NCT04795219

Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Active, enrolled Last updated 23 January 2026

What this trial tests

trial in NAFLD in 1,250 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 July 2021

Primary endpoint
1 September 2031

30 September 2031

Quick facts

Lead sponsor	University of California, San Francisco
Status	Active, enrolled
Study type	OBSERVATIONAL
Enrollment	1,250
Start date	19 July 2021
Primary completion	1 September 2031
Estimated completion	30 September 2031
Sites	8 locations across United States

Conditions studied

• NAFLD — all drugs for NAFLD →
• NAFLD-HIV — all drugs for NAFLD-HIV →
• Hiv — all drugs for Hiv →

Sponsor

University of California, San Francisco

Who can join

18 and older, any sex, with NAFLD or NAFLD-HIV. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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. NAFLD is the most common liver disease in US adults and the second leading cause for liver transplantation in the US. The natural history of NAFLD in the general population has been well described, with those with non-alcoholic fatty liver (NAFL, or simple steatosis) destined to have rare incidence of hepatic events compared to those with non-alcoholic steatohepatitis (NASH), who are at high risk for future development of cirrhosis, liver cancer and liver failure. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002, through the mechanism of RFA-DK-01-025, to further the understanding of diagnosis, mechanisms, progression and therapies of NASH. The NASH CRN 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 these persons was thought to be different from that in the general population due to HIV, ART, concomitant medications, and co-infections. This has resulted in major knowledge gaps regarding NAFLD in the setting of HIV. This ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), HNC 001 goal is to examine the prevalence of hepatic steatosis and NAFLD in a large, multicenter, and multiethnic cohort of PLWH (Steatosis in HIV Study)

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Effects of Food Insecurity on Hepatic Steatosis and Fibrosis in People With HIV.
   Kardashian A, Lloyd A, Vilar-Gomez E, Naggie S, et al · · 2024 · cited 6× · PMID 38582290 · DOI 10.1016/j.cgh.2024.03.017
2. Non-Hispanic Black Persons With HIV Have a Lower Risk of Metabolic Dysfunction-Associated Steatotic Liver Disease and Clinically Significant Fibrosis Compared to Non-Hispanic White and Hispanic Individuals.
   Woreta TA, Gawrieh S, Wilson LA, Xin Y, et al · · 2026 · PMID 42100186 · DOI 10.1093/ofid/ofag001
3. Female Sex is Protective Against MASLD With Clinically Significant Fibrosis in a Large Cross-sectional Cohort of Persons With HIV.
   Wegermann K, Suzuki A, Sarmiento E, Boyd L, et al · · 2025 · PMID 41229880 · DOI 10.1093/ofid/ofaf637