HIV Infections Clinical Trial
Official title:
Frailty in People Living With HIV Aged 70 Years or More : Screening Feasibility, Prevalence, Risk Factors and Impact on Pejorative Events
Verified date | May 2022 |
Source | ANRS, Emerging Infectious Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Active, not recruiting |
Enrollment | 512 |
Est. completion date | June 22, 2024 |
Est. primary completion date | June 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 70 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Service de Maladies Infectieuses, CHU Hôtel-Dieu | Nantes |
Lead Sponsor | Collaborator |
---|---|
ANRS, Emerging Infectious Diseases |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of frail patients at baseline | Proportion of patients classified as frail according to Fried at Baseline | 12 months | |
Secondary | Proportion of frail subjects at M12, M24, M36, M48 and M60 | Proportion of frail subjects at M12, M24, M36, M48 and M60 according to Fried | 60 months | |
Secondary | Correlation between Baseline frailty status and early pejorative events incidence | Measure of association between frailty status and the existence of adverse health events (composite criterion defined by the existence of severe or repeated falls, use of emergency services, unscheduled hospitalization, institutionalization, loss of 1 point on the ADL scale, or death in the last 12 months) | 12 months | |
Secondary | Correlation between Baseline frailty status and long terme pejorative events incidence | Measure of association between frailty status and the existence of adverse health events (composite criterion defined by the existence of severe or repeated falls, use of emergency services, unscheduled hospitalization, institutionalization, loss of an ADL score, or death over the entire follow-up period to 60 months) | 60 months | |
Secondary | Transition between frail and non-frail status during 5 years of follow up | Evolution of the Fragility phenotype with estimation of the number of transitions from fragile to pre-fragile or robust status and the number of transitions from robust and pre-fragile status to fragile status. | 60 months | |
Secondary | Proportion of frail subjects accoding different frailty scores | Proportion of frail subjects according to different frailty indexes or scores : Fried, Cumulative Health deficits Index, French HAS score, VACS Index | 60 months |
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