Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Recruiting

• Conditions: NAFLD; NAFLD-HIV; Hiv

• Registration Number: NCT04795219
• Lead Sponsor: University of California, San Francisco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-3-9
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1250

Inclusion Criteria

Inclusion Criteria:<br><br> - 18 years of age or older<br><br> - HIV-1, documented historically by any licensed rapid HIV test or HIV enzyme or<br> chemiluminescence immunoassay (E/CIA) test kit and confirmed by a licensed Western<br> blot or a second antibody test by a method other than the initial rapid HIV and/or<br> E/CIA, or by HIV-1 antigen or plasma HIV-1 RNA.<br><br> - On ART for 6 months prior to screening with HIV RNA <200 copies/mL at entry<br><br>Exclusion Criteria:<br><br> - Evidence of current or prior chronic HBV, as marked by the presence of HBsAg in<br> serum at any time prior to enrollment (patients with isolated antibody to hepatitis<br> B core antigen, anti-HBc total, are not excluded)<br><br> - Evidence of recent or current HCV as marked by the presence of anti-HCV antibody<br> with detectable HCV RNA in serum within 3 years prior to enrollment. Participants<br> with anti-HCV antibody positivity who have undetectable HCV RNA 3 years prior to<br> enrollment (either due to spontaneous clearance or clearance with treatment) will be<br> eligible to participate if HCV RNA at entry remains undetected.<br><br> - Known other chronic liver disease, including but not limited to alpha-1- antitrypsin<br> deficiency, Wilson's disease, hemochromatosis, polycystic liver disease, autoimmune<br> hepatitis, and primary biliary cholangitis. Note that alcohol-related liver disease<br> is not exclusionary.<br><br> - Disseminated or advanced malignancy<br><br> - Pregnancy<br><br> - Concomitant severe underlying systemic illness that, in the opinion of the<br> investigator, would interfere with completion of study procedures<br><br> - Inability to complete a FibroScan® VCTE scan:<br><br> - Use of implantable active medical device such as a pacemaker or defibrillator<br><br> - Wound care near the application site of the FibroScan®<br><br> - Pregnancy<br><br> - Ascites (fluid in the abdominal area)<br><br> - Unable or unwilling to complete the FibroScan® without sedation or unable to lie<br> still for sufficient duration to complete the exam<br><br> - Any other condition that, in the opinion of the investigator, would impede<br> compliance or hinder completion of study procedures<br><br> - Inability to complete the informed consent process or comply with study procedures

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of hepatic steatosis in persons living with HIV (PLWH).

Secondary Outcome Measures

Name	Time	Method
Prevalence of nonalcoholic fatty liver disease (NAFLD) in PLWH