Clinical trial NCT05724524: Exploratory Study on the Role of the Digestive Microbiota in Adults Living With HIV-1
Official title: Exploratory Study on the Role of the Digestive Microbiota and Bacterial Translocation in the Immune Activation Profile Associated With Insulin Resistance in Male Caucasian Adults Living With HIV-1 on Effective Antiretroviral Therapy.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HIV
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult men with HIV-1 infection on effective antiretroviral therapy stable for more than 6 months.

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.


Eligibility criteria: Inclusion Criteria:

* 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 on effective triple antiretroviral therapy, stable for more than 6 months, with a plasma viral load \<50 copies / ml for at least 6 months before inclusion (2 measurements).
* 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

Exclusion Criteria:

* 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 having undergone treatment with an immunomodulator molecule or chemotherapy within 60 days before inclusion in the research or has an indication planned for the duration of the research.
* Patient with a chronic digestive pathology or who had been operated on the previous year
* The subject is participating in a category 1 interventional study, has participated in another interventional study in the last 3 months or is in a period of exclusion determined by a previous study
* 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

Primary outcomes:
measure: Nature of gut microbiota bacterial proteins in patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
measure: Nature of gut microbiota taxonomy in patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
measure: Relative quantification of gut microbiota bacterial proteins in patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
measure: Relative quantification of gut microbiota taxonomy in patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
Secondary outcomes:
measure: Richness of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
measure: Diversity of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
measure: beta-diversity of Firmicutes and Bacteroidetes in patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
measure: Level of phyla and minority species in the stool in patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
measure: Level of CD14S in serum of patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
measure: Level of Lipopolysaccharide Binding Protein (LBP) in serum of patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
measure: Level of intestinal fatty acid binding protein (I-FABP) in serum of patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
measure: Level of bacterial 16S rDNA in plasma of patients with immune activation profile 2 versus all other profiles
timeFrame: Day 0
measure: Transcriptomic analysis of peripheral blood mononuclear cells
timeFrame: Day 0
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Gui de Chauliac
city: Nîmes
country: France
facility: CHU de Nîmes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nīmes
name: Jean-Philippe Lavigne
role: STUDY_DIRECTOR
References: