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

Recruiting now · Not applicable

Conditions studied: HIV Infection

In brief

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 facts

Study ID

NCT05652088

Run by

Icahn School of Medicine at Mount Sinai

People needed

10

Starts

2023-06-30

Expected to finish

2026-06-01

Last updated by the study team

2025-07-04

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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