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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: Active study of HIV and NAFLD, sponsored by University of California, San Francisco.
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. According to ClinicalTrials.gov, the official US trial registry.
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)
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 1,250 participants |
| Start Date | 2021-07-19 |
| Est. Completion | 2031-09-30 |
What the registry record for NCT04795219 still lists
NCT04795219 is an observational study that tracks outcomes without assigning an intervention. Its 1,250 participants enrollment target places it among the larger protocols in the corpus, above the 436-participant average among 303 other HIV trials with a reported enrollment target (187% higher).
The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 0 interventions.
NCT04795219 lists 8 locations in 7 states (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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Where NCT04795219's enrollment target sits among peer trials
1,250 15th of 303 higher than 289 of 303 other HIV trials
participants (enrollment target), bucketed by value
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