NCT01397669 Characteristics of Immunity in Gut Mucosa, Spinal Fluid, Lymph Node and Blood of HIV Negative Thais and Thais With HIV Infection
| NCT ID | NCT01397669 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SEARCH Research Foundation |
| Condition | HIV-infection |
| Study Type | INTERVENTIONAL |
| Enrollment | 232 participants |
| Start Date | 2011-07 |
| Primary Completion | 2031-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 232 participants in total. It began in 2011-07 with a primary completion date of 2031-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Nitiya Chomchey, RN
✉ nitiya.c@searchthailand.orgFrequently Asked Questions
Who can join the NCT01397669 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 50 Years, studying HIV-infection. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01397669 currently recruiting?
Yes, NCT01397669 is actively recruiting participants. Contact the research team at nitiya.c@searchthailand.org for enrollment information.
Where is the NCT01397669 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT01397669 clinical trial?
NCT01397669 is sponsored by SEARCH Research Foundation. The trial plans to enroll 232 participants.
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