NCT04795219Active, not recruiting
Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV
Source: ClinicalTrials.gov · Last updated 23 Jan 2026
Brief summary (registry, in English)
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)
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1250 (estimated)
- First submitted
- 9 Mar 2021
- Start date
- 19 Jul 2021
- Primary completion date
- 1 Sept 2031
- Lead sponsor
- University of California, San Francisco
- Diseases
- HIV, Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04795219
What you commit to
- Study type: Observational
- Planned participants: 1250
- From 19 Jul 2021 to the primary completion date, 1 Sept 2031
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant severe underlying systemic illness that, in the opinion of the investigator, would interfere with completion of study procedures
Other illness
- Known other chronic liver disease, including but not limited to alpha-1- antitrypsin deficiency, Wilson's disease, hemochromatosis, polycystic liver disease, autoimmune hepatitis, and primary biliary cholangitis. Note that alcohol-related liver disease is not exclusionary.
- Disseminated or advanced malignancy
- Any other condition that, in the opinion of the investigator, would impede compliance or hinder completion of study procedures
Lab values
- Evidence of current or prior chronic HBV, as marked by the presence of HBsAg in serum at any time prior to enrollment (patients with isolated antibody to hepatitis B core antigen, anti-HBc total, are not excluded)
- Evidence of recent or current 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.
Other
- Pregnancy
- Inability to complete a FibroScan® VCTE scan:
- Use of implantable active medical device such as a pacemaker or defibrillator
- Wound care near the application site of the FibroScan®
- Pregnancy
- Ascites (fluid in the abdominal area)
- Unable or unwilling to complete the FibroScan® without sedation or unable to lie still for sufficient duration to complete the exam
- Inability to complete the informed consent process or comply with study procedures
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| John Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| University of Texas Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Indiana University School of Medicine Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of California San Diego Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of Alabama Coordinator of this site? Confirm its status | Tuscaloosa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.