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Frailty in People Living With HIV Aged 70 Years or More

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ClinicalTrials.gov Identifier: NCT03958786
Recruitment Status : Recruiting
First Posted : May 22, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Tracking Information
First Submitted Date  ICMJE May 20, 2019
First Posted Date  ICMJE May 22, 2019
Last Update Posted Date May 23, 2019
Actual Study Start Date  ICMJE May 15, 2019
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2019)
Proportion of frail patients [ Time Frame: 12 months ]
Proportion of patients classified as frail according to Fried at Baseline
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03958786 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Frailty in People Living With HIV Aged 70 Years or More
Official Title  ICMJE Frailty in People Living With HIV Aged 70 Years or More : Screening Feasibility, Prevalence, Risk Factors and Impact on Pejorative Events
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)
  • Proportion of subjects with a pejorative event at 12 months of follow-up (recurrent or serious falls, emergency department visit, unscheduled hospitalization, institutionalization, loss of one point on the IADL scale or death)
  • Association between baseline evaluation of frailty and pejorative events incidence during the 12 months of follow-up.
  • Transition between frail or non frail status during the 12 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE HIV Infections
Intervention  ICMJE
  • Other: Simplified Geriatric Evaluation
    • Questionnaires
    • Self assessment questionnaires
    • Mobility and balance tests
  • Other: Sampling
    - Blood samples : 35 ml will be collected at baseline, after signature of written informed consent
Study Arms  ICMJE Experimental: single arm
500 HIV-1 infected patients, aged 70 years and older
Interventions:
  • Other: Simplified Geriatric Evaluation
  • Other: Sampling
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 20, 2019)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 15, 2021
Estimated Primary Completion Date May 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mariem Raho +33 (0)1 49 59 19 83 mariem.raho-moussa@inserm.fr
Contact: Faroudy Boufassa faroudy.boufassa@inserm.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958786
Other Study ID Numbers  ICMJE ANRS EP66 SEPTAVIH
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor  ICMJE French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP