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

NCT07656077 | Not Yet Recruiting

• 1 other identifier: ANRS 00853-R-PR GALT-2
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

HIV-1 Infection; Antiretroviral Therapy; HIV Reservoir

Keywords

HIV-1; Tissue-Resident Memory T Cells; Viral Reservoir; ART; Intestinal Mucosa; Mucosal Immunity; CD4 T Cells; HIV Persistence

Outcome Measures

Primary Outcomes (1)

• Frequency and Immunophenotypic Profile of Intestinal CD4+ and CD8+ Tissue-Resident Memory T Cells Measured by Multiparameter Flow Cytometry

  Frequency and expression of tissue-resident memory T-cell markers (CD69, CD103, CCR7, S1PR1), differentiation markers (CD45RA/RO, CD27, CD28), survival markers (CD127, TCF-1), activation and exhaustion markers (HLA-DR, CD38, CD57, KLRG1, CD101, PD-1, TIGIT, TIM-3, CD39), and homing markers (CD49d, β7, CCR5, CCR6, CXCR3, CXCR6, CX3CR1) on intestinal CD4+ and CD8+ T cells measured by multiparameter flow cytometry on colonic mucosal biopsy specimens.

  Day 1

Secondary Outcomes (3)

• Single-Cell Transcriptomic and T-Cell Receptor Repertoire Profiles of Intestinal Tissue-Resident Memory T Cells Measured by CITE-seq

  Day 1

• Total and Intact HIV-1 Proviral DNA Levels in Intestinal CD4+ Tissue-Resident Memory T Cells Measured by Multiplex ddPCR Intact Proviral DNA Assay (IPDA)

  Day 1

• Cytokine Production, Degranulation, and Proliferative Capacity of Intestinal Tissue-Resident Memory T Cells Measured by Functional Flow Cytometry Assays

  Day 1

Study Arms (2)

HIV-1-Infected Participants Receiving Suppressive Antiretroviral Therapy

EXPERIMENTAL

Participants living with HIV-1 receiving suppressive antiretroviral therapy (ART) and undergoing clinically indicated colonoscopy will undergo blood sampling and additional colonic mucosal biopsies for immunological and virological analyses.

Procedure: Colonic Mucosal Biopsies

HIV-Seronegative Controls

EXPERIMENTAL

HIV-seronegative participants undergoing clinically indicated colonoscopy will undergo blood sampling and additional colonic mucosal biopsies for immunological analyses.

Procedure: Colonic Mucosal Biopsies

Interventions

Colonic Mucosal Biopsies PROCEDURE

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

Also known as: Blood Sampling

HIV-1-Infected Participants Receiving Suppressive Antiretroviral Therapy; HIV-Seronegative Controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Vulnerable individuals, including minors, individuals under guardianship, or persons deprived of liberty
• 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

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Pierre Delobel, MD, PhD

  University Hospital of Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre Delobel, MD, PhD

CONTACT

+33 5 61 77 75 08; delobel.p@chu-toulouse.fr

Marcia Trumeau, MS

CONTACT

marcia.trumeau@anrs.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be applied in this study. This is an open-label physiopathological study without randomization or blinded intervention. Laboratory analyses will be performed on biological samples collected from study participants.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants undergoing clinically indicated colonoscopy will undergo additional blood sampling and colonic mucosal biopsies for immunological and virological analyses. HIV-1-infected participants receiving suppressive antiretroviral therapy and HIV-seronegative controls will be enrolled.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 18, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2030
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share