NCT05652088 The Role of the Gastrointestinal-associated Lymphoid Tissue in the Cure of HIV Infection
| NCT ID | NCT05652088 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | HIV Infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-06-30 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2023-06-30 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Francesca Cossarini, MD
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT05652088 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying HIV Infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05652088 currently recruiting?
Yes, NCT05652088 is actively recruiting participants. Contact the research team at francesca.cossarini@mountsinai.org for enrollment information.
Where is the NCT05652088 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT05652088 clinical trial?
NCT05652088 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Francesca Cossarini, MD at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 10 participants.
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