Clinical trial NCT06019273: Impacts of Different ART Regimens on Lipid Metabolism in People Living With HIV
Official title: Impacts of Different ART Regimens on Lipid Metabolism in People Living With Human Immunodeficiency Virus
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infection
Combined Antiretroviral Therapy
Keywords: HIV antiretroviral therapy lipid metabolism
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in lipid metabolism across ART treatment groups
timeFrame: 24 weeks, 48 weeks
Secondary outcomes:
measure: conventional clinical lipid
timeFrame: 24weeks, 48weeks
measure: levels of inflammatory cytokines
timeFrame: 24weeks, 48weeks
measure: T-cell subsets
timeFrame: 24weeks, 48weeks
measure: Immune activation
timeFrame: 24weeks, 48weeks
measure: Gut microbiome
timeFrame: 24weeks, 48weeks
measure: Tolerability and safety outcomes
timeFrame: 24weeks, 48weeks
measure: Cardiovascular Disease Risk
timeFrame: 24weeks, 48weeks
measure: Nonalcoholic Fatty Liver Disease
timeFrame: 24weeks, 48weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhikai Wan
state: Zhejiang
Study officials:
References: