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

HIV Infection Clinical Trial

— ART  

Official title:

Impacts of Different ART Regimens on Lipid Metabolism in People Living With Human Immunodeficiency Virus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06019273
• Other study ID #: FAHZUIIT20220125B
• Status: Recruiting
• Start date: April 25, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: August 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: Biao Zhu
• Phone: 86-0571-87236437
• Email: zhubiao1327[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: May 1, 2024
• Est. primary completion date: April 25, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HIV Infection
• HIV Infections

Locations

Country	Name	City	State
China	Zhikai Wan	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	conventional clinical lipid	change from baseline in clinical blood lipid at 24 weeks and 48 weeks	24weeks, 48weeks
Secondary	levels of inflammatory cytokines	The following inflammatory cytokines: interferon-alpha (IFN-a), TNF-a, IL-1, IL-6	24weeks, 48weeks
Secondary	T-cell subsets	Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells.	24weeks, 48weeks
Secondary	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
Secondary	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
Secondary	Tolerability and safety outcomes	Discontinuation and occurrence of adverse event.	24weeks, 48weeks
Secondary	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
Secondary	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