Nonalcoholic Fatty Liver Disease in HIV Database

Launched by JOHNS HOPKINS UNIVERSITY · Aug 25, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) in people living with HIV. NAFLD is a condition where fat builds up in the liver, which can lead to serious problems like liver injury or failure. This study aims to understand how NAFLD affects individuals with HIV, as previous research has often excluded them. By gathering more information, the researchers hope to fill in the gaps in knowledge about this condition in the context of HIV.

To be eligible for this study, participants must be at least 18 years old and have a documented HIV infection that is well-controlled with medication. They must also have evidence of NAFLD, which can be confirmed through liver tests or imaging. Participants will need to commit to being part of the study for at least one year and will undergo various assessments to help researchers learn more about how NAFLD progresses in people with HIV. This study is important because it seeks to improve understanding and treatment options for those dealing with both HIV and fatty liver disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Documented HIV infection
• • ≥18 of age at time of initial screening
• • 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
• * Participants must meet at least one of the following inclusion criteria:
• • Histologically confirmed NAFLD \[defined as NAFL (\>5% steatosis, with or without lobular or portal inflammation), borderline NASH or definitive NASH\] within 6 months prior to screening (per local pathology report)
• • Liver stiffness measurement (LSM) ≥6 kPa from FibroScan exam performed during screening or within 12 months prior to screening and a diagnosis of NAFLD based on clinical and imaging (FibroScan CAP≥263 dB/m, ultrasound, CT or MRI) diagnosis at any time
• • LSM ≥8 kPa from FibroScan exam performed during screening or within 12 months prior to screening, in the absence of CAP ≥263 dB/m
• • Able to provide written informed consent to part
• • Willingness to be in the study for 1 or more years
• • Provision of written informed consent
• Exclusion Criteria:
• • Positive hepatitis B surface antigen
• • 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
• • Significant alcohol consumption (≥ 3 drinks daily on average in men and ≥ 2 drinks daily on average in women)
• • Evidence of other causes of chronic liver disease
• • History of prolonged (\> 1 month) total parenteral nutrition within a 6-month period before liver biopsy or before baseline FibroScan VCTE exam
• • Short bowel syndrome
• • History of biliopancreatic diversion
• • History of bariatric surgery within 2 years of enrollment (participants expecting to undergo bariatric surgery can be enrolled prior to the procedure)
• • Solid organ transplant recipients
• • Other condition that is likely to interfere with study follow-up