RECRUITING

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

Description

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

HIV Infection
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Related Conditions:

HIV Infection

Study Overview

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Study Details

Study overview

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.

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

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

Condition
HIV Infection
Intervention / Treatment

-

Contacts and Locations

New York

Icahn School of Medicine at Mount Sinai, New York, New York, United States, 10029

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Icahn School of Medicine at Mount Sinai,

Francesca Cossarini, MD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

2026-06