Characteristics of Immune Cells in Gut Mucosa of HIV Negative and HIV Positive Thais
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01397669 |
Recruitment Status
:
Recruiting
First Posted
: July 19, 2011
Last Update Posted
: April 19, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV-infection | Procedure: Colon biopsy, lymph node biopsy, lumbar puncture | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Study Start Date : | July 2011 |
Estimated Primary Completion Date : | September 2021 |
Estimated Study Completion Date : | September 2021 |

Arm | Intervention/treatment |
---|---|
HIV infection and non HIV infection |
Procedure: Colon biopsy, lymph node biopsy, lumbar puncture
Eligible subjects will undergo a flexible sigmoidoscopy and biopsy, lumbar puncture, lymph node biopsy at Chulalongkorn University Hospital.
|
- Number of HIV and non-HIV related clinical events [ Time Frame: It will take approximately 24 months to complete the study. ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01397669
Contact: Nitiya Chomchey, RN | 662 254 2566 ext 110 | nitiya.c@searchthailand.org |
Thailand | |
Thai Red Cross AIDS Research Center | Recruiting |
Bangkok, Thailand | |
Contact: Nitiya Chomchey, RN 662 254 2566 ext 110 nitiya.c@searchthailand.org | |
Principal Investigator: Jintanat Ananworanich, M.D.,Ph.D |
Principal Investigator: | Jintanat Ananworanich, MD | Department of Retrovirology USAMC-AFRIMS (SARCH office) |
Responsible Party: | Nittaya Phanuphak, MD, PhD, Chief of SEARCH, South East Asia Research Collaboration with Hawaii |
ClinicalTrials.gov Identifier: | NCT01397669 History of Changes |
Other Study ID Numbers: |
WRAIR#1751 /RV304/ SEARCH013 |
First Posted: | July 19, 2011 Key Record Dates |
Last Update Posted: | April 19, 2018 |
Last Verified: | March 2018 |
Additional relevant MeSH terms:
HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases |