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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
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.
Beijing University of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
Absolute CD4+ T-cell count
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Time frame: 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.
Time frame: Week 48
Absolute CD4+ T-cell count
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Time frame: 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.
Time frame: Week 96.
CD4+ T-cell proportion
Change in CD4+ T-cell proportion, assessed by comparison between the two randomized groups.
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
Change in CD4+/CD8+ ratio, assessed by comparison between the two randomized groups.
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
Change in CD8+ T-cell proportion, assessed by comparison between the two randomized groups.
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
Change in CD45RA+ T-cell proportion, assessed by comparison between the two randomized groups.
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
Change in CD45RO+ T-cell proportion, assessed by comparison between the two randomized groups.
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
Change in CD4+CD28+ T-cell proportion, assessed by comparison between the two randomized groups.
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
Change in CD8+CD38+ T-cell proportion, assessed by comparison between the two randomized groups.
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
Change in CD4+CD38+ T-cell proportion, assessed by comparison between the two randomized groups.
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
Change in CD38+/HLA-DR+ T-cell activation marker, assessed by comparison between the two randomized groups.
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
Change in regulatory T-cell proportion, assessed by comparison between the two randomized groups.
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
Change in T-cell receptor excision circles level, assessed by comparison between the two randomized groups.
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
Change in CD3+ T-cell level, assessed by comparison between the two randomized groups.
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
Change in CD31+ T-cell level, assessed by comparison between the two randomized groups.
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
Change in interleukin-2 level, assessed by comparison between the two randomized groups.
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
Change in interleukin-4 level, assessed by comparison between the two randomized groups.
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
Change in interleukin-6 level, assessed by comparison between the two randomized groups.
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
Change in interleukin-10 level, assessed by comparison between the two randomized groups.
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
Change in interleukin-17A level, assessed by comparison between the two randomized groups.
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
Change in tumor necrosis factor-alpha level, assessed by comparison between the two randomized groups.
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
Change in interferon-gamma level, assessed by comparison between the two randomized groups.
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
Change in HIV RNA viral load, assessed by comparison between the two randomized groups.
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
Change in quality of life score assessed using the WHOQOL-HIV-BREF questionnaire, compared between the two randomized groups.
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
Response is defined as a \>=30% decrease in TCM syndrome score from baseline; non-response is defined as a \<30% decrease from baseline.
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
Death from any cause during the study period, assessed by comparison between the two randomized groups.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
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
Change in urinary red blood cell result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups.
Time frame: 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.
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
Change in urinary white blood cell result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Concomitant medication use was recorded from randomization through Week 96.
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