Nonalcoholic Fatty Liver Disease in HIV Database

February 8, 2024 updated by: Johns Hopkins University

Nonalcoholic Fatty Liver Disease In Persons Living With HIV Database Study

Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions associated with fat accumulation that ranges from benign, non-progressive liver fat accumulation to severe liver injury, cirrhosis, and liver failure. The spectrum of NAFLD encompasses simple nonalcoholic steatosis (nonalcoholic fatty liver [NAFL]) and nonalcoholic steatohepatitis (NASH) in which there is evidence of hepatocellular injury and/or fibrosis. NAFLD is the most common liver disease in adults and the second leading cause for liver transplantation in the U.S. The natural history of NAFLD in the general population has been well described. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002 to further the understanding of the diagnosis, mechanisms, progression and therapies of NASH. This effort has resulted in numerous seminal studies in the field. However, NASH CRN studies have systematically excluded persons living with HIV (PLWH) , as NAFLD in PLWH was thought to be different from that in the general population due to HIV infection, antiretroviral therapy (ART), concomitant medications and co-infections. This resulted in major knowledge gaps regarding NAFLD in the setting of HIV infection. Thus, the natural history of NAFLD in PLWH is largely unknown. The goal of this ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), is to conduct a prospective, observational, multicenter study of NAFLD in PLWH (HIV-associated NAFLD).

Study Overview

Status

Recruiting

Conditions

Detailed Description

NAFLD is the most prevalent of all liver disorders and is the most common cause of chronic aminotransferase elevations in the U.S. With the availability of highly effective ART, chronic liver disease has become a leading cause of non-AIDS related morbidity and mortality in PLWH. NAFLD is projected to become the leading cause of liver disease in the aging HIV population. While there is evidence that both Hepatitis B and Hepatitis C infection follow an accelerated course in PLWH, it is unknown if NAFLD is also accelerated in PLWH. Unlike NAFLD in the general population, there is a significant lack of characterization of the natural history of NAFLD in PLWH. This prospective observational study of PLWH with NAFLD will examine the natural history of HIV-associated NAFLD. It will also test the accuracy of non-invasive assessments of advanced fibrosis in detecting histologically confirmed advanced fibrosis in PLWH, and establish a robust biospecimen bank (plasma, serum, genomic DNA, and urine; peripheral blood mononuclear cells (PBMCs) and stool at select sites).

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama
        • Contact:
        • Principal Investigator:
          • Sonya Heath, MD
    • California
      • San Diego, California, United States, 92121
        • Recruiting
        • University of California, San Diego
        • Contact:
        • Principal Investigator:
          • Rohit Loomba, MD
      • San Francisco, California, United States, 94143
        • Recruiting
        • University of California, San Francisco
        • Contact:
        • Principal Investigator:
          • Jennifer Price, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Sub-Investigator:
          • Samer Gawrieh, MD
        • Contact:
        • Principal Investigator:
          • Naga Chalasani, MD
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Sub-Investigator:
          • Tinsay Woreta, MD
        • Principal Investigator:
          • Mark Sulkowski, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Susanna Naggie, MD
        • Sub-Investigator:
          • Kara Wegermann, MD
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas
        • Contact:
        • Principal Investigator:
          • Jordan Lake, MD
    • Virginia
      • Richmond, Virginia, United States, 23284
        • Recruiting
        • Virginia Commonwealth University
        • Principal Investigator:
          • Richard Sterling, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

400 participants who are PLWH at least 18 years of age with a diagnosis of NAFLD, NASH, or NASH-related cirrhosis, supported by either a recent liver biopsy or clinical and imaging criteria

Description

Inclusion Criteria:

  • Documented HIV infection
  • ≥18 of age at time of initial screening
  • HIV suppression with HIV RNA <200 copies/ml on stable ART for ≥ 6 months and no change in ART class for ≥ 3 months, prior to enrollment

  • Participants must meet at least one of the following inclusion criteria:

    • Histologically confirmed NAFLD [defined as NAFL (>5% steatosis, with or without lobular or portal inflammation), borderline NASH or definitive NASH] within 6 months prior to screening (per local pathology report)
    • Liver stiffness measurement (LSM) ≥8 kPa from FibroScan exam performed during screening or within 6 months prior to screening and NAFLD based on clinical and imaging (FibroScan CAP≥263 dB/m, ultrasound, CT or MRI) diagnosis
  • Able to provide written informed consent to part
  • Willingness to be in the study for 1 or more years
  • Provision of written informed consent

Exclusion Criteria:

  • Positive hepatitis B surface antigen
  • Evidence of recent or current hepatitis C virus (HCV) as marked by the presence of anti-HCV antibody with detectable HCV RNA in serum within 3 years prior to enrollment. Participants with anti-HCV antibody positivity who have undetectable HCV RNA 3 years prior to enrollment (either due to spontaneous clearance or clearance with treatment) will be eligible to participate if HCV RNA at entry remains undetected
  • Significant alcohol consumption (≥ 3 drinks daily on average in men and ≥ 2 drinks daily on average in women)
  • Evidence of other causes of chronic liver disease
  • History of prolonged (> 1 month) total parenteral nutrition within a 6-month period before liver biopsy or before baseline FibroScan VCTE exam
  • Short bowel syndrome
  • History of biliopancreatic diversion
  • History of bariatric surgery within 2 years of enrollment (participants expecting to undergo bariatric surgery can be enrolled prior to the procedure)
  • Solid organ transplant recipients
  • Other condition that is likely to interfere with study follow-up

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in liver stiffness measurement (LSM) measured by VCTE from baseline to one year
Time Frame: Baseline and 1 year
Vibration-controlled transient elastography (VCTE) measures the speed of a mechanically generated shear wave across the liver to derive a liver stiffness measurement (LSM), which corresponds to the liver fibrosis stage. LSM is measured in kilopascals (kPa).
Baseline and 1 year
Change in controlled attenuation parameter (CAP) measured by VCTE from baseline to one year
Time Frame: Baseline and 1 year
Controlled attenuation parameter (CAP) measures the increased attenuation of ultrasound waves when traveling through fat in the liver and is a non-invasive method to assess hepatic steatosis. CAP is measured in decibels per meter (dB/m).
Baseline and 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Samer Gawrieh, MD, Indiana University
  • Principal Investigator: Tinsay A Woreta, MD, MPH, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2022

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00316850
  • R01DK121378 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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