Fuyang Jiedu Granules Plus Antiretroviral Therapy for HIV Immune Non-Responders With Spleen-Kidney Yang Deficiency

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.

NCT Number	NCT07698548
Lead Sponsor	Beijing University of Chinese Medicine Collaborators: Beijing YouAn Hospital, Capital Medical University, Chengdu Public Health Clinical Center, Chongqing Public Health Medical Center
Conditions	HIV-1 Infection, Acquired Immunodeficiency Syndrome, Immune Reconstitution Failure, Immunological Non-responder, Spleen-Kidney Yang Deficiency Syndrome
Enrollment	240 participants
Start Date	2026-08
Primary Completion	2028-02 (estimated)
Study Completion	2029-02 (estimated)
Updated on ClinicalTrials.gov	2026-07-13