HIV InfectionsNCT03958786

Frailty in People Living With HIV Aged 70 Years or More

A study testing Simplified Geriatric Evaluation and Sampling in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 70 years and older
Conditions the study is for: HIV Infections
What is being tested?: Simplified Geriatric Evaluation and Sampling
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 512 participants
Where: 1 siteFrance
Study dates: 15 May 2019to 22 Jun 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

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 -

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

Service de Maladies Infectieuses, CHU Hôtel-Dieu
Nantes, 44093

Other trials in France

About this study

Official title: Frailty in People Living With HIV Aged 70 Years or More : Screening Feasibility, Prevalence, Risk Factors and Impact on Pejorative Events

SEPTAVIH is a French, multicentre, prospective, observational study which will include 500 HIV-infected participants

Read the 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)
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 :
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
Anthropologic substudy about HIV and polypathologies management
Focus on COVID-19 with clinical questionnaire, self-administrated questionnaire, SARS CoV2 serology and biobank (serum library)

Conditions: HIV Infections
Being tested: Simplified Geriatric Evaluation, Sampling
Medical subject headings: HIV Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Simplified Geriatric EvaluationOther
- Questionnaires
- Self assessment questionnaires
- Mobility and balance tests
SamplingOther
- Blood samples : 35 ml will be collected at baseline, after signature of written informed consent, 7 ml at M12

Study groups in NCT03958786
Study group	Role	What they receive
single arm	Experimental	500 HIV-1 infected patients, aged 70 years and older Receives: Other: Simplified Geriatric Evaluation; Other: Sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of frail patients at baseline
Proportion of patients classified as frail according to Fried at Baseline
Measured: 12 months

Secondary outcomes (5)

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
Measured: 60 months
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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 201922 Jun 2024

First posted22 May 2019
Study start15 May 2019
Primary completion22 Jun 2021
Study completion22 Jun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by ANRS, Emerging Infectious DiseasesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: Multicenter, prospective study
Masking: None (open label)
Enrolment: 512 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03958786
Sponsor's protocol ID: ANRS EP66 SEPTAVIH
Status last verified: May 2022
First submitted: 20 May 2019
Last updated: 17 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 38976641

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

All HIV Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Frailty in People Living With HIV Aged 70 Years or More : Screening Feasibility, Prevalence, Risk Factors and Impact on Pejorative Events
ClinicalTrials.gov ID: NCT03958786
Acronym / sponsor ID: ANRS EP66 SEPTAVIH
Conditions: HIV Infections
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 512 participants (actual)
Lead sponsor: ANRS, Emerging Infectious DiseasesOther government
Study start: 15 May 2019 (actual)
Primary completion: 22 Jun 2021 (actual)
Study completion: 22 Jun 2024 (estimated)
First posted: 22 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)
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 :
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
Anthropologic substudy about HIV and polypathologies management
Focus on COVID-19 with clinical questionnaire, self-administrated questionnaire, SARS CoV2 serology and biobank (serum library)

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Multicenter, prospective study

Arm	Type	Receives
single arm	Experimental	Other: Simplified Geriatric Evaluation, Other: Sampling500 HIV-1 infected patients, aged 70 years and older

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

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 -

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Simplified Geriatric Evaluation* Questionnaires * Self assessment questionnaires * Mobility and balance tests	Other	single arm
Sampling- Blood samples : 35 ml will be collected at baseline, after signature of written informed consent, 7 ml at M12	Other	single arm

Primary outcome

Proportion of frail patients at baseline
Time frame: 12 months
Proportion of patients classified as frail according to Fried at Baseline

5 secondary outcomes

Proportion of frail subjects at M12, M24, M36, M48 and M60
Time frame: 60 months
Correlation between Baseline frailty status and early pejorative events incidence
Time frame: 12 months
Correlation between Baseline frailty status and long terme pejorative events incidence
Time frame: 60 months
Transition between frail and non-frail status during 5 years of follow up
Time frame: 60 months
Proportion of frail subjects accoding different frailty scores
Time frame: 60 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
Derived from this study: PubMed 38976641Sambou 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.

Related trials for HIV Infections

Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clotilde ALLAVENA principal investigator

Infectious Diseases - CHU Nantes- France

Laurence MEYER principal investigator

INSERM CESP - France

Hubert BLAIN principal investigator

Geriatric Department - CHU Montpellier - France

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Simplified Geriatric Evaluation and Sampling in people with HIV Infections, run by ANRS, Emerging Infectious Diseases at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of frail patients at baseline (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03958786, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.