1.4)
    1.1 (0.9 to 1.4)
    1.1 (0.9 to 1.3)
    1.1 (0.9 to 1.3)
    1.1 (0.9 to 1.2)
    1.2 (1.0 to 1.4)
    1.1 (1.0 to 1.4)
    1.3 (1.1 to 1.7)
    Attachments
    		 Untitled (Filename: SSAT 066 metabolic markers - Lipids (HDL).pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of metabolic markers - Lipids (Triglycerides)

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    End point title
    		 Variation from baseline of metabolic markers - Lipids (Triglycerides)
    End point description
    End point type
    Secondary
    End point timeframe
    Change from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 36 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 36 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 36 Str Arm Week 48 Str Arm
    Number of subjects analysed
    20
    19
    17
    18
    18
    18
    19
    20
    20
    18
    20
    19
    20
    20
    17
    18
    19
    19
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    1.0 (0.8 to 1.5)
    0.8 (0.6 to 1.3)
    0.8 (0.6 to 1.1)
    0.8 (0.7 to 1.4)
    0.9 (0.6 to 1.1)
    0.8 (0.6 to 1.3)
    1.0 (0.8 to 1.5)
    0.9 (0.7 to 1.4)
    0.8 (0.7 to 1.3)
    1.1 (0.9 to 1.2)
    0.9 (0.7 to 1.4)
    1.2 (0.8 to 1.6)
    0.9 (0.7 to 1.4)
    1.2 (0.8 to 1.4)
    0.9 (0.8 to 1.2)
    1.1 (0.9 to 1.7)
    1.1 (0.8 to 1.7)
    0.8 (0.7 to 1.4)
    Attachments
    		 Untitled (Filename: SSAT 066 metabolic markers - Lipids (Triglycerides).pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of metabolic markers - Insulin

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    End point title
    		 Variation from baseline of metabolic markers - Insulin
    End point description
    Fasting Insulin Resistance Index (FIRI = fasting glucose × fasting insulin/25) - Duncan MH, Singh BM, Wise PH, Carter G, Alaghband-Zadeh J: A simple measure of insulin resistance. Lancet. 1995, 346: 120-121.
    End point type
    Secondary
    End point timeframe
    Change from baseline at week 24.
    End point values
    		 Baseline RTG Arm Week 24 RTG Arm Baseline DTG Arm Week 24 DTG Arm Baseline Str Arm Week 24 Str Arm
    Number of subjects analysed
    18
    18
    17
    19
    18
    19
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    1.5 (0.9 to 3.1)
    1.5 (0.9 to 2.0)
    1.1 (0.9 to 1.4)
    1.3 (1.1 to 2.2)
    0.9 (0.6 to 1.2)
    1.1 (0.7 to 1.4)
    Attachments
    		 Untitled (Filename: SSAT 066 Metabolic markers - Insulin.pdf)
    No statistical analyses for this end point

    Secondary: Variation from baseline of metabolic markers - Homeostatic Model Assessment (HOMA i)

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    End point title
    		 Variation from baseline of metabolic markers - Homeostatic Model Assessment (HOMA i)
    End point description
    Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. HOMA index: (fasting glucose in mmol/L x fasting insulin in mU/L) / 22.5
    End point type
    Secondary
    End point timeframe
    Change from baseline at week 24.
    End point values
    		 Baseline RTG Arm Week 24 RTG Arm Baseline DTG Arm Week 24 DTG Arm Baseline Str Arm Week 24 Str Arm
    Number of subjects analysed
    19
    18
    19
    20
    19
    19
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    1.6 (1.0 to 4.2)
    1.6 (1.0 to 2.2)
    1.2 (1.0 to 2.4)
    1.4 (1.0 to 2.3)
    1.0 (0.7 to 1.7)
    1.2 (0.7 to 1.6)
    Attachments
    		 Untitled (Filename: SSAT 066 metabolic markers - HOMA.pdf)
    No statistical analyses for this end point

    Other pre-specified: Variation from baseline of eGFR - Urinary cystatin-C/creatinine ratio

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    End point title
    		 Variation from baseline of eGFR - Urinary cystatin-C/creatinine ratio
    End point description
    End point type
    Other pre-specified
    End point timeframe
    Changed from baseline at weeks 4, 12, 24, 36 & 48.
    End point values
    		 Baseline RTG Arm Week 4 RTG Arm Week 12 RTG Arm Week 24 RTG Arm Week 48 RTG Arm Baseline DTG Arm Week 4 DTG Arm Week 12 DTG Arm Week 24 DTG Arm Week 48 DTG Arm Baseline Str Arm Week 4 Str Arm Week 12 Str Arm Week 24 Str Arm Week 48 Str Arm
    Number of subjects analysed
    19
    19
    19
    19
    18
    19
    19
    20
    20
    19
    20
    19
    19
    20
    20
    Units: ug/mmol
        median (inter-quartile range (Q1-Q3))
    4.9 (4.3 to 6.6)
    5.6 (4.4 to 6.5)
    5.4 (4.4 to 6.7)
    5.3 (4.0 to 6.3)
    5.0 (3.9 to 6.3)
    5.3 (4.5 to 7.1)
    5.0 (4.1 to 5.8)
    5.0 (4.0 to 9.9)
    5.2 (4.9 to 5.6)
    5.1 (3.5 to 5.8)
    5.8 (4.0 to 6.8)
    5.3 (4.5 to 6.9)
    5.3 (4.4 to 6.6)
    5.1 (4.0 to 6.6)
    6.0 (4.8 to 7.1)
    Attachments
    		 Untitled (Filename: SSAT 066 eGFR - Urinary cystatin-C & creatinine ratio.pdf)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening to Week 48
    Adverse event reporting additional description
    Subjects questionned at each study visit for AEs. AEs then graded by the ACTG adverse events scale before adding to CRF.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 ACTG Adverse Events
    Dictionary version
    Dec 2004
    Reporting groups
    Reporting group title
    Raltegravir + Truvada
    Reporting group description
    		 Truvada® (200mg/245mg film coated tablets) one tablet once daily + Raltegravir 400mg (one tablet) twice daily

    Reporting group title
    Dolutegravir + Truvada
    Reporting group description
    		 Truvada® + Tivicay® (Dolutegravir) 50mg OD

    Reporting group title
    Stribild
    Reporting group description
    		 Stribild®(150mg Elvitegravir, 150mg Cobicistat, 200mg TenofovirDF, 245mg Emtricitabine) film coated tablet, once daily.

    Serious adverse events
    		 Raltegravir + Truvada Dolutegravir + Truvada Stribild
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Gastrointestinal disorders
    Diarrhoea + Vomitting
    Additional description: Hospitalisation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    diarrhoea + abdominal pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Hepatitis C
    Additional description: Acute Hepatitis C infection
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Raltegravir + Truvada Dolutegravir + Truvada Stribild
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    20 / 20 (100.00%)
    20 / 20 (100.00%)
    20 / 20 (100.00%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Cyst (eyelid)
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Cyst (testicular)
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Kidney cyst
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Dizziness
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    1
    Surgical and medical procedures
    Laparotomy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    Haemorrhoid operation
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Biopsy skin
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Duodenal removal
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Wrist surgery
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    General disorders and administration site conditions
    Cold and cough
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Hair loss
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Nasal congestion and headache
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Nose injury (BMX accident)
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Pain in R Groin
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    0
    0
    Sore throat + cough
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Reproductive system and breast disorders
    Abdominal pain period related
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Penile discharge
    Additional description: Gonorrhea related
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Erectile dysfunction
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Bronchitis
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Cough
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    1
    Nasal congestion
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    1
    2
    decreased libido
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    1
    Vivid dreams
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    2
    3
    low mood
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    low mood/depression
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    low mood/anxiety
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Nightmares
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    1
    depression
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Panic attack
         subjects affected / exposed
    0 / 20 (0.00%)
    3 / 20 (15.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    3
    0
    Stress
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Nervous system disorders
    Tiredness
    Additional description: inc drowziness
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    1
    2
    Fatigue
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    1
    1
    Fine tremour in head
    Additional description: (possibly due to anxiety)
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Headache
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    6 / 20 (30.00%)
         occurrences all number
    1
    1
    6
    Insomnia
         subjects affected / exposed
    0 / 20 (0.00%)
    5 / 20 (25.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    5
    2
    Migraine
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Reduced concentration
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    2
    Sleep disturbance
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    3 / 20 (15.00%)
         occurrences all number
    1
    2
    3
    Ear and labyrinth disorders
    Dx of degenerative hearing disease bilateral (L>R)
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Episodes of sinusitits
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    External otitis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Hayfever (Sinusitits)
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    2
    Worsening of tinnitus
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Eye disorders
    Uveitis
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Gastrointestinal disorders
    Lymphogranuloma venereum (not confirmed)
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Abdominal Cramps
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Abdominal discomfort & flatulance
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Gastroenteritis
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    2
    0
    Anal Fissures
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Anal Tenderness
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Bleeding Gums
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Bloating
         subjects affected / exposed
    2 / 20 (10.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    2
    0
    Bloating & Burping
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Diarrhoea
         subjects affected / exposed
    2 / 20 (10.00%)
    5 / 20 (25.00%)
    3 / 20 (15.00%)
         occurrences all number
    2
    5
    3
    Dyspepsia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Flatulence
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Gastritis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Haemorrhoids
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    2
    0
    Heartburn
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    Internal haemorrhoids
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Laryngitis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Loose Stools
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    2
    2
    Nausea
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    1
    Nausea & vommiting
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    0
    1
    Rectal bleeding
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Rectal pain & Bleeding (LGV)
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Rectal Tear
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Sore Throat
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    2
    1
    Tooth broken
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Toothache
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    1
    3
    Viral Gastroenteritis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    1
    Vomitting and diarrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    20
    0
    Epigastric pain and dyspepsia
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Skin and subcutaneous tissue disorders
    Dandruff
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Dry skin
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Rash
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    1
    1
    irritated scalp
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Perianal ulverative lesions
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Pityriasis versicolor
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Karposis Sarcome lesion
    Additional description: right arm
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Blister
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Cellulitis
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    0
    Seborrhoeic dermatitis
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    2
    0
    Swelling face
    Additional description: Upper eye lid
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Renal and urinary disorders
    Urinary retention
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Musculoskeletal and connective tissue disorders
    Aching joint
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Back pain
         subjects affected / exposed
    1 / 20 (5.00%)
    2 / 20 (10.00%)
    2 / 20 (10.00%)
         occurrences all number
    1
    2
    2
    bilateral foot pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    C2-C4 arthopathy
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    joint pain left hand
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    minor right shoulder trauma
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Neck pain
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Right flank pain unspecified
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Fracture
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Infections and infestations
    Adenovirus infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Camphylobacter Gastroenteritis
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Athletes foot
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    chest infection
         subjects affected / exposed
    3 / 20 (15.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    3
    0
    0
    Chlamydial infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    3 / 20 (15.00%)
         occurrences all number
    0
    0
    3
    Cold
         subjects affected / exposed
    4 / 20 (20.00%)
    6 / 20 (30.00%)
    5 / 20 (25.00%)
         occurrences all number
    4
    6
    5
    Cold upper respiratory tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    cold with flu-like symptoms
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Ear infection
         subjects affected / exposed
    0 / 20 (0.00%)
    2 / 20 (10.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    2
    1
    fever
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Gonorrhoea
         subjects affected / exposed
    1 / 20 (5.00%)
    3 / 20 (15.00%)
    3 / 20 (15.00%)
         occurrences all number
    1
    3
    3
    Influenza
    Additional description: 'flu like syndrome'
         subjects affected / exposed
    3 / 20 (15.00%)
    3 / 20 (15.00%)
    6 / 20 (30.00%)
         occurrences all number
    3
    3
    6
    Gonorrhoea (throat)
         subjects affected / exposed
    2 / 20 (10.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    2
    0
    0
    HSV2 infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Kaposi's sarcoma
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    lower respiratory tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    1
    2
    rectal ghonorrhea
         subjects affected / exposed
    1 / 20 (5.00%)
    0 / 20 (0.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    0
    0
    Primary Herpetic Infect
         subjects affected / exposed
    1 / 20 (5.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    1
    1
    0
    right foot skin bacterial infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Shingles
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Skin infection
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Stomach infection
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    1 / 20 (5.00%)
         occurrences all number
    0
    0
    1
    Syphilis
         subjects affected / exposed
    1 / 20 (5.00%)
    5 / 20 (25.00%)
    1 / 20 (5.00%)
         occurrences all number
    1
    5
    1
    Tinea Pedis
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Tinea unguium
         subjects affected / exposed
    0 / 20 (0.00%)
    1 / 20 (5.00%)
    0 / 20 (0.00%)
         occurrences all number
    0
    1
    0
    Metabolism and nutrition disorders
    Vitamin D deficiency
         subjects affected / exposed
    0 / 20 (0.00%)
    0 / 20 (0.00%)
    2 / 20 (10.00%)
         occurrences all number
    0
    0
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    27 Jan 2015
    Clarification to acceptable birth control methods - requirement for initial study approval
    14 Apr 2015
    Corrections to exclusion criteria
    11 Feb 2016
    Addition of a PK analysis timepoint to samples already collected for a the study

    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.

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