A Prospective, Observational Study to Examine the Effects of Ageing on the 'Pharmacokinetic and Clinical Observations in People Over Fifty' (POPPY)
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Purpose
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.
| Condition |
|---|
|
HIV Positive Ageing |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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 manifestations of ageing [ Time Frame: after 2 years ] [ Designated as safety issue: No ]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.
- variations of anti-retroviral medication associated with age. [ Time Frame: after 2 years ] [ Designated as safety issue: No ]Comparison of two groups HIV+ve >50 and HIV+ <50 measurement of blood concentrations of HIV medications
- to assess the potential impact of age on drug efficacy, drug-drug interactions and co-morbidities. [ Time Frame: two years ] [ Designated as safety issue: No ]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.
- To contribute to the development and implementation of evidence-based recommendations for the clinical monitoring of older HIV-positive patients. [ Time Frame: after 2 years ] [ Designated as safety issue: No ]Comparison of co-morbidities in relation to age in the three groups: HIV+ve >50, HIV+ve <50 and HIV -ve >50.
Biospecimen Retention: Samples With DNA
| Enrollment: | 1374 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | August 2018 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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.
|
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.
- To analyse the incidence and outcomes of co-morbidities in older-HIV-positive people and their relationship with demographic/clinical factors.
- 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.
- 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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01737047
| Ireland | |
| University College Dublin School of Medicine and Medical Sciences, Mater Misericordiae University Hospital | |
| Dublin, Ireland, 7 | |
| United Kingdom | |
| Royal Sussex County Hospital | |
| Brighton, Sussex, United Kingdom, BN2 5BE | |
| Homerton University Hospital NHS Foundation Trust | |
| London, United Kingdom, E9 6SR | |
| Royal Free Hospital | |
| London, United Kingdom, NW3 2QG | |
| Kings College Hospital NHS Trust | |
| London, United Kingdom, SE5 9RJ | |
| Chelsea and Westminster Hospital | |
| London, United Kingdom, SW10 9NH | |
| St Marys Hospital NHS Trust | |
| London, United Kingdom, W2 1NY | |
| University College NHS Trust | |
| London, United Kingdom, WC1E 6JB | |
| Study Director: | Caroline Sabine, PhD | University College, London |
| Study Director: | Alan Winston, MD | Imperial College London |
More Information
| Responsible Party: | Imperial College London |
| ClinicalTrials.gov Identifier: | NCT01737047 History of Changes |
| Other Study ID Numbers: | CRO: 1992 2012-003581-40 |
| Study First Received: | November 1, 2012 |
| Last Updated: | February 19, 2016 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Imperial College London:
|
HIV Ageing |
Additional relevant MeSH terms:
|
HIV Seropositivity HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral |
Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Integrase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 28, 2016