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Not Yet Recruiting
NCT05652088
The Role of the Gastrointestinal-associated Lymphoid Tissue in the Cure of HIV Infection
Conditions: HIV Infection
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 8
Sponsor: Icahn School of Medicine at Mount Sinai
Location: United States
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 formStated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the studyMales and females; Age 18-75Chronic 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 loadReceiving treatment with a molecule with the potential for HIV cureWillingness and ability to undergo colonoscopy twice during the study timeframeExclusion Criteria:Known coagulopathy or altered coagulation studiesConcomitant pregnancy of plans for pregnancy during the study periodConcomitant Inflammatory Bowel Disease, Diarrheal disease or other gastrointestinal disease that might alter the intestinal mucosal tissueConcomitant sexually transmitted infectionAny other condition which in the opinion of investigators would impede competence, compliance or possibly hinder completion of the study
Source: ClinicalTrials.gov (NCT05652088). StuddyBuddy aggregates publicly available trial information.