Frailty in People Living With HIV Aged 70 Years or More

ANRS, Emerging Infectious Diseases

Status

Active, not recruiting

Conditions

HIV Infections

Treatments

Other: Sampling

Other: Simplified Geriatric Evaluation

Study type

Interventional

Funder types

Other

Identifiers

NCT03958786

ANRS EP66 SEPTAVIH

Details and patient eligibility

About

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

Full description

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)

Enrollment

512 patients

Sex

All

Ages

70+ years old

Volunteers

No Healthy Volunteers

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