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    Clinical Trial Results:
    The Liverpool HIV TDM Registry: Studying influences upon plasma HIV drug exposure

    Summary
    EudraCT number
    		 2006-006076-38
    Trial protocol
    		 GB  
    Global end of trial date
    30 Dec 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    25 Mar 2022
    First version publication date
    25 Mar 2022
    Other versions
    Summary report(s)
    		 TDM registry report

    Trial information

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    Trial identification
    Sponsor protocol code
    RLBUHT3173
    Additional study identifiers
    ISRCTN number
    		 ISRCTN65117827
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 Sponsor: UoL000071
    Sponsors
    Sponsor organisation name
    Royal Liverpool & Broadgreen University Hospitals NHS Trust
    Sponsor organisation address
    Prescot Street, Liverpool, United Kingdom, L7 8XP
    Public contact
    Heather Rogers, Royal Liverpool & Broadgreen University Hospitals NHS Trust, 0151 7062000, rgt@rlbuht.nhs.uk
    Scientific contact
    Prof Saye Khoo, University of Liverpool, 0151 7945560, khoo@liv.ac.uk
    Sponsor organisation name
    University of Liverpool
    Sponsor organisation address
    3 Brownlow Street, Liverpool, United Kingdom, L69
    Public contact
    Karen Wilding, University of Liverpool, 0151 7942000, sponsor@liverpool.ac.uk
    Scientific contact
    Prof Saye Khoo, University of Liverpool, 0151 7945560, khoo@liv.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
    30 Dec 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    30 Dec 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    30 Dec 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the association between genetic polymorphisms and a) treatment response (viral load and CD4 count), or b) drug exposure in HIV+ patients. A candidate gene approach will be utilised to examine the following loci of interest: Drug metabolism e.g. CYP P450- 2C9, 2D6 and 2C19 Drug transporters e.g. MDR1 (P-gp), MRP-1, MRP-2, MRP-5 Protein binding e.g. ORM1 Other candidate genes will emerge as genetic polymorphisms are characterised - these include other drug transporter and metabolising enzymes, and their effect on drug efficacy as well as drug toxicity.
    Protection of trial subjects
    This study used samples only from irreversibly anonymised participants. No trial participants were recruited or exposed to IMP.
    Background therapy
    		 HIV antiretroviral therapy
    Evidence for comparator
    		 -
    Actual start date of recruitment
    26 Apr 2007
    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: 99999
    Worldwide total number of subjects
    99999
    EEA total number of subjects
    99999
    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)
    99999
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 No participant recruitment took place for this registry. Ethics approval received to extract DNA samples from samples following second round of anonymisation.

    Pre-assignment
    Screening details
    		 Samples in the registry that were known to be from patients receiving HIV antiretrovirals were available for inclusion in this study.

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

    Arms
    Arm title
    		 Overall trial
    Arm description
    		 -
    Arm type
    		 Sample analysis

    Investigational medicinal product name
    No IMP administered
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Other use
    Dosage and administration details
    No IMP was administered in this study.

    Number of subjects in period 1
    		Overall trial
    Started
    99999
    Completed
    99999

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 99999 99999
    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)
    		 99999 99999
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    Units: Subjects
        Female
    		 99999 99999
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Primary: Drug concentrations

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    End point title
    		 Drug concentrations [1]
    End point description
    0 participants were recruited in this trial. Samples were analysed from the TDM Registry.
    End point type
    Primary
    End point timeframe
    Random samples
    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: See attached document for statistical analysis
    End point values
    		 Overall trial
    Number of subjects analysed
    99999 [2]
    Units: ng.mL
        number (not applicable)
    99999
    Attachments
    		 Untitled (Filename: Statistical analysis.docx)
    Notes
    [2] - Analysis on samples, no patients recruited
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Adverse event reporting was confined to the participation in the therapeutic drug monitoring process. No drug exposure occurred in this study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 DAIDS
    Dictionary version
    2.0
    Reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Serious adverse events
    		 Overall trial
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Overall trial
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 99999 (0.00%)
    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No subjects were enrolled in the trials hence no safety data are available. No intervention was given. This was a study on samples in a registry.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    28 Nov 2006
    Protocol updated to include adverse event reporting in response to the MHRA opinion that the trial qualified as a CTIMP
    02 May 2007
    Substantial amendment to change the trial to a CTIMP following review by the MHRA

    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.
    There were no participants recruited to this study. Irreversibly anonymised samples were used for the study.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/24950369
    http://www.ncbi.nlm.nih.gov/pubmed/22477766
    http://www.ncbi.nlm.nih.gov/pubmed/23435690
    http://www.ncbi.nlm.nih.gov/pubmed/20051929
    http://www.ncbi.nlm.nih.gov/pubmed/20921307
    http://www.ncbi.nlm.nih.gov/pubmed/19897506
    http://www.ncbi.nlm.nih.gov/pubmed/18831695
    http://www.ncbi.nlm.nih.gov/pubmed/18771051
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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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