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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003581-40 | EudraCT Number |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
| Janssen, LP | INDUSTRY |
| ViiV Healthcare | INDUSTRY |
| Bristol-Myers Squibb |
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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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
HIV-negative cohort (n=500):
Exclusion Criteria:
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HIV positive over 50 years HIV positive between 18 and 50 years HIV negative over 50 years White Black african
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Sabine, PhD | University College, London | Study Director |
| Alan Winston, MD | Imperial College London | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University College Dublin School of Medicine and Medical Sciences, Mater Misericordiae University Hospital | Dublin | 7 | Ireland | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27793128 | Background | 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. | |
| 27785907 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | after 1 year |
|
1 year on average
Given the observational and non-interventional nature of this study, the patients underwent aging assessemnt only and no additional information on SAEs was captured for the purpose of the Aging assement.
Also, given the observational and non-interventional nature of this study, no serious, unexpected adverse drug reactions (SUSARs) reporting will be undertaken. As all subjects continue with their general clinical care, which is unaltered during the course of this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. No adverse events have been reported for this group. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan Winston | Imperial College London | 02033121603 | 1603 | a.winston@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2017 | Jun 19, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
| Royal Sussex County Hospital |
| Brighton |
| Sussex |
| BN2 5BE |
| United Kingdom |
| Homerton University Hospital NHS Foundation Trust | London | E9 6SR | United Kingdom |
| Royal Free Hospital | London | NW3 2QG | United Kingdom |
| Kings College Hospital NHS Trust | London | SE5 9RJ | United Kingdom |
| Chelsea and Westminster Hospital | London | SW10 9NH | United Kingdom |
| St Marys Hospital NHS Trust | London | W2 1NY | United Kingdom |
| University College NHS Trust | London | WC1E 6JB | United Kingdom |
| 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. |
| 29746638 | 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. |
| 29641619 | 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. |
| 30465014 | 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. |
| 30548745 | 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. |
| 30700636 | 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. |
| 30734983 | 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. |
| 30999830 | 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. |
| 30873751 | 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. |
| 31259766 | 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. |
| 32311831 | 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. |
| 32167992 | 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. |
| 32892488 | 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. |
| 32773481 | 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. |
| 32732634 | 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. |
| 30289809 | Result | 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. |
| BG001 | 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 |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| HIV Positive Under the Age of 50 (Median Age 43) |
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 |
| OG002 | HIV Negative Over the Age of 50 (Median Age 58) | All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study. |
|
|
| 0 |
| 699 |
| 0 |
| 699 |
| 0 |
| 699 |
| EG001 | 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. No adverse events have been reported for this group. | 0 | 379 | 0 | 379 | 0 | 379 |
| EG002 | 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. No adverse events have been reported for this group. | 0 | 304 | 0 | 304 | 0 | 304 |
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |