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

Inclusion Criteria6

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 Criteria5

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

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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