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Qiling Yiqi Tablets Plus Antiretroviral Therapy for HIV Immune Non-responders With Lung-Spleen Qi Deficiency (QLYQ-INR-pRCT)

7 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

240

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100029
        • Beijing University of Traditional Chinese Medicine
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

No

Descrizione

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.

-

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Qiling Yiqi Tablets plus ART
Participants receive Qiling Yiqi Tablets orally in addition to their background ART regimen for 48 weeks.
Droga: Qiling Yiqi Tablets plus ART
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.
Comparatore attivo: ART alone
Participants continue ART according to applicable domestic and international ART guidelines
Droga: Antiretroviral Therapy (ART)
Background ART regimen according to applicable domestic and international ART guidelines.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Absolute CD4+ T-cell count
Lasso di tempo: Week 48
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Week 48
Immune reconstitution response rate
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Absolute CD4+ T-cell count
Lasso di tempo: Week 96.
Change in absolute CD4+ T-cell count, assessed by comparison between the two randomized groups.
Week 96.
Immune reconstitution response rate
Lasso di tempo: 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.
CD4+ T-cell proportion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
CD45RA+ T-cell proportion
Lasso di tempo: 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 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 and follow-up assessments were Weeks 48 and 96.
CD45RO+ T-cell proportion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
Blood urea nitrogen level
Lasso di tempo: Baseline; Weeks 12, 24, and 48 were observed. The safety laboratory assessments were Weeks 12, 24, and 48.
Change in blood urea nitrogen 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.
Serum creatinine level
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Beijing University of Chinese Medicine

Collaboratori

Chengdu University of Traditional Chinese Medicine

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

  • 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.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 agosto 2026

Completamento primario (Stimato)

1 febbraio 2028

Completamento dello studio (Stimato)

1 febbraio 2029

Date di iscrizione allo studio

Primo inviato

7 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CTCM-HIV-INR-QLYQ-2026

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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