NCT01397669Recruiting
Characteristics of Immunity in Gut Mucosa, Spinal Fluid, Lymph Node and Blood of HIV Negative Thais and Thais With HIV Infection
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 232 (estimated)
- First submitted
- 18 Jul 2011
- Start date
- 1 Jul 2011
- Primary completion date
- 28 Feb 2031
- Lead sponsor
- SEARCH Research Foundation
- Diseases
- HIV
- NCT number
- NCT01397669
What you commit to
- Study type: Interventional
- Planned participants: 232
- From 1 Jul 2011 to the primary completion date, 28 Feb 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
- Have self-reported bleeding disorder
- Untreated syphilis infection
- 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.
Lab values
- Have platelet count \< 150,000 count/ml or PT, PT/PTT \> the upper limit of normal (ULN) or INR \> 1.1
Other
- Abnormal screening neurological examination suggestive of central neurological findings if planning to participate in the lumbar puncture
- Positive urine pregnancy test
Who the study is looking for
- 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.
Age in the registry: 18 years to 50 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SEARCH Research Foundation Coordinator of this site? Confirm its status | Bangkok | Thailand | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.