Effects of HIV treatments on lipid metabolism
Impacts of Different ART Regimens on Lipid Metabolism in People Living With Human Immunodeficiency Virus
This study is testing how different HIV treatments affect fat levels in the body and whether they impact heart health and liver disease risk for people living with HIV.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06019273 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the dynamic changes in lipid metabolism among individuals living with HIV who are treated with various antiretroviral therapy (ART) regimens. It will compare the effects of different ART regimens, such as Biktarvy and DTG/FTC/TDF, on cardiovascular risk and the incidence of non-alcoholic fatty liver disease (NAFLD). The study will also assess the safety and efficacy of these regimens, focusing on identifying cardiovascular risk-related lipid species. Participants will be monitored for their compliance and follow-up throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older living with HIV, on stable antiretroviral therapy, and with controlled viral loads.
Not a fit: Patients with severe comorbidities, poor treatment compliance, or those on medications that interfere with lipid metabolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of lipid metabolism and cardiovascular health in people living with HIV.
How similar studies have performed: Other studies have shown varying impacts of different ART regimens on lipid metabolism, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. People with HIV aged 18 years and older 2. Treated with stable antiretroviral therapy 3. Plasma HIV-1 RNA below 50 copies per milliliter for at least six months 4. Without other comorbidities or concomitant medications 5. Good compliance and can cooperated with the follow-up 6. Willing to participate in the study and sign informed consent. Exclusion Criteria: 1. Pregnant or breast-feeding 2. Patients with poor treatment compliance 3. Patients refused to attend the regular follow-up examination 4. Patients with severe cardiovascular and cerebrovascular diseases or liver and kidney dysfunction 5. Acute infection (malaria, tuberculosis, helminthiasis, pneumonia, meningitis), moderate or severe malnutrition and diarrhea in the last 3 months 6. Take medications that may interfere with lipid metabolism throughout the study, such as statins/fibrates, antidiabetic 7. Participated in other clinical trials within 3 months. 8. Patients with severe mental illness
Where this trial is running
Hangzhou, Zhejiang
- Zhikai Wan — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Biao Zhu
- Email: zhubiao1327@zju.edu.cn
- Phone: 86-0571-87236437
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.