Qiling Yiqi Tablets Plus Antiretroviral Therapy for HIV Immune Non-responders With Lung-Spleen Qi Deficiency (QLYQ-INR-pRCT)
7 de julio de 2026 actualizado por: Mei Han, Beijing University of Chinese Medicine
A Pragmatic Randomized Controlled Trial of Qiling Yiqi Tablets Combined With Antiretroviral Therapy for Immune Reconstitution Failure in People With HIV and Lung-Spleen Qi Deficiency Syndrome
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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
240
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Mei Han, phD
- Número de teléfono: +86 13401131731
- Correo electrónico: hanmeizoujin@163.com
Ubicaciones de estudio
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Beijing Municipality
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Beijing, Beijing Municipality, Porcelana, 100029
- Beijing University of Traditional Chinese Medicine
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Contacto:
- Mei Han, phD
- Número de teléfono: +86 13401131731
- Correo electrónico: hanmeizoujin@163.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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 lung-spleen qi 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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Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Qiling Yiqi Tablets plus ART
Participants receive Qiling Yiqi Tablets orally in addition to their background ART regimen for 48 weeks.
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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.
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Comparador activo: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Absolute CD4+ T-cell count
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Absolute CD4+ T-cell count
Periodo de tiempo: Week 96.
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Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
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Week 96.
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Immune reconstitution response rate
Periodo de tiempo: Week 96.
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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 96.
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CD4+ T-cell proportion
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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CD45RA+ T-cell proportion
Periodo de tiempo: 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 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 and follow-up assessments were Weeks 48 and 96.
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CD45RO+ T-cell proportion
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Blood urea nitrogen level
Periodo de tiempo: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
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Change in blood urea nitrogen 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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Serum creatinine level
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de agosto de 2026
Finalización primaria (Estimado)
1 de febrero de 2028
Finalización del estudio (Estimado)
1 de febrero de 2029
Fechas de registro del estudio
Enviado por primera vez
7 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de julio de 2026
Publicado por primera vez (Actual)
13 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
13 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
7 de julio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones transmitidas por la sangre
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema inmunológico
- Infecciones
- Infecciones por virus de ARN
- Enfermedades virales
- Enfermedades contagiosas
- Enfermedades De Transmisión Sexual Virales
- Enfermedades de transmisión sexual
- Infecciones por lentivirus
- Infecciones por retroviridae
- Síndromes de deficiencia inmunológica
- Enfermedades de virus lentos
- Infecciones por VIH
- Síndrome de inmunodeficiencia adquirida
- Terapéutica
- Terapia con drogas
- Terapia de drogas, combinación
- Terapia antirretroviral, altamente activa
Otros números de identificación del estudio
- CTCM-HIV-INR-QLYQ-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
The study involves HIV-related clinical data.
The clinical data will be de-identified, stored in an EDC system, and exported only after written approval by the principal investigator.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .