This pragmatic randomized controlled trial evaluates whether Fuyang Jiedu Granules combined with antiretroviral therapy (ART) improves immune reconstitution in people with HIV who meet criteria for immune reconstitution failure and spleen-kidney yang deficiency syndrome. Eligible participants are adults aged 18 to 60 years with HIV-1 infection, long-term viral suppression on ART, and persistently low CD4+ T-cell counts. A total of 240 participants will be randomized 1:1 to receive Fuyang Jiedu Granules plus ART or ART alone. Treatment lasts 48 weeks, followed by 48 weeks of follow-up. The primary outcomes are absolute CD4+ T-cell count and immune reconstitution response rate. Secondary outcomes include immune homeostasis markers, T-cell activation and Treg proportion, thymic output and inflammation-related markers, HIV RNA viral load, quality of life, clinical symptom scores, all-cause mortality, and safety.
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Parallel
Fuyang Jiedu Granules
DrugFuyang Jiedu Granules are provided by Quantaitang Group Co., Ltd. (Chinese invention patent No. ZL201210251214.7). The main components include Polygonatum, Epimedium, deer antler, Codonopsis, Scutellaria baicalensis, Scutellaria barbata, and related components. Dose: 1 sachet (9 g) orally twice daily, 30 minutes after morning and evening meals, with warm water for 48 weeks.
Antiretroviral Therapy (ART)
DrugBackground ART regimen according to applicable domestic and international ART guidelines.
Absolute CD4+ T-cell count
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Immune reconstitution response rate
Response is defined as CD4+ T-cell count \>350 cells/uL or a \>=30% increase from baseline; non-response is defined as a \<30% increase from baseline.
Absolute CD4+ T-cell count
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Immune reconstitution response rate
Response is defined as CD4+ T-cell count \>350 cells/uL or a \>=30% increase from baseline; non-response is defined as a \<30% increase from baseline.
CD4+ T-cell proportion
Change in CD4+ T-cell proportion, assessed by comparison between the two randomized groups.
CD4+/CD8+ ratio
Change in CD4+/CD8+ ratio, assessed by comparison between the two randomized groups.
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Beijing University of Chinese Medicine
Lead sponsor
Beijing YouAn Hospital
Collaborator
Capital Medical University
Collaborator
Chengdu Public Health Clinical Center
Collaborator
Chongqing Public Health Medical Center
Collaborator
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