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Nonalcoholic Fatty Liver Disease in HIV Database

Houston, TX
N/A
Recruiting
Led By Tinsay A Woreta, MD, MPH
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 1 year
Awards & highlights
No Placebo-Only Group

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).

See full description
Eligible Conditions
  • Non-alcoholic Fatty Liver Disease
  • HIV (Human Immunodeficiency Virus)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in controlled attenuation parameter (CAP) measured by VCTE from baseline to one year
Change in liver stiffness measurement (LSM) measured by VCTE from baseline to one year

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Find a Location

Closest Location:Indiana University· Indianapolis, IN· 168 miles

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,500 Previous Clinical Trials
4,353,591 Total Patients Enrolled
59 Trials studying Non-alcoholic Fatty Liver Disease
10,022 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Johns Hopkins UniversityLead Sponsor
2,361 Previous Clinical Trials
15,160,080 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
123 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Tinsay A Woreta, MD, MPHPrincipal InvestigatorJohns Hopkins University
Edgar T Overton, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
3 Previous Clinical Trials
1,309 Total Patients Enrolled
Samer Gawrieh, MDPrincipal InvestigatorIndiana University
2 Previous Clinical Trials
106 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
36 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~84 spots leftby Jan 2026