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

Inclusion Criteria:Aged 18 to 60 years, male or female. CD4+ T lymphocyte count \<350 cells/uL. Meets diagnostic criteria for HIV-1 infection according to the Chinese Guidelines for Diagnosis and Treatment of HIV/AIDS (2024 edition). Meets diagnostic criteria for incomplete immune reconstitution: ART for more than 4 years; peripheral blood viral load below the lower limit of detection (\<50 copies/mL) for more than 3 years; persistent CD4+ T-cell count \<350 cells/uL; and exclusion of other causes of long-term low CD4+ T-cell count. Meets the Traditional Chinese Medicine diagnostic criteria for spleen-kidney yang deficiency syndrome, supported by the designated four-diagnostic instrument (model SZY-ZM-1) where applicable. Voluntarily agrees to participate and signs informed consent. - Exclusion Criteria:Uncontrolled acute or chronic physical or mental illness. Poor adherence to ART. WBC \<2 x 10\^9/L, neutrophils \<1.0 x 10\^9/L, hemoglobin \<90 g/L, platelets \<75 x 10\^9/L, or abnormal hepatic/renal function. Hepatic abnormality is defined as AST, ALT, or total bilirubin \>=2 times the upper limit of normal; renal abnormality is defined as creatinine clearance below the normal value. Other serious comorbid disease, such as tumor, cirrhosis, or cardiovascular/cerebrovascular disease. Pregnancy, lactation, or recent plan for pregnancy/childbearing. Use of immunosuppressants or immunomodulators within 6 months before screening. Any other condition judged by the investiga…