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Completed

NCT Number: NCT02906137

Gut-Associated Lymphocyte Trafficking

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.

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Key information

Conditions

HIV-1 Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Purpan - Service de Médecine Interne, Toulouse, France

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral blood and intestinal biopsies will be collected

Other

Blood draw and intestinal biopsies

Primary outcomes

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

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline

    The frequencies of Th22 will be measured by flow cytometry.

Secondary outcomes

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

    Time frame: Baseline

    The quantification of cytokines will be measured by luminex.

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

    Time frame: Baseline

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

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

    Time frame: Baseline

    The quantification of chemiokines will be measured by luminex.

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

    Time frame: Baseline

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

  5. Microbial translocation : Quantification of soluble CD14 in plasma.

    Time frame: 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.

    Time frame: Baseline

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

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

    Time frame: 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.

    Time frame: 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.

    Time frame: Baseline

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

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Registry information

Official study title

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

Acronym: GALT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 19, 2016
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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