Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Frailty in People Living With HIV Aged 70 Years or More

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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)

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


Condition or disease Intervention/treatment Phase
HIV Infections Other: Simplified Geriatric Evaluation Other: Sampling Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Frailty in People Living With HIV Aged 70 Years or More : Screening Feasibility, Prevalence, Risk Factors and Impact on Pejorative Events
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: single arm
500 HIV-1 infected patients, aged 70 years and older
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




Primary Outcome Measures :
  1. Proportion of frail patients [ Time Frame: 12 months ]
    Proportion of patients classified as frail according to Fried at Baseline



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958786


Contacts
Layout table for location contacts
Contact: Mariem Raho +33 (0)1 49 59 19 83 mariem.raho-moussa@inserm.fr
Contact: Faroudy Boufassa faroudy.boufassa@inserm.fr

Locations
Layout table for location information
France
Service de Maladies Infectieuses, CHU Hôtel-Dieu Recruiting
Nantes, France, 44093
Contact: Clotilde Allavena, MD    +33 2 40 08 30 99    clotilde.allavena@chu-nantes.fr   
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Layout table for additonal information
Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT03958786     History of Changes
Other Study ID Numbers: ANRS EP66 SEPTAVIH
First Posted: May 22, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Frailty
Pathologic Processes