NAFLD in HIV Database (HIV & Non-Alcholic Fatty Liver Disease) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to better understand nonalcoholic fatty liver disease in people with HIV. We want to find out what are the most accurate, non-invasive diagnostic tests to detect scarring in the liver for people who have HIV. At this time, we do not have a good understanding of the following characteristics of steatotic liver disease in people with HIV:

  • Causes of the disease
  • Risk factors
  • The most accurate, non-invasive tests to measure liver scarring
  • How the disease progresses
  • Treatment options
What is the Condition Being Studied?

Human Immunodeficiency Virus (HIV) and Non-Alcoholic Fatty Liver Disease (NAFLD)

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with HIV
  • Are diagnosed with steatotic liver disease or have a significant increase in liver stiffness
  • Have been on antiviral HIV treatment for at least 6 months and have not changed their dose of medicine for at least 3 months

For more information about who can join this study, contact the study team at 919-668-3199.

Age Group
Adults

What is Involved?

If you agree to join this study, you will:

  • Come in for a clinic visit at the start of the study, then visit us once a year for as long as you are enrolled in the study
  • Have a physical exam
  • Have a blood draw
  • Have a procedure done called Fibroscan (a painless, ultrasound-based test to check for liver fat or scarring)
  • Answer questionnaires

At your yearly follow-up visits, you will:

  • Have a physical exam
  • Have a blood draw
  • Have a Fibroscan
  • Answer questionnaires

Study Details

Full Title
Nonalcoholic Fatty Liver Disease In Persons Living with HIV Database Study (NAFLD in HIV Database)
Principal Investigator
Infectious Disease Specialist
Protocol Number
IRB: PRO00109968
NCT: NCT05023044
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment