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

NCT01397669 | Recruiting

• 1 other identifier: WRAIR#1751 /RV304/ SEARCH013
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the immunophenotyping and immunochemistry in the gut mucosa of HIV negative and non-acute HIV-infected adults

1. 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. 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. 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. 4.Archive samples for immunologic and virologic testing

Conditions

HIV-infection

Outcome Measures

Primary Outcomes (1)

• Number of HIV and non-HIV related clinical events

  It will take approximately 24 months to complete the study.

Secondary Outcomes (5)

• 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

Study Arms (1)

HIV infection and non HIV infection

OTHER

Procedure: Colon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTI

Interventions

Colon biopsy, lymph node biopsy, lumbar puncture, Leukapheresis, Brain MRI/MRS/DTI PROCEDURE

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.

HIV infection and non HIV infection

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SEARCH Research Foundation: lead
• Armed Forces Research Institute of Medical Sciences, Thailand: collaborator
• Thai Red Cross AIDS Research Centre: collaborator

Study Sites (1)

SEARCH Research Foundation

Bangkok, Bangkok, 10330, Thailand

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Spinal Puncture; Leukapheresis

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Neurological; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Cytapheresis; Biological Therapy; Blood Component Removal; Leukocyte Reduction Procedures; Cell Separation; Cytological Techniques

Central Study Contacts

Nitiya Chomchey, RN

CONTACT

nitiya.c@searchthailand.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Exceutive director of SEARCH Research Foundation

Study Record Dates

• First Submitted: July 18, 2011
• First Posted: July 19, 2011
• Study Start: July 1, 2011
• Primary Completion (Estimated): February 1, 2031
• Study Completion (Estimated): February 1, 2031
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

TH (1)