Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT05652088

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-07-04

10

Participants Needed

1

Research Sites

152 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provision of signed and dated informed consent form
  • Willingness to comply with all study procedures and availability for the study duration
  • Male or female aged 18 to 75 years
  • Chronic HIV-1 infection confirmed by approved tests
  • Receiving treatment with a molecule with potential for HIV cure
  • Willingness and ability to undergo colonoscopy twice during the study
Not Eligible

You will not qualify if you...

  • Known coagulopathy or altered coagulation studies
  • Pregnancy or plans for pregnancy during the study
  • Inflammatory Bowel Disease, diarrheal disease, or other gastrointestinal diseases affecting the intestinal mucosa
  • Current sexually transmitted infection
  • Any condition that may impair study compliance or completion as judged by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

F

Francesca Cossarini, MD

CONTACT

S

Saurabh Mehandru, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

1

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