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NCT07656077

Intestinal Tissue-Resident Memory T Cells and HIV-1 Persistence During Antiretroviral Therapy

Sponsor: ANRS, Emerging Infectious Diseases

View on ClinicalTrials.gov

Summary

The study aims to better characterize intestinal tissue-resident memory T cells (TRM) in people living with HIV-1 receiving suppressive antiretroviral therapy (ART). TRM cells are key components of tissue immunity and may contribute to HIV-1 persistence within the intestinal mucosa, a major viral reservoir. The phenotypic, transcriptomic, and functional characteristics of intestinal CD4+ and CD8+ TRM cells, their susceptibility to HIV-1 infection, and their potential role as viral reservoirs will be investigated. Blood samples and additional colonic biopsies obtained during routine clinically indicated colonoscopy will be collected from HIV-1-infected participants and HIV-seronegative controls.

Official title: Intestinal Tissue-Resident Memory T Cells in HIV-1 Infection: Mechanisms Involved in Their Depletion and Role in Viral Persistence During Antiretroviral Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-08-01

Completion Date

2030-07-31

Last Updated

2026-06-18

Healthy Volunteers

Yes

Conditions

HIV-1 Infection HIV Reservoir Antiretroviral Therapy

Interventions

PROCEDURE

Colonic Mucosal Biopsies

Collection of blood samples and additional colonic mucosal biopsies during clinically indicated colonoscopy for immunological and virological analyses.

I - Inclusion criteria 1 - Group 1: People Living With HIV-1 * Age ≥ 18 years * Documented HIV-1 infection * Continuous suppressive antiretroviral therapy initiated during chronic infection for at least 12 months * Plasma HIV-1 RNA ≤ 50 copies/mL for at least 6 months under ART (one isolated blip ≤ 200 copies/mL allowed) * Blood CD4+ T-cell count ≥ 350 cells/mm³ * Clinically indicated colonoscopy independent of the research protocol * Affiliation with a social security system * Written informed consent obtained before any study-specific procedure 2- Group 2: HIV-Seronegative Controls * Age ≥ 18 years * HIV-seronegative status * Clinically indicated colonoscopy independent of the research protocol * Affiliation with a social security system * Written informed consent obtained before any study-specific procedure II - Exclusion Criteria 1. Group 1: People Living With HIV-1 * HIV-2 infection * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease * Platelet count \< 50 G/L or uncorrectable coagulation disorders contraindicating biopsies * Decompensated cirrhosis * History of lymphoma * Participation in an HIV vaccine or immunotherapy study * Pregnant or breastfeeding women * Participation in another clinical study with an ongoing exclusion period * Vulnerable individuals, including minors, individuals under guardianship, or persons deprived of liberty 2. Group 2: HIV-Seronegative Controls * HIV-1 or HIV-2 infection * Refusal to undergo HIV serology testing * Inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease * Platelet count \< 50 G/L or uncorrectable coagulation disorders contraindicating biopsies * Decompensated cirrhosis * History of lymphoma * Pregnant or breastfeeding women * Participation in another clinical study with an ongoing exclusion period * Vulnerable individuals, including minors, individuals under guardianship, or persons deprived of liberty