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| Name | Class |
|---|---|
| Chengdu University of Traditional Chinese Medicine | OTHER |
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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.
This is a prospective, multicenter, pragmatic, randomized, controlled clinical trial. Participants will be recruited from three HIV treatment-designated hospitals in high-prevalence regions in China. Eligible participants will be randomized by center-stratified block randomization at a 1:1 ratio to the experimental arm or control arm. Randomization codes will be generated using SAS by personnel independent from the clinical trial. The ART regimen is not restricted and follows applicable domestic and international ART guidelines. Clinical data will be collected using a unified CRF/eCRF and managed through an EDC platform with de-identified study codes and access controls.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qiling Yiqi Tablets plus ART | Experimental | Participants receive Qiling Yiqi Tablets orally in addition to their background ART regimen for 48 weeks. |
|
| ART alone | Active Comparator | Participants continue ART according to applicable domestic and international ART guidelines |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qiling Yiqi Tablets plus ART | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute CD4+ T-cell count | Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups. | Week 96. |
| 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. |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Han, phD | Contact | +86 13401131731 | hanmeizoujin@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing University of Traditional Chinese Medicine | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
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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.
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Parallel Assignment
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| Antiretroviral Therapy (ART) | Drug | Background ART regimen according to applicable domestic and international ART guidelines. |
|
| Week 96. |
| CD4+ T-cell proportion | Change in CD4+ T-cell proportion, assessed by comparison between the two randomized groups. | 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 | Change in CD4+/CD8+ ratio, assessed by comparison between the two randomized groups. | 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 | Change in CD8+ T-cell proportion, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| CD45RA+ T-cell proportion | Change in CD45RA+ T-cell proportion, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| CD45RO+ T-cell proportion | Change in CD45RO+ T-cell proportion, assessed by comparison between the two randomized groups. | 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+CD28+ T-cell proportion | Change in CD4+CD28+ T-cell proportion, assessed by comparison between the two randomized groups. | 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+CD38+ T-cell proportion | Change in CD8+CD38+ T-cell proportion, assessed by comparison between the two randomized groups. | 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+CD38+ T-cell proportion | Change in CD4+CD38+ T-cell proportion, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| CD38+/HLA-DR+ T-cell activation marker | Change in CD38+/HLA-DR+ T-cell activation marker, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| Treg proportion | Change in regulatory T-cell proportion, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| TRECs level | Change in T-cell receptor excision circles level, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| CD3+ T-cell level | Change in CD3+ T-cell level, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| CD31+ T-cell level | Change in CD31+ T-cell level, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| IL-2 level | Change in interleukin-2 level, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| IL-4 level | Change in interleukin-4 level, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| IL-6 level | Change in interleukin-6 level, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| IL-10 level | Change in interleukin-10 level, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| IL-17A level | Change in interleukin-17A level, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| TNF-alpha level | Change in tumor necrosis factor-alpha level, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| IFN-gamma level | Change in interferon-gamma level, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| HIV RNA viral load | Change in HIV RNA viral load, assessed by comparison between the two randomized groups. | Baseline; Weeks 48 and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| Quality of life score | Change in quality of life score assessed using the WHOQOL-HIV-BREF questionnaire, compared between the two randomized groups. | Baseline; Weeks 48, 60, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| TCM syndrome response rate | Response is defined as a >=30% decrease in TCM syndrome score from baseline; non-response is defined as a <30% decrease from baseline. | Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96. |
| All-cause mortality rate | Death from any cause during the study period, assessed by comparison between the two randomized groups. | From randomization through Week 96. |
| Red blood cell count | Change in red blood cell count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| White blood cell count | Change in white blood cell count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Hemoglobin level | Change in hemoglobin level as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Platelet count | Change in platelet count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Absolute neutrophil count | Change in absolute neutrophil count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Absolute lymphocyte count | Change in absolute lymphocyte count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Aspartate aminotransferase level | Change in aspartate aminotransferase level as a liver function safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Alanine aminotransferase level | Change in alanine aminotransferase level as a liver function safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Gamma-glutamyl transferase level | Change in gamma-glutamyl transferase level as a liver function safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Blood urea nitrogen level | Change in blood urea nitrogen level as a renal function safety laboratory indicator, assessed by comparison between the two randomized groups | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Serum creatinine level | Change in serum creatinine level as a renal function safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Urinary red blood cell result | Change in urinary red blood cell result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Urinary protein result | Change in urinary protein result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Urinary white blood cell result | Change in urinary white blood cell result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Urinary glucose result | Change in urinary glucose result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups. | Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48. |
| Incidence of adverse events | Incidence of adverse events during the 48-week treatment period and the post-treatment follow-up period, assessed by comparison between the two randomized groups. | Adverse events were monitored from randomization through Week 96. |
| Incidence of serious adverse events | Incidence of serious adverse events during the 48-week treatment period and the post-treatment follow-up period, assessed by comparison between the two randomized groups. | Serious adverse events were monitored from randomization through Week 96. |
| Treatment interruption rate | Proportion of participants with interruption of the assigned study treatment during the 48-week treatment period, assessed by comparison between the two randomized groups. | Treatment interruption was monitored from randomization through Week 48. |
| Concomitant medication use | Use of concomitant medications during the study period, including medication name, reason for use, dosage form, dose, route, frequency, start date, and end date. | Concomitant medication use was recorded from randomization through Week 96. |
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D023241 | Antiretroviral Therapy, Highly Active |
| ID | Term |
|---|---|
| D004359 | Drug Therapy, Combination |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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