Clinical trial NCT03958786: Frailty in People Living With HIV Aged 70 Years or More
Official title: Frailty in People Living With HIV Aged 70 Years or More : Screening Feasibility, Prevalence, Risk Factors and Impact on Pejorative Events
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HIV Infections
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2019-05-22
Enrollment: 512
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter, prospective study
Primary purpose: OTHER

Brief summary: 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

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of frail patients at baseline
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of frail subjects at M12, M24, M36, M48 and M60
timeFrame: 60 months
measure: Correlation between Baseline frailty status and early pejorative events incidence
timeFrame: 12 months
measure: Correlation between Baseline frailty status and long terme pejorative events incidence
timeFrame: 60 months
measure: Transition between frail and non-frail status during 5 years of follow up
timeFrame: 60 months
measure: Proportion of frail subjects accoding different frailty scores
timeFrame: 60 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Service de Maladies Infectieuses, CHU Hôtel-Dieu
Study officials:
affiliation: Infectious Diseases - CHU Nantes- France
name: Clotilde ALLAVENA
role: PRINCIPAL_INVESTIGATOR
affiliation: INSERM CESP - France
name: Laurence MEYER
role: PRINCIPAL_INVESTIGATOR
affiliation: Geriatric Department - CHU Montpellier - France
name: Hubert BLAIN
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious Diseases - CHU Montpellier- France
name: Alain MAKINSON
role: PRINCIPAL_INVESTIGATOR
affiliation: Infectious Diseases - Hôtel Dieu Hospital Paris- France
name: Laurence SLAMA
role: PRINCIPAL_INVESTIGATOR
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