NCT00796146 Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population
| NCT ID | NCT00796146 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SEARCH Research Foundation |
| Condition | Acute HIV Infection |
| Study Type | OBSERVATIONAL |
| Enrollment | 777 participants |
| Start Date | 2009-04 |
| Primary Completion | 2033-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 777 participants in total. It began in 2009-04 with a primary completion date of 2033-07.
⚠ 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 describe clinical, immunological, and virological characteristics of persons with acute HIV infection 1. To describe demographics and behavioral risk factors for those identified with acute HIV infection 2. To describe neurocognitive function and neuroimaging findings in acute HIV infection as well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal fluid. 3. To describe the number and characteristics of sexual contacts 4. To describe the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT) 5. To describe immune response, HIV-1 genotypes and sequences in the genital compartment 6. To describe T cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut T cell during follow up 7. To archive samples for future investigations including determination of viral evolution, and cell-mediated and humoral immune responses in peripheral blood and mucosal compartments
Eligibility Criteria
Inclusion Criteria: 1. Age \>18 years old 2. Have protocol-defined acute HIV-1 infection (Tested 4th generation HIV EIA negative and NAT positive or tested 4th generation HIV EIA positive, negative by less sensitive EIA and NAT positive) 3. 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. 4. Availability for follow-up for the planned study duration Exclusion Criteria: 1. 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. 2. Female participants who are pregnant at the time of screening
Contact & Investigator
Sandhya Vasan, MD
STUDY CHAIR
US Military HIV Research Program
Frequently Asked Questions
Who can join the NCT00796146 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute 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 NCT00796146 currently recruiting?
Yes, NCT00796146 is actively recruiting participants. Contact the research team at Nittaya.p@ihri.org for enrollment information.
Where is the NCT00796146 trial being conducted?
This trial is being conducted at Bangkok, Thailand.
Who is sponsoring the NCT00796146 clinical trial?
NCT00796146 is sponsored by SEARCH Research Foundation. The principal investigator is Sandhya Vasan, MD at US Military HIV Research Program. The trial plans to enroll 777 participants.
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