Gut-Associated Lymphocyte Trafficking (GALT)

ANRS, Emerging Infectious Diseases

Status: Completed

Conditions: HIV-1 Infection

Treatments: Other: Peripheral blood and intestinal biopsies will be collected

Study type: Interventional

Funder types: Other

Identifiers

NCT02906137

ANRS EP61 GALT

Details and patient eligibility

About

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.

Full description

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

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 2 patient groups

HIV-1 infected subjects

Experimental group

Description:

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

Treatment:

Other: Peripheral blood and intestinal biopsies will be collected

Uninfected-controls

Other group

Description:

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

Treatment:

Other: Peripheral blood and intestinal biopsies will be collected