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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Differences 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. | 24 weeks, 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| conventional clinical lipid | change from baseline in clinical blood lipid at 24 weeks and 48 weeks | 24weeks, 48weeks |
| levels of inflammatory cytokines | The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6 |
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Inclusion Criteria:
Exclusion Criteria:
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HIV-infected patients on stable antiretroviral therapy without any Acute infection or other complications. Any patient present meeting the inclusion criteria of the study will be offered to participate in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Biao Zhu | Contact | 86-0571-87236437 | zhubiao1327@zju.edu.cn | |
| Zhikai Wan | Contact | 86-0571-87236437 | 22118234@zju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhikai Wan | Recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38489119 | Derived | Wan Z, Su J, Zhu X, Liu X, Guo Y, Xiang D, Zhou X, Peng X, Tao R, Cao Q, Lang G, Huang Y, Zhu B. Distinct Lipidomic Profiles between People Living with HIV Treated with E/C/F/TAF or B/F/TAF: An Open-Label Prospective Cohort Study. Infect Dis Ther. 2024 Apr;13(4):727-744. doi: 10.1007/s40121-024-00943-0. Epub 2024 Mar 15. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| 24weeks, 48weeks |
| T-cell subsets | Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells. | 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. | 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 | 24weeks, 48weeks |
| Tolerability and safety outcomes | Discontinuation and occurrence of adverse event. | 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 | 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 | 24weeks, 48weeks |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |