Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Description

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. NAFLD is the most common liver disease in US adults and the second leading cause for liver transplantation in the US. The natural history of NAFLD in the general population has been well described, with those with non-alcoholic fatty liver (NAFL, or simple steatosis) destined to have rare incidence of hepatic events compared to those with non-alcoholic steatohepatitis (NASH), who are at high risk for future development of cirrhosis, liver cancer and liver failure. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002, through the mechanism of RFA-DK-01-025, to further the understanding of diagnosis, mechanisms, progression and therapies of NASH. The NASH CRN 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 these persons was thought to be different from that in the general population due to HIV, ART, concomitant medications, and co-infections. This has resulted in major knowledge gaps regarding NAFLD in the setting of HIV. This ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), HNC 001 goal is to examine the prevalence of hepatic steatosis and NAFLD in a large, multicenter, and multiethnic cohort of PLWH (Steatosis in HIV Study)

Conditions

NAFLD, NAFLD-HIV, Hiv

Study Overview

Study Details

Study overview

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. NAFLD is the most common liver disease in US adults and the second leading cause for liver transplantation in the US. The natural history of NAFLD in the general population has been well described, with those with non-alcoholic fatty liver (NAFL, or simple steatosis) destined to have rare incidence of hepatic events compared to those with non-alcoholic steatohepatitis (NASH), who are at high risk for future development of cirrhosis, liver cancer and liver failure. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002, through the mechanism of RFA-DK-01-025, to further the understanding of diagnosis, mechanisms, progression and therapies of NASH. The NASH CRN 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 these persons was thought to be different from that in the general population due to HIV, ART, concomitant medications, and co-infections. This has resulted in major knowledge gaps regarding NAFLD in the setting of HIV. This ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), HNC 001 goal is to examine the prevalence of hepatic steatosis and NAFLD in a large, multicenter, and multiethnic cohort of PLWH (Steatosis in HIV Study)

Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Condition
NAFLD
Intervention / Treatment

-

Contacts and Locations

Tuscaloosa

University of Alabama, Tuscaloosa, Alabama, United States, 35487

La Jolla

University of California, San Diego, La Jolla, California, United States, 92037

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94143

Indianapolis

Indiana University School of Medicine, Indianapolis, Indiana, United States, 46202

Baltimore

John Hopkins University, Baltimore, Maryland, United States, 21287

Durham

Duke University, Durham, North Carolina, United States, 27701

Houston

University of Texas, Houston, Texas, United States, 77030

Richmond

Virginia Commonwealth University, Richmond, Virginia, United States, 23284

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 18 years of age or older
  • * HIV-1, documented historically by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA.
  • * On ART for 6 months prior to screening with HIV RNA \<200 copies/mL at entry
  • * Evidence of current or prior chronic HBV, as marked by the presence of HBsAg in serum at any time prior to enrollment (patients with isolated antibody to hepatitis B core antigen, anti-HBc total, are not excluded)
  • * Evidence of recent or current 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.
  • * Known other chronic liver disease, including but not limited to alpha-1- antitrypsin deficiency, Wilson's disease, hemochromatosis, polycystic liver disease, autoimmune hepatitis, and primary biliary cholangitis. Note that alcohol-related liver disease is not exclusionary.
  • * Disseminated or advanced malignancy
  • * Pregnancy
  • * Concomitant severe underlying systemic illness that, in the opinion of the investigator, would interfere with completion of study procedures
  • * Inability to complete a FibroScan® VCTE scan:
  • * Use of implantable active medical device such as a pacemaker or defibrillator
  • * Wound care near the application site of the FibroScan®
  • * Pregnancy
  • * Ascites (fluid in the abdominal area)
  • * Unable or unwilling to complete the FibroScan® without sedation or unable to lie still for sufficient duration to complete the exam
  • * Any other condition that, in the opinion of the investigator, would impede compliance or hinder completion of study procedures
  • * Inability to complete the informed consent process or comply with study procedures

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of California, San Francisco,

Jennifer Price, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Jordan Lake, MD, MSc, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

2025-01-31