Gut-Associated Lymphocyte Trafficking

NCT ID: NCT02906137

Last Updated: 2022-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-06
• Study Completion Date: 2020-02-25

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.

Detailed Description

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

Conditions

HIV-1 Infection

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Peripheral blood and intestinal biopsies will be collected

Intervention Type: OTHER

Blood draw and intestinal biopsies

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

Group Type: OTHER

Peripheral blood and intestinal biopsies will be collected

Intervention Type: OTHER

Blood draw and intestinal biopsies

Interventions

Peripheral blood and intestinal biopsies will be collected

Blood draw and intestinal biopsies

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Purpan - Service de Médecine Interne

Toulouse, , France

Hôpital Purpan - Service des maladies Infectieuses

Toulouse, , France

Countries

France

Other Identifiers

ANRS EP61 GALT

Identifier Type: -

Identifier Source: org_study_id