Nonalcoholic Fatty Liver Disease for HIV

Recruiting at 7 trial locations

Overseen By Laura Wilson, ScM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must be taking: Antiretroviral therapy

Disqualifiers: Hepatitis B, Hepatitis C, Alcohol use, 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: Unknown

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to learn more about nonalcoholic fatty liver disease (NAFLD) in individuals living with HIV. NAFLD can range from harmless fat build-up in the liver to serious liver damage. The study will observe how NAFLD progresses in those with HIV, as it may behave differently due to factors like HIV and its treatments. Individuals with HIV who are on stable antiretroviral therapy and have been diagnosed with NAFLD might be suitable candidates for this study. As an unphased study, this trial offers a unique opportunity to enhance understanding of NAFLD in the context of HIV, potentially benefiting future treatments.

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to better understand the relationship between nonalcoholic fatty liver disease (NAFLD) and HIV. Unlike standard treatments that focus on managing NAFLD or HIV separately, this trial could help identify unique patterns and factors affecting patients with both conditions. By analyzing data from patients with HIV who have NAFLD, researchers hope to uncover insights that could lead to more targeted and effective treatments in the future. This could be a game-changer for patients dealing with the complexities of both diseases.

Who Is on the Research Team?

Tinsay A Woreta, MD, MPH

Principal Investigator

Johns Hopkins University

Samer Gawrieh, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

Inclusion Criteria

You are prepared to participate in the study for a minimum of one year.

You have provided written approval.

You have a histologically confirmed diagnosis of Non-Alcoholic Fatty Liver Disease (NAFLD) within the past 6 months, as defined by steatosis levels and presence/absence of inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational Study

Prospective observational study of NAFLD in persons living with HIV, including non-invasive assessments and biospecimen collection

1 year

Regular visits for assessments and biospecimen collection

Follow-up

Participants are monitored for changes in liver parameters and overall health

4 weeks

What Are the Treatments Tested in This Trial?

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+