RECRUITING

Nonalcoholic Fatty Liver Disease in HIV Database

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. The spectrum of NAFLD encompasses simple nonalcoholic steatosis (nonalcoholic fatty liver \[NAFL\]) and nonalcoholic steatohepatitis (NASH) in which there is evidence of hepatocellular injury and/or fibrosis. NAFLD is the most common liver disease in adults and the second leading cause for liver transplantation in the U.S. The natural history of NAFLD in the general population has been well described. The NASH Clinical Research Network (NASH CRN) was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) in 2002 to further the understanding of the diagnosis, mechanisms, progression and therapies of NASH. This 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 PLWH was thought to be different from that in the general population due to HIV infection, antiretroviral therapy (ART), concomitant medications and co-infections. This resulted in major knowledge gaps regarding NAFLD in the setting of HIV infection. Thus, the natural history of NAFLD in PLWH is largely unknown. The goal of this ancillary study of NAFLD and NASH in Adults with HIV (HIV NASH CRN), is to conduct a prospective, observational, multicenter study of NAFLD in PLWH (HIV-associated NAFLD).

Official Title

Nonalcoholic Fatty Liver Disease In Persons Living With HIV Database Study

Quick Facts

Study Start:2022-05-12
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05023044

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. * Documented HIV infection
  2. * ≥18 of age at time of initial screening
  3. * HIV suppression with HIV RNA \<200 copies/ml on stable ART for ≥ 6 months and no change in ART class for ≥ 3 months, prior to enrollment
  4. * Participants must meet at least one of the following
  1. * Positive hepatitis B surface antigen
  2. * Evidence of recent or current hepatitis C virus (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. * Significant alcohol consumption (≥ 3 drinks daily on average in men and ≥ 2 drinks daily on average in women)
  4. * Evidence of other causes of chronic liver disease
  5. * History of prolonged (\> 1 month) total parenteral nutrition within a 6-month period before liver biopsy or before baseline FibroScan VCTE exam
  6. * Short bowel syndrome
  7. * History of biliopancreatic diversion
  8. * History of bariatric surgery within 2 years of enrollment (participants expecting to undergo bariatric surgery can be enrolled prior to the procedure)
  9. * Solid organ transplant recipients
  10. * Other condition that is likely to interfere with study follow-up

Contacts and Locations

Study Contact

Tinsay A Woreta, MD, MPH
CONTACT
4106143369
tworeta1@jhmi.edu
Quintara Williams
CONTACT
4109559944
qwillia4@jhmi.edu

Principal Investigator

Tinsay A Woreta, MD, MPH
PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Samer Gawrieh, MD
PRINCIPAL_INVESTIGATOR
Indiana University

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35233
United States
University of California, San Diego
San Diego, California, 92121
United States
University of California, San Francisco
San Francisco, California, 94143
United States
Indiana University
Indianapolis, Indiana, 46202
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Duke University
Durham, North Carolina, 27710
United States
University of Texas
Houston, Texas, 77030
United States
Virginia Commonwealth University
Richmond, Virginia, 23284
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Tinsay A Woreta, MD, MPH, PRINCIPAL_INVESTIGATOR, Johns Hopkins University
  • Samer Gawrieh, MD, PRINCIPAL_INVESTIGATOR, Indiana University

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 Date2022-05-12
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2022-05-12
Study Completion Date2025-01-31

Terms related to this study

Additional Relevant MeSH Terms

  • NAFLD
  • NASH - Nonalcoholic Steatohepatitis
  • Hiv