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

HIV-infection Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01397669
• Other study ID #: WRAIR#1751 /RV304/ SEARCH013
• Status: Recruiting
• Phase: N/A
• Start date: July 2011
• Est. completion date: February 2031

Study information

• Verified date: October 2022
• Source: South East Asia Research Collaboration with Hawaii
• Contact: Nitiya Chomchey, RN
• Phone: 662 254 2566
• Email: nitiya.c[@]searchthailand.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 2031
• Est. primary completion date: February 2031
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Age 18 to 50 years old

2. HIV negative subjects must have negative results by 4th generation EIA and NAT (Aptima)

3. HIV positive subjects must have a positive 4th generation EIA and a positive less sensitive EIA.

4. 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:

1. 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

2. 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.

3. Have platelet count < 150,000 count/ml or PT, PT/PTT > the upper limit of normal (ULN) or INR > 1.1

4. Have self-reported bleeding disorder

5. Untreated syphilis infection

6. Abnormal screening neurological examination suggestive of central neurological findings if planning to participate in the lumbar puncture

7. Positive urine pregnancy test

8. 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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• HIV-infection
• Infections

Intervention

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.

Locations

Country	Name	City	State
Thailand	Thai Red Cross AIDS Research Center	Bangkok

Sponsors (3)

Lead Sponsor	Collaborator
South East Asia Research Collaboration with Hawaii	Armed Forces Research Institute of Medical Sciences, Thailand, Thai Red Cross AIDS Research Centre

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of HIV and non-HIV related clinical events		It will take approximately 24 months to complete the study.
Secondary	the immunophenotyping of the gut mucosa		Approximately 24 months to complete the study.
Secondary	the immunophenotyping of the peripheral blood		approximately 24 months to complete the study
Secondary	immunologic markers in the genital compartment		approximately 24 months to complete the study
Secondary	the immunophenotyping of the CSF		approximately 24 months to complete the study
Secondary	immunologic markers in the lymph node		approximately 24 months to complete the study