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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-31

Study Completion Date

2023-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Profile 2

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

Stool sample collection

Intervention Type OTHER

50mg stool sample taken for protein extraction

Blood sample collection

Intervention Type OTHER

Venous blood sample taken for analysis of serum and plasma

Other profiles

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

Stool sample collection

Intervention Type OTHER

50mg stool sample taken for protein extraction

Blood sample collection

Intervention Type OTHER

Venous blood sample taken for analysis of serum and plasma

Interventions

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Stool sample collection

50mg stool sample taken for protein extraction

Intervention Type OTHER

Blood sample collection

Venous blood sample taken for analysis of serum and plasma

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No