RecruitingNot ApplicableNCT05652088

The Role of the Gastrointestinal-associated Lymphoid Tissue in the Cure of HIV Infection

Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

10 participants

Start Date

Jun 30, 2023

Study Type

INTERVENTIONAL

Conditions

HIV Infection

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether a large reservoir of HIV hides in gut-associated immune tissue — and whether this reservoir needs to be targeted to achieve a cure. It enrolls HIV-positive adults on stable treatment and healthy volunteers for comparison. **You may be eligible if...** - You are between 18 and 75 years old - You have chronic HIV-1 infection - You are on stable antiretroviral therapy with an undetectable viral load (if HIV positive) - OR you are an HIV-negative healthy volunteer **You may NOT be eligible if...** - You have active serious infections or significant other illnesses - You have conditions that make colonoscopy or biopsy procedures unsafe - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREColonoscopy

Colonoscopy 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