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Prospective Evaluation of HIV Patients Using Non-invasive Methods for Estimation of Liver Fibrosis and Steatosis (Prospec-HIV)

15. februar 2019 opdateret af: Oswaldo Cruz Foundation

Prospective Evaluation of HIV Infected Patients Followed at Evandro Chagas National Institute of Infectious Disease (INI) - Oswaldo Cruz Foundation (FIOCRUZ) Using Non-invasive Methods for Estimation of Liver Fibrosis and Steatosis

Human immunodeficiency virus (HIV) infection is a major global health issue with up to 40 million people infected worldwide. Due to highly active antiretroviral therapy, mortality related to acquired immunodeficiency syndrome (AIDS) has been reducing in the last decades. However, liver disease remains as an important cause of severe complications and death.

Hepatic fibrosis progression is the main responsible for liver-related outcomes in HIV-positive patients. Co-infection by hepatitis B (HBV) or hepatitis C virus (HCV) is highly prevalence in HIV patients. Chronic viral co-infection induces faster liver fibrosis progression compared to mono-infected HIV. However, published data have been reporting presence of significant liver fibrosis in HIV without HBV or HCV infection. This might be related to direct action of HIV in hepatocytes or association with others factors, such as non-alcoholic fatty liver disease (NAFLD). NAFLD is associated with metabolic factors, such as obesity and type-2 diabetes mellitus. However, antiretroviral drugs may induce abnormal body fat distribution (lipodistrophy) and insulin resistance playing an important role on this process. Liver biopsy has been historically considered as the gold standard to evaluate liver injury. However, this painful method presents several limitations. Therefore, several non-invasive methods for estimation of liver fibrosis, such as biomarkers (APRI, FIB-4, FibroTest and FibroMeter) and transient elastography by Fibroscan, have been developed as an alternative to liver biopsy. The diagnostic performance and prognostic value of biomarkers and transient elastography have been validated in patients with chronic liver diseases. However, few data are available in HIV patients, especially in those without chronic viral co-infection.

Therefore, patients, medical doctors and scientific community will be beneficiated by the future application of non-invasive methods for estimation of liver injury in clinical practice in HIV patients.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

In HIV-positive patients with or without chronic viral hepatitis co-infection, the primary aims of this project are: (i) to estimate the prevalence and incidence of liver injury (including progression of fibrosis, necro-inflammatory activity and steatosis) and to report the normal values of non-invasive methods in HIV population; (ii) to validate the diagnostic performance of non-invasive methods using a method without a gold standard (Latent Class Analysis); (iii) to validate the prognostic value of non-invasive markers to predict overall mortality and liver-related outcomes and (iv) to correlate liver injury with nutritional status. The secondary aim will be the constitution of a cohort of HIV patients, with or without chronic viral hepatitis co-infection for long-term follow-up of severe outcomes.

This prospective cohort study has been approved by the Local Ethical Committee (CAAE: 32889514.4.0000.5262) and it has been enrolling patients from June 2015 at the Evandro Chagas National Institute of Infectious Diseases - Oswaldo Cruz Foundation (INI - FioCruz), Rio de Janeiro, Brazil. A total of 2,000 patients will be included in this study during the next 5 years. This project aims to report the prevalence and incidence of liver disease in a representative sample of HIV patients with and without chronic viral hepatitis co-infection. In addition, the risk factors associated to presence and progression of liver fibrosis and steatosis will be identified and an innovative non-invasive management for estimation of liver injury in HIV patients will be validated.

Patients have been submitted at the same day to the following procedures: (i) clinical examination (anthropometric and demographic characteristics), (ii) blood sample collection (for blood analysis, calculation of biomarkers and stockage of samples), (iii) transient elastography (with M and XL probes by a single experienced operator (>2,000 examinations) and (iv) nutritional status (bioelectrical impedance and 24h diet recall).

Undersøgelsestype

Observationel

Tilmelding (Forventet)

2000

Kontakter og lokationer

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

Studiesteder

  • Brasilien
    • Rio De Janeiro/RJ
      • Rio de Janeiro, Rio De Janeiro/RJ, Brasilien, 21040-360
        • Rekruttering
        • Evandro Chagas National Institute of Infectious Diseases

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

Sandsynlighedsprøve

Studiebefolkning

Patients infected by HIV with or without chronic viral hepatitis

Beskrivelse

Inclusion Criteria:

  • HIV infection
  • Age >= 18 years

Exclusion Criteria:

  • Auto-immune hepatitis
  • Primary biliary cirrhosis
  • Primary sclerosing cirrhosis
  • Extra-hepatic cholestasis
  • Acute viral hepatitis
  • Hepatic ischemia
  • Hepatic metastasis

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of stage of fibrosis and grade of steatosis in patients infected by HIV
Tidsramme: change of fibrosis stage and steatosis grade from baseline at 5 years
Staging of liver fibrosis and quantification of steatosis using non-invasive methods and correlation with risk factors
change of fibrosis stage and steatosis grade from baseline at 5 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prognostic value of non-invasive methods
Tidsramme: up to 5 years
Evaluation of the prognostic value of non-invasive methods for prediction of severe outcomes and mortality
up to 5 years
Prevalence of liver fibrosis
Tidsramme: up to 3 years
Estimation of liver fibrosis by non-invasive methods
up to 3 years
Prevalence of liver steatosis
Tidsramme: up to 3 years
Estimation of liver steatosis by non-invasive methods
up to 3 years
Diagnostic performance of non-invasive methods
Tidsramme: up to 3 years
Evaluation of diagnostic accuracy (sensitivity and specificity) of non-invasive methods using the Latent Class Analysis
up to 3 years
Nutritional status
Tidsramme: From date of inclusion until the date of first documented alteration on nutritional status, assessed up to 5 years
Evaluation of the nutritional status by bioelectrical impedance and 24h diet recall
From date of inclusion until the date of first documented alteration on nutritional status, assessed up to 5 years
Progression of liver fibrosis
Tidsramme: From date of inclusion until the date of first documented progression of liver fibrosis, assessed up to 5 years
Estimation of liver fibrosis by non-invasive methods
From date of inclusion until the date of first documented progression of liver fibrosis, assessed up to 5 years
Progression of liver steatosis
Tidsramme: From date of inclusion until the date of first documented progression of liver steatosis, assessed up to 5 years
Estimation of liver steatosis by non-invasive methods
From date of inclusion until the date of first documented progression of liver steatosis, assessed up to 5 years

Samarbejdspartnere og efterforskere

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

Sponsor

Oswaldo Cruz Foundation

Efterforskere

  • Ledende efterforsker: Valdilea G Veloso, PhD, Oswaldo Cruz Foundation
  • Ledende efterforsker: Beatriz Grinsztejn, PhD, Oswaldo Cruz Foundation

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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. juni 2015

Primær færdiggørelse (Forventet)

1. maj 2020

Studieafslutning (Forventet)

1. maj 2022

Datoer for studieregistrering

Først indsendt

27. august 2015

Først indsendt, der opfyldte QC-kriterier

2. september 2015

Først opslået (Skøn)

4. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. februar 2019

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 32889514.4.0000.5262

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ingen

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