Ageing Clinical Trial
— POPPYOfficial title:
A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in England and Ireland
Verified date | July 2021 |
Source | Imperial College London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 1377 |
Est. completion date | December 31, 2021 |
Est. primary completion date | January 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Ireland | University College Dublin School of Medicine and Medical Sciences, Mater Misericordiae University Hospital | Dublin | |
United Kingdom | Royal Sussex County Hospital | Brighton | Sussex |
United Kingdom | Chelsea and Westminster Hospital | London | |
United Kingdom | Homerton University Hospital NHS Foundation Trust | London | |
United Kingdom | Kings College Hospital NHS Trust | London | |
United Kingdom | Royal Free Hospital | London | |
United Kingdom | St Marys Hospital NHS Trust | London | |
United Kingdom | University College NHS Trust | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Bristol-Myers Squibb, Gilead Sciences, Janssen, LP, Merck Sharp & Dohme Corp., ViiV Healthcare |
Ireland, United Kingdom,
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 — View 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 — View 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 cogniti — View 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): — View 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 Pe — View 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 i — View 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 — View 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. — View 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, — View 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):2071-20 — View 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 funct — View 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): — View 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 P — View 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-as — View 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 an — View 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 li — View 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: — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older HIV-positive patients. | Comparison of co-morbidities in relation to age in the three groups: HIV+ve >50, HIV+ve <50 and HIV -ve >50. | after 2 years | |
Primary | clinical manifestations of ageing | 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. White or black african - analysis of demographic details and co-morbidity details collected at each visit. | after 2 years | |
Secondary | variations of anti-retroviral medication associated with age. | Comparison of two groups HIV+ve >50 and HIV+ <50 measurement of blood concentrations of HIV medications | after 2 years | |
Secondary | to assess the potential impact of age on drug efficacy, drug-drug interactions and co-morbidities. | Comparison of three groups HIV+ve >50, HIV+<50 and HIV-ve >50. Drug related side effects collected at each visit and also Co-morbidity details collected at each visit. | two years |
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