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NCT04795219 · ClinicalTrials.gov registry record

Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

A clinical trial of HIV and NAFLD, sponsored by University of California, San Francisco.

Active
Registry status
1,250
Enrollment target
8
Study locations

NCT04795219 is a study of HIV and NAFLD that is active but no longer recruiting, run by University of California, San Francisco. The registered enrollment target is 1,250 participants, above the 436-participant average among 303 other HIV trials with a reported enrollment target (187% higher). The trial reports 8 study locations across 7 states.

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The verdict

NCT04795219, a study of HIV and NAFLD, is active but no longer recruiting, sponsored by University of California, San Francisco.

ACTIVE NOT RECRUITING
Registry status
1,250 participants
Enrollment target
8
Study locations

Study 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 Studied

Study Locations (8)

California

  • University of California, San Diego - La Jolla
  • University of California, San Francisco - San Francisco

Alabama

  • University of Alabama - Tuscaloosa

Indiana

  • Indiana University School of Medicine - Indianapolis

Maryland

  • John Hopkins University - Baltimore

North Carolina

  • Duke University - Durham

Texas

  • University of Texas - Houston

Virginia

  • Virginia Commonwealth University - Richmond

Trial Details

FieldValue
Enrollment Target 1,250 participants
Start Date 2021-07-19
Est. Completion 2031-09-30

What the Registry Record Tells You About NCT04795219

The ClinicalTrials.gov registry entry for NCT04795219 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 1,250 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 436-participant average among 303 other HIV trials with a reported enrollment target (187% higher). The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 0 interventions.

NCT04795219 reports 8 study locations spanning 7 distinct geographic areas - top geographies include California, Alabama, Indiana.

Frequently Asked Questions

What is clinical trial NCT04795219 about?

NCT04795219 is a clinical study titled "Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV". 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...

What is the current status of trial NCT04795219?

This trial is currently active not recruiting. The enrollment target is 1,250 participants. The study started on 2021-07-19. Estimated completion is 2031-09-30.

What conditions does trial NCT04795219 study?

This clinical trial studies the following conditions: HIV, NAFLD, NAFLD-HIV.

Who is sponsoring clinical trial NCT04795219?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04795219 being conducted?

This trial has 8 study locations across Alabama, California, Indiana, Maryland, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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