Characteristics of Immune Cells in Gut Mucosa of HIV Negative and HIV Positive Thais

This study is currently recruiting participants. (see Contacts and Locations)

Verified April 2016 by South East Asia Research Collaboration with Hawaii

Sponsor:

Collaborators:

Armed Forces Research Institute of Medical Sciences, Thailand

Thai Red Cross AIDS Research Centre

Information provided by (Responsible Party):

Assoc.Prof.Jintanat Ananworanich, M.D., South East Asia Research Collaboration with Hawaii

ClinicalTrials.gov Identifier:

NCT01397669

First received: July 18, 2011

Last updated: April 17, 2016

Last verified: April 2016

History of Changes

Purpose

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	Intervention
HIV-infection	Procedure: Colon biopsy, lymph node biopsy, lumbar puncture


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

U.S. FDA Resources

Further study details as provided by South East Asia Research Collaboration with Hawaii:

Primary Outcome Measures:

Number of HIV and non-HIV related clinical events [ Time Frame: It will take approximately 24 months to complete the study. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the immunophenotyping of the gut mucosa [ Time Frame: Approximately 24 months to complete the study. ] [ Designated as safety issue: Yes ]
the immunophenotyping of the peripheral blood [ Time Frame: approximately 24 months to complete the study ] [ Designated as safety issue: Yes ]
immunologic markers in the genital compartment [ Time Frame: approximately 24 months to complete the study ] [ Designated as safety issue: Yes ]
the immunophenotyping of the CSF [ Time Frame: approximately 24 months to complete the study ] [ Designated as safety issue: Yes ]
mmunologic markers in the lymph node [ Time Frame: approximately 24 months to complete the study ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	61
Study Start Date:	July 2011
Estimated Study Completion Date:	September 2021
Estimated Primary Completion Date:	September 2021 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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.

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.

Eligibility


Ages Eligible for Study:	18 Years to 50 Years (Adult)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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
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.

Contacts and Locations

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01397669

Contacts


Contact: Nitiya Chomchey, RN	662 254 2566 ext 110	nitiya.c@searchthailand.org

Locations


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

Sponsors and Collaborators

South East Asia Research Collaboration with Hawaii

Armed Forces Research Institute of Medical Sciences, Thailand

Thai Red Cross AIDS Research Centre

Investigators


Principal Investigator:	Jintanat Ananworanich, MD	Department of Retrovirology USAMC-AFRIMS (SARCH office)

More Information


Responsible Party:	Assoc.Prof.Jintanat Ananworanich, M.D., Assoc.Prof., South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier:	NCT01397669 History of Changes
Other Study ID Numbers:	WRAIR#1751 /RV304/ SEARCH013
Study First Received:	July 18, 2011
Last Updated:	April 17, 2016
Health Authority:	Thailand: Ethical Committee United States: Federal Government

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

ClinicalTrials.gov processed this record on September 28, 2016

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