Actively Recruiting

Phase 3
Age: 18Years +
All Genders
ID00796263

Antiretroviral Therapy for Acute and Chronic HIV Infection

Led by SEARCH Research Foundation · Updated on 2025-06-04

900

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

S

SEARCH Research Foundation

Lead Sponsor

V

ViiV Healthcare

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating antiretroviral therapy (ART) for people with acute and chronic HIV infection. This study compares outcomes in different body tissues, including genital secretions, central nervous system, gut, and lymph nodes, among individuals starting treatment during acute versus chronic HIV infection. The study includes participants from two related HIV studies in Thai populations, focusing on immune and virologic responses at various infection stages and ART regimens. Participants receive a highly active antiretroviral therapy (HAART) regimen consisting of one or two nucleoside/nucleotide reverse-transcriptase inhibitors plus dolutegravir (DTG) 50 mg taken orally once daily. The treatment aims to evaluate HIV control and immune function over time. The study follows participants long-term to assess clinical, immunologic, and virologic outcomes, comparing those who start treatment early with those treated during chronic infection. During the study, participants undergo regular monitoring of HIV-related clinical events, immune cell counts, viral load, and drug resistance. Assessments also include functional brain imaging, neuropsychological testing, and analysis of immune activation markers in blood and tissue samples. Researchers track adherence to ART and adverse events related to treatment. The total follow-up period extends over 10 years, allowing comprehensive evaluation of treatment effects and disease progression.

CONDITIONS

Brief Title

Antiretroviral Therapy for Acute and Chronic HIV Infection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Enrolled in the SEARCH 010 or SEARCH 013 protocols with documented acute or chronic HIV-1 infection
  • Able to understand the study and provide informed consent (including use of thumb print if unable to read)
  • Available for follow-up for the planned study duration
Not Eligible

You will not qualify if you...

  • History of medical or psychiatric disorder that interferes with study adherence or ability to consent, as judged by the investigator

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 10 years

Participants receive antiretroviral therapy consisting of 1 or 2 nucleoside/nucleotide analog reverse-transcriptase inhibitor medications plus dolutegravir 50 mg orally once daily.

Regular follow-up visits to monitor treatment adherence, HIV-related clinical events, and immune and virologic parameters

Trial Site Locations

Total: 1 location

1

Institute of HIV Research and Innovation

Bangkok, Thailand, 10330

Actively Recruiting

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Research Team

N

Nitiya Chomchey, RN, PhD

T

Tassanee Luekasemsuk, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

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