Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population
ConditionAcute HIV Infection
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSEARCH Research Foundation
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
The population seeking VCT at the TRCAC will be screened. They are comprised of both men and women of different ages, economic stratus and education level: a large portion of whom are at high risk for HIV infection through commercial sex work and MSM.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Number of HIV and non-HIV related clinical events
Time frame
It will take approximately 72 months to complete the study. The screening and enrollment is 48 months.Secondary outcomes
1
demographics and behavioral risk factors for those identified with acute HIV infection
Time frame
approximately 72 months to complete the study. The screening and enrollment is 48 months2
neurocognitive function and neuroimaging findings in acute HIV infection as well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal fluid
Time frame
approximately 72 months to complete the study. The screening and enrollment is 48 months3
number and characteristics of sexual contacts
Time frame
approximately 72 months to complete the study. The screening and enrollment is 48 months4
the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT)
Time frame
approximately 72 months to complete the study. The screening and enrollment is 48 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
SEARCH Research Foundation
Lead sponsor
Armed Forces Research Institute of Medical Sciences, Thailand
Collaborator
Thai Red Cross AIDS Research Centre
Collaborator
Yale University
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
University of California, San Francisco
Collaborator
National Institutes of Health (NIH)
Collaborator
Johns Hopkins University
Collaborator
University of Missouri-Columbia
Collaborator
Source ClinicalTrials.gov