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NCT Number: NCT07698574

Qiling Yiqi Tablets Plus Antiretroviral Therapy for HIV Immune Non-responders With Lung-Spleen Qi Deficiency

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.

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Key information

Conditions

HIV-1 Infection Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Genital Diseases HIV Infections Immune Reconstitution Failure Immune System Diseases Immunologic Deficiency Syndromes Immunological Non-responder Infections Lentivirus Infections Lung-Spleen Qi Deficiency Syndrome RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing University of Traditional Chinese Medicine

Beijing, Beijing Municipality, 100029, China

Location contact

Mei Han, phD

CONTACT

[email protected]

+86 13401131731

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

-

Treatment and study plan

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.

Antiretroviral therapy (ART)

Drug

Background ART regimen according to applicable domestic and international ART guidelines.

Primary outcomes

  1. Absolute CD4+ T-cell count

    Time frame: Week 48

    Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.

  2. Immune reconstitution response rate

    Time frame: 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.

Secondary outcomes

  1. Absolute CD4+ T-cell count

    Time frame: Week 96.

    Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.

  2. Immune reconstitution response rate

    Time frame: Week 96.

    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.

  3. CD4+ T-cell proportion

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in CD4+ T-cell proportion, assessed by comparison between the two randomized groups.

  4. CD4+/CD8+ ratio

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in CD4+/CD8+ ratio, assessed by comparison between the two randomized groups.

  5. CD8+ T-cell proportion

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in CD8+ T-cell proportion, assessed by comparison between the two randomized groups.

  6. CD45RA+ T-cell proportion

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in CD45RA+ T-cell proportion, assessed by comparison between the two randomized groups.

  7. CD45RO+ T-cell proportion

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in CD45RO+ T-cell proportion, assessed by comparison between the two randomized groups.

  8. CD4+CD28+ T-cell proportion

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in CD4+CD28+ T-cell proportion, assessed by comparison between the two randomized groups.

  9. CD8+CD38+ T-cell proportion

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in CD8+CD38+ T-cell proportion, assessed by comparison between the two randomized groups.

  10. CD4+CD38+ T-cell proportion

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in CD4+CD38+ T-cell proportion, assessed by comparison between the two randomized groups.

  11. CD38+/HLA-DR+ T-cell activation marker

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in CD38+/HLA-DR+ T-cell activation marker, assessed by comparison between the two randomized groups.

  12. Treg proportion

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in regulatory T-cell proportion, assessed by comparison between the two randomized groups.

  13. TRECs level

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in T-cell receptor excision circles level, assessed by comparison between the two randomized groups.

  14. CD3+ T-cell level

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in CD3+ T-cell level, assessed by comparison between the two randomized groups.

  15. CD31+ T-cell level

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in CD31+ T-cell level, assessed by comparison between the two randomized groups.

  16. IL-2 level

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in interleukin-2 level, assessed by comparison between the two randomized groups.

  17. IL-4 level

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in interleukin-4 level, assessed by comparison between the two randomized groups.

  18. IL-6 level

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in interleukin-6 level, assessed by comparison between the two randomized groups.

  19. IL-10 level

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in interleukin-10 level, assessed by comparison between the two randomized groups.

  20. IL-17A level

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in interleukin-17A level, assessed by comparison between the two randomized groups.

  21. TNF-alpha level

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in tumor necrosis factor-alpha level, assessed by comparison between the two randomized groups.

  22. IFN-gamma level

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in interferon-gamma level, assessed by comparison between the two randomized groups.

  23. HIV RNA viral load

    Time frame: Baseline; Weeks 48 and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in HIV RNA viral load, assessed by comparison between the two randomized groups.

  24. Quality of life score

    Time frame: Baseline; Weeks 48, 60, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Change in quality of life score assessed using the WHOQOL-HIV-BREF questionnaire, compared between the two randomized groups.

  25. TCM syndrome response rate

    Time frame: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.

    Response is defined as a >=30% decrease in TCM syndrome score from baseline; non-response is defined as a <30% decrease from baseline.

  26. All-cause mortality rate

    Time frame: From randomization through Week 96.

    Death from any cause during the study period, assessed by comparison between the two randomized groups.

  27. Red blood cell count

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in red blood cell count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.

  28. White blood cell count

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in white blood cell count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.

  29. Hemoglobin level

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in hemoglobin level as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.

  30. Platelet count

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in platelet count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.

  31. Absolute neutrophil count

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in absolute neutrophil count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.

  32. Absolute lymphocyte count

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in absolute lymphocyte count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.

  33. Aspartate aminotransferase level

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in aspartate aminotransferase level as a liver function safety laboratory indicator, assessed by comparison between the two randomized groups.

  34. Alanine aminotransferase level

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in alanine aminotransferase level as a liver function safety laboratory indicator, assessed by comparison between the two randomized groups.

  35. Gamma-glutamyl transferase level

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in gamma-glutamyl transferase level as a liver function safety laboratory indicator, assessed by comparison between the two randomized groups.

  36. Blood urea nitrogen level

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in blood urea nitrogen level as a renal function safety laboratory indicator, assessed by comparison between the two randomized groups

  37. Serum creatinine level

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in serum creatinine level as a renal function safety laboratory indicator, assessed by comparison between the two randomized groups.

  38. Urinary red blood cell result

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in urinary red blood cell result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups.

  39. Urinary protein result

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in urinary protein result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups.

  40. Urinary white blood cell result

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in urinary white blood cell result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups.

  41. Urinary glucose result

    Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.

    Change in urinary glucose result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups.

  42. Incidence of adverse events

    Time frame: Adverse events were monitored from randomization through Week 96.

    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.

  43. Incidence of serious adverse events

    Time frame: Serious adverse events were monitored from randomization through Week 96.

    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.

  44. Treatment interruption rate

    Time frame: Treatment interruption was monitored from randomization through Week 48.

    Proportion of participants with interruption of the assigned study treatment during the 48-week treatment period, assessed by comparison between the two randomized groups.

  45. Concomitant medication use

    Time frame: Concomitant medication use was recorded from randomization through Week 96.

    Use of concomitant medications during the study period, including medication name, reason for use, dosage form, dose, route, frequency, start date, and end date.

Study contacts

Contact information is provided by the study sponsor or research team.

Mei Han, phD

CONTACT

[email protected]

+86 13401131731

Sponsors and collaborators

Lead sponsor

Beijing University of Chinese Medicine

Other

Collaborators

  • Chengdu University of Traditional Chinese Medicine

Registry information

Official study title

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

Acronym: QLYQ-INR-pRCT

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 13, 2026
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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