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Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

RECRUITING
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18 years to 80 years old
This study is NOT accepting healthy volunteers
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

NAFLD, NAFLD-HIV, Hiv

Jennifer Price, MD, PhD - jennifer.price@ucsf.edu
Sterling, Richard, K
N/A
HM20021371
NCT04795219
See this study on ClinicalTrials.gov

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