HIV-1 InfectionQLYQ-INR-pRCTNCT07698574
Qiling Yiqi Tablets Plus Antiretroviral Therapy for HIV Immune Non-responders With Lung-Spleen Qi Deficiency
A study testing Qiling Yiqi Tablets plus ART and Antiretroviral Therapy (ART) in people with HIV-1 Infection and Acquired Immunodeficiency Syndrome, run by Beijing University of Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HIV-1 Infection, Acquired Immunodeficiency Syndrome, Immune Reconstitution Failure
- What is being tested?
- Qiling Yiqi Tablets plus ART and Antiretroviral Therapy (ART)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- Aug 2026to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing University of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100029
Mei Han, phD, +86 13401131731, hanmeizoujin@163.com
About this study
Official 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
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.
Read the detailed description
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.
- Conditions
- HIV-1 Infection, Acquired Immunodeficiency Syndrome, Immune Reconstitution Failure, Immunological Non-responder, Lung-Spleen Qi Deficiency Syndrome
- Being tested
- Qiling Yiqi Tablets plus ART, Antiretroviral Therapy (ART)
- Keywords
- HIV, AIDS, immune non-responder, incomplete immune reconstitution, ART, CD4+ T cell, Traditional Chinese Medicine, Qiling Yiqi Tablets, pragmatic randomized controlled trial, pRCT
- Medical subject headings
- Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qiling Yiqi Tablets plus ARTDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Qiling Yiqi Tablets plus ART | Experimental | Participants receive Qiling Yiqi Tablets orally in addition to their background ART regimen for 48 weeks. Receives: Drug: Qiling Yiqi Tablets plus ART |
| ART alone | Active comparator | Participants continue ART according to applicable domestic and international ART guidelines Receives: Drug: Antiretroviral Therapy (ART) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute CD4+ T-cell count
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Measured: 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.
Measured: Week 48
Secondary outcomes (45)
Absolute CD4+ T-cell count
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Measured: 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.
Measured: Week 96.
CD4+ T-cell proportion
Change in CD4+ T-cell proportion, assessed by comparison between the two randomized groups.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Concomitant medication use was recorded from randomization through Week 96.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIV-1 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine
- Responsible party
- Principal investigator, Mei Han, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698574
- Sponsor's protocol ID
- CTCM-HIV-INR-QLYQ-2026
- Acronym
- QLYQ-INR-pRCT
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07698574
- Acronym / sponsor ID
- QLYQ-INR-pRCT / CTCM-HIV-INR-QLYQ-2026
- Conditions
- HIV-1 Infection, Acquired Immunodeficiency Syndrome, Immune Reconstitution Failure, Immunological Non-responder, Lung-Spleen Qi Deficiency Syndrome
- Keywords
- HIV, AIDS, immune non-responder, incomplete immune reconstitution, ART, CD4+ T cell, Traditional Chinese Medicine, Qiling Yiqi Tablets
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Collaborators
- Chengdu University of Traditional Chinese Medicine
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Qiling Yiqi Tablets plus ART | Experimental | Drug: Qiling Yiqi Tablets plus ARTParticipants receive Qiling Yiqi Tablets orally in addition to their background ART regimen for 48 weeks. |
| ART alone | Active comparator | Drug: Antiretroviral Therapy (ART)Participants continue ART according to applicable domestic and international ART guidelines |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qiling Yiqi Tablets plus ARTQiling 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. | Drug | Qiling Yiqi Tablets plus ART |
| Antiretroviral Therapy (ART)Background ART regimen according to applicable domestic and international ART guidelines. | Drug | ART alone |
Primary outcome
Absolute CD4+ T-cell count
Time frame: Week 48
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
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.
45 secondary outcomes
Absolute CD4+ T-cell count
Time frame: Week 96.
Immune reconstitution response rate
Time frame: Week 96.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
All-cause mortality rate
Time frame: From randomization through Week 96.
Red blood cell count
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
White blood cell count
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Hemoglobin level
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Platelet count
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Absolute neutrophil count
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Absolute lymphocyte count
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Aspartate aminotransferase level
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Alanine aminotransferase level
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Gamma-glutamyl transferase level
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Blood urea nitrogen level
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Serum creatinine level
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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.
Urinary protein result
Time frame: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qiling Yiqi Tablets plus ART and Antiretroviral Therapy (ART) in people with HIV-1 Infection and Acquired Immunodeficiency Syndrome, run by Beijing University of Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mei Han, phD (+86 13401131731, hanmeizoujin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute CD4+ T-cell count (time frame: Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07698574, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.