Actively Recruiting

Age: 18Years +
All Genders
ID00796146

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

Led by SEARCH Research Foundation · Updated on 2026-04-27

777

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

SEARCH Research Foundation

Lead Sponsor

A

Armed Forces Research Institute of Medical Sciences, Thailand

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying people with acute HIV infection to understand their clinical, immune, and virus-related characteristics. The study collects information on participants' demographics, behaviors, brain function, immune responses, and HIV types in blood and other body areas. It also tracks sexual contacts to offer testing and counseling. This observational study aims to help improve HIV vaccine development and understand how HIV affects the body early on. Participants who have acute HIV infection will be followed for up to 192 weeks with visits scheduled frequently in the first weeks and then every 12 weeks. Blood tests will monitor immune cells, virus levels, and other health markers. Optional procedures include collecting genital secretions, spinal fluid, brain scans, colon biopsies, genetic testing, and tracking sexual contacts for voluntary testing. During the study, participants will complete questionnaires about risk behaviors and provide samples for future research. Hospitalization is encouraged for the first few days for observation and easier follow-up. Researchers will measure the number of health events related to HIV and other conditions. They will also assess neurocognitive and immune changes, sexual contact patterns, and immune cells in the gut. The study may last around 6 years, including screening and follow-up.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years old
  • Have protocol-defined acute HIV-1 infection confirmed by specific blood tests
  • Understand the study and provide informed consent (including thumb print if unable to read)
  • Be available for follow-up for the planned study duration
Not Eligible

You will not qualify if you...

  • History of medical or psychiatric disorders that interfere with study adherence or informed consent
  • Female participants who are pregnant at the time of screening

AI-Screening

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Your Study Journey

Screening

Duration - Up to 48 months

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - Up to 192 weeks (approximately 4 years)

Participants with acute HIV infection are followed prospectively to characterize early HIV infection and immune response. Blood tests and behavioral questionnaires are completed, with optional additional sample collections and imaging. Participants are encouraged to be hospitalized for the first 3 to 7 days for observation and follow-up.

Visits at week 0, days 2, 3, 5, 7, 10; weeks 2, 4, 8, 12, 16, 20, 24; then every 12 weeks until study end

Trial Site Locations

Total: 1 location

1

Institute of HIV Research and Innovation (IHRI)

Bangkok, Bangkok, Thailand, 10330

Actively Recruiting

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Research Team

N

Nittaya Phanuphak, MD, PhD

N

Nitiya Chomchey

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Abrupt and altered cell-type specific DNA methylation profiles in blood during acute HIV infection persists despite prompt initiation of ART.

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Deep Sequencing Reveals Central Nervous System Compartmentalization in Multiple Transmitted/Founder Virus Acute HIV-1 Infection.

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Brief Report: Safety and Tolerability of Inguinal Lymph Node Biopsy in Individuals With Acute HIV Infection in Thailand.

Michelle Chintanaphol, Carlo Sacdalan, Suthat Chottanapund...

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Viral kinetics in untreated versus treated acute HIV infection in prospective cohort studies in Thailand.

Jintanat Ananworanich, Leigh Anne Eller, Suteeraporn Pinyakorn...

https://pubmed.ncbi.nlm.nih.gov/28691436

Initiation of Antiretroviral Therapy During Acute HIV-1 Infection Leads to a High Rate of Nonreactive HIV Serology.

Mark S de Souza, Suteeraporn Pinyakorn, Siriwat Akapirat...

https://pubmed.ncbi.nlm.nih.gov/27317797