Last updated on April 2018

Characteristics of Immune Cells in Gut Mucosa of HIV Negative and HIV Positive Thais


Brief description of study

To compare the immunophenotyping and immunochemistry in the gut mucosa of HIV negative and non-acute HIV-infected adults

  1. To compare the immunophenotyping of the gut mucosa to that of the peripheral blood in HIV negative and in non-acute HIV-infected subjects
  2. To compare the immunophenotyping of the peripheral blood in HIV negative and non-acute HIV-infected adults to the findings from acutely HIV-infected subjects in the WRAIR#1494/RV254/ SEARCH 010 study
  3. To compare immunologic markers in the genital compartment compared to the peripheral blood in HIV negative and non-acute HIV-infected adults to the findings from acutely HIV-infected subjects in the WRAIR#1494/RV254/ SEARCH 010 study
  4. Archive samples for immunologic and virologic testing

Detailed Study Description

This study will provide control samples for immunologic and virologic investigations from HIV negative and non-acute HIV-infected subjects to compare to subjects with acute HIV infection in WRAIR#1494/RV254/SEARCH 010 study. These control samples will allow for correct scientific interpretation of the immunologic changes seen in acute HIV infection in the peripheral blood, gut and genital compartments.

Subjects will be recruited at the Thai Red Cross Anonymous Clinic (TRCAC) and Chulalongkorn University Hospital. Eligible subjects will undergo a one-time flexible sigmoidoscopy and biopsy at Chulalongkorn University Hospital. They will have a total of approximately 60 ml of blood draw for immunophenotyping and storage. Genital secretion will be collected in subjects who agree to this optional procedure.

It will take approximately 12 months to complete the study. Each subject will have two visits: the screening visit and the enrollment visit (within 15 days of screening visit). Subjects may also be co-enrolled in other study protocols provided blood volumes are within acceptable limits.

Clinical Study Identifier: NCT01397669

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