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

Sponsor

First Affiliated Hospital of Zhejiang University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06019273

Collaborator

(none)

180

Enrollment

Location

24.2

Anticipated Duration (Months)

7.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infection Combined 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 [Patient Registry]

Anticipated Enrollment :

180 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Apr 25, 2022

Anticipated Primary Completion Date :

Apr 25, 2024

Anticipated Study Completion Date :

May 1, 2024

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhikai Wan	Hangzhou	Zhejiang	China	310000

Sponsors and Collaborators

First Affiliated Hospital of Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital of Zhejiang University

ClinicalTrials.gov Identifier:

NCT06019273

Other Study ID Numbers:

FAHZUIIT20220125B

First Posted:

Aug 31, 2023

Last Update Posted:

Sep 1, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by First Affiliated Hospital of Zhejiang University

HIV antiretroviral therapy lipid metabolism

Additional relevant MeSH terms:

HIV Infections

Study Results

No Results Posted as of Sep 1, 2023