Gut-Associated Lymphocyte Trafficking

HIV-1 Infection Clinical Trial

— GALT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02906137
• Other study ID #: ANRS EP61 GALT
• Status: Completed
• Phase: N/A
• Start date: February 6, 2017
• Est. completion date: February 25, 2020

Study information

• Verified date: December 2021
• Source: ANRS, Emerging Infectious Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 25, 2020
• Est. primary completion date: February 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Other:
• Peripheral blood and intestinal biopsies will be collected
Blood draw and intestinal biopsies

Locations

Country	Name	City	State
France	Hôpital Purpan - Service de Médecine Interne	Toulouse
France	Hôpital Purpan - Service des maladies Infectieuses	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
ANRS, Emerging Infectious Diseases

Country where clinical trial is conducted

France, 

Outcome

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