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

Fundació Clínic per a la Recerca Biomèdica0 个研究点目标入组 60 人开始时间: 2013年7月12日最近更新: 2014年10月27日

适应症

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 60

•1.Any statin in the previous 12 weeks
•2.Previous statin-induced myopathy or hepatitis
•3.History of coronary artery disease, stroke or any other indication for the use of statin therapy (hyperlipidaemia: genetic, secondary or idiopathic)
•4.Concurrent use of:
•?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)
•?other immunosuppressive or immunomodulating drugs
•5.Contra-indication to rosuvastatin therapy:
•?liver transaminases >5 times the upper normal limit
•?creatinine clearance <30 mL/min
•?known myopathy
•?current fibrate therapy
•?known resistance to one or more ?backbone? ART drugs
•6.No potent switch ART drug available to replace the current ritonavir-boosted PI
•7.Known intolerance to rosuvastatin or the proposed switch ART drug
•8.Women attempting or likely to become pregnant, or who are pregnant or breast-feeding
•9.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
•10.Unable to complete study procedures

发起方

Fundació Clínic per a la Recerca Biomèdica