Impacts of Different ART Regimens on Lipid Metabolism in People Living With HIV

Recruiting

• Conditions: Combined Antiretroviral Therapy; HIV Infection

• Registration Number: NCT06019273
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

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 Timeline

• Study Start: 2022-04-25
• Status Verified: 2023-08
• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-23
• Last Update Submitted: 2023-08-30
• Study First Posted: 2023-08-31
• Last Update Posted: 2023-09-01
• Primary Completion: 2024-04-25
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differences in lipid metabolism across ART treatment groups	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 Outcome Measures

Name	Time	Method
conventional clinical lipid	24weeks, 48weeks	change from baseline in clinical blood lipid at 24 weeks and 48 weeks
Tolerability and safety outcomes	24weeks, 48weeks	Discontinuation and occurrence of adverse event.
Immune activation	24weeks, 48weeks	Immune activation measured by the percentage of human leukocyte antigen-DR isotype (HLA-DR) and CD38 expressing T-cells in blood.
Gut microbiome	24weeks, 48weeks	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
Cardiovascular Disease Risk	24weeks, 48weeks	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
T-cell subsets	24weeks, 48weeks	Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells.
levels of inflammatory cytokines	24weeks, 48weeks	The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6
Nonalcoholic Fatty Liver Disease	24weeks, 48weeks	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

Trial Locations

Locations (1)

Zhikai Wan; 🇨🇳 Hangzhou, Zhejiang, China