RecruitingNot ApplicableNCT01397669

Characteristics of Immunity in Gut Mucosa, Spinal Fluid, Lymph Node and Blood of HIV Negative Thais and Thais with HIV Infection

Sponsor

SEARCH Research Foundation

Enrollment

214 participants

Start Date

Jul 1, 2011

Study Type

INTERVENTIONAL

Conditions

HIV Infection

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria4

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.

Exclusion Criteria8

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
Untreated syphilis infection
Abnormal screening neurological examination suggestive of central neurological findings if planning to participate in the lumbar puncture
Positive urine pregnancy test
Persons who have a history of a medical or psychiatric disorder by investigator's interview and physical examination according to standard practices, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.

Interventions

PROCEDUREColon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTI

Eligible 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.