RECRUITING

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

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HIV Infection

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-06-30
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05652088

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provision of signed and dated informed consent form
  2. * Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
  3. * Males and females; Age 18-75
  4. * 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
  5. * Receiving treatment with a molecule with the potential for HIV cure
  6. * Willingness and ability to undergo colonoscopy twice during the study timeframe
  1. * Known coagulopathy or altered coagulation studies
  2. * Concomitant pregnancy of plans for pregnancy during the study period
  3. * Concomitant Inflammatory Bowel Disease, Diarrheal disease or other gastrointestinal disease that might alter the intestinal mucosal tissue
  4. * Concomitant sexually transmitted infection
  5. * Any other condition which in the opinion of investigators would impede competence, compliance or possibly hinder completion of the study

Contacts and Locations

Study Contact

Francesca Cossarini, MD
CONTACT
212-659-9269
francesca.cossarini@mountsinai.org
Saurabh Mehandru, MD
CONTACT
212-659-9206
saurabh.mehandru@mssm.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-30
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-06-30
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • HIV Infection