NCT07453303

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 2, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

March 2, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 20, 2026

Completed
Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

2 months

First QC Date

March 2, 2026

Last Update Submit

March 2, 2026

Conditions

FrailtySarcopenia

Keywords

HIV Infections

Outcome Measures

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.

    Baseline

Study Arms (2)

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.

Eligibility Criteria

Age40 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

FrailtySarcopeniaHIV Infections

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2026

First Posted

March 5, 2026

Study Start

March 2, 2026

Primary Completion

April 20, 2026

Study Completion

April 20, 2026

Last Updated

March 5, 2026

Record last verified: 2026-03