Comprehensive Geriatric Assessment in Adults Aged 40 Years and Older Living With HIV (HIV-AGE40)

March 2, 2026 updated by: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

80

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

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.

Description

Age ≥ 40 years

Confirmed diagnosis of HIV infection (for HIV group)

On stable antiretroviral therapy for at least 6 months (for HIV group)

HIV-negative status confirmed by medical history or testing (for control group)

Ability to provide informed consent

Exclusion Criteria:

Acute infection or hospitalization within the last 4 weeks

Known active malignancy under treatment

Severe psychiatric disorder interfering with assessment

Severe cognitive impairment preventing participation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 2, 2026

Primary Completion (Estimated)

April 20, 2026

Study Completion (Estimated)

April 20, 2026

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TKD-GER-2026-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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