Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05078957
Acronym
FRAMIVIH
Enrollment
132
Registered
2021-10-15
Start date
2023-12-05
Completion date
2030-03-31
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Brief summary

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.

Interventions

OTHERStool sampling

Stool samples will be collected from participants at baseline and annually during 5 years

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.

Blood plasma collection to measure persistent inflammation and immune activation

Sponsors

Hôpital Européen Marseille
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Variation of the Shannon index between 0 and 5 years in different groups of PLWHFive years

Secondary

MeasureTime 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 PLWHFive years
Correlation between the Shannon index and the number of comorbidities associated with 0, 3 and 5 years in the different groups of PLWHFive years

Countries

France

Contacts

Primary ContactMyriam BENNANI
m.bennani@hopital-europeen.fr0413428351

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026