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

Zhejiang University

Status: Enrolling

Conditions: HIV Infection; Combined Antiretroviral Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT06019273

FAHZUIIT20220125B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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