Impacts of Different ART Regimens on Lipid Metabolism in People Living With Human Immunodeficiency Virus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Differences in lipid metabolism across ART treatment groups
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •People with HIV aged 18 years and older
- •Treated with stable antiretroviral therapy
- •Plasma HIV-1 RNA below 50 copies per milliliter for at least six months
- •Without other comorbidities or concomitant medications
- •Good compliance and can cooperated with the follow-up
- •Willing to participate in the study and sign informed consent.
Exclusion Criteria
- •Pregnant or breast-feeding
- •Patients with poor treatment compliance
- •Patients refused to attend the regular follow-up examination
- •Patients with severe cardiovascular and cerebrovascular diseases or liver and kidney dysfunction
- •Acute infection (malaria, tuberculosis, helminthiasis, pneumonia, meningitis), moderate or severe malnutrition and diarrhea in the last 3 months
- •Take medications that may interfere with lipid metabolism throughout the study, such as statins/fibrates, antidiabetic
- •Participated in other clinical trials within 3 months.
- •Patients with severe mental illness
Outcomes
Primary Outcomes
Differences in lipid metabolism across ART treatment groups
Time Frame: 24 weeks, 48 weeks
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.
Secondary Outcomes
- conventional clinical lipid(24weeks, 48weeks)
- Tolerability and safety outcomes(24weeks, 48weeks)
- Immune activation(24weeks, 48weeks)
- Gut microbiome(24weeks, 48weeks)
- Cardiovascular Disease Risk(24weeks, 48weeks)
- T-cell subsets(24weeks, 48weeks)
- levels of inflammatory cytokines(24weeks, 48weeks)
- Nonalcoholic Fatty Liver Disease(24weeks, 48weeks)