Prospective Evaluation of HIV Patients Using Non-invasive Methods for Estimation of Liver Fibrosis and Steatosis (Prospec-HIV)
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.
Panoramica dello studio
Stato
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
-
-
Rio De Janeiro/RJ
-
Rio de Janeiro, Rio De Janeiro/RJ, Brasile, 21040-360
- Reclutamento
- Evandro Chagas National Institute of Infectious Diseases
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Coorte
- Prospettive temporali: Prospettiva
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Evaluation of stage of fibrosis and grade of steatosis in patients infected by HIV
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Prognostic value of non-invasive methods
Lasso di tempo: 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
Lasso di tempo: up to 3 years
|
Estimation of liver fibrosis by non-invasive methods
|
up to 3 years
|
|
Prevalence of liver steatosis
Lasso di tempo: up to 3 years
|
Estimation of liver steatosis by non-invasive methods
|
up to 3 years
|
|
Diagnostic performance of non-invasive methods
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Valdilea G Veloso, PhD, Oswaldo Cruz Foundation
- Investigatore principale: Beatriz Grinsztejn, PhD, Oswaldo Cruz Foundation
Pubblicazioni e link utili
Pubblicazioni generali
- Yanavich C, Perazzo H, Li F, Tobin N, Lee D, Zabih S, Morata M, Almeida C, Veloso VG, Grinsztejn B, Aldrovandi GM. A pilot study of microbial signatures of liver disease in those with HIV mono-infection in Rio de Janeiro, Brazil. AIDS. 2022 Jan 1;36(1):49-58. doi: 10.1097/QAD.0000000000003084.
- Yanavich C, Pacheco AG, Cardoso SW, Nunes EP, Chaves U, Freitas G, Santos R, Morata M, Veloso VG, Grinsztejn B, Perazzo H. Diagnostic value of serological biomarkers for detection of non-alcoholic fatty liver disease (NAFLD) and/or advanced liver fibrosis in people living with HIV. HIV Med. 2021 Jul;22(6):445-456. doi: 10.1111/hiv.13060. Epub 2021 Feb 2.
- Perazzo H, Cardoso SW, Yanavich C, Nunes EP, Morata M, Gorni N, da Silva PS, Cardoso C, Almeida C, Luz P, Veloso VG, Grinsztejn B. Predictive factors associated with liver fibrosis and steatosis by transient elastography in patients with HIV mono-infection under long-term combined antiretroviral therapy. J Int AIDS Soc. 2018 Nov;21(11):e25201. doi: 10.1002/jia2.25201.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Malattie dell'apparato digerente
- Processi patologici
- Infezioni da virus a RNA
- Malattie virali
- Infezioni
- Infezioni a trasmissione ematica
- Malattie trasmissibili
- Malattie sessualmente trasmissibili, virali
- Malattie trasmesse sessualmente
- Infezioni da lentivirus
- Infezioni da retroviridae
- Malattie del sistema immunitario
- Malattie da virus lenti
- Malattie del fegato
- Fibrosi
- Infezioni da HIV
- Cirrosi epatica
- Sindrome da immunodeficienza acquisita
- Sindromi da deficit immunologico
Altri numeri di identificazione dello studio
- 32889514.4.0000.5262
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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 .
Prove cliniche su Malattie del fegato
-
Medical College of WisconsinRitiratoModello alto per il punteggio MELD (end-stage Liver Disease).Stati Uniti