Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Immunomodulation Using VB-201 to Reduce Arterial Inflammation in Treated HIV - VITAL HIV Trial

12. september 2022 opdateret af: Priscilla Hsue, MD
This study is a double blinded, placebo-controlled, randomized, parallel group study, designed to compare the efficacy and safety of VB-201 80mg taken orally once daily to placebo for anti-inflammation in HIV-infected subjects.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Fase

  • Fase 2
  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • California
      • San Francisco, California, Forenede Stater, 94110
        • Zuckerberg San Francisco General Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Documented HIV infection
  • On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
  • CD4 T-cell count > 350 cells/mm3
  • Male or female between the ages ≥ 40 years of age to <≤75
  • Documented cardiovascular disease (1. Prior myocardial infarction, 2. History of percutaneous coronary intervention, 3. History of coronary artery bypass graft OR 4. Angiographic evidence of >50% stenosis in at least one coronary artery] OR 1 CVD risk factor (T2DM, current smoking, hypertension, dyslipidemia, hsCRP≥2mg/L, family history)
  • TBR of >1.6 of the MDS of the carotid/aorta at baseline. This baseline arterial TBR cutoff excludes the rare individual that lacks appreciable arterial inflammation. It is notable that while 5-10% of uninfected individuals will have lower TBRs, it is rare that an HIV infected individual will fall below this range.
  • Female subjects must either be of non-childbearing potential as defined by menopause with amenorrhea for >2 years, bilateral oophorectomy, or agree to use adequate contraception throughout the study and for at least one month following termination and have a negative pregnancy test at screening prior to the first dose of drug.
  • Males must use at least one method of contraception throughout the study.

Exclusion Criteria:

  • Pregnant/nursing women
  • Uncontrolled hypertension or diabetes requiring insulin
  • AST/ALT or alkaline phosphatase >2x ULN
  • Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma
  • Nephrotic syndrome or eGFR <60 mL/min/1.73m2
  • Cytopenias which include 1) WBC <3.5 x103/uL 2) Platelet <120 x103/uL 3) ANC <1.5 x103/uL, and absolute lymphocytes <0.8 x 103/uL
  • Anemia as fined by <10 g/dL
  • Evidence of tuberculosis infection at screening within 30 days prior to screening.
  • Family history of long QT syndrome, using medication that prolongs QT internal, OR evidence of prolonged QT of >470 msec as evidenced by ECG
  • Acute systemic infection within 30 days
  • On additional immunosuppressant or immunomodulatory therapies

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: VB-201
One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
Medicin: VB-201
One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
Placebo komparator: Placebo
One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
Medicin: Placebo
One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Target-to-background ratio (TBR)
Tidsramme: 1 year (Baseline and Week 52)
Change in Target-to-background ratio (TBR) from baseline to follow-up study at 52 weeks as assessed by Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography (FDG PET/CT)
1 year (Baseline and Week 52)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in high sensitivity C-reactive protein (hs-CRP) in mg/L
Tidsramme: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in hs-CRP from baseline to week 24 and baseline to week 52 as measured by blood collection
1 year (Change from baseline to week 24 and baseline to week 52)
Change in Interleukin-6 (IL-6) in pg/mL
Tidsramme: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in IL-6 from baseline to week 24 and baseline to week 52 as measured by blood collection
1 year (Change from baseline to week 24 and baseline to week 52)
Change in soluble cluster of differentiation (sCD163) ng/mL
Tidsramme: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in sCD163 from baseline to week 24 and baseline to week 52 as measured by blood collection
1 year (Change from baseline to week 24 and baseline to week 52)
Change in Lipoprotein (a) [Lp(a)] in mg/dL
Tidsramme: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Lp(a) from baseline to week 24 and baseline to week 52 as measured by blood collection
1 year (Change from baseline to week 24 and baseline to week 52)
Change in Lipoprotein-associated Phospholipase A2 (Lp-PLA2) in ng/mL
Tidsramme: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Lp-PLA2 from baseline to week 24 and baseline to week 52 as measured by blood collection
1 year (Change from baseline to week 24 and baseline to week 52)
Change in D-Dimer (ng/mL)
Tidsramme: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in D-Dimer from baseline to week 24 and baseline to week 52 as measured by blood collection
1 year (Change from baseline to week 24 and baseline to week 52)
Change in Markers of Immune Activation
Tidsramme: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Co-expression of HLA-DR/CD38 on T-cells from baseline to week 24 and baseline to week 52 as measured by blood collection
1 year (Change from baseline to week 24 and baseline to week 52)
Change in Monocyte Activation
Tidsramme: 1 year (Change from baseline to week 24 and baseline to week 52)
Change in Co-expression of CD14/CD16 on Monocytes from baseline to week 24 and baseline to week 52
1 year (Change from baseline to week 24 and baseline to week 52)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in non-calcified plaque progression
Tidsramme: 1 year (Baseline and Week 52)
Change in non-calcified plaque progression from baseline to week 52 as assessed by Coronary Computed Tomography Angiography (Coronary CTA)
1 year (Baseline and Week 52)
Change in high risk plaque
Tidsramme: 1 year (Baseline and Week 52)
Change in high-risk plaque from baseline to week 52 as assessed by Coronary Computed Tomography Angiography (Coronary CTA)
1 year (Baseline and Week 52)
Incidence of new lesions
Tidsramme: 1 year (Baseline and Week 52)
Incidence of new lesions from baseline to week 52 as assessed by Coronary Computed Tomography Angiography (Coronary CTA)
1 year (Baseline and Week 52)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Priscilla Hsue, MD

Samarbejdspartnere

University of California, Los Angeles
University of Utah

Efterforskere

  • Ledende efterforsker: Priscilla Hsue, MD, University of California, San Francisco

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. juli 2022

Primær færdiggørelse (Forventet)

1. juli 2026

Studieafslutning (Forventet)

1. juli 2027

Datoer for studieregistrering

Først indsendt

3. juni 2021

Først indsendt, der opfyldte QC-kriterier

16. juni 2021

Først opslået (Faktiske)

25. juni 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. september 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. september 2022

Sidst verificeret

1. september 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • VITAL HIV

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med HIV-infektion

Kliniske forsøg med VB-201

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Bangladesh

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner