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

Study acronym: FRAMIVIH
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Apr 2025 to Mar 2030
    • Study completion date: Mar 2028 to Mar 2030
    v8
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Sep 2022 to Dec 5, 2023
    • Site details revised
    v7
  3. Start date: Jun 2022 to Sep 2022
    • Primary completion date: Jan 2025 to Apr 2025
    • Study completion date: Dec 2027 to Mar 2028
    v6
  4. Start date: Mar 2022 to Jun 2022v5
  5. Start date: Jan 2022 to Mar 2022v4
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  1. Re-verified, no change to tracked fieldsv3
  2. Secondary endpoints revised (3)v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05078957
Lead Sponsor Hôpital Européen Marseille
Conditions
(from sponsor)		 HIV Infections
Related terms HIV Infections
Enrollment 132 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov