FrailtyHIV-AGE40NCT07453303
Comprehensive Geriatric Assessment in Adults Aged 40 Years and Older Living With HIV
An observational study of Frailty and Sarcopenia, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
People living with HIV are experiencing longer life expectancy due to effective antiretroviral therapy; however, they may develop age-related conditions earlier than the general population. Read more about this study
- Who is it for?
- Ages 40 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Frailty, Sarcopenia
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2026to 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 40 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults aged 40 years and older living with HIV who are followed in the infectious diseases outpatient clinic and age- and sex-matched healthy controls recruited from the community or hospital staff.
Who may be able to join
- Age ≥40 years
- Confirmed diagnosis of HIV infection (HIV group)
- Stable antiretroviral therapy for at least 6 months (HIV group)
- HIV-negative status confirmed by medical history or testing (control group)
- Ability to provide informed consent
Who cannot join
- Acute infection or hospitalization within the previous 4 weeks
- Known active malignancy under treatment
- Severe psychiatric disorder interfering with assessment
- Severe cognitive impairment preventing participation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Tekirdağ Dr. İsmail Fehmi Cumalıoğlu City Hospital
Tekirdağ
About this study
Official title: Prospective Comparative Evaluation of Frailty, Sarcopenia, Nutritional Status, Cognitive Function, and Functional Performance in Adults Aged 40 Years and Older Living With HIV and Age- and Sex-Matched Healthy Controls
People living with HIV are experiencing longer life expectancy due to effective antiretroviral therapy; however, they may develop age-related conditions earlier than the general population. This prospective observational study aims to evaluate frailty, sarcopenia, nutritional status, cognitive function, and functional performance in adults aged 40 years and older living with HIV and to compare them with age- and sex-matched healthy controls.
Read the detailed description
With the widespread use of antiretroviral therapy, individuals living with HIV have achieved near-normal life expectancy. However, emerging evidence suggests that chronic inflammation, immune activation, and long-term treatment exposure may contribute to accelerated or premature aging processes. Frailty, sarcopenia, cognitive decline, and functional impairment have been increasingly reported in middle-aged and older adults living with HIV.
This prospective observational cohort study aims to perform a comprehensive geriatric assessment in adults aged 40 years and older living with HIV and to compare the findings with age- and sex-matched healthy controls. The assessment will include evaluation of frailty, sarcopenia, nutritional status, cognitive function, and functional performance using standardized clinical tools.
The primary objective is to determine the prevalence and characteristics of geriatric vulnerabilities in adults aged ≥40 years living with HIV. Secondary objectives include identifying factors associated with frailty and functional impairment in this population.
- Conditions
- Frailty, Sarcopenia
- Keywords
- HIV Infections
- Medical subject headings
- Frailty, Sarcopenia, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HIV-Positive Participants | Adults aged 40 years and older with confirmed HIV infection receiving antiretroviral therapy and undergoing comprehensive geriatric assessment. | |
| Healthy Controls | Age- and sex-matched HIV-negative adults aged 40 years and older undergoing the same comprehensive geriatric assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Frailty
Frailty status assessed using a validated frailty assessment tool and defined according to established criteria in adults aged 40 years and older living with HIV and age- and sex-matched healthy controls.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Apr 2026
- Primary completion31 May 2026
- Study completion31 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- İrem Utku, Principal investigator, Tekirdağ Doktor İsmail Fehmi Cumalıoğlu City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453303
- Sponsor's protocol ID
- TKD-GER-2026-01
- Acronym
- HIV-AGE40
- Status last verified
- Nov 2026
- First submitted
- 2 Mar 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparative Evaluation of Frailty, Sarcopenia, Nutritional Status, Cognitive Function, and Functional Performance in Adults Aged 40 Years and Older Living With HIV and Age- and Sex-Matched Healthy Controls
- ClinicalTrials.gov ID
- NCT07453303
- Acronym / sponsor ID
- HIV-AGE40 / TKD-GER-2026-01
- Conditions
- Frailty, Sarcopenia
- Keywords
- HIV Infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 May 2026 (actual)
- Study completion
- 31 May 2026 (actual)
- First posted
- 5 Mar 2026 (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.
People living with HIV are experiencing longer life expectancy due to effective antiretroviral therapy; however, they may develop age-related conditions earlier than the general population. This prospective observational study aims to evaluate frailty, sarcopenia, nutritional status, cognitive function, and functional performance in adults aged 40 years and older living with HIV and to compare them with age- and sex-matched healthy controls.
Detailed description
With the widespread use of antiretroviral therapy, individuals living with HIV have achieved near-normal life expectancy. However, emerging evidence suggests that chronic inflammation, immune activation, and long-term treatment exposure may contribute to accelerated or premature aging processes. Frailty, sarcopenia, cognitive decline, and functional impairment have been increasingly reported in middle-aged and older adults living with HIV.
This prospective observational cohort study aims to perform a comprehensive geriatric assessment in adults aged 40 years and older living with HIV and to compare the findings with age- and sex-matched healthy controls. The assessment will include evaluation of frailty, sarcopenia, nutritional status, cognitive function, and functional performance using standardized clinical tools.
The primary objective is to determine the prevalence and characteristics of geriatric vulnerabilities in adults aged ≥40 years living with HIV. Secondary objectives include identifying factors associated with frailty and functional impairment in this population.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIV-Positive Participants | – | –Adults aged 40 years and older with confirmed HIV infection receiving antiretroviral therapy and undergoing comprehensive geriatric assessment. |
| Healthy Controls | – | –Age- and sex-matched HIV-negative adults aged 40 years and older undergoing the same comprehensive geriatric assessment. |
Who may qualify
- Ages
- 40 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 40 years and older living with HIV who are followed in the infectious diseases outpatient clinic and age- and sex-matched healthy controls recruited from the community or hospital staff.
Key inclusion criteria (5 listed)
- Age ≥40 years
- Confirmed diagnosis of HIV infection (HIV group)
- Stable antiretroviral therapy for at least 6 months (HIV group)
- HIV-negative status confirmed by medical history or testing (control group)
- Ability to provide informed consent
Key exclusion criteria (4 listed)
- Acute infection or hospitalization within the previous 4 weeks
- Known active malignancy under treatment
- Severe psychiatric disorder interfering with assessment
- Severe cognitive impairment preventing participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of Frailty
Time frame: Baseline
Frailty status assessed using a validated frailty assessment tool and defined according to established criteria in adults aged 40 years and older living with HIV and age- and sex-matched healthy controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
İrem Utku principal investigator
Tekirdağ Doktor İsmail Fehmi Cumalıoğlu City Hospital
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 Frailty and Sarcopenia, run by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 5 Nov 2026. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Frailty (time frame: Baseline). 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 5 Nov 2026.