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Nonalcoholic Fatty Liver Disease in HIV Database
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).
Conditions:
🦠 NAFLD 🦠 NASH - Nonalcoholic Steatohepatitis 🦠 Hiv
🗓️ Study Start (Actual) 12 May 2022
🗓️ Primary Completion (Estimated) 1 January 2025
✅ Study Completion (Estimated) 31 January 2025
👥 Enrollment (Estimated) 400
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Birmingham, Alabama, United States
📍 San Diego, 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:

    • * 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

      • 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
Ages Eligible for Study: 18 Years to N/A (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 6 August 2021
  • First Submitted that Met QC Criteria 25 August 2021
  • First Posted 26 August 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 8 February 2024
  • Last Update Posted 12 February 2024
  • Last Verified February 2024
I'm interested ...!!