Nonalcoholic Fatty Liver Disease in HIV Database

Running, not enrolling

Conditions studied: NAFLD, NASH - Nonalcoholic Steatohepatitis, Hiv

In brief

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).

Key facts

Study ID: NCT05023044
Run by: Johns Hopkins University
People needed: 400
Starts: 2022-05-12
Expected to finish: 2031-09-30
Last updated by the study team: 2026-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 it is running

University of Alabama — Birmingham, Alabama, United States
University of California, San Diego — San Diego, California, United States
University of California, San Francisco — San Francisco, California, United States
Indiana University — Indianapolis, Indiana, United States
Johns Hopkins University — Baltimore, Maryland, United States
Duke University — Durham, North Carolina, United States
University of Texas — Houston, Texas, United States
Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.