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Exploratory Study on the Role of the Digestive Microbiota in Adults Living With HIV-1

NCT05724524 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-02-13

No results posted yet for this study

Summary

Chronic immune activation present in aviremic people living with HIV under treatment promotes the onset of insulin resistance and metabolic syndrome, paving the way for the comorbidities that are currently the main causes of morbidity. This activation continues despite effective antiretroviral therapy. In the ACTIVIH study (NCT02334943) the analysis of 68 AI markers allowed classification of 120 aviremic PLHIV under treatment for at least 2 years according to 5 different immune activation profiles. Among these 5 profiles, Profile 2 was characterized by high blood pressure figures, high waist sizes, low HDL-cholesterol levels, high triglyceridemia, and especially hyperinsulinemia. Several studies have shown that the digestive microbiota of this population is less rich and less diverse than that of healthy subjects. However, the digestive microbiota and in particular bacterial proteins and metabolites seem to play a key role in immune activation in people living with HIV. Finally, the digestive microbiota has already been shown to have an impact on insulin sensitivity.

The study investigators hypothesize that a particular digestive microbiota could promote the appearance of Profile 2. This microbiota could be the cause of digestive dysbiosis leading to intestinal inflammation, digestive permeability and bacterial translocation.

Conditions

Interventions

OTHER

Stool sample collection

50mg stool sample taken for protein extraction

OTHER

Blood sample collection

Venous blood sample taken for analysis of serum and plasma

Sponsors & Collaborators

  • Centre Hospitalier Universitaire de Nīmes

    lead OTHER

Principal Investigators

  • Jean-Philippe Lavigne · Centre Hospitalier Universitaire de Nīmes

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-31
Primary Completion
2023-02-28
Completion
2023-02-28

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05724524 on ClinicalTrials.gov