Gut-Associated Lymphocyte Trafficking (GALT)

Altered Homing of T Lymphocytes to the Gut and Poor Immune Reconstitution of the Intestinal Mucosa in Treated HIV-infected Individuals

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.

Study Overview

• Status: Completed
• Conditions: HIV-1 Infection
• Intervention / Treatment: Other: Peripheral blood and intestinal biopsies will be collected

Detailed Description

Pathophysiological study in human subjects, comparative, national, multicentric and prospective. Peripheral blood and intestinal biopsies will be collected.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • Hôpital Purpan - Service de Médecine Interne
  • Toulouse, France, 31059
    • Hôpital Purpan - Service des maladies Infectieuses

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIV-1 infected subjects; 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; Blood draw and intestinal biopsies
Other: Uninfected-controls; 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; Blood draw and intestinal biopsies

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immune status: Quantification of cytokines in blood and gut mucosa.	The quantification of cytokines will be measured by luminex.	Baseline
Immune status: Quantification of cytokines in blood and gut mucosa.	The quantification of cytokines will be measured by immuno-histochemistry.	Baseline
Immune status: Quantification of chemiokines in blood and gut mucosa.	The quantification of chemiokines will be measured by luminex.	Baseline
Immune status: Quantification of chemiokines in blood and gut mucosa.	The quantification of chemiokines will be measured by immuno-histochemistry.	Baseline
Microbial translocation : Quantification of soluble CD14 in plasma.	The quantification of CD 14 will be realised by Enzyme-Linked Immunosorbent Assay (ELISA).	Baseline
Microbial translocation : Quantification of soluble soluble CD163 in plasma.	The quantification of CD163 will be realised by Enzyme-Linked Immunosorbent Assay (ELISA) .	Baseline
Microbial translocation : Quantification of Lipopolysaccharide Binding Protein (LBP).	The quantification of Lipopolysaccharide Binding Protein will be realised by Enzyme-Linked Immunosorbent Assay (ELISA).	Baseline
Microbial translocation : Quantification of Intestinal-type Fatty Acid-Binding Protein (I-FABP) in plasma.	The quantification of Intestinal-type Fatty Acid-Binding Protein (I-FABP) will be realised by Enzyme-Linked Immunosorbent Assay (ELISA).	Baseline
Microbial translocation : Quantification of 16S RNA.	The quantification of 16S RNA will be realised by real-time Polymerase Chaine Reaction (qPCR).	Baseline

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): February 25, 2020
• Study Completion (Actual): February 25, 2020

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimated): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ANRS EP61 GALT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No