A Prospective, Observational Study to Examine the Effects of Ageing on the 'Pharmacokinetic and Clinical Observations in People Over Fifty'
This trial is active, not recruiting.
|Conditions||hiv positive, ageing|
|Sponsor||Imperial College London|
|Start date||April 2013|
|End date||December 2017|
|Trial size||1376 participants|
|Trial identifier||NCT01737047, 2012-003581-40, CRO: 1992|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Dublin, Ireland||University College Dublin School of Medicine and Medical Sciences, Mater Misericordiae University Hospital||no longer recruiting|
|Brighton, United Kingdom||Royal Sussex County Hospital||no longer recruiting|
|London, United Kingdom||Homerton University Hospital NHS Foundation Trust||no longer recruiting|
|London, United Kingdom||Royal Free Hospital||no longer recruiting|
|London, United Kingdom||Kings College Hospital NHS Trust||no longer recruiting|
|London, United Kingdom||Chelsea and Westminster Hospital||no longer recruiting|
|London, United Kingdom||St Marys Hospital NHS Trust||no longer recruiting|
|London, United Kingdom||University College NHS Trust||no longer recruiting|
clinical manifestations of ageing
time frame: after 2 years
variations of anti-retroviral medication associated with age.
time frame: after 2 years
to assess the potential impact of age on drug efficacy, drug-drug interactions and co-morbidities.
time frame: two years
All participants at least 18 years old.
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
|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|
|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.|
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