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    Clinical Trial Results:
    A phase III, open-label, multi centre pilot study to assess the feasibility of switching, individuals receiving Atripla or Kivexa plus Efavarinz with continuing Central Nervous System (CNS) toxicity, to a fixed dose combination of tenofovir/emtricitabine/rilpivirine (Eviplera)

    Summary
    EudraCT number
    		 2012-002205-22
    Trial protocol
    		 GB  
    Global end of trial date
    11 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    22 Nov 2017
    First version publication date
    22 Nov 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    SSAT047
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01701882
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    St Stephens Aids Trust
    Sponsor organisation address
    Chelsea Chambers, 262a Fulham Road, London, United Kingdom, SW10 9NH
    Public contact
    Marita Marshall, Head of Project Management, St Stephens Clinical Research, +44 0203 828 0567, marita.marshall@ststcr.com
    Scientific contact
    Prof Mark Nelson, St Stephen's Centre, Chelsea & Westminster Hospital, +44 0203 315 5610 , mark.nelson@chelwest.nhs.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
    15 Jun 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Nov 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate whether switching individuals who have central nervous system (CNS) side effects from taking efavirenz-containing treatment (as Atripla or Kivexa plus efavarinz) to Eviplera resolves the CNS side effects after 12 weeks.
    Protection of trial subjects
    The protocol was written, and the study was conducted according to the ICH GC P. The protocol was approved by the National Regulator and an Independent Ethics Committee as required by national legislation. Written informed consent was obtained from each subject prior to evaluations being performed for eligibility. The inclusion/exclusion criteria were designed to eliminate subjects who may have been put at risk by participating in the study. Safety and tolerability of medications were assessed by questions, physical examination and laboratory parameters. Any changes in health status during the study were recorded and followed up by the clinical team.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Dec 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: 40
    Worldwide total number of subjects
    40
    EEA total number of subjects
    40
    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)
    39
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All subjects were recruited from 4 sites between 10/12/2012 & 18/03/2013

    Pre-assignment
    Screening details
    		 All subjects screened were randomised

    Period 1
    Period 1 title
    Experimental (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Experimental
    Arm description
    		 Single Arm study - all subjects
    Arm type
    		 Experimental

    Investigational medicinal product name
    Eviplera [tenofovir/emtricitabine/rilpivirine fixed dose combination]
    Investigational medicinal product code
    J05AR08
    Other name
    Pharmaceutical forms
    Film-coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    200 mg emtricitabine / 25mg rilpivirine/ 245mg tenofovir

    Number of subjects in period 1
    		Experimental
    Started
    40
    Completed
    39
    Not completed
    1
         Consent withdrawn by subject
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 -

    Reporting group values
    		 Experimental Total
    Number of subjects
    		 40 40
    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)
    		 39 39
        From 65-84 years
    		 1 1
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (full range (min-max))
    		 46.7 (24.4 to 72.9) -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 36 36
    Ethnicity
    Self reported ethnicity
    Units: Subjects
        White/Caucasian
    		 32 32
        Black African
    		 1 1
        Black Caribbean
    		 4 4
        Black Other
    		 1 1
        Other
    		 2 2

    End points

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    End points reporting groups
    Reporting group title
    Experimental
    Reporting group description
    		 Single Arm study - all subjects

    Primary: Rate of Neuropsychiatric and CNS toxicity after 12 weeks of treatment

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    End point title
    		 Rate of Neuropsychiatric and CNS toxicity after 12 weeks of treatment [1]
    End point description
    Measured by a questionnaire based on efavirenz SPC
    End point type
    Primary
    End point timeframe
    Proportion change from baseline at 12 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive stats only
    End point values
    		 Experimental
    Number of subjects analysed
    39 [2]
    Units: % subjects
    20
    Notes
    [2] - 1 subject withrew prior to wk12
    No statistical analyses for this end point

    Primary: Proportion with CNS side effects

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    End point title
    		 Proportion with CNS side effects [3]
    End point description
    End point type
    Primary
    End point timeframe
    at 12 weeks– compared to baseline
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Descriptive stats only
    End point values
    		 Experimental
    Number of subjects analysed
    39 [4]
    Units: % change
        No Change
    20
        Base None/Mild to Mod/Severe
    0
        Base Mod/Severe to None/Mild
    19
    Notes
    [4] - One subject dropped out before week 12
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From consent to subjects final study visit.
    Adverse event reporting additional description
    All CNS related AEs were captured on the CNS questionnaire only but were reviewed by the investigator to evaluate whether they met the SAE reporting criteria. Reasons for any Surgical procedures should be reported as AEs rather than the procedures themselves
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Experimental Arm
    Reporting group description
    		 All subjects

    Serious adverse events
    		 Experimental Arm
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 40 (5.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Vascular disorders
    Worsening Thrombocytopenia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Metabolism and nutrition disorders
    Diabetes mellitus
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences causally related to treatment / all
    1 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Experimental Arm
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    36 / 40 (90.00%)
    Vascular disorders
    Worsening thrombocytopenia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    General disorders and administration site conditions
    Abnormal gait
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Coryzal illness
         subjects affected / exposed
    6 / 40 (15.00%)
         occurrences all number
    6
    Fevers
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Irritability
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Immune system disorders
    Cough
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Cough with sputum
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Dry cough
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Hayfever
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Nasal congestion
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Running nose
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Sneezing
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Sore throat
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Reproductive system and breast disorders
    Erectile dysfunction
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Low tesrosterone
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Worsening of erectile dysfunchion
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    Dyspnea
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Wheezing
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Worsening asthma
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Psychiatric disorders
    Low mood
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Low mood tearful demotivated
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Mood swings + depression
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    sleep disturbances
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    4
    Nervous system disorders
    Decreased range of movement in neck
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Decreased vision
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Fatigue
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    6
    Dysaesthesia
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Headache
         subjects affected / exposed
    5 / 40 (12.50%)
         occurrences all number
    5
    MRI head
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Neck pain
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Pins & needle
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Ear and labyrinth disorders
    Dizziness
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Earache
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    fullness in both ears
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Gastrointestinal disorders
    Abdominal discomfort
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Acidic feeling in throat
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Bloating
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Diahorrea + vomiting
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Diahorrea secondary to lymphagram venereum (LGV)
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Diarrhoea
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Dry mouth
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Flatulence
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Heartburn
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Increased hunger
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Loose stools
         subjects affected / exposed
    7 / 40 (17.50%)
         occurrences all number
    8
    Nausea
         subjects affected / exposed
    3 / 40 (7.50%)
         occurrences all number
    3
    Pain in lower abdomen
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Pain on swallowing
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Perianal ulcers
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    PR bleeds
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Recral bleeding 20 to lymphagram venereum (LGV)
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Vomiting
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Hepatobiliary disorders
    Elevated liver function
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    acneform papules (face)
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Dry Scalp
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Dry skin
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Rash
         subjects affected / exposed
    4 / 40 (10.00%)
         occurrences all number
    4
    Sweating in morning
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Renal and urinary disorders
    Deteriorating renal funchion
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Gout attack
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Smelly urine with
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Urinary tract infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Calf pain
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Loin pain
         subjects affected / exposed
    2 / 40 (5.00%)
         occurrences all number
    2
    Feet pain
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Fractured metatarsal in left
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Muscle aches with abnormal c
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Muscle pain
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Pain in leg
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Sciatic pain radiating to le
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Sore Knee
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Sprained ankle
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Infections and infestations
    Cellulitis
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Cellulitis left foot secondary burn
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Chest infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Dental abscess
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Fungal foot infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    LRTI
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Non specific viral illness
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    presumed upper respiratory tract infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Respiratory tract infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Upper respiratory tract infection
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Diabetes Mellitus
         subjects affected / exposed
    1 / 40 (2.50%)
         occurrences all number
    1
    Leg swelling
         subjects affected / exposed
    1 / 40 (2.50%)
         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
    11 Jun 2013
    Addition of an interim analysis once all subjects had completed week 12.

    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.
    Volume of plasma from each patient & time point was ≤2ml & insufficient for running the HIV-1 RNA assay in its standard format. This was addressed by undertaking extensive assay validation experiments to optimise the nucleic acid extraction protocol
    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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