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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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

Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Francesca Cossarini, MD
francesca.cossarini@mountsinai.org
212-659-9269
Backup
Saurabh Mehandru, MD
saurabh.mehandru@mssm.edu
212-659-9206
Time Frame
Start Date: 2023-06-30
Estimated Completion Date: 2026-06
Participants
Target number of participants: 10
Treatments
Experimental: Patients with HIV Therapy
Subjects receiving therapies with the potential for HIV cure
Related Therapeutic Areas
Sponsors
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov