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NCT07656077
Intestinal Tissue-Resident Memory T Cells and HIV-1 Persistence During Antiretroviral Therapy
Conditions: HIV-1 Infection, HIV Reservoir, Antiretroviral Therapy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: ANRS, Emerging Infectious Diseases
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07656077). StuddyBuddy aggregates publicly available trial information.