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Active, not recruiting No phase listed Observational

Nonalcoholic Fatty Liver Disease in HIV Database

ClinicalTrials.gov ID: NCT05023044

Public ClinicalTrials.gov record NCT05023044. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 13, 2026, 12:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Nonalcoholic Fatty Liver Disease In Persons Living With HIV Database Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

Study identification

NCT ID
NCT05023044
Recruitment status
Active, not recruiting
Study type
Observational
Phase
Not listed
Lead sponsor
Johns Hopkins University
Other
Enrollment
400 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 11, 2022
Primary completion
Aug 31, 2031
Completion
Sep 29, 2031
Last update posted
Jan 14, 2026

2022 – 2031

United States locations

U.S. sites
8
U.S. states
7
U.S. cities
8
Facility City State ZIP Site status
University of Alabama Birmingham Alabama 35233
University of California, San Diego San Diego California 92121
University of California, San Francisco San Francisco California 94143
Indiana University Indianapolis Indiana 46202
Johns Hopkins University Baltimore Maryland 21287
Duke University Durham North Carolina 27710
University of Texas Houston Texas 77030
Virginia Commonwealth University Richmond Virginia 23284

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05023044, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 14, 2026 · Synced Sep 13, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05023044 live on ClinicalTrials.gov.

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