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

ConditionHIV Infection
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Colonoscopy

Treatment groups

10 Participants
are divided into 1 treatment group