None listed
Conditions
Brief 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.
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.
Sponsors
St. Vincent's Hospital, Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. HIV-positive status 2. Adults (>=18 years of age) 3. Stable and well-tolerated combination ART including a ritonavir-boosted PI for the previous 6 months 4. HIV RNA <50 copies/mL for at least the preceding 3 months 5. Fasting total cholesterol >5.5 mmol/L (>213 mg/dL) 6. Framingham risk score >=8% at 10 years OR diabetes mellitus OR a family history of premature coronary artery disease in a first-degree relative 7. Provision of written, informed consent.
Exclusion criteria
8. Any statin in the previous 12 weeks 9. Previous statin-induced myopathy or hepatitis 10. History of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic) 11. 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 12. 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 13. No potent switch ART drug available to replace the current ritonavir-boosted PI 14. Known intolerance to rosuvastatin or the proposed switch ART drug 15. Women attempting or likely to become pregnant, or who are pregnant or breast-feeding 16. 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 17. Unable to complete study procedures.
Outcome results
None listed