Nonalcoholic Fatty Liver Disease in HIV Database

Last updated: January 14, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hiv

Liver Disease

Primary Biliary Cholangitis

Treatment

N/A

Clinical Study ID

NCT05023044
IRB00316850
R01DK121378
  • Ages > 18
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

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 nochange 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 withoutlobular or portal inflammation), borderline NASH or definitive NASH] within 6months prior to screening (per local pathology report)

  • Liver stiffness measurement (LSM) ≥6 kPa from FibroScan exam performed duringscreening or within 12 months prior to screening and a diagnosis of NAFLD basedon clinical and imaging (FibroScan CAP≥263 dB/m, ultrasound, CT or MRI)diagnosis at any time

  • LSM ≥8 kPa from FibroScan exam performed during screening or within 12 monthsprior to screening, in the absence of CAP ≥263 dB/m

  • 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

Exclusion Criteria:

  • Positive hepatitis B surface antigen

  • Evidence of recent or current hepatitis C virus (HCV) as marked by the presence ofanti-HCV antibody with detectable HCV RNA in serum within 3 years prior toenrollment. Participants with anti-HCV antibody positivity who have undetectable HCVRNA 3 years prior to enrollment (either due to spontaneous clearance or clearancewith treatment) will be eligible to participate if HCV RNA at entry remainsundetected

  • Significant alcohol consumption (≥ 3 drinks daily on average in men and ≥ 2 drinksdaily on average in women)

  • Evidence of other causes of chronic liver disease

  • History of prolonged (> 1 month) total parenteral nutrition within a 6-month periodbefore 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 toundergo 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 Design

Total Participants: 400
Study Start date:
May 12, 2022
Estimated Completion Date:
January 31, 2026

Study 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).

Connect with a study center

  • University of Alabama

    Birmingham, Alabama 35233
    United States

    Active - Recruiting

  • University of California, San Diego

    San Diego, California 92121
    United States

    Active - Recruiting

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Indiana University

    Indianapolis, Indiana 46202
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Duke University

    Durham, North Carolina 27710
    United States

    Active - Recruiting

  • University of Texas

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Virginia Commonwealth University

    Richmond, Virginia 23284
    United States

    Active - Recruiting

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