- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07698548
Fuyang Jiedu Granules Plus Antiretroviral Therapy for HIV Immune Non-Responders With Spleen-Kidney Yang Deficiency (FYJD-INR-pRCT)
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
연구 개요
상태
정황
상세 설명
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mei Han, phD
- 전화번호: +86 13401131731
- 이메일: hanmeizoujin@163.com
연구 장소
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Beijing Municipality
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Beijing, Beijing Municipality, 중국, 100029
- Beijing University of Traditional Chinese Medicine
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연락하다:
- Mei Han, phD
- 전화번호: +86 13401131731
- 이메일: hanmeizoujin@163.com
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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.
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: ART alone
Participants continue ART according to applicable domestic and international ART guidelines
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Background ART regimen according to applicable domestic and international ART guidelines.
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실험적: Fuyang Jiedu Granules plus ART
Participants receive Fuyang Jiedu Granules orally in addition to their background ART regimen for 48 weeks.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Absolute CD4+ T-cell count
기간: Week 48.
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Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
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Week 48.
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Immune reconstitution response rate
기간: Week 48.
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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.
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Week 48.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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CD4+ T-cell proportion
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in CD4+ T-cell proportion, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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CD4+/CD8+ ratio
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in CD4+/CD8+ ratio, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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CD8+ T-cell proportion
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in CD8+ T-cell proportion, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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CD45RO+ T-cell proportion
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in CD45RO+ T-cell proportion, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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CD4+CD28+ T-cell proportion
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in CD4+CD28+ T-cell proportion, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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CD8+CD38+ T-cell proportion
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in CD8+CD38+ T-cell proportion, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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CD4+CD38+ T-cell proportion
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in CD4+CD38+ T-cell proportion, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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CD38+/HLA-DR+ T-cell activation marker
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in CD38+/HLA-DR+ T-cell activation marker, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Treg proportion
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in regulatory T-cell proportion, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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TRECs level
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in T-cell receptor excision circles level, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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CD3+ T-cell level
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in CD3+ T-cell level, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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CD31+ T-cell level
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in CD31+ T-cell level, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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IL-2 level
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in interleukin-2 level, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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IL-4 level
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in interleukin-4 level, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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IL-6 level
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in interleukin-6 level, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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IL-10 level
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in interleukin-10 level, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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IL-17A level
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in interleukin-17A level, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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TNF-alpha level
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in tumor necrosis factor-alpha level, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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IFN-gamma level
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in interferon-gamma level, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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HIV RNA viral load
기간: Baseline; Weeks 48 and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in HIV RNA viral load, assessed by comparison between the two randomized groups.
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Baseline; Weeks 48 and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Quality of life score
기간: Baseline; Weeks 48, 60, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Change in quality of life score assessed using the WHOQOL-HIV-BREF questionnaire, compared between the two randomized groups.
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Baseline; Weeks 48, 60, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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TCM syndrome response rate
기간: Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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Response is defined as a >=30% decrease in TCM syndrome score from baseline; non-response is defined as a <30% decrease from baseline.
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Baseline; Weeks 12, 24, 36, 48, 60, 78, and 96 were observed. The treatment-period and follow-up assessments were Weeks 48 and 96.
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All-cause mortality rate
기간: From randomization through Week 96.
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Death from any cause during the study period, assessed by comparison between the two randomized groups.
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From randomization through Week 96.
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Red blood cell count
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in red blood cell count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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White blood cell count
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in white blood cell count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Hemoglobin level
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in hemoglobin level as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Platelet count
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in platelet count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Absolute neutrophil count
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in absolute neutrophil count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Absolute lymphocyte count
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in absolute lymphocyte count as a blood routine safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Aspartate aminotransferase level
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in aspartate aminotransferase level as a liver function safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Alanine aminotransferase level
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in alanine aminotransferase level as a liver function safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Gamma-glutamyl transferase level
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in gamma-glutamyl transferase level as a liver function safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Serum creatinine level
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in serum creatinine level as a renal function safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Urinary red blood cell result
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in urinary red blood cell result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Urinary protein result
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in urinary protein result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Urinary white blood cell result
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in urinary white blood cell result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Urinary glucose result
기간: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in urinary glucose result as a urinalysis safety laboratory indicator, assessed by comparison between the two randomized groups.
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Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Incidence of adverse events
기간: Adverse events were monitored from randomization through Week 96.
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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.
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Adverse events were monitored from randomization through Week 96.
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Incidence of serious adverse events
기간: Serious adverse events were monitored from randomization through Week 96.
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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.
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Serious adverse events were monitored from randomization through Week 96.
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Treatment interruption rate
기간: Treatment interruption was monitored from randomization through Week 48.
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Proportion of participants with interruption of the assigned study treatment during the 48-week treatment period, assessed by comparison between the two randomized groups.
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Treatment interruption was monitored from randomization through Week 48.
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Concomitant medication use
기간: Concomitant medication use was recorded from randomization through Week 96.
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Use of concomitant medications during the study period, including medication name, reason for use, dosage form, dose, route, frequency, start date, and end date.
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Concomitant medication use was recorded from randomization through Week 96.
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Absolute CD4+ T-cell count
기간: Week 96
|
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
|
Week 96
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|
Immune reconstitution response rate
기간: 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
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CD45RA+ T-cell proportion
기간: 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.
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Change in CD45RA+ T-cell proportion, assessed by comparison between the two randomized groups.
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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.
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
- 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
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CTCM-HIV-INR-FYJD-2026
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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University of Kansas Medical CenterNational Institutes of Health (NIH)아직 모집하지 않음
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Yale UniversityNational Institute of Mental Health (NIMH); Fogarty International Center of the National...모병
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Tang-Du HospitalZhejiang University; Chipscreen Biosciences, Ltd.; First Affiliated Hospital of Guangxi Medical...알려지지 않은
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University of WashingtonBill and Melinda Gates Foundation완전한