Establish and Characterize an Acute HIV Infection Cohort in a High Risk Population

Recruiting

• Conditions: Acute HIV Infection

• Registration Number: NCT00796146
• Lead Sponsor: SEARCH Research Foundation

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

Detailed Description

This study will establish an acute infection cohort which is predominantly non-subtype B. Description of the early events in HIV infection is critical to HIV vaccine development and understanding HIV-1 immunopathogenesis. The ability to establish this cohort and identify individuals with acute HIV-1 infection would provide the basis for future hypothesis-driven proposals.

Subjects will be recruited at the TRCARC. Subjects seeking VCT will be asked to provide contact information. Blood samples, either plasma or whole blood collected on filter paper (dried blood spots, or DBS) will be screened for acute HIV infection by pooled or individual NAT if non-reactive after screening by an EIA capable of detecting both HIV antibody and antigen (4th generation or sensitive EIA). Additionally, 4th generation reactive samples will be screened with a non-IgM sensitive EIA capable of detecting HIV antibody only (less sensitive EIA) within 1-2 days of sample collection. Those who are found to have acute HIV infection will be asked to enroll in the cohort study. These acute HIV-infected participants will be followed prospectively at week 0, day 2, 3, 5, 7, 10 then weeks 2, 4, 8, 12, 16, 20, 24, then every 12 weeks until the end of the study (maximum of 192 weeks of follow up). Subjects will receive blood testing for CD4, HIV RNA, ALT, creatinine and lipids, and urinalysis. Subjects will be asked to complete a questionnaire on HIV risk behavior. Archiving of plasma and PBMC for future immunologic and virologic testing will be performed. Optional study procedures include 1) collection of genital secretions 2) collection of cerebrospinal fluid 3) brain MRI/MRS without gadolinium 4) sampling of gut-associated lymphoid tissue by colon biopsy 5) genetic testing 6) tracking of and offering VCT to sexual contacts of acute HIV-infected subjects. Subjects are encouraged to be hospitalized for the first 3-7 days for post-procedural observation and for ease of follow up.

Study Timeline

• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Study First Posted: 2008-11-24
• Study Start: 2009-04
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-24
• Last Update Posted: 2024-11-27
• Primary Completion: 2033-07
• Study Completion: 2033-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 750

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of HIV and non-HIV related clinical events	It will take approximately 72 months to complete the study. The screening and enrollment is 48 months.

Secondary Outcome Measures

Name	Time	Method
demographics and behavioral risk factors for those identified with acute HIV infection	approximately 72 months to complete the study. The screening and enrollment is 48 months
neurocognitive function and neuroimaging findings in acute HIV infection as well as describe immune response, HIV-1 genotypes and sequences in the cerebrospinal fluid	approximately 72 months to complete the study. The screening and enrollment is 48 months
number and characteristics of sexual contacts	approximately 72 months to complete the study. The screening and enrollment is 48 months
the willingness of acute HIV-infected subjects to allow the tracking of their sexual contacts for voluntary HIV counseling and testing (VCT)	approximately 72 months to complete the study. The screening and enrollment is 48 months
immune response, HIV-1 genotypes and sequences in the genital compartment	approximately 72 months to complete the study. The screening and enrollment is 48 months
T cell depletion in the gut mucosa in acute HIV infection and describe the changes in gut T cells during follow up	approximately 72 months to complete the study. The screening and enrollment is 48 months

Trial Locations

Locations (1)

Institute of HIV Research and Innovation (IHRI); 🇹🇭 Bangkok, Thailand