Status:
NOT_YET_RECRUITING
A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in South Korea
Lead Sponsor:
Yonsei University
Conditions:
HIV Infection
Eligibility:
MALE
19+ years
Brief Summary
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 th...
Detailed Description
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- in the opinion of the investigator, those unable or unwilling to comply with the requirements of the study
- life expectancy less than 6 months
Key Trial Info
Start Date :
July 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04914130
Start Date
July 1 2021
End Date
May 31 2026
Last Update
June 4 2021
Active Locations (1)
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1
Yonsei University Health System, Severance Hospital
Seoul, South Korea