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

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.

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Key information

Conditions

Frailty Atrophy Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sarcopenia Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Signs and Symptoms Urogenital Diseases Virus Diseases

Age range

40 year–99 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Acronym: HIV-AGE40

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Mar 5, 2026
Registry last updated: Mar 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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