The gut immune barrier is not fully restored in HIV-1-infected subjects despite they were receiving antiretroviral treatment. This leaky gut leads to microbial translocation from the gut lumen into the bloodstream that fuels deleterious systemic inflammation. The chemotaxis axes that allow T lymphocytes to migrate from the blood to the gut mucosa in order to reconstitute the mucosal immune barrier seems altered in treated HIV-1-infected subjects.This study aims at better understanding the mechanisms involved in this lack of mucosal immune restoration.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria are:
For HIV-1-infected subjects group :
* Age at least 18-year old
* HIV-1 infection
* Receiving continuous cART for ≥ 12 months, started during the chronic phase
* Plasma viral load ≤50 copies/mL for ≥ 6 months (one blip ≤200 copies/mL authorized)
* Blood CD4+ T cells count ≥ 350 cells/mm3
* Indication for upper and/or lower digestive endoscopy
* Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme)
* Written informed consent.
For uninfected control group :
* Age at least 18-year old
* Indication for upper and/or lower digestive endoscopy
* Patient enrolled in or a beneficiary of a Social Security programme (State Medical Aid or AME is not a Social Security programme)
* Written informed consent
Exclusion Criteria are:
For HIV-1-infected subject group :
* HIV-2 infection
* Inflammatory bowel diseases (Crohn's disease, ulcerative colitis) ; coeliac disease
* Platelets count \<50 G/L or abnormal hemostasis tests
* Decompensated cirrhosis
* Past or current lymphoma
* Involvement in an HIV-1 immunotherapeutic vaccine study
* Pregnant or breastfeeding women
* Subjects participating in a study excluding participating in another study
* Vulnerability, such as an age under 18, tutorship, trusteeship, or subjects deprived of liberty by a legal or administrative decision.
For uninfected control group :
* HIV-1 and 2 infection
* Inflammatory bowel diseases (Crohn's disease, ulcerativ…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Immune status: Measure of the frequencies of Th1 in peripheral blood and gut mucosa.
Timeframe: Baseline
2
Immune status: Measure of the frequencies of Th17 in peripheral blood and gut mucosa.
Timeframe: Baseline
3
Immune status: Measure of the frequencies of Th22 in peripheral blood and gut mucosa.