Rosuvastatin Versus Pravastatin in HIV Patients Treated With Boosted Protease Inhibitors (PI) (ANRS126)

Study Overview
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Brief Summary
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In HIV hypercholesterolemic patients treated with protease inhibitors, some drugs of the statin group are used to control cholesterol level. New and potentially more efficient statins may interfere with protease inhibitors and hence loose a part of their activity. They have thus to be compared with a more established drug of the same class (e.g. pravastatin). The protocol compares the efficacy and safety of rosuvastatin and pravastatin.

Detailed Description
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The study compares the efficacy and safety of rosuvastatin and pravastatin among dyslipidemic HIV-seropositive patients treated with antiretroviral agents including a boosted protease inhibitor. It is an open, multicenter, randomised trial, with two parallel groups comparing rosuvastatin with pravastatin. Statins are administered from D0, with a single daily dose in the morning, for 45 consecutive days. The duration of the study for each patient will be 45 days not including the preselection period (maximum 15 days). The primary end-point compares the change in LDL cholesterol between D0 and D45, in patients receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral agents including a boosted Protease Inhibitor. Secondary end-points compares changes in triglycerides and HDL cholesterol; percentage of patients with a normal value of LDL cholesterol, HDL cholesterol and triglycerides on D45; clinical safety and laboratory safety parameters of rosuvastatin and pravastatin; distribution profile of the diameter of LDL cholesterol particles. Cmin of rosuvastatin, pravastatin and protease inhibitors (PI) are controlled at D15 for statins and PI.

Official Title
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Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126

Conditions
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Hyperlipidemia, HIV Infections

Intervention / Treatment
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* Drug: Pravastatin
* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fasting LDL cholesterol over 4.1 mmol/L (1.6 g/l) Blood triglycerides over 8.8 mmol/L (8 g/l) HIV-1 infection Viral load above or equal to 10.000 copies/ml Stable antiretroviral regimen for past two months Exclusion Criteria: Coronary disease Genetic muscular disease CPK over 5N Hepatic or renal insufficiency Alcohol intake more than 40g/d Hypothyroidism Pregnancy and breast feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pravastatin|nan|
|Drug: Rosuvastatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the change in LDL cholesterol between D0 and D45, in patients receiving rosuvastatin (10 mg/day) or pravastatin (40 mg/day) and treated by antiretroviral agents including a boosted protease inhibitor on D45. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in triglycerides and HDL cholesterol on D45 |  |  | 
| Percentage of patients with a normal value of LDL cholesterol, HDL cholesterol and triglycerides on D45 Clinical and biological safety parameters of rosuvastatin and pravastatin |  |  | 
| Distribution profile of the diameter of LDL cholesterol particles |  |  | 
| Cmin of rosuvastatin and pravastatin on D15 |  |  | 
| Cmin of protease inhibitors on D15. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV infections, Hyperlipidemia, STATINS, HMG-COA, Protease Inhibitor, Treatment Experienced