Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Launched by UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · Mar 9, 2021

Keywords

ClinConnect Summary

This clinical trial is called the "Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV." It aims to understand how common a liver condition called nonalcoholic fatty liver disease (NAFLD) is among people living with HIV. NAFLD occurs when there is too much fat in the liver, which can lead to serious health issues like cirrhosis or liver failure. This study is important because people with HIV may experience NAFLD differently than those without HIV, and more research is needed to fill in the gaps in our knowledge.

To participate in this trial, you need to be at least 18 years old and have a documented HIV infection. You should also have been on HIV treatment for at least six months and have low levels of HIV in your blood. The study is currently recruiting participants of all genders and various ethnic backgrounds. If you join, you'll undergo certain tests, including a painless scan to check the health of your liver. It's a great opportunity to contribute to important research that could improve our understanding of liver health in people living with HIV.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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