Comparing immune characteristics in HIV negative and HIV infected Thais

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

This study is testing the differences in immune system features between HIV-negative people and those with non-acute HIV infection to learn more about how the virus affects the body.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 232 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: SEARCH Research Foundation (other)
• Locations: 1 site (Bangkok, Bangkok)
• Trial ID: NCT01397669 on ClinicalTrials.gov

What this trial studies

This study aims to compare the immunophenotyping and immunochemistry of gut mucosa, blood, and genital compartments between HIV negative individuals and those with non-acute HIV infection. Participants will undergo a one-time flexible sigmoidoscopy and biopsy, along with blood draws for immunophenotyping. The study will also archive samples for future immunologic and virologic testing, providing control samples for comparison with acutely HIV-infected subjects. The research will take approximately 12 months and will involve two visits for each participant.

Who should consider this trial

Good fit: Ideal candidates are Thai adults aged 18 to 50, both HIV negative and those with non-acute HIV infection.

Not a fit: Patients with gastrointestinal disorders or active AIDS-defining opportunistic infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of immune responses in HIV infection, potentially leading to improved treatment strategies.

How similar studies have performed: While this study builds on existing knowledge, it employs a novel approach by comparing specific immunologic markers across different compartments in the context of HIV infection.

Eligibility 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. 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.

Where this trial is running

Bangkok, Bangkok

• SEARCH Research Foundation — Bangkok, Bangkok, Thailand (RECRUITING)

Study contacts

• Study coordinator: Nitiya Chomchey, RN

Conditions: HIV-infection