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

NCT05724524 | Withdrawn

• 1 other identifier: AOI GCS-MERRI/2019/JPL-01
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

HIV

Outcome Measures

Primary Outcomes (4)

• Nature of gut microbiota bacterial proteins in patients with immune activation profile 2 versus all other profiles

  Number of bacterial proteins present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry

  Day 0

• Nature of gut microbiota taxonomy in patients with immune activation profile 2 versus all other profiles

  Number of operational taxonomic units present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry

  Day 0

• Relative quantification of gut microbiota bacterial proteins in patients with immune activation profile 2 versus all other profiles

  Percentage of the various bacterial proteins present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry (%)

  Day 0

• Relative quantification of gut microbiota taxonomy in patients with immune activation profile 2 versus all other profiles

  Percentage of the various operational taxonomic units present in stool samples from patients, identified by high-performance liquid chromatography mass spectrometry (%)

  Day 0

Secondary Outcomes (9)

• Richness of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles

  Day 0

• Diversity of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles

  Day 0

• beta-diversity of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles

  Day 0

• Level of phyla and minority species in the stool in patients with immune activation profile 2 versus all other profiles

  Day 0

• Level of CD14S in serum of patients with immune activation profile 2 versus all other profiles

  Day 0

Study Arms (2)

Profile 2

People living with HIV with immune activation profile 2: inflammatory profile - high level of sTNFRI

Other: Stool sample collection; Other: Blood sample collection

Other profiles

People living with HIV with immune activation profiles1 + 3-5: T8, NK, T4 and monocyte profiles

Other: Stool sample collection; Other: Blood sample collection

Interventions

Stool sample collection OTHER

50mg stool sample taken for protein extraction

Other profiles; Profile 2

Blood sample collection OTHER

Venous blood sample taken for analysis of serum and plasma

Other profiles; Profile 2

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult men with HIV-1 infection on effective antiretroviral therapy stable for more than 6 months.

You may qualify if:

• Patient informed of the implementation of the study, its objectives, its constraints and the patient's rights.
• Male and Caucasian patient.
• Patient with HIV-1 infection determined by positive serology or plasma viral load (HIV RNA) measurement.
• Patient whose immune activation profile has been characterized beforehand (profiles 1, 2, 3, 4 and 5).
• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan

You may not qualify if:

• Vulnerable person according to article L1121-6 of the CSP.
• Adult person protected according to article L1121-8 of the CSP.
• Patient presenting with a non-infectious pathology which may be the cause of an immune abnormality.
• Patient with a chronic digestive pathology or who had been operated on the previous year
• The subject refuses to sign the consent
• It is impossible to give the subject informed information
• The patient is under safeguard of justice or state guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (2)

CHU Gui de Chauliac

Montpellier, France

Location

CHU de Nîmes

Nîmes, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, serum and stool samples

Study Officials

• Jean-Philippe Lavigne

  Centre Hospitalier Universitaire de Nīmes

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 13, 2023
• Study Start: May 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

FR (2)