HIV InfectionNCT04914130
A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in South Korea
An observational study of HIV Infection, run by Yonsei University at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV Infection
- What is being tested?
- Study specific testing procedures
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2021to 31 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Show all 19Show fewer
- 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.
Who cannot join
- in the opinion of the investigator, those unable or unwilling to comply with the requirements of the study
- life expectancy less than 6 months
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
Jun Yong Choi, +82-2-2228-1974, seran@yuhs.ac
About this study
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.
Read the 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 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
- the number of HIV pts of three participating hospitals (NMC≒1200, severance≒700, SMC≒300) 2) feasibility of recruitment 3) and possible budget
- Screening Each subject must sign an Informed Consent Form prior to the conduct of any screening procedures. The purpose of the screening visit is to evaluate that the subject meets study inclusion/exclusion criteria. HIV antibody testing will be undertaken for subjects undergoing screening for the HIV-negative cohort.
- Visit 1 (Baseline visit) The baseline visit will perform evaluations as per schedule of visits. The baseline visit is expected to take 1-2 hours; if possible the subject should attend fasted. The following information will be collected:
- Baseline demographics: age; sex; sexual orientation; date of birth; education.
- Socio-economic status: employment; household dependents; household income; housing.
- Quality of life questionnaire.
- Anthropometrics: height; weight; body mass index; waist circumference.
- Lifestyle factors: current/past cigarette smoking; alcohol use; recreational drug use.
- Full clinical history: to include cardiovascular events (hypertension, myocardial infarction, angina or acute coronary syndromes, cardiogenic arrhythmias, coronary artery stenting/bypass grafting, peripheral vascular disease), renal failure, liver failure, diabetes, malignancies, falls, fractures, joint disease or joint replacements.
- Simple measurement of walking speed over a distance of 15 feet (457 cms).
- Blood pressure will be estimated using an automated device.
- Family medical history: to include any cardiovascular disease, type 2 diabetes mellitus, malignancies, mental illness, dementia or Alzheimer's disease, parental hip fractures.
- Current and recent (over past 12 months) antiretroviral use: type of antiretroviral; start/stop dates; dose; frequency of dosing; side effects; reasons for prior changes/discontinuations.
- Duration of HIV infection and date of HIV-seroconversion if known
- Adherence assessment
- Use of any other medications (including, but not limited to, anti-hypertensives, anti-depressants, vitamin D and/or calcium replacement therapy, lipid-lowering drugs, regular use of analgesics, herbal remedies, other over-the-counter drugs): type of drug; start/stop dates; dose; frequency of dosing; side effects.
- Neurocognitive function: specific memory and cognitive testing assessing cortical and sub-cortical function.
- Pain assessment: regional and widespread pain collected using a validated mannequin; nature of onset; duration; intensity; resulting disability
- Falls risk (study questionnaire)
- Fracture risk (study questionnaire)
- Frailty assessment (study questionnaire)
- Most recent laboratory tests will be recorded (assessed in the HIV-negative cohort): renal, liver, lipid and bone profiles, glucose, full blood count, sexual health screen, hepatitis C serology. These tests should have been performed within a year of the clinic visit.
- Blood (serum, plasma, and PBMC) and urine samples: stored for subsequent projects of the potential pathogenic mechanisms underlying age-related diseases. This will include assessment of vitamin-D and PTH
- Blood (plasma) will be collected for pharmacokinetic analysis (including but not limited to antiretroviral drug exposure)
- Visit 2 (1st year follow up visit) This follow up visit will be performed as per schedule of visits. Only HIV-positive cohorts will be invited to undertake this visit with this visit expected to take 1 hour. The following will be assessed:
- Changes to lifestyle and socio-economic status over the past year.
- Significant clinical events occurring over the past year: dates of onset and resolution, use of medical services, changes to antiretroviral and other medications, and resulting ongoing health concerns.
- Blood pressure will be estimated using an automated device.
- Details of access to health care services over the past year: visits to hospital, and medical investigations performed (information obtained by direct questioning and through medical records review).
- Most recent laboratory tests will be recorded: renal, liver, lipid and bone profiles, glucose, full blood count, sexual health screen, hepatitis C serology (Within the past year)
- Concomitant medications: start/stop dates; dose; dosing frequency; side effects.
- Fracture occurrence and fracture risk (see study questionnaire in appendix 1)
- Regional and widespread pain.
3a Visit 2 (1st year follow up visit) for HIV negative participants.
These participants will be contacted by telephone by arrangement with the study nurse. They may be asked to attend the clinic in order to facilitate this visit.
Details of any changes in circumstances or illnesses and medication will be documented.
4 Visit 3 (2nd year follow up visit)
This follow up visit will be performed as per schedule of visits (2.0).
This visit is expected to take 1-2 hours; if possible the subject should attend fasted. The following information will be collected:
- Changes to lifestyle and socio-economic status over the past year.
- Significant clinical events occurring over the past year: dates of onset and resolution, use of medical services, treatments, and resulting ongoing health concerns.
- Details of access to health care services over the past year: visits to hospital, and medical investigations performed (information obtained by direct questioning and through medical records review).
- Simple measurement of walking speed over a distance of 15 feet (457 cms).
- Blood pressure will be estimated using an automated device.
- Concomitant medications: start/stop dates; dose; dosing frequency; side effects.
- Fracture occurrence and fracture risk (see study questionnaire in appendix 1).
- Neurocognitive function: specific memory and cognitive testing assessing cortical and sub-cortical function.
- Respiratory questionnaire
- Regional and widespread pain.
- Quality of life questionnaire.
- Most recent laboratory tests will be recorded (assessed in the HIV-negative cohort): renal, liver, lipid and bone profiles, glucose, full blood count, sexual health screen, hepatitis C serology (within the previous year)
- Blood (serum, plasma, and PBMC) and urine samples: stored for subsequent projects of the potential pathogenic mechanisms underlying age-related diseases. This will included assessment of vitamin-D and PTH
- Blood (plasma) will be collected for pharmacokinetic analysis (including but not limited to antiretroviral drug exposure) 5 MRI Sub-study
- A sub-study will be conducted at the Severance Hospital site for participants equal to and over the age of 50 both HIV +ve (n=20) and HIV -ve (n=20). Matching criteria would be age, sexual orientation, and socio-economic status (i.e. insurance coverage status).
The study will comprise of three study visits:
- Screening
- Visit 1 (Baseline visit)
- Visit 2 (Follow up visit after 2 years) The study visits will include the following assessments Blood (serum, plasma, and PBMC), urine, CSF and stool samples stored for future analysis (genetic polymorphism associated with neurocognitive dysfunction, CSF concentrations of antiretrovirals, biomarkers such as CSF neurofilament light (NFL) chain concentration, microbiome of stool, etc) Neurocognitive testing Lumbar puncture examination Cerebral MRI scan Respiratory function and cardiac function assessments
6 Withdrawal of subjects from study
Subjects are allowed to decline further participation in the study at any time. This will not affect their future care.
7 Study timelines
Recruitment and baseline visits (visit 1) will take place from months 1-12, with annual visits from months 13-24 (visit 2) and 25-36 (visit 3)
- Conditions
- HIV Infection
- Being tested
- Study specific testing procedures
- Keywords
- HIV, Aging, Comorbidity, non-communicable diseases
- Medical subject headings
- HIV Infections, Noncommunicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study specific testing proceduresOther
Study specific procedures includes blood sampling, neurocognitive testing, respiratory questionnaire, brain MRI for MRI substudy group, lumbar puncture for MRI substudy group, etc
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: 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. Receives: Other: Study specific testing procedures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
Incidence of neurocognitive disease
Incidence of neurocognitive disease The incidence of neurocognitive disease will be determined by following assessment.
- A short patient questionnaire
- Staff administered neurocognitive testing
- Computerised cognitive testing
Subjects will complete a detailed neuropsychological assessment measuring their functioning in cognitive domains known to be commonly affected by HIV. The Frascati criteria were used for diagnosing HAND, classified into asymptomatic neurocognitive impairment (ANI), minor neurocognitive disorder (MND) and HIV-associated dementia
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study startJul 2021 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion31 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Yong Choi, Principal investigator, Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914130
- Sponsor's protocol ID
- 4-2019-0853
- Status last verified
- May 2021
- First submitted
- 24 May 2021
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study to Examine the Effects of Ageing on the Clinical Outcomes of People Living With HIV in South Korea
- ClinicalTrials.gov ID
- NCT04914130
- Acronym / sponsor ID
- 4-2019-0853
- Conditions
- HIV Infection
- Keywords
- HIV, Aging, Comorbidity, non-communicable diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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
- the number of HIV pts of three participating hospitals (NMC≒1200, severance≒700, SMC≒300) 2) feasibility of recruitment 3) and possible budget
- Screening Each subject must sign an Informed Consent Form prior to the conduct of any screening procedures. The purpose of the screening visit is to evaluate that the subject meets study inclusion/exclusion criteria. HIV antibody testing will be undertaken for subjects undergoing screening for the HIV-negative cohort.
- Visit 1 (Baseline visit) The baseline visit will perform evaluations as per schedule of visits. The baseline visit is expected to take 1-2 hours; if possible the subject should attend fasted. The following information will be collected:
- Baseline demographics: age; sex; sexual orientation; date of birth; education.
- Socio-economic status: employment; household dependents; household income; housing.
- Quality of life questionnaire.
- Anthropometrics: height; weight; body mass index; waist circumference.
- Lifestyle factors: current/past cigarette smoking; alcohol use; recreational drug use.
- Full clinical history: to include cardiovascular events (hypertension, myocardial infarction, angina or acute coronary syndromes, cardiogenic arrhythmias, coronary artery stenting/bypass grafting, peripheral vascular disease), renal failure, liver failure, diabetes, malignancies, falls, fractures, joint disease or joint replacements.
- Simple measurement of walking speed over a distance of 15 feet (457 cms).
- Blood pressure will be estimated using an automated device.
- Family medical history: to include any cardiovascular disease, type 2 diabetes mellitus, malignancies, mental illness, dementia or Alzheimer's disease, parental hip fractures.
- Current and recent (over past 12 months) antiretroviral use: type of antiretroviral; start/stop dates; dose; frequency of dosing; side effects; reasons for prior changes/discontinuations.
- Duration of HIV infection and date of HIV-seroconversion if known
- Adherence assessment
- Use of any other medications (including, but not limited to, anti-hypertensives, anti-depressants, vitamin D and/or calcium replacement therapy, lipid-lowering drugs, regular use of analgesics, herbal remedies, other over-the-counter drugs): type of drug; start/stop dates; dose; frequency of dosing; side effects.
- Neurocognitive function: specific memory and cognitive testing assessing cortical and sub-cortical function.
- Pain assessment: regional and widespread pain collected using a validated mannequin; nature of onset; duration; intensity; resulting disability
- Falls risk (study questionnaire)
- Fracture risk (study questionnaire)
- Frailty assessment (study questionnaire)
- Most recent laboratory tests will be recorded (assessed in the HIV-negative cohort): renal, liver, lipid and bone profiles, glucose, full blood count, sexual health screen, hepatitis C serology. These tests should have been performed within a year of the clinic visit.
- Blood (serum, plasma, and PBMC) and urine samples: stored for subsequent projects of the potential pathogenic mechanisms underlying age-related diseases. This will include assessment of vitamin-D and PTH
- Blood (plasma) will be collected for pharmacokinetic analysis (including but not limited to antiretroviral drug exposure)
- Visit 2 (1st year follow up visit) This follow up visit will be performed as per schedule of visits. Only HIV-positive cohorts will be invited to undertake this visit with this visit expected to take 1 hour. The following will be assessed:
- Changes to lifestyle and socio-economic status over the past year.
- Significant clinical events occurring over the past year: dates of onset and resolution, use of medical services, changes to antiretroviral and other medications, and resulting ongoing health concerns.
- Blood pressure will be estimated using an automated device.
- Details of access to health care services over the past year: visits to hospital, and medical investigations performed (information obtained by direct questioning and through medical records review).
- Most recent laboratory tests will be recorded: renal, liver, lipid and bone profiles, glucose, full blood count, sexual health screen, hepatitis C serology (Within the past year)
- Concomitant medications: start/stop dates; dose; dosing frequency; side effects.
- Fracture occurrence and fracture risk (see study questionnaire in appendix 1)
- Regional and widespread pain.
3a Visit 2 (1st year follow up visit) for HIV negative participants.
These participants will be contacted by telephone by arrangement with the study nurse. They may be asked to attend the clinic in order to facilitate this visit.
Details of any changes in circumstances or illnesses and medication will be documented.
4 Visit 3 (2nd year follow up visit)
This follow up visit will be performed as per schedule of visits (2.0).
This visit is expected to take 1-2 hours; if possible the subject should attend fasted. The following information will be collected:
- Changes to lifestyle and socio-economic status over the past year.
- Significant clinical events occurring over the past year: dates of onset and resolution, use of medical services, treatments, and resulting ongoing health concerns.
- Details of access to health care services over the past year: visits to hospital, and medical investigations performed (information obtained by direct questioning and through medical records review).
- Simple measurement of walking speed over a distance of 15 feet (457 cms).
- Blood pressure will be estimated using an automated device.
- Concomitant medications: start/stop dates; dose; dosing frequency; side effects.
- Fracture occurrence and fracture risk (see study questionnaire in appendix 1).
- Neurocognitive function: specific memory and cognitive testing assessing cortical and sub-cortical function.
- Respiratory questionnaire
- Regional and widespread pain.
- Quality of life questionnaire.
- Most recent laboratory tests will be recorded (assessed in the HIV-negative cohort): renal, liver, lipid and bone profiles, glucose, full blood count, sexual health screen, hepatitis C serology (within the previous year)
- Blood (serum, plasma, and PBMC) and urine samples: stored for subsequent projects of the potential pathogenic mechanisms underlying age-related diseases. This will included assessment of vitamin-D and PTH
- Blood (plasma) will be collected for pharmacokinetic analysis (including but not limited to antiretroviral drug exposure) 5 MRI Sub-study
- A sub-study will be conducted at the Severance Hospital site for participants equal to and over the age of 50 both HIV +ve (n=20) and HIV -ve (n=20). Matching criteria would be age, sexual orientation, and socio-economic status (i.e. insurance coverage status).
The study will comprise of three study visits:
- Screening
- Visit 1 (Baseline visit)
- Visit 2 (Follow up visit after 2 years) The study visits will include the following assessments Blood (serum, plasma, and PBMC), urine, CSF and stool samples stored for future analysis (genetic polymorphism associated with neurocognitive dysfunction, CSF concentrations of antiretrovirals, biomarkers such as CSF neurofilament light (NFL) chain concentration, microbiome of stool, etc) Neurocognitive testing Lumbar puncture examination Cerebral MRI scan Respiratory function and cardiac function assessments
6 Withdrawal of subjects from study
Subjects are allowed to decline further participation in the study at any time. This will not affect their future care.
7 Study timelines
Recruitment and baseline visits (visit 1) will take place from months 1-12, with annual visits from months 13-24 (visit 2) and 25-36 (visit 3)
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Older HIV-positive cohort (n=500) | – | Other: Study specific testing procedures* 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) | – | Other: Study specific testing procedures* 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) | – | Other: Study specific testing procedures* 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (19 listed)
- Older HIV-positive cohort (n=500):
- Younger HIV-positive cohort (n=250):
- HIV-negative cohort (n=250):
- To enroll matched control, we will try to match age, sexual orientation, and participating clinic.
Key exclusion criteria (2 listed)
- in the opinion of the investigator, those unable or unwilling to comply with the requirements of the study
- life expectancy less than 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study specific testing proceduresStudy specific procedures includes blood sampling, neurocognitive testing, respiratory questionnaire, brain MRI for MRI substudy group, lumbar puncture for MRI substudy group, etc | Other | HIV-negative cohort (n=250), Older HIV-positive cohort (n=500), Younger HIV-positive cohort (n=250) |
Primary outcome
Incidence of serious medical conditions
Time frame: 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.
1 secondary outcome
Incidence of neurocognitive disease
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Yong Choi principal investigator
Division of Infectious Diseases, Department of Internal Medicine, Severance Hospital, Yonsei University Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV Infection, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Yong Choi (+82-2-2228-1974, seran@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious medical conditions (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.