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

ID#: NCT05652088

Age: 18 - 75 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Enrolling by invitation

Start Date: March 14, 2023

End Date: May 31, 2024

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.

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