Understanding liver fat accumulation in people living with HIV
Prevalence and Predictors of Hepatic Steatosis in Persons Living With HIV
This study looks at how common liver fat buildup is in people living with HIV and what factors might contribute to it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1250 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 8 sites (Tuscaloosa, Alabama and 7 other locations) |
| Trial ID | NCT04795219 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the prevalence and predictors of nonalcoholic fatty liver disease (NAFLD) in individuals living with HIV. It will involve a large, multi-ethnic, and multi-centric cohort to systematically characterize NAFLD, which is increasingly recognized as a significant health issue in this population. The study will utilize various imaging modalities and criteria to define NAFLD, providing a comprehensive understanding of its prevalence compared to the general population. By focusing on a diverse group of participants, the study seeks to fill gaps in current knowledge regarding NAFLD in people living with HIV.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are living with HIV and have been on antiretroviral therapy for at least six months.
Not a fit: Patients with current or prior chronic hepatitis B or recent hepatitis C infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved screening and management strategies for liver disease in individuals living with HIV.
How similar studies have performed: Other studies have indicated a high prevalence of NAFLD in people living with HIV, suggesting that this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tuscaloosa, Alabama and 7 other locations
- University of Alabama — Tuscaloosa, Alabama, United States (Recruiting)
- University of California, San Diego — La Jolla, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
- Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)
- John Hopkins University — Baltimore, Maryland, United States (Recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- University of Texas — Houston, Texas, United States (Recruiting)
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Price, MD, PhD — University of California, San Francisco
- Study coordinator: Jennifer Price, MD, PhD
- Email: jennifer.price@ucsf.edu
- Phone: 415-502-1429
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.