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

NCT ID: NCT05078957

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 132 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-12-05
• Study Completion Date: 2030-03-31

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.

Conditions

HIV Infections

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Frail PLWH

Stool sampling

Intervention Type: OTHER

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

Frailty phenotype

Intervention Type: OTHER

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

Intervention Type: OTHER

Blood plasma collection to measure persistent inflammation and immune activation

Pre frail PLWH

Stool sampling

Intervention Type: OTHER

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

Frailty phenotype

Intervention Type: OTHER

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

Intervention Type: OTHER

Blood plasma collection to measure persistent inflammation and immune activation

No frail PLWH

Stool sampling

Intervention Type: OTHER

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

Frailty phenotype

Intervention Type: OTHER

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

Intervention Type: OTHER

Blood plasma collection to measure persistent inflammation and immune activation

Interventions

Stool sampling

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

Intervention Type: 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.

Intervention Type: OTHER

Blood plasma collection

Blood plasma collection to measure persistent inflammation and immune activation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Européen Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Européen Marseille

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Myriam BENNANI

Role: CONTACT

m.bennani@hopital-europeen.fr

0413428351

Facility Contacts

Myriam BENNANI

Role: primary

Other Identifiers

21-33

Identifier Type: -

Identifier Source: org_study_id