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

Primary Purpose

HIV-infection

Status

Recruiting

Phase

Not Applicable

Locations

Thailand

Study Type

Interventional

Intervention

Colon biopsy, lymph node biopsy, lumbar puncture

About this trial

This is an interventional basic science trial for HIV-infection

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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
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.

Sites / Locations

Thai Red Cross AIDS Research CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

HIV infection and non HIV infection

Arm Description

Outcomes

Primary Outcome Measures

Number of HIV and non-HIV related clinical events

Secondary Outcome Measures

the immunophenotyping of the gut mucosa

the immunophenotyping of the peripheral blood

immunologic markers in the genital compartment

the immunophenotyping of the CSF

immunologic markers in the lymph node

Full Information

NCT ID

NCT01397669

First Posted

July 18, 2011

Last Updated

October 19, 2022

Sponsor

SEARCH Research Foundation

Collaborators

Armed Forces Research Institute of Medical Sciences, Thailand, Thai Red Cross AIDS Research Centre

1. Study Identification

Unique Protocol Identification Number

NCT01397669

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 2011 (undefined)

Primary Completion Date

February 2031 (Anticipated)

Study Completion Date

February 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

SEARCH Research Foundation

Collaborators

Armed Forces Research Institute of Medical Sciences, Thailand, Thai Red Cross AIDS Research Centre

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV-infection

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HIV infection and non HIV infection

Arm Type

Other

Intervention Type

Procedure

Intervention Name(s)

Colon biopsy, lymph node biopsy, lumbar puncture

Intervention Description

Eligible subjects will undergo a flexible sigmoidoscopy and biopsy, lumbar puncture, lymph node biopsy at Chulalongkorn University Hospital.

Primary Outcome Measure Information:

Title

Number of HIV and non-HIV related clinical events

Time Frame

It will take approximately 24 months to complete the study.

Secondary Outcome Measure Information:

Title

the immunophenotyping of the gut mucosa

Time Frame

Approximately 24 months to complete the study.

Title

the immunophenotyping of the peripheral blood

Time Frame

approximately 24 months to complete the study

Title

immunologic markers in the genital compartment

Time Frame

approximately 24 months to complete the study

Title

the immunophenotyping of the CSF

Time Frame

approximately 24 months to complete the study

Title

immunologic markers in the lymph node

Time Frame

approximately 24 months to complete the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Nitiya Chomchey, RN

Phone

662 254 2566

Ext

110

nitiya.c@searchthailand.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jintanat Ananworanich, MD

Organizational Affiliation

Department of Retrovirology USAMC-AFRIMS (SARCH office)

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thai Red Cross AIDS Research Center

City

Bangkok

Country

Thailand

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nitiya Chomchey, RN

Phone

662 254 2566

Ext

110

nitiya.c@searchthailand.org

First Name & Middle Initial & Last Name & Degree

Jintanat Ananworanich, M.D.,Ph.D

12. IPD Sharing Statement

Learn more about this trial

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

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