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

HIV Infections Clinical Trial

— FRAMIVIH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05078957
• Other study ID #: 21-33
• Status: Recruiting
• Start date: December 5, 2023
• Est. completion date: March 2028

Study information

• Verified date: December 2023
• Source: Hôpital Européen Marseille
• Contact: Myriam BENNANI
• Phone: 0413428351
• Email: m.bennani[@]hopital-europeen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: March 2028
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty
• HIV Infections

Intervention

Other:
• Stool sampling
Stool samples will be collected from participants at baseline and annually during 5 years
• 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.
• Blood plasma collection
Blood plasma collection to measure persistent inflammation and immune activation

Locations

Country	Name	City	State
France	Hôpital Européen Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of the Shannon index between 0 and 5 years in different groups of PLWH		Five years
Secondary	Variation of the Shannon index between 0 and 3 years in different groups of PLWH (frail, pre frail, not frail)		Three years
Secondary	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
Secondary	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