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Not recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT05023044

Conditions

NAFLD

NASH - Nonalcoholic Steatohepatitis

Hiv

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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. The spectrum of NAFLD encompasses simple nonalcoholic steatosis (nonalcoholic fatty liver \[NAFL\]) and nonalcoholic steatohepatitis (NASH) in which there is evidence of hepatocellular injury and/or fibrosis. NAFLD is the most common liver disease in adults and the second leading cause for liver transplantation in the U.S. The natural history of NAFLD in the general population has been well described. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002 to further the understanding of the diagnosis, mechanisms, progression and therapies of NASH. This 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 PLWH was thought to be different from that in the general population due to HIV infection, antiretroviral therapy (ART), concomitant medications and co-infections. This resulted in major knowledge gaps regarding NAFLD in the setting of HIV infection. Thus, the natural history of NAFLD in PLWH is largely unknown. The goal of this ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), is to conduct a prospective, observational, multicenter study of NAFLD in PLWH (HIV-associated NAFLD).

Conditions

NAFLD

NASH - Nonalcoholic Steatohepatitis

Hiv

Study ID

NCT05023044

Start date

May 12, 2022

Status verified date

Sep, 2025

Completion date

Jan 31, 2026

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Documented HIV infection
  • ≥18 of age at time of initial screening
  • HIV suppression with HIV RNA <200 copies/ml on stable ART for ≥ 6 months and no change in ART class for ≥ 3 months, prior to enrollment
  • Participants must meet at least one of the following inclusion criteria:

  • Histologically confirmed NAFLD \[defined as NAFL (>5% steatosis, with or without lobular or portal inflammation), borderline NASH or definitive NASH\] within 6 months prior to screening (per local pathology report)
  • Liver stiffness measurement (LSM) ≥6 kPa from FibroScan exam performed during screening or within 12 months prior to screening and a diagnosis of NAFLD based on clinical and imaging (FibroScan CAP≥263 dB/m, ultrasound, CT or MRI) diagnosis at any time
  • LSM ≥8 kPa from FibroScan exam performed during screening or within 12 months prior to screening, in the absence of CAP ≥263 dB/m
  • Able to provide written informed consent to part
  • Willingness to be in the study for 1 or more years
  • Provision of written informed consent

Exclusion Criteria:

  • Positive hepatitis B surface antigen
  • Evidence of recent or current hepatitis C virus (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
  • Significant alcohol consumption (≥ 3 drinks daily on average in men and ≥ 2 drinks daily on average in women)
  • Evidence of other causes of chronic liver disease
  • History of prolonged (> 1 month) total parenteral nutrition within a 6-month period before liver biopsy or before baseline FibroScan VCTE exam
  • Short bowel syndrome
  • History of biliopancreatic diversion
  • History of bariatric surgery within 2 years of enrollment (participants expecting to undergo bariatric surgery can be enrolled prior to the procedure)
  • Solid organ transplant recipients
  • Other condition that is likely to interfere with study follow-up

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Change in liver stiffness measurement (LSM) measured by VCTE from baseline to one year [ Time Frame: Baseline and 1 year ]
  • Change in controlled attenuation parameter (CAP) measured by VCTE from baseline to one year [ Time Frame: Baseline and 1 year ]

Central Contacts and Locations

Central contacts

Tinsay A Woreta, MD, MPH

4106143369tworeta1@jhmi.edu

Locations

University of Alabama

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

Principal Investigator:

Sonya Heath, MD

University of California, San Diego

Recruiting

San Diego, California, United States, 92121

Contacts

Principal Investigator:

Rohit Loomba, MD

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Principal Investigator:

Jennifer Price, MD

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Principal Investigator:

Naga Chalasani, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Principal Investigator:

Mark Sulkowski, MD

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Susanna Naggie, MD

University of Texas

Recruiting

Houston, Texas, United States, 77030

Contacts

Principal Investigator:

Jordan Lake, MD

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23284

Contacts

Principal Investigator:

Richard Sterling, MD

More Information

Sponsor

Johns Hopkins University

Last update posted

Sep 5, 2025

Last verified

Sep, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-20. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-09-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.