NCT05652088Recruiting
The Role of the Gastrointestinal-associated Lymphoid Tissue in the Cure of HIV Infection
Source: ClinicalTrials.gov · Last updated 4 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 7 Dec 2022
- Start date
- 30 Jun 2023
- Primary completion date
- Jun 2026
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- HIV
- NCT number
- NCT05652088
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 30 Jun 2023 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Any other condition which in the opinion of investigators would impede competence, compliance or possibly hinder completion of the study
Other
- Known coagulopathy or altered coagulation studies
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.