Clinical Trial

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

Study acronym: FRAMIVIH
Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-10-01; most recent amendment 2025-09-24.
Status change: Not Yet Recruiting → Recruiting 2023-12-08
Trial Details
NCT Number NCT05078957
Lead Sponsor Hôpital Européen Marseille
Conditions HIV Infections
Enrollment 132 participants
Start Date 2023-12-05
Primary Completion 2030-03 (estimated)
Study Completion 2030-03 (estimated)
Updated on ClinicalTrials.gov 2025-09-25