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    Clinical Trial Results:
    A prospective, observational study to examine the effects of ageing on the clinical outcomes of people living with HIV in England and Ireland.

    Summary
    EudraCT number
    		 2012-003581-40
    Trial protocol
    		 GB   IE  
    Global end of trial date
    31 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    09 May 2024
    First version publication date
    09 May 2024
    Other versions
    Summary report(s)
    		 POPPY Results
    POPPY Results

    Trial information

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    Trial identification
    Sponsor protocol code
    CRO1992
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01737047
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Imperial College London
    Sponsor organisation address
    Imperial College Clinical Trials Unit, 1st Floor, Stadium House, 68 Wood Lane, London, United Kingdom, W12 7RH
    Public contact
    Alan Winston, Alan Winston, 0044 2033121603, a.winston@imperial.ac.uk
    Scientific contact
    Alan Winston, Imperial College London, 0044 2033121603, 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
    31 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Mar 2023
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To analyse the incidence and outcomes of intercurrent illnesses (other illnesses occurring or recurring) in older HIV-positive people and their relationship with demographic( for example age, gender, ethnicity employment, housing and relationship status) and clinical factors (for example any details of past or present illnesses and treatments). Also history of illnesses within the family.
    Protection of trial subjects
    Informed Consent obtained. Regulatory Approval including ethics obtained. Steering Committee reviewed trial conduct and patients safety.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Apr 2013
    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: 1296
    Country: Number of subjects enrolled
    Ireland: 81
    Worldwide total number of subjects
    1377
    EEA total number of subjects
    81
    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)
    1200
    From 65 to 84 years
    175
    85 years and over
    2

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruited through HIV clinics

    Pre-assignment
    Screening details
    		 Participants were recruited via participant sites (HIV clinics), screened and consented to join the study

    Pre-assignment period milestones
    Number of subjects started
    		 1377
    Number of subjects completed
    		 1377

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded
    Blinding implementation details
    Not applicable

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Older PWLH
    Arm description
    		 Not applicable
    Arm type
    		 Not applicable

    Investigational medicinal product name
    Not applicable
    Investigational medicinal product code
    Not applicable
    Other name
    Not applicable
    Pharmaceutical forms
    Not assigned
    Routes of administration
    Unknown use
    Dosage and administration details
    Not applicable

    Arm title
    		 Younger PWLH
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 HIV-Negative
    Arm description
    		 -
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Older PWLH Younger PWLH HIV-Negative
    Started
    699
    374
    304
    Not applicable
    699
    Completed
    699
    374
    304

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Older PWLH
    Reporting group description
    		 Not applicable

    Reporting group title
    Younger PWLH
    Reporting group description
    		 -

    Reporting group title
    HIV-Negative
    Reporting group description
    		 -

    Reporting group values
    		 Older PWLH Younger PWLH HIV-Negative Total
    Number of subjects
    		 699 374 304 1377
    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))
    		 57 (53 to 62) 43 (37 to 47) 58 (53 to 63) -
    Gender categorical
    Units: Subjects
        Female
    		 87 72 109 268
        Male
    		 612 302 195 1109

    End points

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    End points reporting groups
    Reporting group title
    Older PWLH
    Reporting group description
    		 Not applicable

    Reporting group title
    Younger PWLH
    Reporting group description
    		 -

    Reporting group title
    HIV-Negative
    Reporting group description
    		 -

    Subject analysis set title
    N/A
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    N/A

    Primary: Not applicable

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    End point title
    		 Not applicable
    End point description
    Not applicable
    End point type
    Primary
    End point timeframe
    Not applicable
    End point values
    		 Older PWLH Younger PWLH HIV-Negative
    Number of subjects analysed
    699 [1]
    374 [2]
    304 [3]
    Units: Not applicable
        Not applicable
    0
    0
    0
    Notes
    [1] - Not applicable
    [2] - Not applicable
    [3] - Not applicable
    Statistical analysis title
    		 Not applicable
    Statistical analysis description
    Not applicable
    Comparison groups
    Older PWLH v Younger PWLH v HIV-Negative
    Number of subjects included in analysis
    1377
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 < 1 [5]
    Method
    		 Not applicable
    Parameter type
    		 Not applicable
    Point estimate
    0
    Confidence interval
         level
    		 0%
         sides
    2-sided
         lower limit
    		 0
         upper limit
    		 1
    Variability estimate
    Standard deviation
    Dispersion value
    0
    Notes
    [4] - Not applicable
    [5] - Not applicable

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From consent to visit 3
    Adverse event reporting additional description
    Non-serious adverse events were not reported for this study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 Not coded
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 1%
    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: Non-serious adverse events were not reported for this study.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    05 Feb 2013
    Addition of letter of invitation to participant
    04 Apr 2013
    HIV negative subjects can attend visit 2 in person
    21 Jun 2013
    Addition of short summary of information sheet for the HIV+ve participants
    10 Sep 2013
    Addition of short summary of information sheet for the HIV+ve participants
    09 Dec 2013
    Twitter account introduced for adverts
    17 Dec 2013
    Allow recruitment from POPPY cohort for other sub-studies (special interest groups)
    07 Apr 2014
    New recruitment material to target the HIV negative group
    08 May 2014
    Not to perform neurocognitive computerised tests at the 2nd year follow up visit
    26 May 2015
    Change in PI at Brighton
    08 Sep 2015
    Change in PI at Brighton & addition of RFH
    24 Aug 2016
    Change in Trial Manager Addition of respiratory questionnaire Removal of NC at visit 2 and removal of PE
    20 Dec 2016
    IRISH HPRA ONLY: Removal of all IMPs (with the exception of Viread) from Irish CTA form and updated details
    22 Jun 2017
    UK only: Addition of end of trial definition
    03 Jul 2017
    Irish site only: Addition of end of trial definition

    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 POPPY Trial is not a CTIMP but in 2012 was classified by the MHRA as a CTIMP. It is only an observational study and has been assessing clinical outcomes of people living with HIV (PLWH) over the age of 50 in England and Ireland.

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/29746638
    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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