A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in England and Ireland
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,377
- 试验地点
- 8
- 主要终点
- The Prevalence of Reported Aches and Pains in the Last Month Across the 3 Age Groups
研究概览
简要总结
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 individuals with HIV infection are monitored. The results may also assist in the design of future studies for the treatment of diseases associated with ageing.
详细描述
Multicentre, prospective, observational study over 3 years.
The study will describe the impact of advancing age on the experience of living with HIV in England and Ireland. To address this cohorts of HIV-positive people aged >50 and <50 years (as well as demographically matched HIV-negative people aged >50 years) will be established.
- 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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •in the opinion of the investigator, those unable or unwilling to comply with the requirements of the study
- •life expectancy less than 6 months
结局指标
主要结局
The Prevalence of Reported Aches and Pains in the Last Month Across the 3 Age Groups
时间窗: after 1 year
The number of patients reporting aches and pains in the 3 arms were used 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.
次要结局
未报告次要终点