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GALT: Gut-Associated Lymphocyte Trafficking

Sponsor
ANRS, Emerging Infectious Diseases (Other)
Overall Status
Completed
CT.gov ID
NCT02906137
Collaborator
(none)
80
Enrollment
2
Locations
2
Arms
36.6
Actual Duration (Months)
40
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Peripheral blood and intestinal biopsies will be collected
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Altered Homing of T Lymphocytes to the Gut and Poor Immune Reconstitution of the Intestinal Mucosa in Treated HIV-infected Individuals
Actual Study Start Date :
Feb 6, 2017
Actual Primary Completion Date :
Feb 25, 2020
Actual Study Completion Date :
Feb 25, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Immune status: Measure of the frequencies of Th1 in peripheral blood and gut mucosa. [Baseline]

    The frequencies of Th1 will be measured by flow cytometry.

  2. Immune status: Measure of the frequencies of Th17 in peripheral blood and gut mucosa. [Baseline]

    The frequencies of Th17 will be measured by flow cytometry.

  3. Immune status: Measure of the frequencies of Th22 in peripheral blood and gut mucosa. [Baseline]

    The frequencies of Th22 will be measured by flow cytometry.

Secondary Outcome Measures

  1. Immune status: Quantification of cytokines in blood and gut mucosa. [Baseline]

    The quantification of cytokines will be measured by luminex.

  2. Immune status: Quantification of cytokines in blood and gut mucosa. [Baseline]

    The quantification of cytokines will be measured by immuno-histochemistry.

  3. Immune status: Quantification of chemiokines in blood and gut mucosa. [Baseline]

    The quantification of chemiokines will be measured by luminex.

  4. Immune status: Quantification of chemiokines in blood and gut mucosa. [Baseline]

    The quantification of chemiokines will be measured by immuno-histochemistry.

  5. Microbial translocation : Quantification of soluble CD14 in plasma. [Baseline]

    The quantification of CD 14 will be realised by Enzyme-Linked Immunosorbent Assay (ELISA).

  6. Microbial translocation : Quantification of soluble soluble CD163 in plasma. [Baseline]

    The quantification of CD163 will be realised by Enzyme-Linked Immunosorbent Assay (ELISA) .

  7. Microbial translocation : Quantification of Lipopolysaccharide Binding Protein (LBP). [Baseline]

    The quantification of Lipopolysaccharide Binding Protein will be realised by Enzyme-Linked Immunosorbent Assay (ELISA).

  8. Microbial translocation : Quantification of Intestinal-type Fatty Acid-Binding Protein (I-FABP) in plasma. [Baseline]

    The quantification of Intestinal-type Fatty Acid-Binding Protein (I-FABP) will be realised by Enzyme-Linked Immunosorbent Assay (ELISA).

  9. Microbial translocation : Quantification of 16S RNA. [Baseline]

    The quantification of 16S RNA will be realised by real-time Polymerase Chaine Reaction (qPCR).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hôpital Purpan - Service de Médecine Interne Toulouse France 31059
2 Hôpital Purpan - Service des maladies Infectieuses Toulouse France 31059

Sponsors and Collaborators

  • ANRS, Emerging Infectious Diseases

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ANRS, Emerging Infectious Diseases
ClinicalTrials.gov Identifier:
NCT02906137
Other Study ID Numbers:
  • ANRS EP61 GALT
First Posted:
Sep 19, 2016
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 14, 2022