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.

Condition	Intervention	Phase
Hyperlipidemia HIV Infections	Drug: Pravastatin  Drug: Rosuvastatin	Phase IV

Further Study Details: 

Primary Outcomes: 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 Outcomes: 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.
Expected Total Enrollment:  86

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00117494

Elisabeth Aslangul, MD      00 33 1 42 34 83 46    elisabeth.aslangul@htd.ap-hop-paris.fr
Marc-Antoine Valantin, MD      00 331 42 16 01 71  Ext. 44    marc-antoine.valantin@psl.ap-hop-paris

France
      service de Médecine Interne Hopital Hotel Dieu, Paris,  75004,  France

Study chairs or principal investigators

Elisabeth Aslangul, MD,  Principal Investigator,  Hopital Hôtel Dieu Paris   
Dominique Costagliola,  Study Director,  Inserm U720 Paris Pitié Salpétrière   

Study ID Numbers:  2005-001451-38; ANRS 126
Record last reviewed:  June 2005
Last Updated:  July 25, 2005
Record first received:  July 6, 2005
ClinicalTrials.gov Identifier:  NCT00117494
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-07-26