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

Study Overview
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Brief Summary
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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 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
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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.

Official Title
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A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in England and Ireland

Conditions
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HIV Positive, Ageing

Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV positive over 50 years of age<br>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<br>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<br>All study subjects will undergo a whole body DEXA scan (dual energy X-ray absorptiometry). at the beginning and end of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, Ageing