Changes in lipid profile in people living with HIV on stable protease inhibitors (PIs)-based regimens as second-line ART regimens switch to dolutegravir (DTG)-based regimens
Completed
- Conditions
- people living with HIVlipid profile, protease inhibitors, second-line ART regimens, switching, dolutegravir
- Registration Number
- TCTR20240717004
- Lead Sponsor
- Faculty of Medicine, Chulalongkorn University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 144
Inclusion Criteria
People living with HIV
Aged at least 18 years
On PIs-based regimens as a second-line ART treatment
Virologically suppressed in past 6 months
Exclusion Criteria
Previous exposure to any INSTIs
Documented ASCVD or disease required lipid-lowering agent
On lipid-lowering agent
Pregnancy
eGFR < 30 mL/min/1.73m2
Hypothyroidism
Cirrhosis CTP B or C
On thiazide, loop diuretic, glucocorticoids, calcineurin inhibitors, danazol, vitamin A
Oral contraceptive pill
Hormonal replacement therapy
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method DL-cholesterol 24 weeks after switching from PIs-based regimens to DTG-based regimens group calculated LDL-cholesterol from lipid profile's blood test
- Secondary Outcome Measures
Name Time Method Efficacy 24 weeks after switching HIV-RNA and CD4 count from blood test,Other metabolic parameters 24 weeks after switching Fasting plasma glucose, total cholesterol, triglycerides, HDL-cholesterol from blood test,Body mass index 24 weeks after switching body weight and height measurement,Renal function 24 weeks after switching eGFR by creatinine from blood test,Depression score 24 weeks after switching Patient Health Questionnaire-9