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

Phase 4

Completed

• Conditions: Hyperlipidemia; HIV Infections

• Registration Number: NCT00117494
• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-06-30
• Study First Posted: 2005-07-07
• Study Start: 2005-10
• Primary Completion: 2007-03
• Study Completion: 2007-06
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-21
• Last Update Posted: 2011-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

service de Médecine Interne Hopital Hotel Dieu; 🇫🇷 Paris, France