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
Age 18 to 50 years old
HIV negative subjects must have negative results by 4th generation EIA and NAT (Aptima)
HIV positive subjects must have a positive 4th generation EIA and a positive less sensitive EIA.
Understand the study and sign informed consent form. Persons who cannot read will have the consent form read to them by a study staff and they can give informed consent by using thumb print.
Have gastrointestinal disorders or gastrointestinal symptoms that require endoscopy for diagnostic purposes or have systemic disorders, which include but may not be limited to autoimmune diseases such as rheumatoid arthritis, systemic lupus erythematosus or psoriasis, that in the judgment of investigators could cause colon mucosa to be abnormal on biopsy
Active AIDS-defining opportunistic infection (OI) within 30 days prior to entry for HIV-positive subjects. Subjects must be off all acute treatments for OI for at least 14 days prior to entry. Subjects on maintenance or prophylactic therapy for AIDS-related OIs will be eligible.
Have platelet count < 150,000 count/ml or PT, PT/PTT > the upper limit of normal (ULN) or INR > 1.1
Have self-reported bleeding disorder
Single group
Colon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTI
Procedure/SurgeryEligible subjects will undergo a flexible sigmoidoscopy/biopsy and Brain MRI/MRS/DTI at Chulalongkorn University Hospital. Lumbar puncture, lymph node biopsy, and leukapheresis will be done at TRCARC or IHRI.
Number of HIV and non-HIV related clinical events
the immunophenotyping of the gut mucosa
the immunophenotyping of the peripheral blood
immunologic markers in the genital compartment
the immunophenotyping of the CSF
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SEARCH Research Foundation
Lead sponsor
Armed Forces Research Institute of Medical Sciences, Thailand
Collaborator
Thai Red Cross AIDS Research Centre
Collaborator
