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Human Immunodeficiency VirusProspec-HIVNCT02542020

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

An observational study of Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome Virus, run by Oswaldo Cruz Foundation at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
2,000 participants
Where
1 siteBrazil
Study dates
Jun 2015to May 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients infected by HIV with or without chronic viral hepatitis

Who may be able to join

  • HIV infection
  • Age >= 18 years

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Hugo Perazzo, PhD contact

+55 21 3865-9587

hugo.perazzo@ini.fiocruz.br

Brazil1 site, 1 recruiting

  • Evandro Chagas National Institute of Infectious Diseases

    Rio de Janeiro, Rio de Janeiro/RJ, 21040-360

    Hugo Perazzo, PhD, +5521 3865-9587, hugo.perazzo@ini.fiocruz.br

    Recruiting

Other trials in Brazil

About this study

Official title: 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.

Read the detailed description

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).

Medical subject headings
Acquired Immunodeficiency Syndrome, Liver Diseases, Liver Cirrhosis, Fibrosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: change of fibrosis stage and steatosis grade from baseline at 5 years

Secondary outcomes (7)

  1. Prognostic value of non-invasive methods

    Evaluation of the prognostic value of non-invasive methods for prediction of severe outcomes and mortality

    Measured: up to 5 years

  2. Prevalence of liver fibrosis

    Estimation of liver fibrosis by non-invasive methods

    Measured: up to 3 years

  3. Prevalence of liver steatosis

    Estimation of liver steatosis by non-invasive methods

    Measured: up to 3 years

  4. Diagnostic performance of non-invasive methods

    Evaluation of diagnostic accuracy (sensitivity and specificity) of non-invasive methods using the Latent Class Analysis

    Measured: up to 3 years

  5. Nutritional status

    Evaluation of the nutritional status by bioelectrical impedance and 24h diet recall

    Measured: From date of inclusion until the date of first documented alteration on nutritional status, assessed up to 5 years

  6. Progression of liver fibrosis

    Estimation of liver fibrosis by non-invasive methods

    Measured: From date of inclusion until the date of first documented progression of liver fibrosis, assessed up to 5 years

  7. Progression of liver steatosis

    Estimation of liver steatosis by non-invasive methods

    Measured: From date of inclusion until the date of first documented progression of liver steatosis, assessed up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionMay 2020 (estimated)
  4. Study completionMay 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02542020
Sponsor's protocol ID
32889514.4.0000.5262
Acronym
Prospec-HIV
Status last verified
Feb 2018
First submitted
27 Aug 2015
Last updated
18 Feb 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 34873092

  • 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.

    PubMed 33529485

  • 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.

    PubMed 30394678

Questions about this trial

What is this clinical trial studying?

An observational study of Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome Virus, run by Oswaldo Cruz Foundation at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hugo Perazzo, PhD (+55 21 3865-9587, hugo.perazzo@ini.fiocruz.br), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of stage of fibrosis and grade of steatosis in patients infected by HIV (time frame: change of fibrosis stage and steatosis grade from baseline at 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02542020, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.

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