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

Ageing Clinical Trial

— POPPY  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01737047
• Other study ID #: CRO: 1992
• Secondary ID: 2012-003581-40
• Status: Active, not recruiting
• Start date: April 1, 2013
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Ageing
• HIV Positive
• HIV Seropositivity

Locations

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

Sponsors (6)

Lead Sponsor	Collaborator
Imperial College London	Bristol-Myers Squibb, Gilead Sciences, Janssen, LP, Merck Sharp & Dohme Corp., ViiV Healthcare

Countries where clinical trial is conducted

Ireland,  United Kingdom, 

References & Publications (17)

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

Outcome

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