HIV AND HYPERCHOLESTEROLAEMIA MedDRA version: 16.0 Level: LLT Classification code 10068341 Term: HIV-1 infection System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Crestor
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: Rosuvastatin calcium
CAS Number: 287714-41-4
Other descriptive name: ROSUVASTATIN
Sponsors
Fundació Clínic per a la Recerca Biomèdica
Eligibility
Sex/Gender
All
Inclusion criteria
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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of rosuvastatin to protease inhibitor switching on fasting total cholesterol over 12 weeks;Secondary Objective: To compare the effects of rosuvastatin to protease inhibitor switching on: 1.Total cholesterol through week 12 2.Safety parameters (HIV viral load, clinical adverse events, serious adverse events, laboratory adverse events, modifications to antiretroviral therapy) 3.Quality of life (SF-12) 4.Fasting LDL cholesterol (estimated with Friedwald equation unless triglycerides >400mg/dL, in which case LDL-C would be measured directly), HDL cholesterol, total : HDL cholesterol ratio, LDL particles sizes, triglycerides 5.Fasting glucose and insulin 6.Framingham cardiovascular risk score 7.D:A:D 5-year estimated risk calculator;Primary end point(s): Percentage change from baseline in total cholesterol at 12 weeks;Timepoint(s) of evaluation of this end point: 12weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? 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 Friedwald 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 (available at: http://hp2010.nhlbihin.net/atpiii/calculator.asp?usertype=prof) ? D:A:D 5-year estimated risk calculator (available at: http://www.cphiv.dk/TOOLS/DADRiskEquations/tabid/437/Default.aspx);Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Australia, Spain
Contacts
Public ContactJoan Albert Arnaiz
Clinical Trial Unit
Outcome results
None listed