Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population
Recruiting · NCT00796146 · Observational (researchers observe without assigning treatment) · Lead sponsor: SEARCH Research Foundation
View the official record on ClinicalTrials.gov →What this trial is about
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
Who can take part
Inclusion criteria
- Age \>18 years old
- 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)
- 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.
- Availability for follow-up for the planned study duration
Exclusion criteria
- 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.
- Female participants who are pregnant at the time of screening
Where it is running
1 location listed.
- Institute of HIV Research and Innovation (IHRI) - Bangkok, Bangkok, Thailand