Assessing liver fat levels in HIV/AIDS patients on different medications
Screening and Follow-up in Patients With HIV Infection Combined With Metabolic Associated Fatty Liver Disease
This study is trying to see how different HIV medications affect liver fat levels in patients living with HIV/AIDS to understand the risk of liver disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Peking Union Medical College Hospital Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT05330923 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the prevalence and severity of nonalcoholic fatty liver disease (NAFLD) among patients living with HIV/AIDS, particularly focusing on those treated with integrase inhibitors (INSTIs) versus non-nucleoside reverse transcriptase inhibitors (NNRTIs). By utilizing various imaging techniques such as ultrasonography and elastography, the study seeks to identify patients at risk of severe liver conditions like nonalcoholic steatohepatitis (NASH) and fibrosis. The research will involve a cross-sectional analysis of newly treated or treated AIDS patients who are compliant with their medication and follow-up visits. The findings could provide insights into the impact of different antiretroviral therapies on liver health in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are newly treated or treated AIDS patients who are compliant with their medication and follow-up visits.
Not a fit: Patients who have mobility difficulties that prevent them from completing necessary imaging examinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for liver health in HIV/AIDS patients, potentially reducing the risk of severe liver disease.
How similar studies have performed: While there is emerging evidence regarding the effects of ART on NAFLD, this specific comparative approach between INSTIs and NNRTIs in HIV/AIDS patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly treated or treated AIDS patients; * Regular follow-up visits to the hospital, medication compliance is good; * Patients or their family members were willing to participate in the study by understanding the study plan and providing written informed consent. Exclusion Criteria: * Unable to complete the position requirements of ultrasonic examination (lying flat) due to mobility difficulties; * Patients have poor compliance and cannot follow up regularly or take medicine on time; * Patients or family members cannot understand the conditions and objectives of the study; * Other conditions considered unsuitable for inclusion by the investigator.
Where this trial is running
Beijing, Beijing Municipality
- Chinese Academy of Medical Sciences Peking Union Medical College Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: WEI Lyu — Department of Infectious Diseases, PekingUMCH
- Study coordinator: Qing Zhang
- Email: zhangqingpumch@163.com
- Phone: 15001278131
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.