Clinical trial NCT01737047: The Effects of Ageing on the 'Pharmacokinetic and Clinical Observations in People Over Fifty'
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV Positive
Ageing
Keywords: HIV
Ageing
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
name: Janssen, LP
name: ViiV Healthcare
name: Bristol-Myers Squibb
name: Merck Sharp & Dohme LLC
First posted: 2012-11-29
Enrollment: 1377
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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 we monitor individuals with HIV infection. The results may also assist in the design of future studies for the treatment of diseases associated with ageing.

Detailed description: Multicentre, prospective, observational study over 3 years.

Our study will describe the impact of advancing age on the experience of living with HIV in England and Ireland. To address this we will establish cohorts of HIV-positive people aged \>50 and \<50 years as well as demographically matched HIV-negative people aged \>50 years.

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.

Eligibility criteria: Inclusion Criteria:

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
* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: clinical manifestations of ageing
timeFrame: after 2 years
Secondary outcomes:
measure: variations of anti-retroviral medication associated with age.
timeFrame: after 2 years
measure: to assess the potential impact of age on drug efficacy, drug-drug interactions and co-morbidities.
timeFrame: two years
Other outcomes:
measure: To contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older HIV-positive patients.
timeFrame: after 2 years
Locations:
city: Dublin
country: Ireland
facility: University College Dublin School of Medicine and Medical Sciences, Mater Misericordiae University Hospital
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
state: Sussex
city: London
country: United Kingdom
facility: Homerton University Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Kings College Hospital NHS Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital
city: London
country: United Kingdom
facility: St Marys Hospital NHS Trust
city: London
country: United Kingdom
facility: University College NHS Trust
Study officials:
affiliation: University College, London
name: Caroline Sabine, PhD
role: STUDY_DIRECTOR
affiliation: Imperial College London
name: Alan Winston, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.