A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in South Korea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of serious medical conditions
研究概览
简要总结
This study is to investigate how HIV affects ageing process, especially in Asian populations in various organ system, including brain, kidney, liver and etc. There are some articles that describing the ageing process in PWHIV, but there has been a limited number of articles that comparing ageing process by ethnicities. And the endpoints of those limited number of articles are including more general variables like all-cause mortality, detectable viral load and days to regimen changes. There is no extensive study of ageing by function of each organ system in Asia. This proposal contains more specific observation points on function/dysfxn of each organ system, especially for brain function as an MRI sub-study. The MRI sub-study has a large portion of this proposal as analysis of the neurocognitive function in HIV ageing, which has not been extensively studied in Asia, nor it hasn't been compared to other ethnic groups.
With this proposal, we can see if there are differences by ethnicities compared to POPPY/COBRA results, and even if there are no differences, we can increase the number and diversify of cohort subjects and strengthen the level of evidence of cohort study.
Our study, by enrolling both younger and older HIV-positive individuals with a matched HIV-negative control group, will be in the unique position to determine the effects of ageing and HIV status on chronic HIV-infection. In addition, results from this study will be well placed to assist in informing future HIV treatment guidelines on the monitoring of chronic HIV infection in older subjects and assisting in the design of future interventional studies for the treatment of age associated co-morbidities.
详细描述
Study Design: Multicentre, prospective, observational study over 3 years. Our study will describe the impact of advancing age on the experience of living with HIV in South Korea. 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. Although 2 years of follow up duration is short period to evaluate the effect of aging, this period could give us an insights for necessity of longer follow up study.
Setting:
Subjects will be recruited from three clinics: Severance Hospital; Seoul Medical Center; National Medical Center.
Number of Patients: Older HIV-positive cohort (n=500); Younger HIV-positive cohort (n=250); HIV-negative cohort (n=250). We arbitrarily decided these numbers of subjects considering the numbers of subjects of POPPY-UK study (1000, 500, and 500 subjects, respectively), feasibility of recruitment, and possible budget. Our choice of sample size is largely pragmatic, reflecting the number of older patients receiving care and the proportion that are expected to participate. Detailed sample size calculations are difficult given the wide range of topics and methodological approaches proposed.
Sample size was chosen pragmatically based on
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Older HIV-positive cohort (n=500):
- •documented HIV infection
- •age >50 years at study entry
- •Korean ethnicity
- •likely route of HIV acquisition via sexual exposure by male to male exposure
- •able to comprehend study patient information leaflet.
- •Virologically suppressed subjects Subjects with primary HIV infection are eligible and investigators are encouraged to recruit such subjects. Our target population (those infected with HIV via sexual routes of men who have sex with men) has been chosen as this group represent the vast majority of older HIV-positive individuals attending for care in Korea; analyses of other groups (e.g. injection drug users, those infected through blood/blood products and transgender individuals), who may have very different needs and outcomes, would likely be under-powered.
- •Younger HIV-positive cohort (n=250):
- •documented HIV infection
- •age <50 at study entry*
- •Korean ethnicity
- •likely route of HIV acquisition via sexual exposure by male to male exposure
- •able to comprehend study patient information leaflet * this group will comprise of at least 70 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=250):
- •documented negative HIV test at screening
- •age >50 years at study entry
- •Korean ethnicity
- •self reported sexual preferences of men who have sex with men
- •To enroll matched control, we will try to match age, sexual orientation, and participating clinic.
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
Incidence of serious medical conditions
时间窗: 2 years
• the incidence and presenting features of serious medical conditions such as coronary heart disease, stroke, renal disease, cancer and liver disease etc. thd diagnosis of serious medical conditions will be defined by the latest clinical diagnostic criteria for each serious medical conditions. For example, Coronary heart disease (CHD)/ Myocardial infarction (MI) Definitive MI: Evolving diagnostic ECG Or Diagnostic biomarkers Probable MI: Positive ECG findings plus cardiac symptoms or signs plus missing biomarkers, Or Positive ECG findings plus equivocal biomarkers. Possible MI: Equivocal biomarkers plus nonspecific ECG findings, Or Equivocal biomarkers plus cardiac symptoms or signs, Or Missing biomarkers plus positive ECG.
次要结局
- Incidence of neurocognitive disease(2 years)