How gut immune tissue responds to HIV cure treatments
Official title: The Role of the Gastrointestinal-associated Lymphoid Tissue in the Cure of HIV Infection
Run by Icahn School of Medicine at Mount Sinai · NCT05652088 · Data updated 2026-11-12
This trial will test whether HIV cure–intent therapies change immune cells in the gut and lower tissue-associated HIV in people living with HIV.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | June 30, 2023 |
| Main results expected | June 2026 |
| Study ends | June 2026 |
| Registry record updated | July 4, 2025 |
| Trial ID | NCT05652088 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–75 with chronic HIV who are receiving a molecule with potential for HIV cure and who can undergo two research colonoscopies are the ideal candidates.
✕Probably not a fit
People not receiving cure-directed therapies, those with active gastrointestinal disease, pregnancy, bleeding disorders, or who cannot undergo colonoscopy are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will collect gastrointestinal tissue by colonoscopy from people with chronic HIV who are receiving therapies thought to have cure potential. Tissue samples will be used to measure immune effector cells in the gut (for example NK cells and cytotoxic CD8+ T cells) and the amount of HIV present in gut-associated lymphoid tissue. The team will compare immune and viral measures before and after exposure to the investigational molecules to see if the treatments induce immune activation and reduce the tissue viral reservoir. Findings will inform whether these therapeutic approaches reach and affect a key site of HIV persistence.
Why it matters
Potential benefit: If successful, the work could show that certain therapies reach the gut reservoir and help guide treatments that more effectively reduce or clear HIV from tissue, advancing cure efforts.
How similar studies have gone: Related approaches have produced immune effects in blood, but applying them specifically to reduce gut-associated HIV is less well tested and remains an area of active research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study * Males and females; Age 18-75 * Chronic HIV-1 infection, documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen, plasma HIV-1 RNA viral load * Receiving treatment with a molecule with the potential for HIV cure * Willingness and ability to undergo colonoscopy twice during the study timeframe Exclusion Criteria: * Known coagulopathy or altered coagulation studies * Concomitant pregnancy of plans for pregnancy during the study period * Concomitant Inflammatory Bowel Disease, Diarrheal disease or other gastrointestinal disease that might alter the intestinal mucosal tissue * Concomitant sexually transmitted infection * Any other condition which in the opinion of investigators would impede competence, compliance or possibly hinder completion of the study
Where it's running
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Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Francesca Cossarini, MD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Francesca Cossarini, MD
- Email: francesca.cossarini@mountsinai.org
- Phone: 212-659-9269
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.