
StudyFinder
Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

RECRUITING
18 years to 80 years old
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 proceduresNAFLD, NAFLD-HIV, Hiv
Jennifer Price, MD, PhD - jennifer.price@ucsf.edu
Sterling, Richard, K
N/A
HM20021371
NCT04795219
See this study on ClinicalTrials.gov