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HIV PositivePOPPYNCT01737047

The Effects of Ageing on the 'Pharmacokinetic and Clinical Observations in People Over Fifty'

An observational study of HIV Positive and Ageing, run by Imperial College London at 8 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to identify medical conditions that may cause particular problems to individuals receiving care for HIV infection over the age of 50. In addition, as the effects and potentially the side effects, of HIV medication may change with age, this study will also investigate the association… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
HIV Positive, Ageing
How many people
1,377 participants
Where
8 sitesin 2 countries
Study dates
1 Apr 2013to 13 Mar 2023
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: HIV positive over 50 years HIV positive between 18 and 50 years HIV negative over 50 years White Black african

Who may be able to join

  • Older HIV-positive cohort (n=1000):
  • documented HIV infection
  • age >50 years at study entry
  • self defined white or black African ethnicity
  • likely route of HIV acquisition via sexual exposure Either by male to male exposure if white or by heterosexual exposure if white or black African
  • able to comprehend study patient information leaflet
Show all 18Show fewer
  • -Younger HIV-positive cohort (n=500):
  • documented HIV infection
  • age <50 at study entry*
  • self defined white or black African ethnicity
  • likely route of HIV acquisition via sexual exposure Either by male to male exposure if white or by heterosexual exposure if white or black African.
  • able to comprehend study patient information leaflet
  • this group will comprise of at least 150 subjects in each of the following age groups: 20-29, 30-39, 40-49 years. Recruitment will be monitored by the Study Monitoring Team.
  • HIV-negative cohort (n=500):
  • documented negative HIV test at screening
  • age >50 years at study entry
  • self defined white or black African ethnicity
  • registered with a General Practitioner and gives permission for contact with that General Practitioner.

Who cannot join

  • in the opinion of the investigator, those unable or unwilling to comply with the requirements of the study
  • life expectancy less than 6 months

Trial locations and contacts

8 sites in 2 countries.

8 sites in 2 countries

United Kingdom7 sites
  • Royal Sussex County Hospital

    Brighton, Sussex, BN2 5BE

  • Homerton University Hospital NHS Foundation Trust

    London, E9 6SR

  • Royal Free Hospital

    London, NW3 2QG

  • Kings College Hospital NHS Trust

    London, SE5 9RJ

  • Chelsea and Westminster Hospital

    London, SW10 9NH

  • St Marys Hospital NHS Trust

    London, W2 1NY

  • University College NHS Trust

    London, WC1E 6JB

Other trials in United Kingdom

Ireland1 site
  • University College Dublin School of Medicine and Medical Sciences, Mater Misericordiae University Hospital

    Dublin, 7

Other trials in Ireland

About this study

Official title: A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in England and Ireland

The purpose of this study is to identify medical conditions that may cause particular problems to individuals receiving care for HIV infection over the age of 50. In addition, as the effects and potentially the side effects, of HIV medication may change with age, this study will also investigate the association between age and differing effects of antiretroviral therapies such as treatment outcomes, side effects and the levels of drugs in blood.

Results from this study may inform future HIV treatment guidelines on how individuals with HIV infection are monitored. The results may also assist in the design of future studies for the treatment of diseases associated with ageing.

Read the detailed description

Multicentre, prospective, observational study over 3 years.

The study will describe the impact of advancing age on the experience of living with HIV in England and Ireland. To address this cohorts of HIV-positive people aged >50 and <50 years (as well as demographically matched HIV-negative people aged >50 years) will be established.

  1. To analyse the incidence and outcomes of co-morbidities in older-HIV-positive people and their relationship with demographic/clinical factors.
  2. To evaluate associations between antiretroviral drug concentrations and age, and to assess the potential impact of age on drug efficacy, drug-drug interactions and co-morbidities.
  3. To contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older HIV-positive patients.

2000 will be recruited in all either white or black african individuals (self reported) 1000 will be Over 50 years of age and HIV positive, 500 will be under the age of 50 and will be HIV positive and 500 will be over the age of 50 and be HIV negative.

Conditions
HIV Positive, Ageing
Keywords
HIV, Ageing
Medical subject headings
HIV Seropositivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01737047
Study groupRoleWhat they receive
HIV positive over 50 years of ageAll study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study. Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn
HIV positive under the age of 50All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study. Blood sample collections for the determination of the plasma concentrations of tenofovir and the third agent (i.e. a non-nucleoside reverse transcriptase, protease, entry or integrase inhibitor) in the patient's regimen will be drawn
HIV negative over the age of 50All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Prevalence of Reported Aches and Pains in the Last Month Across the 3 Age Groups

    The number of patients reporting aches and pains in the 3 arms were used to analyse the incidence and outcomes of co-morbidities in older-HIV-positive people and their relationship with demographic/clinical factors.Comparison of three groups HIV+ve >50, HIV+<50 and HIV-ve >50.

    Measured: after 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study start1 Apr 2013
  3. Primary completion31 Jan 2018
  4. Study completion13 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,377 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01737047
Sponsor's protocol ID
CRO: 1992
Other IDs
2012-003581-40
Acronym
POPPY
Status last verified
Sep 2025
First submitted
1 Nov 2012
Last updated
18 Sep 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • De Francesco D, Underwood J, Post FA, Vera JH, Williams I, Boffito M, Sachikonye M, Anderson J, Mallon PW, Winston A, Sabin CA; POPPY study group. Defining cognitive impairment in people-living-with-HIV: the POPPY study. BMC Infect Dis. 2016 Oct 28;16(1):617. doi: 10.1186/s12879-016-1970-8.

    PubMed 27793128
  • Underwood J, De Francesco D, Post FA, Vera JH, Williams I, Boffito M, Mallon PW, Anderson J, Sachikonye M, Sabin C, Winston A; Pharmacokinetic and Clinical Observations in People Over Fifty (POPPY) study group. Associations between cognitive impairment and patient-reported measures of physical/mental functioning in older people living with HIV. HIV Med. 2017 May;18(5):363-369. doi: 10.1111/hiv.12434. Epub 2016 Oct 26.

    PubMed 27785907
  • Bagkeris E, Burgess L, Mallon PW, Post FA, Boffito M, Sachikonye M, Anderson J, Asboe D, Garvey L, Vera J, Williams I, Johnson M, Babalis D, De Francesco D, Winston A, Sabin CA. Cohort profile: The Pharmacokinetic and clinical Observations in PeoPle over fiftY (POPPY) study. Int J Epidemiol. 2018 Oct 1;47(5):1391-1392e. doi: 10.1093/ije/dyy072. No abstract available.

    PubMed 29746638
  • Underwood J, De Francesco D, Leech R, Sabin CA, Winston A; Pharmacokinetic and Clinical Observations in PeoPle Over fiftY (POPPY) study. Medicalising normality? Using a simulated dataset to assess the performance of different diagnostic criteria of HIV-associated cognitive impairment. PLoS One. 2018 Apr 11;13(4):e0194760. doi: 10.1371/journal.pone.0194760. eCollection 2018.

    PubMed 29641619
  • De Francesco D, Verboeket SO, Underwood J, Bagkeris E, Wit FW, Mallon PWG, Winston A, Reiss P, Sabin CA; Pharmacokinetic and Clinical Observations in PeoPle Over fiftY (POPPY) study and the AGEhIV Cohort Study. Patterns of Co-occurring Comorbidities in People Living With HIV. Open Forum Infect Dis. 2018 Oct 24;5(11):ofy272. doi: 10.1093/ofid/ofy272. eCollection 2018 Nov.

    PubMed 30465014
  • Pool E, Winston A, Bagkeris E, Vera JH, Mallon P, Sachikonye M, Post FA, Pozniak A, Boffito M, Anderson J, Williams I, Johnson M, Burgess L, Sabin CA; Pharmacokinetic and Clinical Observations in People over Fifty (POPPY) study team. High-risk behaviours, and their associations with mental health, adherence to antiretroviral therapy and HIV parameters, in HIV-positive men who have sex with men. HIV Med. 2019 Feb;20(2):131-136. doi: 10.1111/hiv.12690. Epub 2018 Dec 12.

    PubMed 30548745
  • Halloran MO, Boyle C, Kehoe B, Bagkeris E, Mallon P, Post FA, Vera J, Williams I, Anderson J, Winston A, Sachikonye M, Sabin C, Boffito M. Polypharmacy and drug-drug interactions in older and younger people living with HIV: the POPPY study. Antivir Ther. 2019;24(3):193-201. doi: 10.3851/IMP3293.

    PubMed 30700636
  • De Francesco D, Underwood J, Bagkeris E, Boffito M, Post FA, Mallon P, Vera JH, Williams I, Anderson J, Johnson M, Sabin CA, Winston A; Pharmacokinetic and Clinical Observations in People over Fifty (POPPY) study. Depression, lifestyle factors and cognitive function in people living with HIV and comparable HIV-negative controls. HIV Med. 2019 Apr;20(4):274-285. doi: 10.1111/hiv.12714. Epub 2019 Feb 8.

    PubMed 30734983
  • De Francesco D, Winston A, Underwood J, Cresswell FV, Anderson J, Post FA, Williams I, Mallon PW, Sachikonye M, Babalis D, Vera JH, Bagkeris E, Milinkovic A, Sabin CA. Cognitive function, depressive symptoms and syphilis in HIV-positive and HIV-negative individuals. Int J STD AIDS. 2019 Apr;30(5):440-446. doi: 10.1177/0956462418817612. Epub 2019 Jan 10.

    PubMed 30999830
  • Dhillon S, Sabin CA, Alagaratnam J, Bagkeris E, Post FA, Boffito M, Anderson J, Vera J, Williams I, Johnson M, Sachikonye M, Babalis D, Mallon PW, Winston A; Pharmacokinetic and Clinical Observations in People over Fifty (POPPY) study. Level of agreement between frequently used cardiovascular risk calculators in people living with HIV. HIV Med. 2019 May;20(5):347-352. doi: 10.1111/hiv.12731. Epub 2019 Mar 14.

    PubMed 30873751
  • De Francesco D, Underwood J, Bagkeris E, Anderson J, Williams I, Vera JH, Post FA, Boffito M, Johnson M, Mallon PWG, Winston A, Sabin CA; Pharmacokinetic and Clinical Observations in PeoPle Over fiftY (POPPY) study. Risk factors and impact of patterns of co-occurring comorbidities in people living with HIV. AIDS. 2019 Oct 1;33(12):1871-1880. doi: 10.1097/QAD.0000000000002293.

    PubMed 31259766
  • Savinelli S, De Francesco D, Feeney ER, Babalis D, Bagkeris E, Post FA, Boffito M, Williams I, Vera J, Johnson M, Anderson J, Sachikonye M, Winston A, Sabin C, Mallon P. Factors associated with obesity in the Pharmacokinetic and Clinical Observations in People over Fifty (POPPY) cohort: an observational cross-sectional analysis. HIV Med. 2020 Aug;21(7):441-452. doi: 10.1111/hiv.12857. Epub 2020 Apr 20.

    PubMed 32311831
  • Wang X, Boffito M, Dickinson L, Bagkeris E, Khoo S, Post FA, Vera J, Williams I, Ndoutoumou A, Anderson J, Mallon P, McClure M, Winston A, Sabin C; POPPY Study. Plasma nucleotide reverse transcriptase inhibitor concentration and their associations with liver and renal parameters in people living with HIV. AIDS. 2020 Apr 1;34(5):790-793. doi: 10.1097/QAD.0000000000002479.

    PubMed 32167992
  • Sabin CA, Kunisaki KM, Bagkeris E, Post FA, Sachikonye M, Boffito M, Anderson J, Mallon P, Williams I, Vera JH, Johnson M, Babalis D, Winston A. Respiratory symptoms and chronic bronchitis in people with and without HIV infection. HIV Med. 2021 Jan;22(1):11-21. doi: 10.1111/hiv.12955. Epub 2020 Sep 6.

    PubMed 32892488
  • Sabin CA, Harding R, Bagkeris E, Geressu A, Nkhoma K, Post FA, Sachikonye M, Boffito M, Anderson J, Mallon PWG, Williams I, Vera J, Johnson MA, Babalis D, Winston A. The predictors of pain extent in people living with HIV. AIDS. 2020 Nov 15;34(14):2071-2079. doi: 10.1097/QAD.0000000000002660.

    PubMed 32773481

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Positive and Ageing, run by Imperial College London at 8 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United Kingdom, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Prevalence of Reported Aches and Pains in the Last Month Across the 3 Age Groups (time frame: after 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01737047, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.

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