NCT05078957 Microbiota Footprint and Frailty Phenotype in Virologically Suppressed People Living With HIV
| NCT ID | NCT05078957 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hôpital Européen Marseille |
| Condition | HIV Infections |
| Study Type | OBSERVATIONAL |
| Enrollment | 132 participants |
| Start Date | 2023-12-05 |
| Primary Completion | 2030-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 132 participants in total. It began in 2023-12-05 with a primary completion date of 2030-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05078957 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying HIV Infections. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05078957 currently recruiting?
Yes, NCT05078957 is actively recruiting participants. Contact the research team at m.bennani@hopital-europeen.fr for enrollment information.
Where is the NCT05078957 trial being conducted?
This trial is being conducted at Marseille, France.
Who is sponsoring the NCT05078957 clinical trial?
NCT05078957 is sponsored by Hôpital Européen Marseille. The trial plans to enroll 132 participants.
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