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

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ClinicalTrials.gov Identifier: NCT01397669
Recruitment Status : Recruiting
First Posted : July 19, 2011
Last Update Posted : April 19, 2018
Sponsor:
Collaborators:
Armed Forces Research Institute of Medical Sciences, Thailand
Thai Red Cross AIDS Research Centre
Information provided by (Responsible Party):
Nittaya Phanuphak, MD, PhD, South East Asia Research Collaboration with Hawaii

Study Description
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Brief 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

Condition or disease Intervention/treatment Phase
HIV-infection Procedure: Colon biopsy, lymph node biopsy, lumbar puncture Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Study Start Date : July 2011
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of HIV and non-HIV related clinical events [ Time Frame: It will take approximately 24 months to complete the study. ]

Secondary Outcome Measures :
  1. the immunophenotyping of the gut mucosa [ Time Frame: Approximately 24 months to complete the study. ]
  2. the immunophenotyping of the peripheral blood [ Time Frame: approximately 24 months to complete the study ]
  3. immunologic markers in the genital compartment [ Time Frame: approximately 24 months to complete the study ]
  4. the immunophenotyping of the CSF [ Time Frame: approximately 24 months to complete the study ]
  5. immunologic markers in the lymph node [ Time Frame: approximately 24 months to complete the study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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. Positive urine pregnancy test
  6. 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Nittaya Phanuphak, MD, PhD, Chief of SEARCH, South East Asia Research Collaboration with Hawaii
ClinicalTrials.gov Identifier: NCT01397669     History of Changes
Other Study ID Numbers: WRAIR#1751 /RV304/ SEARCH013
First Posted: July 19, 2011    Key Record Dates
Last Update Posted: April 19, 2018
Last Verified: March 2018

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