HIV Infections Clinical Trial
Official title:
Randomised Comparative Study of the Efficacy and Safety of Rosuvastatin and Pravastatin in Dyslipidemic Patients Treated With Antiretroviral Agents. Anrs 126
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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