Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05078957

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

HIV Infections Blood-Borne Infections Communicable Diseases Genital Diseases Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Urogenital Diseases Virus Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Européen Marseille

Marseille, 13003, France

Location status: Recruiting

Location contact

Christina PSOMAS, Dr

PRINCIPAL_INVESTIGATOR

Myriam BENNANI

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stool sampling

Other

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

Frailty phenotype

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

Other

Blood plasma collection to measure persistent inflammation and immune activation

Primary outcomes

  1. Variation of the Shannon index between 0 and 5 years in different groups of PLWH

    Time frame: Five years

Secondary outcomes

  1. Variation of the Shannon index between 0 and 3 years in different groups of PLWH (frail, pre frail, not frail)

    Time frame: Three years

  2. 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

    Time frame: Five years

  3. Correlation between the Shannon index and the number of comorbidities associated with 0, 3 and 5 years in the different groups of PLWH

    Time frame: Five years

Study contacts

Contact information is provided by the study sponsor or research team.

Myriam BENNANI

CONTACT

[email protected]

0413428351

Sponsors and collaborators

Lead sponsor

Hôpital Européen Marseille

Other

Registry information

Acronym: FRAMIVIH

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Oct 15, 2021
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.