Peg-IFN-Alpha Plus ART for Acute HIV Infection: Beijing Trial Protocol

02 Jul 20266 min read0 viewsJournal Feed

GIST (Key Takeaways)

Introduction HIV cure remains one of the major unsolved global health challenges. The persistence of the HIV reservoir is the key barrier to achieving viral eradication. The acute HIV infection (AHI) is crucial for reservoir establishment, making early intervention essential for long-term viral remission.
Pegylated interferon-α (Peg-IFN-α) exhibits potent antiviral and immunomodulatory properties that may enhance reservoir clearance when combined with antiretroviral therapy (ART). This study aims to evaluate the efficacy and safety of Peg-IFN-α combined with ART in promoting reservoir reduction and immune reconstitution in individuals with AHI. Methods and analysis This randomised, parallel-controlled, open-label clinical trial will enrol 68 participants with confirmed AHI.
Eligible participants will be randomly assigned (1:1) to receive Peg-IFN-α plus ART or ART alone. All participants will continue ART for a total of 48 weeks. The primary outcome is the percentage reduction in total HIV-1 DNA at week 48.
Secondary outcomes include HIV-1 DNA reduction at week 12, CD4 + T-cell recovery, cytokine profiles and safety endpoints. Statistical analysis will be performed using the intention-to-treat principle.

Clinical Editorial

BMJ Open published a clinical update in Research Highlights on 02 Jul 2026.

The item focuses on Effectiveness of pegylated interferon-{alpha} combined with antiretroviral therapy on HIV reservoir clearance in acute HIV infection: study protocol for a randomised controlled trial at a tertiary infectious disease hospital in Beijing, China.

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