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HIV InfectionARTNCT06019273

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

An observational study of HIV Infection and Combined Antiretroviral Therapy, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
180 participants
Where
1 siteChina
Study dates
25 Apr 2022to 1 May 2024
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Biao Zhu contact

86-0571-87236437

zhubiao1327@zju.edu.cn

Zhikai Wan contact

86-0571-87236437

22118234@zju.edu.cn

China1 site, 1 recruiting

  • Zhikai Wan

    Hangzhou, Zhejiang, 310000

    Zhikai Wan, 86-0571-87236417, 22118234@zju.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Keywords
HIV antiretroviral therapy lipid metabolism
Medical subject headings
HIV Infections

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 weeks, 48 weeks

Secondary outcomes (8)

  1. conventional clinical lipid

    change from baseline in clinical blood lipid at 24 weeks and 48 weeks

    Measured: 24weeks, 48weeks

  2. levels of inflammatory cytokines

    The following inflammatory cytokines: interferon-alpha (IFN-α), TNF-α, IL-1, IL-6

    Measured: 24weeks, 48weeks

  3. T-cell subsets

    Absolute CD4+ and CD8+ T-cell counts and CD4/CD8 ratio were measured on peripheral blood mononuclear cells.

    Measured: 24weeks, 48weeks

  4. Immune activation

    Immune activation measured by the percentage of human leukocyte antigen-DR isotype (HLA-DR) and CD38 expressing T-cells in blood.

    Measured: 24weeks, 48weeks

  5. 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

    Measured: 24weeks, 48weeks

  6. Tolerability and safety outcomes

    Discontinuation and occurrence of adverse event.

    Measured: 24weeks, 48weeks

  7. 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

    Measured: 24weeks, 48weeks

  8. 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

    Measured: 24weeks, 48weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2023
  2. Study start25 Apr 2022
  3. Primary completion25 Apr 2024 (estimated)
  4. Study completion1 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
180 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06019273
Sponsor's protocol ID
FAHZUIIT20220125B
Acronym
ART
Status last verified
Aug 2023
First submitted
16 Aug 2023
Last updated
1 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38489119

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infection and Combined Antiretroviral Therapy, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Biao Zhu (86-0571-87236437, zhubiao1327@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in lipid metabolism across ART treatment groups (time frame: 24 weeks, 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06019273, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.

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