Status:
RECRUITING
Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
NAFLD
NAFLD-HIV
Eligibility:
All Genders
18-80 years
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, cirr...
Detailed Description
NAFLD is the most prevalent of all liver disorders and is the most common cause of chronic aminotransferase elevations in the United States. NAFLD also represents a major health threat worldwide, with...
Eligibility Criteria
Inclusion
- 18 years of age or older
- HIV-1, documented historically by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA.
- On ART for 6 months prior to screening with HIV RNA \<200 copies/mL at entry
Exclusion
- Evidence of current or prior chronic HBV, as marked by the presence of HBsAg in serum at any time prior to enrollment (patients with isolated antibody to hepatitis B core antigen, anti-HBc total, are not excluded)
- Evidence of recent or current 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.
- Known other chronic liver disease, including but not limited to alpha-1- antitrypsin deficiency, Wilson's disease, hemochromatosis, polycystic liver disease, autoimmune hepatitis, and primary biliary cholangitis. Note that alcohol-related liver disease is not exclusionary.
- Disseminated or advanced malignancy
- Pregnancy
- Concomitant severe underlying systemic illness that, in the opinion of the investigator, would interfere with completion of study procedures
- Inability to complete a FibroScan® VCTE scan:
- Use of implantable active medical device such as a pacemaker or defibrillator
- Wound care near the application site of the FibroScan®
- Pregnancy
- Ascites (fluid in the abdominal area)
- Unable or unwilling to complete the FibroScan® without sedation or unable to lie still for sufficient duration to complete the exam
- Any other condition that, in the opinion of the investigator, would impede compliance or hinder completion of study procedures
- Inability to complete the informed consent process or comply with study procedures
Key Trial Info
Start Date :
July 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
1250 Patients enrolled
Trial Details
Trial ID
NCT04795219
Start Date
July 19 2021
End Date
December 31 2025
Last Update
June 8 2025
Active Locations (8)
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1
University of Alabama
Tuscaloosa, Alabama, United States, 35487
2
University of California, San Diego
La Jolla, California, United States, 92037
3
University of California, San Francisco
San Francisco, California, United States, 94143
4
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202