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

NCT05652088 | Recruiting

• 1 other identifier: STUDY-22-01294
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HIV Infection

Outcome Measures

Primary Outcomes (1)

• Change in HIV tissue viral load

  Change in HIV in tissue-associated HIV RNA viral load at the end of the study at month one compared to baseline

  End of the study (at month one) compared to baseline

Secondary Outcomes (2)

• Change in number of Cytotoxic T cells

  End of the study (at month one) compared to baseline

• Change in number of NK Cells

  End of the study (at month one) compared to baseline

Study Arms (1)

Patients with HIV Therapy

EXPERIMENTAL

Subjects receiving therapies with the potential for HIV cure

Procedure: Colonoscopy

Interventions

Colonoscopy PROCEDURE

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

Patients with HIV Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

HIV Infections

Interventions

Colonoscopy

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Francesca Cossarini, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Cossarini, MD

CONTACT

212-659-9269; francesca.cossarini@mountsinai.org

Saurabh Mehandru, MD

CONTACT

212-659-9206; saurabh.mehandru@mssm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Model Details: All subjects receiving therapies with the potential for HIV cure who agree to participate in this study, will undergo a colonoscopy to obtain tissue samples for research assays before and after receiving such treatment.

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: June 30, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)