Qiling Yiqi Tablets Plus Antiretroviral Therapy for HIV Immune Non-responders With Lung-Spleen Qi Deficiency
QLYQ-INR-pRCT
A Pragmatic Randomized Controlled Trial of Qiling Yiqi Tablets Combined With Antiretroviral Therapy for Immune Reconstitution Failure in People With HIV and Lung-Spleen Qi Deficiency Syndrome
1 other identifier
interventional
240
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2026
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2026
CompletedFirst Posted
Study publicly available on registry
July 13, 2026
CompletedStudy Start
First participant enrolled
August 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
Study Completion
Last participant's last visit for all outcomes
February 1, 2029
July 13, 2026
June 1, 2026
1.5 years
July 7, 2026
July 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Absolute CD4+ T-cell count
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Week 48
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.
Week 48
Secondary Outcomes (45)
Absolute CD4+ T-cell count
Week 96.
Immune reconstitution response rate
Week 96.
CD4+ T-cell proportion
Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
CD4+/CD8+ ratio
Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
CD8+ T-cell proportion
Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
- +40 more secondary outcomes
Study Arms (2)
Qiling Yiqi Tablets plus ART
EXPERIMENTALParticipants receive Qiling Yiqi Tablets orally in addition to their background ART regimen for 48 weeks.
ART alone
ACTIVE COMPARATORParticipants continue ART according to applicable domestic and international ART guidelines
Interventions
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.
Background ART regimen according to applicable domestic and international ART guidelines.
Eligibility Criteria
You may qualify if:
- 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. -
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing University of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100029, China
Related Publications (3)
中华中医药学会防治艾滋病分会, 刘颖, 梁碧颜. 艾滋病中医诊疗专家共识[J]. 中国艾滋病性病, 2025, 31(9): 1029-1034. DOI: 10.13419/j.cnki.aids.2025.09.18.
BACKGROUND中华医学会感染病学分会艾滋病丙型肝炎学组. 艾滋病免疫功能重建不全者临床诊疗专家共识（2023版）[J]. 中华传染病杂志, 2024, 42(1): 3-13. DOI: 10.3760/cma.j.cn311365-20230927-00098.
BACKGROUND中华医学会感染病学分会艾滋病学组, 中国疾病预防控制中心. 中国艾滋病诊疗指南（2024版）[J]. 协和医学杂志, 2024, 15(6): 1261-1288. DOI: 10.12290/xhyxzz.2024-0766.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Beijing University of Chinese Medicine
Study Record Dates
First Submitted
July 7, 2026
First Posted
July 13, 2026
Study Start (Estimated)
August 1, 2026
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
February 1, 2029
Last Updated
July 13, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share
The study involves HIV-related clinical data. The clinical data will be de-identified, stored in an EDC system, and exported only after written approval by the principal investigator.