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:<ul>
<li>Causes of the disease</li>
<li>Risk factors</li>
<li>The most accurate, non-invasive tests to measure liver scarring</li>
<li>How the disease progresses</li>
<li>Treatment options</li></ul>
<li>Causes of the disease</li>
<li>Risk factors</li>
<li>The most accurate, non-invasive tests to measure liver scarring</li>
<li>How the disease progresses</li>
<li>Treatment options</li></ul>
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with HIV</li>
<li>Are diagnosed with steatotic liver disease or have a significant increase in liver stiffness</li>
<li>Have been on antiviral HIV treatment for at least 6 months and have not changed their dose of medicine for at least 3 months</li></ul>
For more information about who can join this study, contact the study team at 919-668-3199.
<li>Are diagnosed with HIV</li>
<li>Are diagnosed with steatotic liver disease or have a significant increase in liver stiffness</li>
<li>Have been on antiviral HIV treatment for at least 6 months and have not changed their dose of medicine for at least 3 months</li></ul>
For more information about who can join this study, contact the study team at 919-668-3199.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you agree to join this study, you will:<ul>
<li>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</li>
<li>Have a physical exam</li>
<li>Have a blood draw</li>
<li>Have a procedure done called Fibroscan (a painless, ultrasound-based test to check for liver fat or scarring)</li>
<li>Answer questionnaires</li></ul>
At your yearly follow-up visits, you will:<ul>
<li>Have a physical exam</li>
<li>Have a blood draw</li>
<li>Have a Fibroscan</li>
<li>Answer questionnaires</li></ul>
<li>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</li>
<li>Have a physical exam</li>
<li>Have a blood draw</li>
<li>Have a procedure done called Fibroscan (a painless, ultrasound-based test to check for liver fat or scarring)</li>
<li>Answer questionnaires</li></ul>
At your yearly follow-up visits, you will:<ul>
<li>Have a physical exam</li>
<li>Have a blood draw</li>
<li>Have a Fibroscan</li>
<li>Answer questionnaires</li></ul>
Locations
Duke University Hospital
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
Nonalcoholic Fatty Liver Disease In Persons Living with HIV Database Study (NAFLD in HIV Database)
Principal Investigator
Susanna
Naggie
Protocol Number
PRO00109968
NCT ID
NCT05023044
Phase
N/A
Enrollment Status
Open to Enrollment