ACTIVE_NOT_RECRUITING

Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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, cirrhosis, and liver failure. NAFLD is the most common liver disease in US adults and the second leading cause for liver transplantation in the US. The natural history of NAFLD in the general population has been well described, with those with non-alcoholic fatty liver (NAFL, or simple steatosis) destined to have rare incidence of hepatic events compared to those with non-alcoholic steatohepatitis (NASH), who are at high risk for future development of cirrhosis, liver cancer and liver failure. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002, through the mechanism of RFA-DK-01-025, to further the understanding of diagnosis, mechanisms, progression and therapies of NASH. The NASH CRN effort has resulted in numerous seminal studies in the field. However, NASH CRN studies have systematically excluded persons living with HIV (PLWH), as NAFLD in these persons was thought to be different from that in the general population due to HIV, ART, concomitant medications, and co-infections. This has resulted in major knowledge gaps regarding NAFLD in the setting of HIV. This ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), HNC 001 goal is to examine the prevalence of hepatic steatosis and NAFLD in a large, multicenter, and multiethnic cohort of PLWH (Steatosis in HIV Study)

Official Title

Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV

Quick Facts

Study Start:2021-07-19
Study Completion:2031-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04795219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 years of age or older
  2. * 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.
  3. * On ART for 6 months prior to screening with HIV RNA \<200 copies/mL at entry
  1. * 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)
  2. * 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.
  3. * 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.
  4. * Disseminated or advanced malignancy
  5. * Pregnancy
  6. * Concomitant severe underlying systemic illness that, in the opinion of the investigator, would interfere with completion of study procedures
  7. * Inability to complete a FibroScan® VCTE scan:
  8. * Use of implantable active medical device such as a pacemaker or defibrillator
  9. * Wound care near the application site of the FibroScan®
  10. * Pregnancy
  11. * Ascites (fluid in the abdominal area)
  12. * Unable or unwilling to complete the FibroScan® without sedation or unable to lie still for sufficient duration to complete the exam
  13. * Any other condition that, in the opinion of the investigator, would impede compliance or hinder completion of study procedures
  14. * Inability to complete the informed consent process or comply with study procedures

Contacts and Locations

Principal Investigator

Jennifer Price, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Jordan Lake, MD, MSc
PRINCIPAL_INVESTIGATOR
University of Texas

Study Locations (Sites)

University of Alabama
Tuscaloosa, Alabama, 35487
United States
University of California, San Diego
La Jolla, California, 92037
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202
United States
John Hopkins University
Baltimore, Maryland, 21287
United States
Duke University
Durham, North Carolina, 27701
United States
University of Texas
Houston, Texas, 77030
United States
Virginia Commonwealth University
Richmond, Virginia, 23284
United States

Collaborators and Investigators

Sponsor: University of California, San Francisco

  • Jennifer Price, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco
  • Jordan Lake, MD, MSc, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-19
Study Completion Date2031-09-30

Study Record Updates

Study Start Date2021-07-19
Study Completion Date2031-09-30

Terms related to this study

Additional Relevant MeSH Terms

  • NAFLD
  • NAFLD-HIV
  • Hiv