Qiling Yiqi Tablets plus ART: Qiling 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): Background ART regimen according to applicable domestic and international ART guidelines.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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 lung-spleen qi 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 investigator to make the participant unsuitable for the study.
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Primary outcome measure(s)
Absolute CD4+ T-cell count — Week 48 Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Immune reconstitution response rate — Week 48 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.
Trial sites (1)
Facility
City
Region
Status
Beijing University of Traditional Chinese Medicine
Beijing
Beijing Municipality
More Beijing University of Chinese Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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