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Fuyang Jiedu Granules Plus Antiretroviral Therapy for HIV Immune Non-Responders With Spleen-Kidney Yang Deficiency

NCT07698548 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-07-13

No results posted yet for this study

Summary

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.

Conditions

  • HIV-1 Infection
  • Acquired Immunodeficiency Syndrome
  • Immune Reconstitution Failure
  • Immunological Non-responder
  • Spleen-Kidney Yang Deficiency Syndrome

Interventions

DRUG

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.

DRUG

Antiretroviral Therapy (ART)

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

Sponsors & Collaborators

  • Beijing YouAn Hospital

    collaborator OTHER

  • Capital Medical University

    collaborator OTHER

  • Chengdu Public Health Clinical Center

    collaborator OTHER

  • Chongqing Public Health Medical Center

    collaborator OTHER

  • Beijing University of Chinese Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2028-02-29
Completion
2029-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07698548 on ClinicalTrials.gov