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.
調査の概要
状態
詳細な説明
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).
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Hugo Perazzo, PhD
- 電話番号：+55 21 3865-9587
- メール：hugo.perazzo@ini.fiocruz.br
研究場所
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Rio De Janeiro/RJ
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Rio de Janeiro、Rio De Janeiro/RJ、ブラジル、21040-360
- 募集
- Evandro Chagas National Institute of Infectious Diseases
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：コホート
- 時間の展望：見込みのある
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Evaluation of stage of fibrosis and grade of steatosis in patients infected by HIV
時間枠：change of fibrosis stage and steatosis grade from baseline at 5 years
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Staging of liver fibrosis and quantification of steatosis using non-invasive methods and correlation with risk factors
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change of fibrosis stage and steatosis grade from baseline at 5 years
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Prognostic value of non-invasive methods
時間枠：up to 5 years
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Evaluation of the prognostic value of non-invasive methods for prediction of severe outcomes and mortality
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up to 5 years
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Prevalence of liver fibrosis
時間枠：up to 3 years
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Estimation of liver fibrosis by non-invasive methods
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up to 3 years
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Prevalence of liver steatosis
時間枠：up to 3 years
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Estimation of liver steatosis by non-invasive methods
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up to 3 years
|
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Diagnostic performance of non-invasive methods
時間枠：up to 3 years
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Evaluation of diagnostic accuracy (sensitivity and specificity) of non-invasive methods using the Latent Class Analysis
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up to 3 years
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Nutritional status
時間枠：From date of inclusion until the date of first documented alteration on nutritional status, assessed up to 5 years
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Evaluation of the nutritional status by bioelectrical impedance and 24h diet recall
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From date of inclusion until the date of first documented alteration on nutritional status, assessed up to 5 years
|
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Progression of liver fibrosis
時間枠：From date of inclusion until the date of first documented progression of liver fibrosis, assessed up to 5 years
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Estimation of liver fibrosis by non-invasive methods
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From date of inclusion until the date of first documented progression of liver fibrosis, assessed up to 5 years
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Progression of liver steatosis
時間枠：From date of inclusion until the date of first documented progression of liver steatosis, assessed up to 5 years
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Estimation of liver steatosis by non-invasive methods
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From date of inclusion until the date of first documented progression of liver steatosis, assessed up to 5 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Valdilea G Veloso, PhD、Oswaldo Cruz Foundation
- 主任研究者：Beatriz Grinsztejn, PhD、Oswaldo Cruz Foundation
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 32889514.4.0000.5262
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