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Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Durham, NC
N/A
Recruiting
Led By Jennifer Price, MD, PhD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

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)

See full description
Eligible Conditions
  • Non-alcoholic Fatty Liver Disease
  • HIV (Human Immunodeficiency Virus)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Prevalence of hepatic steatosis in persons living with HIV (PLWH).
Secondary study objectives
Prevalence of nonalcoholic fatty liver disease (NAFLD) in PLWH
Other study objectives
Prevalence of advanced fibrosis in PLWH.
Prevalence of alcohol-related steatosis in PLWH.

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Find a Location

Closest Location:Indiana University School of Medicine· Indianapolis, IN· 168 miles

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,500 Previous Clinical Trials
4,352,741 Total Patients Enrolled
59 Trials studying Non-alcoholic Fatty Liver Disease
9,172 Patients Enrolled for Non-alcoholic Fatty Liver Disease
University of California, San FranciscoLead Sponsor
2,628 Previous Clinical Trials
19,027,642 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
2,276 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Jennifer Price, MD, PhDPrincipal InvestigatorUniversity of California, San Francisco
Jordan Lake, MD, MScPrincipal InvestigatorUniversity of Texas
~273 spots leftby Mar 2026