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A Prospective, Longitudinal Study of Endothelial Function in HIV/HCV Coinfected Subjects (CTSI-PLACE)

20. december 2021 opdateret af: Kara Chew, University of California, Los Angeles

Clinical and Translational Science Institute Prospective Longitudinal Assessment of Coinfected Subjects With HIV/Hepatitis C for Endothelial Function Study

The CTSI-PLACE Study is a study for men and women with HIV/hepatitis C co-infection or HIV only. The study looks at the impact of having hepatitis C virus in addition to HIV on risk for cardiovascular disease. Participants will undergo non-invasive assessment of cardiovascular disease risk through measurements of endothelial function and blood biomarkers at baseline and 1 year (or 4 weeks and 24 weeks after end of HCV treatment for those that undergo HCV treatment during study follow-up).

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

87

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90025
        • UCLA CARE Center

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

HIV/HCV coinfected and HIV monoinfected adults with well-controlled HIV

Beskrivelse

Inclusion Criteria

  1. Men and women ≥ 18 years
  2. Hepatitis C negative or chronic hepatitis C infection
  3. Chronic HIV infection
  4. CD4+ T-cell count > 200 cells/mm3
  5. Plasma HIV-1 RNA < 50 copies/mL
  6. On continuous and stable ART for at least 12 weeks
  7. Ability and willingness to provide written informed consent.

Exclusion Criteria

  1. Known cardiovascular disease
  2. Diabetes requiring insulin therapy or hemoglobin A1c > 8%
  3. Inability to conform to requirements for PAT testing
  4. Decompensated liver disease
  5. Other known causes of significant liver disease
  6. Serious illness including acute liver-related disease and malignancy requiring systemic treatment or hospitalization within 12 weeks prior to study entry
  7. Presence of active or acute AIDS-defining opportunistic infections (OIs) within 12 weeks prior to study entry
  8. History of major organ transplantation with an existing functional graft and on immunosuppressive therapy
  9. History of known vascular or autoimmune disease
  10. Pregnancy
  11. HCV treatment (any approved or investigational agents) within 24 weeks prior to study entry
  12. Use of immune-based therapies or systemic corticosteroids within 12 weeks prior to study entry
  13. Advanced renal insufficiency as defined by glomerular filtration rate (GFR) < 30 mL/min/1.73 m2 or treatment by dialysis

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Group A (HIV/HCV coinfected)
Group B (HIV monoinfected)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Reactive Hyperemia Index (RHI) by Peripheral Arterial Tonometry (PAT)
Tidsramme: Baseline
Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)
Baseline

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Tidsramme: Baseline
Serum hsCRP
Baseline
Reactive Hyperemia Index (RHI)
Tidsramme: Week 52
Ratio of the average pulse wave amplitude (PWA) over a 1 minute interval starting 1 minute following cuff release to the pre-occlusion PWA (average over 3.5 minutes pre-cuff inflation)
Week 52
Soluble Biomarkers (Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Tidsramme: Week 52
Serum hsCRP
Week 52
Insulin Resistance by HOMA-IR
Tidsramme: Baseline
fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405
Baseline
Insulin Resistance by HOMA-IR
Tidsramme: Week 52
fasting insulin (μU/mL) x fasting glucose (mg/dl) / 405
Week 52
Framingham Risk Score (FRS), 10-year Risk (%)
Tidsramme: Baseline
Estimate of 10-year risk for developing coronary heart disease (CHD), calculated as described in ATP III Executive Summary, JAMA, May 16, 2001-Vol 285, No. 19. Range of values is <1 to >/= 30% Higher risk % is worse predicted outcome.
Baseline
Framingham Risk Score (FRS), 10-year Risk (%)
Tidsramme: Week 52
Estimate of 10-year risk for developing coronary heart disease (CHD), calculated as described in ATP III Executive Summary, JAMA, May 16, 2001-Vol 285, No. 19. Range of values is <1 to >/= 30% Higher risk % is worse predicted outcome.
Week 52
Change in RHI
Tidsramme: Baseline to Week 52
Baseline to Week 52
Change in Level of Each Soluble Biomarker (Components of Fasting Lipid Panel, hsCRP, IL-6, D-dimer, sICAM-1, sE-selectin, Lp-PLA2, sCD14, sCD163)
Tidsramme: Baseline to Week 52
Change in serum hsCRP level
Baseline to Week 52
Change in HOMA-IR
Tidsramme: Baseline to Week 52
Baseline to Week 52
Change in Framingham Risk Score (10-year Risk, %)
Tidsramme: Baseline to Week 52
Change in estimated 10-year risk (% risk) for developing coronary heart disease (CHD). Positive value indicates increase in estimated 10-year risk for CHD from baseline to Week 52. Negative value indicates decrease in estimated 10-year risk for CHD from baseline to Week 52.
Baseline to Week 52

Samarbejdspartnere og efterforskere

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

Sponsor

University of California, Los Angeles

Samarbejdspartnere

Merck Sharp & Dohme LLC

Efterforskere

  • Ledende efterforsker: Kara W. Chew, M.D., M.S., University of California, Los Angeles

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

1. oktober 2013

Primær færdiggørelse (Faktiske)

1. januar 2019

Studieafslutning (Faktiske)

1. januar 2020

Datoer for studieregistrering

Først indsendt

30. oktober 2015

Først indsendt, der opfyldte QC-kriterier

3. november 2015

Først opslået (Skøn)

5. november 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. januar 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. december 2021

Sidst verificeret

1. december 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 12-001792 (CTSI-PLACE)
  • N/A (Parent P30AI028697) (Andet bevillings-/finansieringsnummer: UCLA AIDS Institute/Center for AIDS Research)
  • N/A (Parent UL1TR000124) (Andet bevillings-/finansieringsnummer: UCLA Clinical and Translational Science Institute)
  • 52767 (Andet bevillings-/finansieringsnummer: Merck Investigator Studies Program)

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 .

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Betingelser

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Sponsor / samarbejdspartnere

Placeringer

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