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

Brief 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.

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.

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 & 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

Primary Outcome Measures

Name	Time	Method
clinical manifestations of ageing	after 2 years	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.

Secondary Outcome Measures

Name	Time	Method
variations of anti-retroviral medication associated with age.	after 2 years	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.	two years	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.

Locations (8): Royal Sussex County Hospital
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Brighton, Sussex, United Kingdom
Chelsea and Westminster Hospital
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London, United Kingdom
Royal Free Hospital
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London, United Kingdom
University College Dublin School of Medicine and Medical Sciences, Mater Misericordiae University Hospital
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Dublin, Ireland
St Marys Hospital NHS Trust
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London, United Kingdom
Homerton University Hospital NHS Foundation Trust
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London, United Kingdom
University College NHS Trust
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London, United Kingdom
Kings College Hospital NHS Trust
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London, United Kingdom