NCT07698548

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
31mo left

Started Aug 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2029

Last Updated

July 13, 2026

Status Verified

June 1, 2026

Enrollment Period

1.5 years

First QC Date

July 7, 2026

Last Update Submit

July 7, 2026

Conditions

HIV-1 InfectionAcquired Immunodeficiency SyndromeImmune Reconstitution FailureImmunological Non-responderSpleen-Kidney Yang Deficiency Syndrome

Keywords

HIVAIDSimmune non-responderincomplete immune reconstitutionARTCD4+ T cellTraditional Chinese MedicineFuyang Jiedu Granulespragmatic randomized controlled trialpRCT

Outcome Measures

Primary Outcomes (2)

  • Absolute CD4+ T-cell count

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

    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.

    Week 48.

Secondary Outcomes (44)

  • Absolute CD4+ T-cell count

    Week 96

  • Immune reconstitution response rate

    Week 96

  • CD4+ T-cell proportion

    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

    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

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

  • +39 more secondary outcomes

Study Arms (2)

Fuyang Jiedu Granules plus ART

EXPERIMENTAL

Participants receive Fuyang Jiedu Granules orally in addition to their background ART regimen for 48 weeks.

Drug: Fuyang Jiedu Granules

ART alone

ACTIVE COMPARATOR

Participants continue ART according to applicable domestic and international ART guidelines

Drug: Antiretroviral Therapy (ART)

Interventions

Fuyang Jiedu GranulesDRUG

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.

Fuyang Jiedu Granules plus ART
Antiretroviral Therapy (ART)DRUG

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

ART alone

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing University of Traditional Chinese Medicine

Beijing, Beijing Municipality, 100029, China

Location

Related Publications (3)

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Interventions

Antiretroviral Therapy, Highly Active

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, CombinationDrug TherapyTherapeutics

Central Study Contacts

Mei Han, phD

CONTACT

+86 13401131731hanmeizoujin@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Beijing University of Chinese Medicine

Study Record Dates

First Submitted

July 7, 2026

First Posted

July 13, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2029

Last Updated

July 13, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations

CN(1)