RecruitingPhase 4ACTRN12612000732886

Rosuvastatin versus Protease Inhibitor Switching for Hypercholesterolaemia in HIV-infected Adults.

To compare the effects of rosuvastatin (10 mg daily) and ritonavir-boosted protease inhibitor switching on the fasting total cholesterol of treatment-experienced HIV-infected adults over 12 weeks.


Sponsor

St. Vincent's Hospital, Sydney

Enrollment

60 participants

Start Date

Jul 8, 2012

Study Type

Interventional

Conditions

Summary

To compare the effects of adding rosuvastatin to switching of ritonavir-boosted protease inhibitor on total cholesterol levels in HIV-infected adults with increased cardiovascular risk profiles over a 12-week period.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study compares two approaches for lowering high cholesterol in HIV-positive adults who are on certain antiretroviral medications. High cholesterol is a common side effect of some HIV drugs. The study compares adding a cholesterol-lowering drug (rosuvastatin) versus switching the HIV drug that is causing the problem, to see which approach works better over 12 weeks. You may be eligible if: - You are 18 or older and HIV-positive - You have been on stable HIV treatment including a ritonavir-boosted protease inhibitor for at least 6 months - Your HIV is well controlled (undetectable viral load for at least 3 months) - Your total cholesterol is above 5.5 mmol/L - You have a meaningful cardiovascular risk (Framingham score 8% or above, or diabetes, or family history of early heart disease) You may NOT be eligible if: - You have taken a statin medication in the last 12 weeks - You have previously had muscle damage from a statin - You have an existing diagnosis of heart disease or stroke - You are pregnant or may become pregnant - You have significant liver or kidney problems Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Rosuvastatin tablets, dose 10 mg daily (5 mg daily in Asian participants), taken once daily for 12 weeks. Participants assigned to this intervention will continue ritonavir-boosted anti-retroviral the

Rosuvastatin tablets, dose 10 mg daily (5 mg daily in Asian participants), taken once daily for 12 weeks. Participants assigned to this intervention will continue ritonavir-boosted anti-retroviral therapy.


Locations(1)

Australia

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ACTRN12612000732886