The Role of the Gastrointestinal-associated Lymphoid Tissue in the Cure of HIV Infection
Part of paid clinical trials in New York, New York.
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Study ID
- NCT05652088
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Colonoscopy — PROCEDUREColonoscopy is a procedure where an instrument called colonoscope is inserted through the rectum to look at the entire internal surface of the intestine. Participants will be placed on a stretcher on the left side. A colonoscope will be advanced into the colon and into the terminal ileum. The entire procedure should take approximately 40 minutes
Study Details
The objective of this study is to understand the effects of HIV cure strategies on the virus and immune cells that reside within the gastrointestinal tract. Subjects receiving therapies with the potential for HIV cure will undergo a colonoscopy to obtain gastrointestinal tissue for research assays. This study will test whether receiving these therapies will induce changes in the immune cells in the gastrointestinal tract and reduce the tissue-associated HIV viral levels.
Key Dates
- Start date
- Jun 30, 2023
- Status verified
- Jul 2025
- Primary completion
- Jun 30, 2026
- Completion
- Jun 30, 2026
Study Design
- Enrollment
- 10 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- BASIC_SCIENCE
Arms
- Experimental: Patients with HIV TherapySubjects receiving therapies with the potential for HIV cure
Primary Outcome Measure
Change in HIV tissue viral load [ Time Frame: End of the study (at month one) compared to baseline ]
Central Contacts
- Francesca Cossarini, MD212-659-9269
- Saurabh Mehandru, MD212-659-9206
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | Francesca Cossarini (PRINCIPAL_INVESTIGATOR) |
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