Gut-Associated Lymphocyte Trafficking

NCT02906137 | Completed

• 1 other identifier: ANRS EP61 GALT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

HIV-1 Infection

Outcome Measures

Primary Outcomes (3)

• Immune status: Measure of the frequencies of Th1 in peripheral blood and gut mucosa.

  The frequencies of Th1 will be measured by flow cytometry.

  Baseline

• Immune status: Measure of the frequencies of Th17 in peripheral blood and gut mucosa.

  The frequencies of Th17 will be measured by flow cytometry.

  Baseline

• Immune status: Measure of the frequencies of Th22 in peripheral blood and gut mucosa.

  The frequencies of Th22 will be measured by flow cytometry.

  Baseline

Secondary Outcomes (9)

• Immune status: Quantification of cytokines in blood and gut mucosa.

  Baseline

• Immune status: Quantification of cytokines in blood and gut mucosa.

  Baseline

• Immune status: Quantification of chemiokines in blood and gut mucosa.

  Baseline

• Immune status: Quantification of chemiokines in blood and gut mucosa.

  Baseline

• Microbial translocation : Quantification of soluble CD14 in plasma.

  Baseline

Study Arms (2)

HIV-1 infected subjects

EXPERIMENTAL

40 subjects will be recruited in the Department of Infectious Diseases of Toulouse University Hospital, France: * 15 subjects will have an upper endoscopy (gastroscopy) with duodenal sampling * 15 subjects will have a lower endoscopy (coloscopy) with colonic and ileal sampling * 10 subjects will have both a gastroscopy and a coloscopy

Other: Peripheral blood and intestinal biopsies will be collected

Uninfected-controls

OTHER

40 subjects will be recruited in the Department of Internal Medicine of Toulouse University Hospital, France: * 10 subjects will have an upper endoscopy (gastroscopy) with duodenal sampling * 10 subjects will have a lower endoscopy (coloscopy) with colonic and ileal sampling * 20 subjects will have both a gastroscopy and a coloscopy

Other: Peripheral blood and intestinal biopsies will be collected

Interventions

Peripheral blood and intestinal biopsies will be collected OTHER

Blood draw and intestinal biopsies

HIV-1 infected subjects; Uninfected-controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, ulcerative colitis) ; coeliac disease
• Platelets count \<50 G/L or abnormal hemostasis tests
• Decompensated cirrhosis

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

Study Sites (2)

Hôpital Purpan - Service de Médecine Interne

Toulouse, 31059, France

Location

Hôpital Purpan - Service des maladies Infectieuses

Toulouse, 31059, France

Location

Related Publications (1)

• Nayrac M, Requena M, Loiseau C, Cazabat M, Suc B, Carrere N, Barange K, Alric L, Martin-Blondel G, Izopet J, Delobel P. Th22 cells are efficiently recruited in the gut by CCL28 as an alternative to CCL20 but do not compensate for the loss of Th17 cells in treated HIV-1-infected individuals. Mucosal Immunol. 2021 Jan;14(1):219-228. doi: 10.1038/s41385-020-0286-6. Epub 2020 Apr 28.

  PMID: 32346082 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: September 19, 2016
• Study Start: February 6, 2017
• Primary Completion: February 25, 2020
• Study Completion: February 25, 2020
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)