To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks.
To compare the effects of rosuvastatin to protease inhibitor switching on: * Total cholesterol through week 12 * Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy) * Quality of life (SF-12) * Fasting LDL cholesterol (estimated with Friedewald equation unless triglycerides \>400mg/dL, in which case LDL-C would be measured directly), HDL cholesterol, total : HDL cholesterol ratio, LDL particles sizes, triglycerides * Fasting glucose and insulin * Framingham cardiovascular risk score * D:A:D 5-year estimated risk calculator
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
Hospital Clinic of Barcelona
Barcelona, Spain
Percentage Change From Baseline in Total Cholesterol at 12 Weeks.
The outcome was defined as the percentage change in fasting total cholesterol from baseline (week 0) to week 12. Fasting blood samples were collected after a 12-hour fast, and total cholesterol was measured in mmol/L. The percentage change was calculated for each participant and compared between the rosuvastatin and PI/r switch groups using an intention-to-treat analysis.
Time frame: 12 weeks from baseline (week 0 to week 12)
Total Cholesterol Through Week 12
Time frame: 12 weeks
Safety Parameters (HIV Viral Load, Clinical Adverse Events, Serious Adverse Events, Laboratory Adverse Events, Modifications to Antiretroviral Therapy)
Time frame: 12 weeks
Quality of Life (SF-12)
Time frame: 12 weeks
Fasting LDL Cholesterol (Estimated With Friedewald Equation Unless Triglycerides >400mg/dL, in Which Case LDL-C Would be Measured Directly), HDL Cholesterol, Total : HDL Cholesterol Ratio, LDL Particles Sizes, Triglycerides
Time frame: 12 weeks
Fasting Glucose and Insulin.
Time frame: 12 weeks
Framingham Cardiovascular Risk Score (10-year Risk Estimate)
The Framingham Risk Score is a sex-specific algorithm used to estimate the 10-year risk of developing cardiovascular disease (CVD), including coronary heart disease, stroke, peripheral artery disease, and heart failure. It is based on factors such as age, sex, total cholesterol, HDL cholesterol, systolic blood pressure, treatment for hypertension, smoking status, and diabetes. Scale Title: Framingham 10-Year Cardiovascular Risk Score Minimum Value: 0% Maximum Value: 100% Interpretation: Higher scores indicate a worse outcome, meaning a higher estimated risk of developing cardiovascular disease within 10 years.
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Time frame: Screening and week 12
D:A:D 5-year Estimated Risk Calculator.
Time frame: Screening and week 12.