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
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.
| Estimated Enrollment: | 2000 |
| Study Start Date: | April 2013 |
| Estimated Study Completion Date: | May 2016 |
| Estimated Primary Completion Date: | May 2016 (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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
HIV positive over 50 years HIV positive between 18 and 50 years HIV negative over 50 years White Black african
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
| Contact: Andrew Whitehouse, MB BS | 00442075943413 | a.whitehouse@imperial.ac.uk | |
| Contact: Alan `Winston, MD | 004420 3312 1603 | a.winston@imperial.ac.uk |
| Ireland | |
| University College Dublin School of Medicine and Medical Sciences, Mater Misericordiae University Hospital | Not yet recruiting |
| Dublin, Ireland, 7 | |
| Contact: Liz Coghlan 0 353 1 7164599 Elizabeth.coghlan@ucd.ie | |
| Contact: Patrick Mallon, MD 00353 1 7164495 paddy.mallon@ucd.ie | |
| Principal Investigator: Paddy Mallon, MD | |
| United Kingdom | |
| Royal Sussex County Hospital | Not yet recruiting |
| Brighton, Sussex, United Kingdom, BN2 5BE | |
| Contact: Nicky Perry 01273 523079 Nicky.Perry@bsuh.nhs.uk | |
| Contact: Martin Fisher 01273 664731 Martin.Fisher@bsuh.nhs.uk | |
| Principal Investigator: Martin Fisher, MD | |
| Chelsea and Westminster Hospital | Not yet recruiting |
| London, United Kingdom, SW10 9NH | |
| Contact: Chris Higgs 02033156135 Chris.higgs@chelwest.nhs.uk | |
| Contact: Marta Boffito, MD 020331556507 marta.boffito@chelwest.nhs.uk | |
| Principal Investigator: Marta Bofito, MD | |
| Homerton University Hospital NHS Foundation Trust | Not yet recruiting |
| London, United Kingdom, E9 6SR | |
| Contact: Sifiso Mguni 0208510 5117 Sifiso.mguni@homerton.nhs.uk | |
| Contact: Jane Anderson, MD 020 8510 7438 janderson@nhs.net | |
| Principal Investigator: Jane Anderson, MD | |
| Kings College Hospital NHS Trust | Not yet recruiting |
| London, United Kingdom, SE5 9RJ | |
| Contact: Lucy Campbell 0207 848 5776 Lucy.campbell@kcl.ac.uk | |
| Contact: Frank Post, MD 0207 848 5779/5776 Frank.post@kcl.ac.uk | |
| Principal Investigator: Frank Post, MD | |
| St Marys Hospital NHS Trust | Recruiting |
| London, United Kingdom, W2 1NY | |
| Contact: Alan Winston, MD 020 3312 1603 a.winston@imperial.ac.uk | |
| Contact: Kenneth Legg 020 3312 1464 k.legg@imperial.ac.uk | |
| Principal Investigator: Alan Winston, MD | |
| University College NHS Trust | Not yet recruiting |
| London, United Kingdom, WC1E 6JB | |
| Contact: Ana Milinkovic 020 3108 2100 a.milinkovic@ucl.ac.uk | |
| Contact: Ian Williams, MD 020 3108 2078 Ian.williams@ucl.ac.uk | |
| Principal Investigator: Ian Williams, MD | |
| Study Director: | Caroline Sabine, PhD | University College, London | |
| Study Director: | Alan Winston, MD | Imperial College London |
More Information
No publications provided
| 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: | August 1, 2013 |
| 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 Immune System Diseases Immunologic Deficiency Syndromes Lentivirus Infections |
RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Virus Diseases |
ClinicalTrials.gov processed this record on February 26, 2015