Non-alcoholic Fatty Liver Disease for People with HIV

Recruiting at 7 trial locations

Overseen By Yesenia Laguardia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must be taking: Antiretrovirals

Disqualifiers: Chronic HBV, Chronic HCV, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

1250 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how common liver fat buildup is in people living with HIV and identify factors that might predict it. The focus is on nonalcoholic fatty liver disease (NAFLD), a liver condition that can lead to serious liver problems. Researchers are examining individuals with HIV who have been on antiretroviral therapy (ART) for at least six months and have controlled HIV levels. The trial is ideal for those with HIV who do not have other chronic liver diseases, such as hepatitis B or C.

As an unphased study, this trial provides participants the opportunity to contribute to vital research that could enhance understanding and treatment of liver conditions in people with HIV.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to uncover why some people living with HIV develop hepatic steatosis, which is a buildup of fat in the liver. While current treatments for hepatic steatosis often involve lifestyle changes or medications targeting fat metabolism, this study focuses on identifying predictors and prevalence in a specific population. By understanding these factors, future treatments can be better tailored to address the root causes of liver issues in people with HIV, potentially leading to more effective and personalized care strategies.

Who Is on the Research Team?

Jennifer Price, MD, PhD

Principal Investigator

University of California, San Francisco

Jordan Lake, MD, MSc

Principal Investigator

University of Texas

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cross-sectional Study

Participants are enrolled and assessed for hepatic steatosis and NAFLD using clinical, diagnostic, and VCTE criteria

Baseline

1 visit (in-person)

Data Collection

Collection of clinical, demographic, behavioral, anthropometric, and laboratory information

Ongoing

Follow-up

Participants are monitored for safety and effectiveness after initial assessment

4 weeks

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+