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    Clinical Trial Results:
    A randomised, prospective study, assessing changes in cerebral function in treatment naive HIV-1 infected subjects commencing either boosted atazanavir with Truvada or boosted darunavir with maraviroc and Kivexa

    Summary
    EudraCT number
    		 2011-002656-14
    Trial protocol
    		 GB  
    Global end of trial date
    20 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jun 2017
    First version publication date
    01 Jun 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1733
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01367236
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    Room 221, Medical School Building, St Marys Campus, Norfolk Place , London, United Kingdom, W2 1PG
    Public contact
    Alan Winston, Imperial College London, +44 207886 1603, a.winston@imperial.ac.uk
    Scientific contact
    Alan Winston, Imperial College London, +44 207886 1603, a.winston@imperial.ac.uk
    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
    21 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Oct 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    When commencing antiretroviral therapy (anti-HIV therapy) for the first time, improvements in the function of the brain are frequently observed. For example memory and concentration may improve. However, whether these improvements may differ between different anti-HIV therapies is largely unknown. The purpose of this study is to compare two different combination anti-HIV therapies over 48 weeks and to assess if differences in improvement in the function of the brain are observed over this period.
    Protection of trial subjects
    Ethical approval was gained prior to the trial commencing. Suitable subjects currently attending one of the trial sites for the management of their HIV care were recruited during routine hospital visits, and hence were under the care of a HIV consultant. Subjects did not exit their standard care pathway and study participation caused no additional risk. Each subject signed an Informed Consent Form prior to the conduct of any screening procedures.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 May 2012
    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

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    Recruitment
    Recruitment details
    		 60 subjects were recruited in total - the first subject was consented on 08/03/2013 and randomised on 26/03/2013; the final subject was consented on 30/10/2014 and randomised on 17/11/2014. All subjects were recruited in the UK at 6 trial sites.

    Pre-assignment
    Screening details
    		 Suitable subjects currently attending one of the trial sites for the management of their HIV care will be recruited during routine hospital visits. Each subject must sign an Informed Consent Form prior to the conduct of any screening procedures after having adequate time to read through the PIS. 72 subjects screened in total (12 screen failures).

    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
    		 Standard of care – non ‘neuroART’ arm
    Arm description
    		 Standard HIV antiretroviral therapy treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Atazanavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Atazanavir 300 mg daily

    Investigational medicinal product name
    Truvada
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Tenofovir 245 mg daily* Emtricitabine 200 mg daily* * as the fixed dose combination Truvada™

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir 100 mg daily

    Arm title
    		 Novel therapeutic approach – ‘neuroART’ arm
    Arm description
    		 Novel therapeutic approach
    Arm type
    		 Experimental

    Investigational medicinal product name
    Kivexa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Lamivudine 300 mg daily** Abacavir 600 mg daily** ** as the fixed dose combination Kivexa ™

    Investigational medicinal product name
    Maraviroc
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Maraviroc 150 mg once daily

    Investigational medicinal product name
    Ritonavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Ritonavir 100 mg daily

    Investigational medicinal product name
    Darunavir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Darunavir 800 mg daily

    Number of subjects in period 1
    		Standard of care – non ‘neuroART’ arm Novel therapeutic approach – ‘neuroART’ arm
    Started
    30
    30
    Completed
    27
    29
    Not completed
    3
    1
         Consent withdrawn by subject
    3
    -
         Lost to follow-up
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Standard of care – non ‘neuroART’ arm
    Reporting group description
    		 Standard HIV antiretroviral therapy treatment

    Reporting group title
    Novel therapeutic approach – ‘neuroART’ arm
    Reporting group description
    		 Novel therapeutic approach

    Reporting group values
    		 Standard of care – non ‘neuroART’ arm Novel therapeutic approach – ‘neuroART’ arm Total
    Number of subjects
    		 30 30 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
        median (inter-quartile range (Q1-Q3))
    		 31.24 (27.1 to 38) 34.84 (28.19 to 40.57) -
    Gender categorical
    Units: Subjects
        Female
    		 1 1 2
        Male
    		 29 29 58
    Site
    Number of subjects recruited per site
    Units: Subjects
        Brighton
    		 7 7 14
        Birmingham
    		 3 3 6
        Chelsea & Westminster
    		 2 1 3
        King' College
    		 3 4 7
        St Thomas
    		 7 8 15
        St Mary's
    		 8 7 15
    Race
    Units: Subjects
        Black
    		 5 6 11
        Mixed
    		 1 1 2
        Other
    		 1 1 2
        White
    		 23 22 45
    Employment Status
    Units: Subjects
        Employed or self-employed full-time
    		 17 17 34
        Employed or self-employed part-time
    		 4 3 7
        Full time student/education/training
    		 1 6 7
        Unemployed
    		 5 3 8
        Unknown
    		 3 1 4
    Screening CD4+ lymphocyte count ≤ 350 cells/µL
    Units: Subjects
        Yes
    		 17 15 32
        No
    		 12 12 24
        Unknown
    		 1 3 4
    Educational status
    Units: Subjects
        A levels (or equivalent qualifications at age 18)
    		 2 9 11
        Finished education with no qualifications
    		 2 0 2
        O levels/GCSEs (or equivalent qualifications at 16
    		 7 0 7
        Other qualifications
    		 3 5 8
        University degree or above
    		 13 15 28
        Unknown
    		 3 1 4
    Tropism results
    Units: Subjects
        Dual tropic
    		 0 1 1
        Mixed tropic
    		 0 1 1
        r5 tropic
    		 21 19 40
        x4 tropic
    		 5 4 9
        Unknown
    		 4 5 9
    HIV-Clade
    Units: Subjects
        HIV-Clade a
    		 0 1 1
        HIV-Clade b
    		 22 23 45
        HIV-Clade c
    		 3 1 4
        HIV-Clade d
    		 0 1 1
        Other
    		 5 3 8
        Unknown
    		 0 1 1
    Plasma HIV-RNA5
    Viral load value
    Units: Subjects
        Above 500
    		 1 0 1
        Between 100k to 499k
    		 5 4 9
        Between 51k to 99k
    		 24 26 50
    Smoking history
    Units: Subjects
        The patient is not a current smoker
    		 19 18 37
        The patient is a current smoker
    		 11 12 23
    Alcohol History
    Units: Subjects
        The patient currently drinks alcohol
    		 23 21 44
        Th patient does not currently drink alcohol
    		 7 9 16
    Recreational Drug History
    Units: Subjects
        The patient does not currently take drugs
    		 21 23 44
        The patient currently takes recreational drugs
    		 9 7 16
    Medical History
    Units: Subjects
        Not experienced any past and/or disease or surgery
    		 13 12 25
        Experienced any past and/or diseases or surgeries
    		 16 18 34
        Unknown
    		 1 0 1
    HLA-B5701
    Units: Subjects
        HLA-B5701 negative
    		 30 30 60
        HLA-B5701 positive
    		 0 0 0
    AIDS events
    Units: Subjects
        Number of subjects with an AIDS Event
    		 2 1 3
        Number of subjects without an AIDS Event
    		 28 29 57
    Patient Questionnaire – I have trouble remembering things
    Units: Subjects
        No
    		 23 24 47
        Yes
    		 6 6 12
        Unknown
    		 1 0 1
    Patient Questionnaire – I have trouble concentrating
    Units: Subjects
        No
    		 26 22 48
        Yes
    		 3 8 11
        Unknown
    		 1 0 1
    Patient Questionnaire – My thinking is clear
    Units: Subjects
        No
    		 2 3 5
        Yes
    		 27 26 53
        Unknown
    		 1 1 2
    Lawton Instrumental Activities of Daily Living Scale – Ability to use telephone
    Units: Subjects
        Operates telephone on own initiative
    		 29 30 59
        Unknown
    		 1 0 1
    Lawton Instrumental Activities of Daily Living Scale – Shopping
    Units: Subjects
        Takes care of all shopping needs independently
    		 28 30 58
        Shops independently for small purchases
    		 1 0 1
        Unknown
    		 1 0 1
    Lawton Instrumental Activities of Daily Living Scale – Food Preparation
    Units: Subjects
        Plans, prepares and serves adequate meals independ
    		 29 30 59
        Unknown
    		 1 0 1
    Lawton Instrumental Activities of Daily Living Scale – Housekeeping
    Units: Subjects
        Maintains house alone with occasional assistance
    		 28 28 56
        Performs light daily tasks such as dishwashing
    		 1 2 3
        Unknown
    		 1 0 1
    Lawton Instrumental Activities of Daily Living Scale – Laundry
    Units: Subjects
        Does personal laundry completely
    		 29 30 59
        Unknown
    		 1 0 1
    Lawton Instrumental Activities of Daily Living Scale – Mode of Transportation
    Units: Subjects
        Travels independently on public transportation
    		 28 30 58
        Travels on public transportation when assisted
    		 1 0 1
        Unknown
    		 1 0 1
    Lawton Instrumental Activities of Daily Living Scale – Responsibility for own medication
    Units: Subjects
        Is responsible for taking medication
    		 29 30 59
        Unknown
    		 1 0 1
    Lawton Instrumental Activities of Daily Living Scale – Ability to handle finances
    Units: Subjects
        Manages financial matters independently
    		 28 28 56
        Manages day to day purchases
    		 1 1 2
        Incapable of handling money
    		 0 1 1
        Unknown
    		 1 0 1
    Framingham Risk Score
    Units: Subjects
        Over 30%
    		 7 10 17
        12%
    		 0 1 1
        5%
    		 0 1 1
        2%
    		 0 2 2
        <1%
    		 2 1 3
        Error
    		 20 13 33
        1%
    		 1 2 3
    CD4+ lymphocyte count (screening)
    At screening
    Units: cells/µL
        median (inter-quartile range (Q1-Q3))
    		 367.5 (286 to 576) 410 (330 to 541) -
    CD4+ lymphocyte count (baseline)
    Units: cells/µL
        median (inter-quartile range (Q1-Q3))
    		 434 (308 to 540) 364.5 (301 to 509) -
    Biochemistry blood test - glucose
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 5 (4 to 5) 5 (4 to 5) -
    Biochemistry blood test - Amylase
    Units: U/L
        median (inter-quartile range (Q1-Q3))
    		 67 (53 to 91) 55 (40 to 71) -
    Biochemistry blood test - Sodium
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 139 (138 to 140) 140 (138 to 140) -
    Biochemistry blood test - Potassium
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 4 (4 to 4) 4 (4 to 4) -
    Biochemistry blood test - Creatinine
    Units: µmol/L
        median (inter-quartile range (Q1-Q3))
    		 73 (69 to 85) 81 (67 to 85) -
    Biochemistry blood test - ALT
    Units: iU/L
        median (inter-quartile range (Q1-Q3))
    		 23 (21 to 29) 23 (17 to 36) -
    Biochemistry blood test - AST
    Units: iU/L
        median (inter-quartile range (Q1-Q3))
    		 27 (24 to 42) 27 (22 to 33) -
    Biochemistry blood test - Alkaline Phosphatase
    Units: iU/L
        median (inter-quartile range (Q1-Q3))
    		 70 (61 to 81) 65 (58 to 77) -
    Biochemistry blood test - Bilirubin
    Units: umol/L
        median (inter-quartile range (Q1-Q3))
    		 9 (7 to 11) 8 (7 to 10) -
    Biochemistry blood test - Protein
    Units: g/L
        median (inter-quartile range (Q1-Q3))
    		 77 (72 to 80) 76 (74 to 79) -
    Fasting lipids blood test - Total Cholesterol
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 3.8 (3.4 to 4.3) 4.2 (3.5 to 4.7) -
    Fasting lipids blood test - HDL
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 1.03 (0.86 to 1.34) 1.1 (0.82 to 1.3) -
    Fasting lipids blood test - LDL
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 2.31 (1.9 to 2.7) 2.52 (2 to 3) -
    Fasting lipids blood test - Triglycerides
    Units: mmol/L
        median (inter-quartile range (Q1-Q3))
    		 1.3 (1 to 1.45) 1.2 (1 to 1.6) -
    Haematology blood test - Hb
    Units: g/dl
        median (inter-quartile range (Q1-Q3))
    		 14.35 (13.5 to 15.2) 14.3 (13.7 to 15.5) -
    Haematology blood test - WBC
    Units: x109/l
        median (inter-quartile range (Q1-Q3))
    		 5.05 (4.3 to 7.1) 4.9 (4.3 to 5.6) -
    Haematology blood test - RBC
    Units: x1012/l
        median (inter-quartile range (Q1-Q3))
    		 4.92 (4.55 to 5.04) 4.88 (4.53 to 5.19) -
    Haematology blood test - Neutrophils
    Units: x109/l
        median (inter-quartile range (Q1-Q3))
    		 2.45 (1.8 to 3.3) 2.45 (2.1 to 3.1) -
    Haematology blood test - Monocytes
    Units: x109/l
        median (inter-quartile range (Q1-Q3))
    		 0.55 (0.4 to 0.7) 0.5 (0.4 to 0.5) -
    Haematology blood test - Platelets
    Units: x109/l
        median (inter-quartile range (Q1-Q3))
    		 200.5 (166 to 233) 212 (177 to 240) -
    Haematology blood test - Eosinophils
    Units: x109/l
        median (inter-quartile range (Q1-Q3))
    		 0.1 (0.04 to 0.2) 0.14 (0.1 to 0.3) -
    Vital signs - height
    Units: cm
        median (inter-quartile range (Q1-Q3))
    		 178.25 (173 to 181.1) 175.25 (170.1 to 182) -
    Vital signs - weight
    Units: kg
        median (inter-quartile range (Q1-Q3))
    		 75.75 (65.6 to 84.9) 77 (67.6 to 87.8) -
    Vital signs - systolic blood pressure
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 123 (116 to 133) 126 (117 to 132) -
    Vital signs - diastolic blood pressure
    Units: mmHg
        median (inter-quartile range (Q1-Q3))
    		 71 (67 to 81) 72.5 (68 to 77) -
    Viral Load
    Units: copies per milliliter of blood
        median (inter-quartile range (Q1-Q3))
    		 44864 (21292 to 70841) 50959 (26491 to 76141) -

    End points

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    End points reporting groups
    Reporting group title
    Standard of care – non ‘neuroART’ arm
    Reporting group description
    		 Standard HIV antiretroviral therapy treatment

    Reporting group title
    Novel therapeutic approach – ‘neuroART’ arm
    Reporting group description
    		 Novel therapeutic approach

    Primary: To assess differences in neurocognitive function at week 48 between study treatment arms

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    End point title
    		 To assess differences in neurocognitive function at week 48 between study treatment arms
    End point description
    COGSTATE battery comprised of 11 tasks in the form of a computerised assessment.
    End point type
    Primary
    End point timeframe
    48 weeks
    End point values
    		 Standard of care – non ‘neuroART’ arm Novel therapeutic approach – ‘neuroART’ arm
    Number of subjects analysed
    27
    29
    Units: neurocognitive score
        arithmetic mean (confidence interval 95%)
    0.1596713 (-0.0401165 to 0.3270786)
    0.2532748 (0.0525634 to 0.4155249)
    Attachments
    		 CogUK primary analysis graph
    Statistical analysis title
    		 generalised linear mixed model
    Statistical analysis description
    Adjusting valuables: treatment, baseline cognitive score, time, centre, plasma group, time x treatment interaction
    Comparison groups
    Standard of care – non ‘neuroART’ arm v Novel therapeutic approach – ‘neuroART’ arm
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.437 [1]
    Method
    		 Mixed models analysis
    Confidence interval
    Notes
    [1] - Initial status (intercept) for treatment effect, adjusted = -0.00304 (-0.12, 0.11). P-value = 0.96 Rate of change (slope) for treatment at week 48 = 0.09360 (-0.14, 0.33). P-value = 0.437

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    An assessment of all Serious Adverse Events (SAEs) and Adverse Events (AEs) that have occurred was undertaken at every patient visit and recorded on the eCRF from randomisation to week 48.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Full analysis set
    Reporting group description
    		 -

    Serious adverse events
    		 Full analysis set
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 60 (5.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Glioma
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Migraine
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Gastrointestinal disorders
    Gastritis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Full analysis set
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    53 / 60 (88.33%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Anogenital warts
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Penile neoplasm
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Pregnancy, puerperium and perinatal conditions
    Pregnancy
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    General disorders and administration site conditions
    Fatigue
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    5
    Feeling cold
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Local swelling
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Pain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Pyrexia
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Immune system disorders
    Seasonal allergy
         subjects affected / exposed
    6 / 60 (10.00%)
         occurrences all number
    6
    Reproductive system and breast disorders
    Dysmenorrhoea
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    5
    Epistaxis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Oropharyngeal pain
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    6
    Rhinitis allergic
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Rhinorrhoea
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Psychiatric disorders
    Depressed mood
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Depression
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    4
    Disorientation
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Euphoric mood
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Insomnia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Mood swings
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Sleep disorder
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Investigations
    Weight decreased
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Injury, poisoning and procedural complications
    Muscle strain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Repetitive strain injury
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Cardiac disorders
    Palpitations
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Nervous system disorders
    Burning sensation
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Dizziness
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    3
    Dysgeusia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    11 / 60 (18.33%)
         occurrences all number
    16
    Lethargy
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Paraesthesia
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Somnolence
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Neutropenia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Eye disorders
    Dry eye
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Ocular icterus
         subjects affected / exposed
    9 / 60 (15.00%)
         occurrences all number
    10
    Scleral discolouration
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Gastrointestinal disorders
    Abdominal distension
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Abdominal pain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Abdominal pain upper
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Constipation
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Diarrhoea
         subjects affected / exposed
    22 / 60 (36.67%)
         occurrences all number
    25
    Dyspepsia
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    3
    Haematochezia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Mouth ulceration
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    10 / 60 (16.67%)
         occurrences all number
    13
    Oesophageal pain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Proctitis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Rectal haemorrhage
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Toothache
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Vomiting
         subjects affected / exposed
    6 / 60 (10.00%)
         occurrences all number
    6
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Skin and subcutaneous tissue disorders
    Acne
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Alopecia
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Blister
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Eczema
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Hyperhidrosis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Night sweats
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Pruritus
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Rash
         subjects affected / exposed
    6 / 60 (10.00%)
         occurrences all number
    6
    Rash pruritic
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Yellow skin
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Renal and urinary disorders
    Haematuria
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Polyuria
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Proteinuria
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Renal mass
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Back pain
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Muscle spasms
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Infections and infestations
    Anal abscess
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Chlamydial infection
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    3
    Conjunctivitis
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Conjunctivitis viral
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Ear infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Gastrointestinal infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Genital Herpes
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Genital herpes simplex
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Gonorrhoea
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Herpes simplex
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Herpes virus infection
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    6
    Herpes zoster
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Hordeolum
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    4
    Influenza
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    4
    Lower respiratory tract infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Nasopharyngitis
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    4
    Oral candidiasis
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    3
    Oral herpes
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Pharyngitis
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Pilonidal cyst
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Proctitis gonococcal
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Respiratory tract infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Rhinitis
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Sinusitis
         subjects affected / exposed
    2 / 60 (3.33%)
         occurrences all number
    2
    Syphilis
         subjects affected / exposed
    4 / 60 (6.67%)
         occurrences all number
    4
    Tonsillitis
         subjects affected / exposed
    5 / 60 (8.33%)
         occurrences all number
    5
    Tooth infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    3 / 60 (5.00%)
         occurrences all number
    4
    Urinary tract infection
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Decreased appetite
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Dehydration
         subjects affected / exposed
    1 / 60 (1.67%)
         occurrences all number
    1
    Vitamin D deficiency
         subjects affected / exposed
    1 / 60 (1.67%)
         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
    14 Nov 2011
    Minor changes to Patient Information Sheet, Informed Consent Form, GP letter and patient appointment card
    05 Mar 2013
    Change in protocol - It is considered that at the screening visit blood tests may be used if estimated within the previous 28 days. This is in line with the routine medical procedures at clinic visits and saves the patient from unnecessary venepuncture.
    25 Apr 2013
    Change in inclusion criteria - remove the inclusion criteria relating to CD4 lymphocyte count
    07 May 2013
    Change in protocol - A new 800mg strength of DARUNAVIR has been authorised. Therefore, for patients randomised to ARM 2 (Novel therapeutic approach – ‘neuroART’ arm), a single 800mg tablet of Darunavir will be prescribed where possible. This will simplify and reduce the tablet burden and the final doses prescribed will not alter.
    29 Jan 2015
    The Principal Investigator at the site in Brighton, Professor Martin Fisher has transferred his duties for the CogUK trial to Dr Amanda Clarke.

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

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

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