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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: March 2007

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.

Intervention(s) in this Clinical Trial

• Drug: Pravastatin
• Drug: Rosuvastatin

Primary Measures

• 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 Measures

• 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.

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis

Overall Clinical Trial Officials and Contacts

Elisabeth Aslangul, MD Principal Investigator Hopital Hôtel Dieu Paris  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00117494

Study ID Number: 2005-001451-38

ClinicalTrials.gov Identifier: NCT00117494

Health Authority: France: Afssaps - French Health Products Safety Agency