Status:
RECRUITING
Characteristics of Immunity in Gut Mucosa, Spinal Fluid, Lymph Node and Blood of HIV Negative Thais and Thais with HIV Infection
Lead Sponsor:
SEARCH Research Foundation
Collaborating Sponsors:
Armed Forces Research Institute of Medical Sciences, Thailand
Thai Red Cross AIDS Research Centre
Conditions:
HIV-infection
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief 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 periphera...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2031
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT01397669
Start Date
July 1 2011
End Date
February 1 2031
Last Update
November 27 2024
Active Locations (1)
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1
Institute of HIV Research and Innovation (IHRI)
Bangkok, Bangkok, Thailand, 10330