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

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

Study Overview

• Status: Recruiting
• Conditions: HIV-infection
• Intervention / Treatment: Procedure: Colon biopsy, lymph node biopsy, lumbar puncture

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nitiya Chomchey, RN; Phone Number: 110 662 254 2566; Email: nitiya.c@searchthailand.org

Study Locations

• Thailand
  • Bangkok, Thailand
    • Recruiting
    • Thai Red Cross AIDS Research Center
    • Contact: Nitiya Chomchey, RN; Phone Number: 110 662 254 2566; Email: nitiya.c@searchthailand.org
    • Principal Investigator: Jintanat Ananworanich, M.D.,Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of HIV and non-HIV related clinical events	It will take approximately 24 months to complete the study.

Secondary Outcome Measures

Outcome Measure	Time Frame
the immunophenotyping of the gut mucosa	Approximately 24 months to complete the study.
the immunophenotyping of the peripheral blood	approximately 24 months to complete the study
immunologic markers in the genital compartment	approximately 24 months to complete the study
the immunophenotyping of the CSF	approximately 24 months to complete the study
immunologic markers in the lymph node	approximately 24 months to complete the study

Collaborators and Investigators

• Sponsor: South East Asia Research Collaboration with Hawaii
• Collaborators: Thai Red Cross AIDS Research Centre; Armed Forces Research Institute of Medical Sciences, Thailand
• Investigators: Principal Investigator: Jintanat Ananworanich, MD, Department of Retrovirology USAMC-AFRIMS (SARCH office)

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Anticipated): February 1, 2031
• Study Completion (Anticipated): February 1, 2031

Study Registration Dates

• First Submitted: July 18, 2011
• First Submitted That Met QC Criteria: July 18, 2011
• First Posted (Estimate): July 19, 2011

Study Record Updates

• Last Update Posted (Actual): October 20, 2022
• Last Update Submitted That Met QC Criteria: October 19, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Slow Virus Diseases; HIV Infections; Infections; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: WRAIR#1751 /RV304/ SEARCH013