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Fuyang Jiedu Granules Plus Antiretroviral Therapy for HIV Immune Non-Responders With Spleen-Kidney Yang Deficiency
Sponsor: Beijing University of Chinese Medicine
Summary
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.
Official title: A Pragmatic Randomized Controlled Trial of Fuyang Jiedu Granules Combined With Antiretroviral Therapy for Immune Reconstitution Failure in People With HIV and Spleen-Kidney Yang Deficiency Syndrome
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2026-08
Completion Date
2029-02
Last Updated
2026-07-13
Healthy Volunteers
No
Conditions
Interventions
Fuyang Jiedu Granules
Fuyang 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)
Background ART regimen according to applicable domestic and international ART guidelines.
Locations (1)
Beijing University of Traditional Chinese Medicine
Beijing, Beijing Municipality, China