Prospective Evaluation of HIV Patients Using Non-invasive Methods for Estimation of Liver Fibrosis and Steatosis
Prospec-HIV
1 other identifier
observational
2,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 27, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedFebruary 18, 2019
February 1, 2018
4.9 years
August 27, 2015
February 15, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of stage of fibrosis and grade of steatosis in patients infected by HIV
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
Secondary Outcomes (7)
Prognostic value of non-invasive methods
up to 5 years
Prevalence of liver fibrosis
up to 3 years
Prevalence of liver steatosis
up to 3 years
Diagnostic performance of non-invasive methods
up to 3 years
Nutritional status
From date of inclusion until the date of first documented alteration on nutritional status, assessed up to 5 years
- +2 more secondary outcomes
Eligibility Criteria
Patients infected by HIV with or without chronic viral hepatitis
You may qualify if:
- HIV infection
- Age \>= 18 years
You may not qualify if:
- Auto-immune hepatitis
- Primary biliary cirrhosis
- Primary sclerosing cirrhosis
- Extra-hepatic cholestasis
- Acute viral hepatitis
- Hepatic ischemia
- Hepatic metastasis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Evandro Chagas National Institute of Infectious Diseases
Rio de Janeiro, Rio de Janeiro/RJ, 21040-360, Brazil
Related Publications (3)
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.
PMID: 34873092DERIVEDYanavich 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.
PMID: 33529485DERIVEDPerazzo 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.
PMID: 30394678DERIVED
Biospecimen
Blood samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Valdilea G Veloso, PhD
Oswaldo Cruz Foundation
- PRINCIPAL INVESTIGATOR
Beatriz Grinsztejn, PhD
Oswaldo Cruz Foundation
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 27, 2015
First Posted
September 4, 2015
Study Start
June 1, 2015
Primary Completion
May 1, 2020
Study Completion
May 1, 2022
Last Updated
February 18, 2019
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will not share