NCT03958786

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
512

participants targeted

Target at P75+ for not_applicable hiv-infections

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable hiv-infections

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2019

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2021

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2024

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

2.1 years

First QC Date

May 20, 2019

Last Update Submit

May 13, 2022

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (1)

  • Proportion of frail patients at baseline

    Proportion of patients classified as frail according to Fried at Baseline

    12 months

Secondary Outcomes (5)

  • Proportion of frail subjects at M12, M24, M36, M48 and M60

    60 months

  • Correlation between Baseline frailty status and early pejorative events incidence

    12 months

  • Correlation between Baseline frailty status and long terme pejorative events incidence

    60 months

  • Transition between frail and non-frail status during 5 years of follow up

    60 months

  • Proportion of frail subjects accoding different frailty scores

    60 months

Study Arms (1)

single arm

EXPERIMENTAL

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

Other: Simplified Geriatric EvaluationOther: Sampling

Interventions

Simplified Geriatric EvaluationOTHER

* Questionnaires * Self assessment questionnaires * Mobility and balance tests

single arm
SamplingOTHER

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

single arm

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Maladies Infectieuses, CHU Hôtel-Dieu

Nantes, 44093, France

Location

Related Publications (1)

  • 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.

    PMID: 38976641DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Multicenter, prospective study
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

May 22, 2019

Study Start

May 15, 2019

Primary Completion

June 22, 2021

Study Completion

June 22, 2024

Last Updated

May 17, 2022

Record last verified: 2022-05

Locations

FR(1)