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.
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
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
Single group
Colonoscopy
Procedure/SurgeryColonoscopy 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
Change in HIV tissue viral load
Change in HIV in tissue-associated HIV RNA viral load at the end of the study at month one compared to baseline
Change in number of Cytotoxic T cells
Change in number of tissue-associated cytotoxic T cells at the end of the study (at month one) period compared to baseline
Change in number of NK Cells
Change in number of tissue-associated NK cells at the end of the study (at month one) period compared to baseline
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