Understanding liver disease in people living with HIV
Nonalcoholic Fatty Liver Disease In Persons Living With HIV Database Study
This study looks at how nonalcoholic fatty liver disease affects people living with HIV to see how it progresses and how well we can detect serious liver damage without invasive tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 8 sites (Birmingham, Alabama and 7 other locations) |
| Trial ID | NCT05023044 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the natural history of nonalcoholic fatty liver disease (NAFLD) in individuals living with HIV. It aims to characterize the progression of NAFLD, which can range from benign fat accumulation to severe liver injury, in this specific population. The study will also evaluate the effectiveness of non-invasive methods for detecting advanced liver fibrosis and will establish a biospecimen bank for future research. Participants will be closely monitored to gather data on their liver health and the impact of HIV on NAFLD.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with documented HIV infection and evidence of NAFLD.
Not a fit: Patients without HIV or those who do not have NAFLD will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of liver disease in people living with HIV.
How similar studies have performed: While studies have explored NAFLD in the general population, this specific focus on HIV-associated NAFLD is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * Participants must meet at least one of the following 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) ≥6 kPa from FibroScan exam performed during screening or within 12 months prior to screening and a diagnosis of NAFLD based on clinical and imaging (FibroScan CAP≥263 dB/m, ultrasound, CT or MRI) diagnosis at any time * LSM ≥8 kPa from FibroScan exam performed during screening or within 12 months prior to screening, in the absence of CAP ≥263 dB/m * 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
Where this trial is running
Birmingham, Alabama and 7 other locations
- University of Alabama — Birmingham, Alabama, United States (Recruiting)
- University of California, San Diego — San Diego, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Indiana University — Indianapolis, Indiana, United States (Recruiting)
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- University of Texas — Houston, Texas, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Tinsay A Woreta, MD, MPH — Johns Hopkins University
- Study coordinator: Tinsay A Woreta, MD, MPH
- Email: tworeta1@jhmi.edu
- Phone: 4106143369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.