Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Status: Recruiting
Location: See all (8) locations...
Study Type: Observational
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 18 years of age or older

• HIV-1, documented historically by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA.

• On ART for 6 months prior to screening with HIV RNA \<200 copies/mL at entry

Locations
United States
Alabama
University of Alabama
ACTIVE_NOT_RECRUITING
Tuscaloosa
California
University of California, San Diego
ACTIVE_NOT_RECRUITING
La Jolla
University of California, San Francisco
ACTIVE_NOT_RECRUITING
San Francisco
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Maryland
John Hopkins University
ACTIVE_NOT_RECRUITING
Baltimore
North Carolina
Duke University
RECRUITING
Durham
Texas
University of Texas
RECRUITING
Houston
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Jennifer Price, MD, PhD
jennifer.price@ucsf.edu
415-502-1429
Backup
Yesenia Laguardia
yesenia.laguardia@ucsf.edu
415-917-3518
Time Frame
Start Date: 2021-07-19
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1250
Authors
Rohit Loomba, Mark Sulkowski
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov