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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
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 :
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | 500 HIV-1 infected patients, aged 70 years and older |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simplified Geriatric Evaluation | Other |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of frail patients at baseline | Proportion of patients classified as frail according to Fried at Baseline | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Correlation between Baseline frailty status and early pejorative events incidence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clotilde ALLAVENA | Infectious Diseases - CHU Nantes- France | Principal Investigator |
| Laurence MEYER | INSERM CESP - France | Principal Investigator |
| Hubert BLAIN | Geriatric Department - CHU Montpellier - France | Principal Investigator |
| Alain MAKINSON | Infectious Diseases - CHU Montpellier- France | Principal Investigator |
| Laurence SLAMA | Infectious Diseases - Hôtel Dieu Hospital Paris- France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Maladies Infectieuses, CHU Hôtel-Dieu | Nantes | 44093 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38976641 | Derived | Sambou C, Pourette D, Debeaudrap P, Slama L, Katlama C, Cazanave C, Bonnet F, Meyer L, Allavena C. The burden of secrecy in the management of multimorbidity in older people living with HIV aged 70 and over. AIDS Care. 2024 Aug;36(8):1094-1101. doi: 10.1080/09540121.2024.2372723. Epub 2024 Jul 8. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 3, 2025 | |
| Reset | Sep 19, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 3, 2025 | Sep 19, 2025 |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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Multicenter, prospective study
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| Sampling | Other | - Blood samples : 35 ml will be collected at baseline, after signature of written informed consent, 7 ml at M12 |
|
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 |
| 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 |
| 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 |
| 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 |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |