To compare the dynamic changes of lipid metabolism of people living HIV who treated with different antiretroviral therapy (ART) regimens such as Biktarvy EVG/c/TAF/FTC, DTG/FTC/TDF, TDF/3TC/EFV, etc. And to assess the safety and efficacy of different antiretroviral therapy.
This was a prospective observational study aiming to evaluate dynamic changes of lipid metabolism in people living HIV who treated with different antiretroviral therapy (ART) regimens. At the same time, cardiovascular risk and the incidence of non-alcoholic fatty liver disease are assessed so as to compare the effects of different regimen on cardiovascular risk and NAFLD and hope to discover several cardiovascular risk-related individual lipid species.
Study Type
OBSERVATIONAL
Enrollment
180
Zhikai Wan
Hangzhou, Zhejiang, China
RECRUITINGDifferences in lipid metabolism across ART treatment groups
Morning fasting blood was drawn at the time of interview. lipidomic profile was identified by liquid chromatography-mass spectrometry (LC-MS). Change from baseline in lipidomic profile at 24 weeks and 48 weeks. Distinct lipidomic profile between different ART treatment groups at week 24 and week 48.
Time frame: 24 weeks, 48 weeks
conventional clinical lipid
change from baseline in clinical blood lipid at 24 weeks and 48 weeks
Time frame: 24weeks, 48weeks
levels of inflammatory cytokines
The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6
Time frame: 24weeks, 48weeks
T-cell subsets
Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells.
Time frame: 24weeks, 48weeks
Immune activation
Immune activation measured by the percentage of human leukocyte antigen-DR isotype (HLA-DR) and CD38 expressing T-cells in blood.
Time frame: 24weeks, 48weeks
Gut microbiome
Fecal samples of the participants were collected in sterile container before their clinic visits. The DNA was extracted using a QIAamp DNA stool mini kit. And gut microbiome was identified by using metagenome sequencing. Diversity and composition of gut microbiome in different groups at 24 weeks and 48 weeks
Time frame: 24weeks, 48weeks
Tolerability and safety outcomes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Discontinuation and occurrence of adverse event.
Time frame: 24weeks, 48weeks
Cardiovascular Disease Risk
the cardiovascular disease risk was determined by a Framingham cardiovascular risk score(FRS). Change from baseline in Framingham cardiovascular risk score at 24weeks and 48weeks The range of FRS is 0-100, participants are considered a higher 10-year cardiovascular risk who have a higher scores in FRS system
Time frame: 24weeks, 48weeks
Nonalcoholic Fatty Liver Disease
the nonalcoholic fatty liver disease was identified by hepatic steatosis index score. Change from baseline in incidence of Nonalcoholic fatty liver disease at 24weeks and 48weeks. The hepatic steatosis index (HSI) was used as a surrogate marker for non-alcoholic fatty liver disease (NAFLD). The range of HSI is 0-100. HSI = 8 × (ALT/AST) + BMI + (2, if diabetes mellitus) + (2, if female), with values \< 30 ruling out and values\>36 ruling in steatosis
Time frame: 24weeks, 48weeks