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

NCT01737047 | Completed Results DMC

• 2 other identifiers: CRO: 19922012-003581-40
• Study Type: observational
• Target: 1,377
• Locations: 2 countries
• Sites: 8

Brief 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 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.

Conditions

HIV Positive; Ageing

Keywords

HIV; Ageing

Outcome Measures

Primary Outcomes (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.

  after 1 year

Study Arms (3)

HIV positive over 50 years of age

All 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 50

All 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 50

All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Imperial College London: lead
• Gilead Sciences: collaborator
• Janssen, LP: collaborator
• ViiV Healthcare: collaborator
• Bristol-Myers Squibb: collaborator
• Merck Sharp & Dohme LLC: collaborator

Study Sites (8)

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

Dublin, 7, Ireland

Location

Royal Sussex County Hospital

Brighton, Sussex, BN2 5BE, United Kingdom

Location

Homerton University Hospital NHS Foundation Trust

London, E9 6SR, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Kings College Hospital NHS Trust

London, SE5 9RJ, United Kingdom

Location

Chelsea and Westminster Hospital

London, SW10 9NH, United Kingdom

Location

St Marys Hospital NHS Trust

London, W2 1NY, United Kingdom

Location

University College NHS Trust

London, WC1E 6JB, United Kingdom

Location

Related Publications (17)

• 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.

  PMID: 27793128 BACKGROUND

• 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.

  PMID: 27785907 BACKGROUND

• 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.

  PMID: 29746638 BACKGROUND

• 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.

  PMID: 29641619 BACKGROUND

• 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.

  PMID: 30465014 BACKGROUND

• 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.

  PMID: 30548745 BACKGROUND

• 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.

  PMID: 30700636 BACKGROUND

• 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.

  PMID: 30734983 BACKGROUND

• 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.

  PMID: 30999830 BACKGROUND

• 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.

  PMID: 30873751 BACKGROUND

• 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.

  PMID: 31259766 BACKGROUND

• 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.

  PMID: 32311831 BACKGROUND

• 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.

  PMID: 32167992 BACKGROUND

• 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.

  PMID: 32892488 BACKGROUND

• 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.

  PMID: 32773481 BACKGROUND

• Winston A, De Francesco D, Post F, Boffito M, Vera J, Williams I, Anderson J, Mallon PWG, Sabin CA; POPPY Study Group. Comorbidity indices in people with HIV and considerations for coronavirus disease 2019 outcomes. AIDS. 2020 Oct 1;34(12):1795-1800. doi: 10.1097/QAD.0000000000002606.

  PMID: 32732634 BACKGROUND

• Sabin CA, Harding R, Bagkeris E, Nkhoma K, Post FA, Sachikonye M, Boffito M, Anderson J, Mallon PWG, Williams I, Vera J, Johnson M, Babalis D, Winston A. Pain in people living with HIV and its association with healthcare resource use, well being and functional status. AIDS. 2018 Nov 28;32(18):2697-2706. doi: 10.1097/QAD.0000000000002021.

  PMID: 30289809 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood for storage Blood (serum and plasma,) and urine samples will be collected at visits 1 and 3 stored for subsequent projects of the potential pathogenic mechanisms underlying age-related diseases. This will include assessment of vitamin-D and PTH and probably DNA analysis.

MeSH Terms

Conditions

HIV Seropositivity

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Limitations of the POPPY study include the lack of a young HIV-negative group that would facilitate a direct comparison with the younger group of PLWH, and an over representation of white women among the HIV-negative control group. Due to time and budget constraints, this was not feasible. Future studies should consider incorporating such a group in their design in order to understand patterns and behaviours as well as similarities and differences compared with younger PLWH.

Results Point of Contact

• Title: Alan Winston
• Organization: Imperial College London

a.winston@imperial.ac.uk

02033121603

Study Officials

• Caroline Sabine, PhD

  University College, London

  STUDY DIRECTOR

• Alan Winston, MD

  Imperial College London

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2012
• First Posted: November 29, 2012
• Study Start: April 1, 2013
• Primary Completion: January 31, 2018
• Study Completion: March 13, 2023
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1); GB (7)