A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in South Korea

NCT04914130 | Not Yet Recruiting

• 1 other identifier: 4-2019-0853
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

HIV Infection

Keywords

HIV; Aging; Comorbidity; non-communicable diseases

Outcome Measures

Primary Outcomes (1)

• Incidence of serious medical conditions

  • 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.

  2 years

Secondary Outcomes (1)

• Incidence of neurocognitive disease

  2 years

Study Arms (3)

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.

Other: Study specific testing procedures

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

Other: Study specific testing procedures

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.

Other: Study specific testing procedures

Interventions

Study specific testing procedures OTHER

Study specific procedures includes blood sampling, neurocognitive testing, respiratory questionnaire, brain MRI for MRI substudy group, lumbar puncture for MRI substudy group, etc

HIV-negative cohort (n=250); Older HIV-positive cohort (n=500); Younger HIV-positive cohort (n=250)

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: 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.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV infected population who visit the study hospitals (a tertiary care hospital and two secondary care hopitals) and HIV-noninfected population from community

You may qualify if:

• 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

You may not qualify if:

• in the opinion of the investigator, those unable or unwilling to comply with the requirements of the study
• life expectancy less than 6 months

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

* Blood (up to 91ml for the HIV positive group and 73ml in the HIV negative group) * Urine sample (20 - 30 mL) * Stool sample (2 or 3 scoops) * Plus storage samples collected during the lumbar puncture, as described in section 8.5 All samples for storage will be collected at the clinic; however the stool sample may be collected by the subject at home. In this case the subject will be provided with a container without medium and advised to collect two to three scoops of faeces.

MeSH Terms

Conditions

HIV Infections; Noncommunicable Diseases

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jun Yong Choi

  Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Yong Choi

CONTACT

+82-2-2228-1974; seran@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2021
• First Posted: June 4, 2021
• Study Start: July 1, 2021
• Primary Completion: November 30, 2025
• Study Completion: May 31, 2026
• Last Updated: June 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)