Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV (FRAMIVIH)

Analysis of gut microbiota becomes more and more accessible in recent years. Experimental data in both animal and human studies have demonstrated that imbalance of the gut microbiota which is called symbiosis may participate in an accelerated procedure of ageing as well as the expression of frailty phenotype. People living with HIV (PLHIV) present markers of phenotypic frailty on average 10 years before uninfected people.

In this population structural and functional modifications of GALT (Gut Associated Lymphoid Tissue) are observed early after HIV infection and persist despite virological suppression on ART (AntiRetroviral Treatment). These GALT modifications are associated with microbial translocation that is also correlated with immune activation and dysbiosis.

The objective of study is to explore gut microbiota of PLWH over 5 years, as well as to study associations of its longitudinal evolution with frailty markers and burden of comorbidities.

Study Overview

• Status: Recruiting
• Conditions: HIV Infections
• Intervention / Treatment: Other: Stool sampling; Other: Frailty phenotype; Other: Blood plasma collection

• Study Type: Observational
• Enrollment (Estimated): 132

Contacts and Locations

• Study Contact: Name: Myriam BENNANI; Phone Number: 0413428351; Email: m.bennani@hopital-europeen.fr

Study Locations

• France
  • Marseille, France, 13003
    • Recruiting
    • Hôpital Européen Marseille
    • Contact: Myriam BENNANI
    • Principal Investigator: Christina PSOMAS, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People Living with HIV (PLWH)

Description

Inclusion Criteria:

• Individuals infected with HIV in the stable phase of their disease (absence of disease outbreak and absence of therapeutic modification within 3 months before inclusion),
• Subject with ongoing HIV follow-up on an outpatient basis (outpatient or day hospital consultation) in the participating center, and having virological suppression at the threshold of 50 copies / mL for at least 5 years (tolerance of blips < 200 copies / mL during this period)
• Aged ≥ 55 at baseline
• CD4 + T cell nadir> 200 / mm3
• Giving free and informed written consent
• Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

• Persons treated with antibiotics, probiotics, prebiotics or any other treatment that may disrupt the gut microbiota within two months before stool sampling.
• Subject not followed regularly in the participating center,
• Subject only coming for full hospitalization
• Subject in the primary infection phase of less than 1 year

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Frail PLWH	Other: Stool sampling; Stool samples will be collected from participants at baseline and annually during 5 years; Other: Frailty phenotype; According to Fried frailty phenotype based on the assessment of 5 criteria: shrinking (unintentional weight loss), weakness (grip strength), poor endurance (exhaustion), slowness (walking speed) and physical activity. Frail phenotype is defined as the presence of at least 3 criteria of the above mentioned and Pre-frail phenotype as the presence of 1 or 2 criteria.; Other: Blood plasma collection; Blood plasma collection to measure persistent inflammation and immune activation
Pre frail PLWH	Other: Stool sampling; Stool samples will be collected from participants at baseline and annually during 5 years; Other: Frailty phenotype; According to Fried frailty phenotype based on the assessment of 5 criteria: shrinking (unintentional weight loss), weakness (grip strength), poor endurance (exhaustion), slowness (walking speed) and physical activity. Frail phenotype is defined as the presence of at least 3 criteria of the above mentioned and Pre-frail phenotype as the presence of 1 or 2 criteria.; Other: Blood plasma collection; Blood plasma collection to measure persistent inflammation and immune activation
No frail PLWH	Other: Stool sampling; Stool samples will be collected from participants at baseline and annually during 5 years; Other: Frailty phenotype; According to Fried frailty phenotype based on the assessment of 5 criteria: shrinking (unintentional weight loss), weakness (grip strength), poor endurance (exhaustion), slowness (walking speed) and physical activity. Frail phenotype is defined as the presence of at least 3 criteria of the above mentioned and Pre-frail phenotype as the presence of 1 or 2 criteria.; Other: Blood plasma collection; Blood plasma collection to measure persistent inflammation and immune activation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Variation of the Shannon index between 0 and 5 years in different groups of PLWH	Five years

Secondary Outcome Measures

Outcome Measure	Time Frame
Variation of the Shannon index between 0 and 3 years in different groups of PLWH (frail, pre frail, not frail)	Three years
Assaying inflammation markers(CRP, IL-6, sCD14, sCD163, TNFa, IP10, I-FABP, LBP, D-dimers, K/T ratio) annually and for 5 years in different groups of PLWH	Five years
Correlation between the Shannon index and the number of comorbidities associated with 0, 3 and 5 years in the different groups of PLWH	Five years

Collaborators and Investigators

• Sponsor: Hôpital Européen Marseille

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: September 17, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 21-33

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No