HIV-infectionNCT01397669
Characteristics of Immunity in Gut Mucosa, Spinal Fluid, Lymph Node and Blood of HIV Negative Thais and Thais With HIV Infection
A study testing Colon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTI in people with HIV-infection, run by SEARCH Research Foundation at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-infection
- What is being tested?
- Colon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2011to Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nitiya Chomchey, RN contact
Thailand1 site, 1 recruiting
- Recruiting
SEARCH Research Foundation
Bangkok, Bangkok, 10330
Nitiya Chomchey, RN, nitiya.c@searchthailand.org
Somchai Sriplienchan, M.D., MPH
About this study
To compare the immunophenotyping and immunochemistry in the gut mucosa of HIV negative and non-acute HIV-infected adults
- To compare the immunophenotyping of the gut mucosa to that of the peripheral blood in HIV negative and in non-acute HIV-infected subjects
- 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
- 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
- Archive samples for immunologic and virologic testing
Read the 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/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.
- Conditions
- HIV-infection
- Being tested
- Colon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTI
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| HIV infection and non HIV infection | Other | Not described Receives: Procedure: Colon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HIV and non-HIV related clinical events
Measured: It will take approximately 24 months to complete the study.
Secondary outcomes (5)
the immunophenotyping of the gut mucosa
Measured: Approximately 24 months to complete the study.
the immunophenotyping of the peripheral blood
Measured: approximately 24 months to complete the study
immunologic markers in the genital compartment
Measured: approximately 24 months to complete the study
the immunophenotyping of the CSF
Measured: approximately 24 months to complete the study
immunologic markers in the lymph node
Measured: approximately 24 months to complete the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2031 (estimated)
- Study completionFeb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SEARCH Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Armed Forces Research Institute of Medical Sciences, Thailand, Thai Red Cross AIDS Research Centre
- Responsible party
- Principal investigator, Somchai Sriplienchan, MD, SEARCH Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01397669
- Sponsor's protocol ID
- WRAIR#1751 /RV304/ SEARCH013
- Status last verified
- Apr 2026
- First submitted
- 18 Jul 2011
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characteristics of Immunity in Gut Mucosa, Spinal Fluid, Lymph Node and Blood of HIV Negative Thais and Thais With HIV Infection
- ClinicalTrials.gov ID
- NCT01397669
- Acronym / sponsor ID
- WRAIR#1751 /RV304/ SEARCH013
- Conditions
- HIV-infection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- SEARCH Research FoundationUniversity, hospital or other
- Collaborators
- Armed Forces Research Institute of Medical Sciences, Thailand, Thai Red Cross AIDS Research Centre
- Study start
- Jul 2011 (actual)
- Primary completion
- Feb 2031 (estimated)
- Study completion
- Feb 2031 (estimated)
- First posted
- 19 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the immunophenotyping and immunochemistry in the gut mucosa of HIV negative and non-acute HIV-infected adults
- To compare the immunophenotyping of the gut mucosa to that of the peripheral blood in HIV negative and in non-acute HIV-infected subjects
- 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
- 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
- Archive samples for immunologic and virologic testing
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/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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIV infection and non HIV infection | Other | Procedure: Colon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTI |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTIEligible 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. | Procedure or surgery | HIV infection and non HIV infection |
Primary outcome
Number of HIV and non-HIV related clinical events
Time frame: It will take approximately 24 months to complete the study.
5 secondary outcomes
the immunophenotyping of the gut mucosa
Time frame: Approximately 24 months to complete the study.
the immunophenotyping of the peripheral blood
Time frame: approximately 24 months to complete the study
immunologic markers in the genital compartment
Time frame: approximately 24 months to complete the study
the immunophenotyping of the CSF
Time frame: approximately 24 months to complete the study
immunologic markers in the lymph node
Time frame: approximately 24 months to complete the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
Related trials for HIV-infection
Not yet recruiting
HealthMpowerment Korea: Pilot Testing the Cultural Adaptation of a Digital HIV Intervention for Men Who Have Sex With Men in South Korea
HIV Infections, HIV Prevention and Care
Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Recruiting
Evaluating the Impact of Using the B-OK Bottles for HIV and ART Literacy in South Africa
HIV, HIV Treatment
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
RecruitingObservational study
Olfactory Function and Model-Based Behavior in People Living With HIV and SUD
HIV, Substance Use Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nitiya Chomchey, RN contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTI in people with HIV-infection, run by SEARCH Research Foundation at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nitiya Chomchey, RN (nitiya.c@searchthailand.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of HIV and non-HIV related clinical events (time frame: It will take approximately 24 months to complete the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.