NCT07656077Not yet recruiting
Intestinal Tissue-Resident Memory T Cells and HIV-1 Persistence During Antiretroviral Therapy
Intestinal Tissue-Resident Memory T Cells in HIV-1 Infection: Mechanisms Involved in Their Depletion and Role in Viral Persistence During Antiretroviral Therapy
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 10 Jun 2026
- Start date
- 1 Aug 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Diseases
- HIV
- NCT number
- NCT07656077
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Aug 2026 to the primary completion date, 31 Jul 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Criteria the registry did not label
- 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
- 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
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.