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Fuyang Jiedu Granules Plus Antiretroviral Therapy for HIV Immune Non-Responders With Spleen-Kidney Yang Deficiency (FYJD-INR-pRCT)

7 juli 2026 uppdaterad av: Mei Han, Beijing University of Chinese Medicine

A Pragmatic Randomized Controlled Trial of Fuyang Jiedu Granules Combined With Antiretroviral Therapy for Immune Reconstitution Failure in People With HIV and Spleen-Kidney Yang Deficiency Syndrome

This pragmatic randomized controlled trial evaluates whether Fuyang Jiedu Granules combined with antiretroviral therapy (ART) improves immune reconstitution in people with HIV who meet criteria for immune reconstitution failure and spleen-kidney yang 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 Fuyang Jiedu Granules 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

240

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100029
        • Beijing University of Traditional Chinese Medicine
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Nej

Beskrivning

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 spleen-kidney yang 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.

-

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: ART alone
Participants continue ART according to applicable domestic and international ART guidelines
Läkemedel: Antiretroviral Therapy (ART)
Background ART regimen according to applicable domestic and international ART guidelines.
Experimentell: Fuyang Jiedu Granules plus ART
Participants receive Fuyang Jiedu Granules orally in addition to their background ART regimen for 48 weeks.
Läkemedel: Fuyang Jiedu Granules
Fuyang Jiedu Granules are provided by Quantaitang Group Co., Ltd. (Chinese invention patent No. ZL201210251214.7). The main components include Polygonatum, Epimedium, deer antler, Codonopsis, Scutellaria baicalensis, Scutellaria barbata, and related components. Dose: 1 sachet (9 g) orally twice daily, 30 minutes after morning and evening meals, with warm water for 48 weeks.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Absolute CD4+ T-cell count
Tidsram: Week 48.
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Week 48.
Immune reconstitution response rate
Tidsram: 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.
Week 48.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
CD4+ T-cell proportion
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
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
Tidsram: 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.
Baseline; Weeks 48 and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
Quality of life score
Tidsram: 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.
Baseline; Weeks 48, 60, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
TCM syndrome response rate
Tidsram: 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.
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
Tidsram: From randomization through Week 96.
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
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
White blood cell count
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Hemoglobin level
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Platelet count
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Absolute neutrophil count
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Absolute lymphocyte count
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Aspartate aminotransferase level
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Alanine aminotransferase level
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Gamma-glutamyl transferase level
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Serum creatinine level
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Urinary red blood cell result
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Urinary protein result
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Urinary white blood cell result
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Urinary glucose result
Tidsram: 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.
Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Incidence of adverse events
Tidsram: 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.
Adverse events were monitored from randomization through Week 96.
Incidence of serious adverse events
Tidsram: 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.
Serious adverse events were monitored from randomization through Week 96.
Treatment interruption rate
Tidsram: 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.
Treatment interruption was monitored from randomization through Week 48.
Concomitant medication use
Tidsram: 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.
Concomitant medication use was recorded from randomization through Week 96.
Absolute CD4+ T-cell count
Tidsram: Week 96
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Week 96
Immune reconstitution response rate
Tidsram: 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.
Week 96
CD45RA+ T-cell proportion
Tidsram: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period aUrinary red blood cell resultnd follow-up assessments were Weeks 48 and 96.
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 aUrinary red blood cell resultnd follow-up assessments were Weeks 48 and 96.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Beijing University of Chinese Medicine

Samarbetspartners

Beijing YouAn Hospital
Capital Medical University
Chongqing Public Health Medical Center
Chengdu Public Health Clinical Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

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Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 februari 2028

Avslutad studie (Beräknad)

1 februari 2029

Studieregistreringsdatum

Först inskickad

7 juli 2026

Först inskickad som uppfyllde QC-kriterierna

7 juli 2026

Första postat (Faktisk)

13 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

13 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

7 juli 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CTCM-HIV-INR-FYJD-2026

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

The clinical data will be de-identified, stored in an EDC system, and exported only after written approval by the principal investigator.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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