Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

NCT04795219 | Active Not Recruiting DMC

• 2 other identifiers: HNC-001R01DK121378-01
• Study Type: observational
• Target: 1,250
• Locations: 1 country
• Sites: 8

Brief 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)

Conditions

NAFLD; NAFLD-HIV; Hiv

Outcome Measures

Primary Outcomes (1)

• Prevalence of hepatic steatosis in persons living with HIV (PLWH).

  Prevalence of hepatic steatosis in PLWH will be reported as the number of participants with hepatic steatosis, defined by controlled attenuation parameter (CAP) ≥263 dB/m, over the total number of participants assessed.

  Baseline

Secondary Outcomes (1)

• Prevalence of nonalcoholic fatty liver disease (NAFLD) in PLWH

  Baseline

Other Outcomes (2)

• Prevalence of alcohol-related steatosis in PLWH.

  Baseline

• Prevalence of advanced fibrosis in PLWH.

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinically diagnosed HIV-1, historically documented 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

You may qualify if:

• 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

You may not qualify if:

• 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.
• Disseminated or advanced malignancy
• Pregnancy
• Concomitant severe underlying systemic illness that, in the opinion of the investigator, would interfere with completion of study procedures
• 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
• Any other condition that, in the opinion of the investigator, would impede compliance or hinder completion of study procedures
• Inability to complete the informed consent process or comply with study procedures

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (8)

University of Alabama

Tuscaloosa, Alabama, 35487, United States

Location

University of California, San Diego

La Jolla, California, 92037, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

John Hopkins University

Baltimore, Maryland, 21287, United States

Location

Duke University

Durham, North Carolina, 27701, United States

Location

University of Texas

Houston, Texas, 77030, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23284, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Fasting blood samples will be collected for plasma, serum, PBMCs, and DNA extraction for research purposes. If the patient provided additional consent, blood will be collected during screening and shipped to the Indiana University Genetics Repository for extraction of DNA and banking.

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Jennifer Price, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Jordan Lake, MD, MSc

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2021
• First Posted: March 12, 2021
• Study Start: July 19, 2021
• Primary Completion (Estimated): September 1, 2031
• Study Completion (Estimated): September 30, 2031
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)