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Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV
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 Start (Actual) 19 July 2021
🗓️ Primary Completion (Estimated) 1 January 2025
✅ Study Completion (Estimated) 31 January 2025
👥 Enrollment (Estimated) 1250
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Tuscaloosa, Alabama, United States
📍 La Jolla, California, United States
📍 San Francisco, California, United States
📍 Indianapolis, Indiana, United States
📍 Baltimore, Maryland, United States
📍 Durham, North Carolina, United States
📍 Houston, Texas, United States
📍 Richmond, Virginia, United States
More locations available...

📋 Eligibility Criteria

Description

    Inclusion 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

    Exclusion Criteria:

    • * 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 (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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 Registration Dates

  • First Submitted 9 March 2021
  • First Submitted that Met QC Criteria 9 March 2021
  • First Posted 12 March 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 June 2024
  • Last Update Posted 24 June 2024
  • Last Verified June 2024
I'm interested ...!!