Recruiting

HIV Cure Strategies

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT05652088

Conditions

HIV Infection

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Colonoscopy

Study Details

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

Study ID

NCT05652088

Start date

Jun 30, 2023

Status verified date

Jul, 2025

Completion date

Jun, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Patients with HIV Therapy

Subjects receiving therapies with the potential for HIV cure

Interventions

Colonoscopy

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

Primary outcome measure

  • Change in HIV tissue viral load [ Time Frame: End of the study (at month one) compared to baseline ]

Central Contacts and Locations

Central contacts

Francesca Cossarini, MD

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

Saurabh Mehandru, MD

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

Locations

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Francesca Cossarini, MD

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

Saurabh Mehandru, MD

212-659-9206Saurabh.mehandru@mssm.edu

Principal Investigator:

Francesca Cossarini

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Jul 4, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-07-04.