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    Clinical Trial Results:
    A multicentre, prospective, single arm, open-label 96 week observational trial of the tolerability, adherence and efficacy of a dolutegravir/abacavir/lamivudine single tablet regimen in HIV-1 antibody positive people living with HIV with a history of injection drug use switching from existing ART or starting treatment after discontinuation of ART

    Summary
    EudraCT number
    		 2016-000087-42
    Trial protocol
    		 IE   ES  
    Global end of trial date
    06 Sep 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 May 2025
    First version publication date
    22 May 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    TAISTR 16
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02659761
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University College Dublin
    Sponsor organisation address
    Belfield, Dublin, Ireland, Dublin 4
    Public contact
    Centre for Experimental Pathogen Host Research , University College Dublin, cephr@ucd.ie
    Scientific contact
    Centre for Experimental Pathogen Host Research , University College Dublin, cephr@ucd.ie
    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
    11 Dec 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Sep 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Sep 2021
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess the tolerability, adherence and efficacy of single tablet dolutegravir/abacavir/lamivudine antiretroviral therapy in people living with HIV with a history of injection drug use (current/recent IDU) switching from existing ART or starting treatment after discontinuation of ART
    Protection of trial subjects
    This trial was conducted in accordance with International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) regulations/guidelines. All subjects provided written informed consent before undergoing any trial related procedures. The trial was reviewed and approved by the Competent Authorities and the local Research Ethics Committees (REC). An independent Data and Safety Monitoring Board (DSMB) was established to monitor all aspects of the trial. The DSMB consideres findings from any other relevant studies and reviews trial data on recruitment, safety, and adherence to trial strategies and efficacy in strict confidence approximately every 6 months. Subjects attended a total of 11 clinic visits over 96 weeks of the study. All visits included medical/clinical review including assessments of safety and records of adverse events. For women of childbearing potential, pregnancy tests were performed at the screening visit (urinary βHCG lateral flow) and subsequently during the study visits. If a subject was found to be pregnant, they were discontinued from the study and the outcome of the pregnancy test recorded in the study CRF. Female subjects were instructed to notify the investigator if they became pregnant at any time during the study, or if they became pregnant within 30 days of last study drug dose. Subjects who became pregnant or who suspected that they were pregnant during the study had to report the information to the investigator and discontinue study drug immediately. The investigator would counsel all patients on the protocol-specified methods for avoiding pregnancy during the study. All men subjects were educated in using a barrier contraception method in order to reduce the risk of viral transmission to their partners.
    Background therapy
    		 At enrolment subjects are allocated to receive a once-daily, fixed-dose combination (FDC) single-tablet regimen (STR) containing the integrase strand transfer inhibitor (INSTI) dolutegravir (DTG) 50 mg with the nucleoside reverse transcriptase inhibitors (NRTIs) abacavir sulfate (abacavir, ABC) 600 mg and lamivudine (3TC) 300 mg.
    Evidence for comparator
    		 N/A
    Actual start date of recruitment
    01 Mar 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ireland: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    33
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment started in Ireland in March 2016. Of 45 recruited, 8 were screen failure, 4 were lost after screening and 33 subjects contributed to the analyses (ITT population). The first participant was recruited on 27/02/2017 and the last on 01/03/2019.

    Pre-assignment
    Screening details
    		 Study population will comprised HIV-1 positive, adult, people living with HIV (PLWH) with a history of injecting drug use (IDU) who were either ART-naïve or switched from existing ART or started treatment after discontinuation of ART. (IDU as HIV acquisition risk or current or recent (past 12 months) history of IDU)

    Period 1
    Period 1 title
    Final Analysis (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    N/A

    Arms
    Arm title
    		 Treatment arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    ABC/3TC/DTG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    The study treatments consist of Triumeq- a film-coated once-daily fixed-dose combination (FDC) single-tablet regimen (STR) that contains 50 mg of the integrase inhibitor (INI) dolutegravir (DTG), 600 mg of the nucleoside reverse transcriptase inhibitor (NRTIs) abacavir sulfate (abacavir, ABC) and 300 mg of the NRTI lamivudine (3TC). The recommended dose of Triumeq is one tablet (600 mg abacavir, 50 mg dolutegravir and 300 mg lamivudine), taken orally, once daily. Directions for dosage timing, food requirements and special precautions will be provided by clinic doctor or pharmacist as part of routine care to ensure the appropriate intake of the IMP.

    Number of subjects in period 1
    		Treatment arm
    Started
    33
    Completed
    24
    Not completed
    9
         Adverse event, serious fatal
    1
         Consent withdrawn by subject
    2
         Unknown
    1
         Lost to follow-up
    5

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Final Analysis (overall period)
    Reporting group description
    		 -

    Reporting group values
    		 Final Analysis (overall period) Total
    Number of subjects
    		 33 33
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 33 33
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 43 (40 to 47) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9
        Male
    		 24 24
    Ethnicity
    Units: Subjects
        Caucasian
    		 33 33
    HIV transmission risk group
    Units: Subjects
        Injecting drug use
    		 21 21
        Heterosexual contact
    		 6 6
        Needle stick injury
    		 2 2
        Victim of sexul assualt
    		 2 2
        Unknown
    		 2 2
    Employment status
    Units: Subjects
        Unemployed
    		 21 21
        Employed
    		 2 2
        Unknown
    		 3 3
        Missing
    		 7 7
    Highest educational grade achieved
    Units: Subjects
        Primary
    		 9 9
        Secondary
    		 23 23
        Missing
    		 1 1
    Housing status
    Units: Subjects
        Stable accommodation
    		 22 22
        Temporary accommodation
    		 8 8
        Homeless
    		 3 3
    Smoking status
    Units: Subjects
        Current Smoker
    		 28 28
        Non-smoker
    		 3 3
        Missing
    		 2 2
    ART status
    Units: Subjects
        ART-experienced
    		 31 31
        ART-naive
    		 2 2
    PI-based ART
    Units: Subjects
        Yes
    		 30 30
        No
    		 3 3
    Undetectable HIV RNA copies/ml
    Units: Subjects
        >200 cps/ml
    		 12 12
        <200 cps/ml
    		 20 20
        Missing
    		 1 1
    Baseline CD4+ T-cells
    Units: cells/mm^3
        median (inter-quartile range (Q1-Q3))
    		 541.5 (377.0 to 774.0) -
    Baseline CD8+ T-cells
    Units: cells/mm^3
        median (inter-quartile range (Q1-Q3))
    		 916.0 (606.0 to 1049.0) -
    Baseline BMI
    Units: kg/m^2
        median (inter-quartile range (Q1-Q3))
    		 21.3 (18.6 to 24.1) -
    Length of HIV diagnosis
    Units: years
        median (inter-quartile range (Q1-Q3))
    		 10.0 (4.0 to 13.0) -

    End points

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    End points reporting groups
    Reporting group title
    Treatment arm
    Reporting group description
    		 -

    Subject analysis set title
    Treatment arm
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Enrolled subjects

    Primary: Efficacy - Percentage of subjects with HIV-VL <=40 copies/mL at week 48

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    End point title
    		 Efficacy - Percentage of subjects with HIV-VL <=40 copies/mL at week 48
    End point description
    For the analysis of efficacy, virological suppression was defined as HIV-RNA <40 copies/mL. The percentage of subjects with virological suppression at each visit was summarised using descriptive statistics (n and %).
    End point type
    Primary
    End point timeframe
    From baseline to week 48
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    20 [1]
    20
    Units: subjects
        <=40 copies/ml
    15
    15
        >40 copies/ml
    5
    5
    Notes
    [1] - Of 33 subjects, 20 had follow up data on this endpoint
    Statistical analysis title
    		 Percentage of subjects with HIV-VL <=40 copies/mL
    Statistical analysis description
    Percentage is based on subject with measurements at each visit. Confidence interval are based on Clopper-Pearson
    Comparison groups
    Treatment arm v Treatment arm
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Proportion
    Point estimate
    75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 50.9
         upper limit
    		 91.3

    Primary: Tolerability - Self Reported adverse effects over 96 weeks

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    End point title
    		 Tolerability - Self Reported adverse effects over 96 weeks [2]
    End point description
    Tolerability through self-reported adverse effects and directed symptom questionnaire. Proportions will be used to quantify the occurrence of self-reported adverse effects.
    End point type
    Primary
    End point timeframe
    From baseline to week 96
    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: Descriptive analysis only was planned for this endpoint
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    33 [3]
    33 [4]
    Units: number of subjects
    27
    27
    Notes
    [3] - Of 33 enrolled subjects, 27 had available data on this endpoint
    [4] - Of 33 enrolled subjects, 27 had available data on this endpoint
    No statistical analyses for this end point

    Primary: Adherence - Percentage of subject with unscheduled ART interruptions over 96 weeks

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    End point title
    		 Adherence - Percentage of subject with unscheduled ART interruptions over 96 weeks [5]
    End point description
    Percentage of subject with unscheduled ART discontinuations/interruptions over 96 weeks. The percentage of subjects is summarised using descriptive statistics (n and %).
    End point type
    Primary
    End point timeframe
    From baseline to week 96
    Notes
    [5] - 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: Descriptive analysis only was planned for this endpoint
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    33 [6]
    33 [7]
    Units: subjects
    20
    20
    Notes
    [6] - Of 33 enrolled subjects, 20 had data on this endpoint
    [7] - Of 33 enrolled subjects, 20 had data on this endpoint
    No statistical analyses for this end point

    Primary: Adherence - Change of Medication possession ratio (MPR) at 48 weeks

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    End point title
    		 Adherence - Change of Medication possession ratio (MPR) at 48 weeks
    End point description
    MPR is a widely used measure of adherence based on pharmacy accounts, and it measures the proportion of days since ART initiation that a patient is in possession of medications. MPR at each visit was calculated as the total treatment days of supply(prescription fills) divided by the days of follow-up from baseline (treatment started) MPR ≥0.8 considered adequate adherence.
    End point type
    Primary
    End point timeframe
    From baseline to week 48
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    22 [8]
    22 [9]
    Units: ratio
        arithmetic mean (standard deviation)
    0.84 ( 0.246 )
    0.84 ( 0.246 )
    Notes
    [8] - Of 33 subjects, 22 had follow up data on this endpoint
    [9] - Of 33 subjects, 22 had follow up data on this endpoint
    Statistical analysis title
    		 Change in MPR at week 48
    Comparison groups
    Treatment arm v Treatment arm
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.93
    Variability estimate
    Standard deviation
    Dispersion value
    0.246
    Notes
    [10] - MPR was calculated at each study visit as mean and standard deviation (SD). Confidence interval are based on one sample t-test formula

    Secondary: Percentage of subjects with HIV-VL <=40 copies/mL at week 96

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    End point title
    		 Percentage of subjects with HIV-VL <=40 copies/mL at week 96
    End point description
    For the analysis of efficacy, virological suppression was defined as HIV-RNA <40 copies/mL. The percentage of subjects with virological suppression at each visit was summarised using descriptive statistics (n and %).
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    22 [11]
    22 [12]
    Units: subjects
        <=40 copies/ml
    18
    18
        >40 copies/ml
    4
    4
    Notes
    [11] - Of 33 enrolled subjects, 22 had data on this endpoint
    [12] - Of 33 enrolled subjects, 22 had data on this endpoint
    Statistical analysis title
    		 Percentage of subjects with HIV-VL <=40 copies/mL
    Statistical analysis description
    Percentage is based on subject with measurements at each visit. Confidence interval are based on Clopper-Pearson
    Comparison groups
    Treatment arm v Treatment arm
    Number of subjects included in analysis
    44
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Proportion
    Point estimate
    81.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 59.7
         upper limit
    		 94.8

    Secondary: Change of Medication possession ratio (MPR) at 96 weeks

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    End point title
    		 Change of Medication possession ratio (MPR) at 96 weeks
    End point description
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    24
    24
    Units: ratio
        arithmetic mean (standard deviation)
    0.75 ( 0.308 )
    0.75 ( 0.308 )
    Statistical analysis title
    		 Change in MPR at week 96
    Comparison groups
    Treatment arm v Treatment arm
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Mean difference (final values)
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 0.85
    Variability estimate
    Standard deviation
    Dispersion value
    0.308

    Secondary: Change in CD4+ T-cell counts over 96 weeks

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    End point title
    		 Change in CD4+ T-cell counts over 96 weeks
    End point description
    Change from baseline on CD4+ T-cell counts for the analysis of efficacy
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    19 [13]
    19 [14]
    Units: cells/mm3
        median (inter-quartile range (Q1-Q3))
    -4.0 (-148.0 to 214.0)
    -4.0 (-148.0 to 214.0)
    Notes
    [13] - Of 33 subjects enrolled, 19 had follow-up data available on this endpoint
    [14] - Of 33 subjects enrolled, 19 had follow-up data available on this endpoint
    No statistical analyses for this end point

    Secondary: Estimated number of weeks of missed ART over 96 weeks of follow-up

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    End point title
    		 Estimated number of weeks of missed ART over 96 weeks of follow-up
    End point description
    Median duration of ART interruption/discontinuation in weeks. Excludes subject who discontinued IMP completely (and switched to other ART) but remained in the study
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    28
    28
    Units: weeks
        median (inter-quartile range (Q1-Q3))
    12.3 (4.9 to 33.2)
    12.3 (4.9 to 33.2)
    No statistical analyses for this end point

    Secondary: Change in BMD LS over 96 weeks

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    End point title
    		 Change in BMD LS over 96 weeks
    End point description
    Bone mineral density (BMD) was determined by dual energy X-ray Absorptiometry (DXA). Whole body and regional DXA scan for BMD were measured at baseline and 24, 48 and 96 weeks. Change in BMD at the Lumbar spine (LS) is expressed as median (IQR)
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    16 [15]
    16 [16]
    Units: g/cm2
        median (inter-quartile range (Q1-Q3))
    0.030 (-0.001 to 0.055)
    0.030 (-0.001 to 0.055)
    Notes
    [15] - Of 33 subjects enrolled, 16 had value available on this endpoint
    [16] - Of 33 subjects enrolled, 16 had value available on this endpoint
    No statistical analyses for this end point

    Secondary: Change in BMD FN over 96 weeks

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    End point title
    		 Change in BMD FN over 96 weeks
    End point description
    Bone mineral density (BMD) was determined by dual energy X-ray Absorptiometry (DXA). Whole body and regional DXA scan for BMD were measured at baseline and 24, 48 and 96 weeks. Change in BMD at the Femoral Neck (FN) is expressed as median (IQR)
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    19
    19
    Units: g/cm2
        median (inter-quartile range (Q1-Q3))
    0.005 (-0.035 to 0.033)
    0.005 (-0.035 to 0.033)
    No statistical analyses for this end point

    Secondary: Change in BMD TH over 96 weeks

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    End point title
    		 Change in BMD TH over 96 weeks
    End point description
    Bone mineral density (BMD) was determined by dual energy X-ray Absorptiometry (DXA). Whole body and regional DXA scan for BMD were measured at baseline and 24, 48 and 96 weeks. Change in BMD at the Total Hip (TH) is expressed as median (IQR)
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    19
    19
    Units: g/cm2
        median (inter-quartile range (Q1-Q3))
    0.023 (-0.020 to 0.031)
    0.023 (-0.020 to 0.031)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Emotional well-being domain at week 48

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    End point title
    		 Change in HRQOL - Emotional well-being domain at week 48
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    Baseline to week 48
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    13
    13
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    0.0 (-12.0 to 4.0)
    0.0 (-12.0 to 4.0)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Energy/fatigue domain at week 48

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    End point title
    		 Change in HRQOL - Energy/fatigue domain at week 48
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    Baseline to week 48
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    13
    13
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    0.0 (-15.0 to 5.0)
    0.0 (-15.0 to 5.0)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - General Health domain at week 48

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    End point title
    		 Change in HRQOL - General Health domain at week 48
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    16
    16
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    -10.0 (-27.5 to -2.5)
    -10.0 (-27.5 to -2.5)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Pain domain at week 48

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    End point title
    		 Change in HRQOL - Pain domain at week 48
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    16
    16
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    -5.0 (-38.8 to 11.3)
    -5.0 (-38.8 to 11.3)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Physical functioning domain at week 48

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    End point title
    		 Change in HRQOL - Physical functioning domain at week 48
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    16
    16
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    2.5 (0.0 to 32.5)
    2.5 (0.0 to 32.5)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Role functioning/emotional domain at week 48

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    End point title
    		 Change in HRQOL - Role functioning/emotional domain at week 48
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    14
    14
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    0.0 (-33.3 to 0.0)
    0.0 (-33.3 to 0.0)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Role functioning/physical domain at week 48

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    End point title
    		 Change in HRQOL - Role functioning/physical domain at week 48
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    16
    16
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    0.0 (0.0 to 37.5)
    0.0 (0.0 to 37.5)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Social functioning domain at week 48

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    End point title
    		 Change in HRQOL - Social functioning domain at week 48
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 48
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    14
    14
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    0.0 (-25.0 to 0.0)
    0.0 (-25.0 to 0.0)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Emotional well-being Domain at week 96

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    End point title
    		 Change in HRQOL - Emotional well-being Domain at week 96
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    19
    19
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    0.0 (-12.0 to 4.0)
    0.0 (-12.0 to 4.0)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Energy/fatigue domain at week 96

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    End point title
    		 Change in HRQOL - Energy/fatigue domain at week 96
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    19
    19
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    -5.0 (-20.0 to 15.0)
    -5.0 (-20.0 to 15.0)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - General Health domain at week 96

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    End point title
    		 Change in HRQOL - General Health domain at week 96
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    21
    21
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    -5.0 (-20.0 to 5.0)
    -5.0 (-20.0 to 5.0)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Pain domain at week 96

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    End point title
    		 Change in HRQOL - Pain domain at week 96
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    21
    21
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    -7.5 (-22.5 to 10.0)
    -7.5 (-22.5 to 10.0)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Physical functioning domain at week 96

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    End point title
    		 Change in HRQOL - Physical functioning domain at week 96
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    20
    20
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    5.0 (-2.5 to 21.1)
    5.0 (-2.5 to 21.1)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Role functioning/emotional domain at week 96

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    End point title
    		 Change in HRQOL - Role functioning/emotional domain at week 96
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    18
    18
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    0.0 (-33.3 to 0.0)
    0.0 (-33.3 to 0.0)
    No statistical analyses for this end point

    Secondary: Change in HRQOL - Role functioning/physical domain at week 96

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    End point title
    		 Change in HRQOL - Role functioning/physical domain at week 96
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    21
    21
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    0.0 (0.0 to 0.0)
    0.0 (0.0 to 0.0)
    No statistical analyses for this end point

    Secondary: Chnage in HRQOL - Social Functioning domain at week 96

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    End point title
    		 Chnage in HRQOL - Social Functioning domain at week 96
    End point description
    Health Related Quality of Life (HRQOL) was estimated using the SF-36 health survey items with data collected at baseline, week 48 and week 96. Responses were summarized into common sub-domains of the measures including emotional wellbeing, energy/fatigue, general health, pain, physical functioning, role functioning/emotional, role functioning/physical and social functioning. Each subdomain was scored from 0-100, with higher scores indicating better health.
    End point type
    Secondary
    End point timeframe
    From baseline to week 96
    End point values
    		 Treatment arm Treatment arm
    Number of subjects analysed
    19
    19
    Units: score 0 to 100
        median (inter-quartile range (Q1-Q3))
    0.0 (-12.5 to 12.5)
    0.0 (-12.5 to 12.5)
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From Signing of Informed Consent through End of Study (Up to 96 weeks)
    Adverse event reporting additional description
    Data from all subjects entering the study will be included in the analysis of safety. Adverse event (AE) term recorded during the study will be mapped to a system organ class and preferred term
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21
    Reporting groups
    Reporting group title
    Safety population
    Reporting group description
    		 Data from all subjects entering the study will be included in the analysis of safety. The number of adverse events (AEs) and serious adverse events (SAEs) will be tabulated by severity and treatment received

    Serious adverse events
    		 Safety population
    Total subjects affected by serious adverse events
         subjects affected / exposed
    13 / 33 (39.39%)
         number of deaths (all causes)
    1
         number of deaths resulting from adverse events
    1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acrochordon
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Injury, poisoning and procedural complications
    Upper limb fracture
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Alcohol poisoning
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Lower limb fracture
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Multiple fractures
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Skin laceration
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Seizure
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dysphagia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastroenteritis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Dyspnoea
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Psychiatric disorders
    Intentional self-injury
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    Mental status changes
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Lower respiratory tract infection bacterial
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences causally related to treatment / all
    0 / 6
         deaths causally related to treatment / all
    0 / 0
    Groin abcess
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences causally related to treatment / all
    0 / 5
         deaths causally related to treatment / all
    0 / 0
    Appendicitis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Bacterial pyelonephritis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Pelvic inflammatory disease
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Vascular graft infection
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Otitis externa
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Safety population
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    31 / 33 (93.94%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acrochordon
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Skin papilloma
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Vascular disorders
    Deep vein thrombosis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    2
    General disorders and administration site conditions
    Pain
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3
    Fatigue
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Injury associated with device
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Vaginal haemorrhage
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea
         subjects affected / exposed
    5 / 33 (15.15%)
         occurrences all number
    5
    Cough
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Bronchial secretion retention
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Pharyngeal ulceration
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Wheezing
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    5 / 33 (15.15%)
         occurrences all number
    5
    Insomnia
         subjects affected / exposed
    5 / 33 (15.15%)
         occurrences all number
    5
    Anxiety
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3
    Mental status changes
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Acute psychosis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Intentional self-injury
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Alcoholism
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Mood swings
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Panic attack
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Investigations
    Weight increased
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3
    Alanine aminotransferase increase
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    C-reactive protein increased
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Helicobacter test positive
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Liver function test increased
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Upper limb fracture
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Alcohol poisoning
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Fall
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Head injury
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Lower limb fracture
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Multiple fractures
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Skin laceration
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Cardiac disorders
    Angina pectoris
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Nervous system disorders
    Headache
         subjects affected / exposed
    10 / 33 (30.30%)
         occurrences all number
    10
    Neuropathy peripheral
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Paraesthesia
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Dizziness
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Restless legs syndrome
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Seizure
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    2
    Seizure like phenomena
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Thrombocytopenia
         subjects affected / exposed
    10 / 33 (30.30%)
         occurrences all number
    10
    Anaemia
         subjects affected / exposed
    5 / 33 (15.15%)
         occurrences all number
    5
    Anaemia folate deficiency
         subjects affected / exposed
    4 / 33 (12.12%)
         occurrences all number
    4
    Neutropenia
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3
    Leukocytosis
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Leukopenia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Pancytopenia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    8 / 33 (24.24%)
         occurrences all number
    10
    Diarrhoea
         subjects affected / exposed
    6 / 33 (18.18%)
         occurrences all number
    6
    Abdominal pain
         subjects affected / exposed
    5 / 33 (15.15%)
         occurrences all number
    5
    Vomiting
         subjects affected / exposed
    5 / 33 (15.15%)
         occurrences all number
    5
    Constipation
         subjects affected / exposed
    4 / 33 (12.12%)
         occurrences all number
    4
    Flatulence
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Gastritis erosive
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Abdominal discomfort
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Abdominal pain lower
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Barrett's oesophagus
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Decreased appetite
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Dyspepsia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Dysphagia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Epigastric discomfort
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    2
    Gastrointestinal motility disorder
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Gastrooesophageal reflux disease
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Portal hypertensive gastropathy
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Tongue dysplasia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Hepatobiliary disorders
    Cholelithiasis obstructive
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Hepatic steatosis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Hepatitis C
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Pruritus
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Rash papular
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Dry skin
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Skin ulcer
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    5 / 33 (15.15%)
         occurrences all number
    5
    Dysuria
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Endocrine disorders
    Primary hypoparathyroidism
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Muscle spasms
         subjects affected / exposed
    3 / 33 (9.09%)
         occurrences all number
    3
    Osteopenia
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Arthralgia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Infections and infestations
    Lower respiratory track infection bacterial
         subjects affected / exposed
    8 / 33 (24.24%)
         occurrences all number
    12
    HIV viraemia
         subjects affected / exposed
    5 / 33 (15.15%)
         occurrences all number
    5
    Genital candidiasis
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Groin abscess
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    6
    Hepatitis C
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Appendicitis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Bacterial pyelonephritis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Body tinea
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Bronchitis bacterial
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Fungal skin infection
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Infective exacerbation of chronic obstructive airways disease
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Influenza
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Otitis externa
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Oesophageal candidiasis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Onychomycosis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Oral candidiasis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Otitis media
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Pelvic inflammatory disease
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Tooth abscess
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Vascular graft infection
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Viral rash
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypercholesterolaemia
         subjects affected / exposed
    11 / 33 (33.33%)
         occurrences all number
    11
    Vitamin D deficiency
         subjects affected / exposed
    4 / 33 (12.12%)
         occurrences all number
    4
    Abnormal loss of weight
         subjects affected / exposed
    2 / 33 (6.06%)
         occurrences all number
    2
    Decreased appetite
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Hyperkalaemia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Hypoglycemia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1
    Hypomagnesaemia
         subjects affected / exposed
    1 / 33 (3.03%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Jan 2020
    Addition of a recruiting clinical site in Spain

    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.
    The study was stopped prematurely on 6th September 2021, without reaching the recruitment target as recruitment was difficult. The study recruited in Ireland only and is representative of the IVDU population (mostly male and Caucasian)
    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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