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.
St. Vincent's Hospital, Sydney
60 participants
Jul 8, 2012
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
Inclusion Criteria7
- HIV-positive status
- Adults (>=18 years of age)
- Stable and well-tolerated combination ART including a ritonavir-boosted PI for the previous 6 months
- HIV RNA <50 copies/mL for at least the preceding 3 months
- Fasting total cholesterol >5.5 mmol/L (>213 mg/dL)
- Framingham risk score >=8% at 10 years OR diabetes mellitus OR a family history of premature coronary artery disease in a first-degree relative
- Provision of written, informed consent.
Exclusion Criteria17
- Any statin in the previous 12 weeks
- Previous statin-induced myopathy or hepatitis
- History of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic)
- Concurrent use of:
- a). oral corticosteroids use other than for replacement therapy (ie. prednisolone 5-7.5 mg, hydrocortisone 20-30 mg, cortisone acetate 25-37.5 mg daily)
- b). other immunosuppressive or immunomodulating drugs
- Contra-indication to rosuvastatin therapy:
- a). liver transaminases >5 times the upper normal limit
- b). creatinine clearance <30 mL/min
- c). known myopathy
- d). current fibrate therapy
- e). known resistance to one or more “backbone” ART drugs
- No potent switch ART drug available to replace the current ritonavir-boosted PI
- Known intolerance to rosuvastatin or the proposed switch ART drug
- Women attempting or likely to become pregnant, or who are pregnant or breast-feeding
- A patient with a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study, or interfere with the patient’s participation for the full duration of the study
- Unable to complete study procedures.
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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 therapy.
Locations(1)
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ACTRN12612000732886