ClinicalTrials.gg
CompletedNCT07453303HIV-AGE40Updated Nov 5, 2026

Comprehensive Geriatric Assessment in Adults Aged 40 Years and Older Living With HIV

An observational study in Frailty and Sarcopenia, sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 40 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Observational

Updated Nov 5, 2026Now CompletedFirst site in Turkey (Türkiye)+6 moreGo to Updates ↓
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
103
Ages
40 Years to 99 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Frailty
  • Sarcopenia

Keywords

  • HIV Infections
03

In context

Frailty

1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.

This study's enrollment of 103 is below the median of 225 across 493 observational studies indexed under Frailty.

Browse Frailty studies →

Lead sponsor

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital is the lead sponsor of 41 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Nov 5, 2026. See what changed

Ages eligible
40 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥40 years
  • Confirmed diagnosis of 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

Exclusion criteria

Exclusion Criteria:

  • Acute infection or hospitalization within the previous 4 weeks
  • Known active under treatment
  • Severe psychiatric disorder interfering with assessment
  • Severe cognitive impairment preventing participation
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
103 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

07

Study locations

1 site
  • Tekirdağ Dr. İsmail Fehmi Cumalıoğlu City Hospital
    Tekirdağ, Turkey (Türkiye)
08

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Completed
changed Nov 5, 2026
Sites
1 site added — first site in Turkey (Türkiye)
Show site
  • Tekirdağ Dr. İsmail Fehmi Cumalıoğlu City Hospital · Tekirdağ, Turkey (Türkiye)
Nov 5, 2026
Start date
Mar 2, 2026→Apr 1, 2026 (actual)
Nov 5, 2026
Primary completion
Apr 20, 2026→May 31, 2026 (actual)
Nov 5, 2026
Study completion
Apr 20, 2026→May 31, 2026 (actual)
Nov 5, 2026
Enrollment
80 (estimated)→103 (actual)
Nov 5, 2026
Eligibility
3 inclusion criteria edited; 1 exclusion criterion edited; 1 criterion removed
What changed in the criteria
  • RemovedExclusion Criteria:
Inclusion criteria
  • EditedConfirmed diagnosis of HIV infection (for HIV group)
  • EditedOn stableStable antiretroviral therapy for at least 6 months (for HIV group)
  • EditedHIV-negative status confirmed by medical history or testing (for control group)
Exclusion criteria
  • EditedAcute infection or hospitalization within the lastprevious 4 weeks
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Not yet recruiting→Completed
    1 site added — first site in Turkey (Türkiye)
    Show site
    • Tekirdağ Dr. İsmail Fehmi Cumalıoğlu City Hospital · Tekirdağ, Turkey (Türkiye)
    Start date Mar 2, 2026→Apr 1, 2026 (now actual)
    Primary completion Apr 20, 2026→May 31, 2026 (now actual)
    Study completion Apr 20, 2026→May 31, 2026 (now actual)
    Enrollment 80 (estimated)→103 (actual)
    Eligibility 3 inclusion criteria edited; 1 exclusion criterion edited; 1 criterion removed
    What changed in the criteria
    • RemovedExclusion Criteria:
    Inclusion criteria
    • EditedConfirmed diagnosis of HIV infection (for HIV group)
    • EditedOn stableStable antiretroviral therapy for at least 6 months (for HIV group)
    • EditedHIV-negative status confirmed by medical history or testing (for control group)
    Exclusion criteria
    • EditedAcute infection or hospitalization within the lastprevious 4 weeks
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07453303
Lead sponsor
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Responsible party
Sponsor
First posted
Mar 5, 2026
Start date
Apr 1, 2026
Primary completion
May 31, 2026
Completion
May 31, 2026
Last update
Nov 5, 2026

Study contacts

İrem Utku
principal investigator · Tekirdağ Doktor İsmail Fehmi Cumalıoğlu City Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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