This pragmatic randomized controlled trial evaluates whether Qiling Yiqi Tablets combined with antiretroviral therapy (ART) improves immune reconstitution in people with HIV who meet criteria for immune reconstitution failure and lung-spleen qi 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 Qiling Yiqi Tablets 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.
None
None
Parallel
Qiling Yiqi Tablets plus ART
DrugQiling Yiqi Tablets: Qiling Yiqi Tablets are a marketed Chinese patent medicine (NMPA approval No. Z20050483; Sichuan Enwei Pharmaceutical Co., Ltd.). The formula includes Astragalus, Codonopsis, Atractylodes macrocephala, Poria, and related components. Dose: 6 tablets orally three times daily after meals with warm water for 48 weeks.Participants receive Qiling Yiqi Tablets orally in addition to their background ART regimen 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
Chengdu University of Traditional Chinese Medicine
Collaborator
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