Frailty in People Living With HIV Aged 70 Years or More

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

512 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-15

Study Completion Date

2024-06-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The ANRS EP66 SEPTAVIH Study aims to screen feasibility of evaluating frailty in people living with HIV aged 70 or older, to estimate its prevalence, to analyse associated risk factors and to evaluate the impact of frailty on pejorative events.

SEPTAVIH is a French, multicentre, prospective, observational study which will include 500 HIV-infected participants

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV

NCT05078957

HIV Infections

RECRUITING

Medico-social Description of Seniors Living With HIV, Associated With a Qualitative Survey on Their Care in the Paris Region Structures

NCT05135689

HIV-positive

UNKNOWN

Spanish Cohort of Patients with HIV Infection Older Than 50 Years for the Study of Fragility and Physical Function

NCT03558438

HIV Infections Frail Older Adults

ACTIVE_NOT_RECRUITING

Search for Fragility Indicators Among People Aged 50+ With Chronic HIV Infection

NCT02874118

Frail in HIV Population

COMPLETED NA

My Smart Age With HIV: Smartphone Self-assessment of Frailty

NCT02663856

HIV Infection Aging

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The primary objective is to assess the prevalence of frailty at baseline in People living with HIV (PLWH) aged 70 years and older, using the Fried index.

The main secondary objectives of this study are :

* To assess frequency frailty according to different indexes or scores (Fried, Health deficits Index, HAS score, VACS index)
* To evaluate the association between frailty and specific HIV-related characteristics (for example known duration of HIV infection), or non-specific factors (such as non- HIV-related diseases or living conditions)
* To evaluate theproportion of subjects with a pejorative event at 60 months of follow-up (recurrent or serious falls, emergency department visit, unscheduled hospitalization, institutionalization, loss of one point on the IADL scale or death)
* To evaluate the association between baseline frailty status and early / long-term pejorative events incidence
* Association between baseline evaluation of frailty and pejorative events incidence during the 60 months of follow-up.
* Transition between frail or non frail status during the 60 months of follow-up
* To assess the prevalence of sarcopenia and osteoporosis
* To describe study population including :

* Demographic characteristics
* HIV medical history and antiretroviral therapy
* Comorbidities, polymedication and evaluation of drug-drug interactions
* Mental Health, quality of life, socioeconomic status
* Healthcare use and additional care implementation (nursing, physical therapy, home care services, …)
* Assessment of Inflammatory and Immunosenescence biomarkers at Baseline
* Anthropologic substudy about HIV and polypathologies management
* Focus on COVID-19 with clinical questionnaire, self-administrated questionnaire, SARS CoV2 serology and biobank (serum library)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HIV Infections

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Multicenter, prospective study

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

single arm

500 HIV-1 infected patients, aged 70 years and older

Group Type EXPERIMENTAL

Simplified Geriatric Evaluation

Intervention Type OTHER

* Questionnaires
* Self assessment questionnaires
* Mobility and balance tests

Sampling

Intervention Type OTHER

\- Blood samples : 35 ml will be collected at baseline, after signature of written informed consent, 7 ml at M12

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Simplified Geriatric Evaluation

* Questionnaires
* Self assessment questionnaires
* Mobility and balance tests

Intervention Type OTHER

Sampling

\- Blood samples : 35 ml will be collected at baseline, after signature of written informed consent, 7 ml at M12

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient aged 70 years and older
* HIV-1 infection
* Antiretroviral therapy for at least 12 months
* Free and signed informed consent (article L1122-1-1-1 of the French Public Health Code)
* Person affiliated or benefiting from a social security scheme -

Exclusion Criteria

* Participation in another research study excluding participation in other studies
* Person under legal protection or deprived of liberty by a judicial or administrative decision
* Isolated HIV-2 infection
* Life expectancy of less than 6 months

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No