Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-infected Patients With Hyperlipidemia (ROSALKA)

open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.

To determine the effect of rosuvastatin on plasma lipids, lipoproteins, and endothelial function in HIV-infected patients on stable lopinavir/ritonavir therapy and to evaluate the safety of combined use of rosuvastatin and lopinavir/ritonavir. Also to determine the effect of lopinavir/ritonavir on the pharmacokinetics of rosuvastatin compared to historical controls an to determine the effect of rosuvastatin on the pk of lopinavir/ritonavir compared to historical controls and by intrapatient comparison.

Inclusion Criteria:

• use of lopinavir 400mg/ritonavir 100mg bid > 3months
• HIV-1 RNA <400cop/mL
• fasting total cholesterol > 6.2mmol/L

Exclusion Criteria:

• history of sensitivity/idiosyncrasy to the drug or compounds used
• history or current condition that might interfere with absorption,distribution metabolism or excretion
• pregnant or breast-feeding
• serum transaminase levels >3 times upper limit of normal, creatinine clearance <60ml/min
• fasting plasma triglycerides level >8.0 mmol/L
• history of statin-related rhabdomyolysis or inheritable muscle diseases in family history
• clinical symptoms of myopathy or abnormal CK level
• change in antiretroviral medication within the 3 months immediately preceding first dose of rosuvastatin
• use of any statin or fibrate within 6 weeks immediately preceding first dose of rosuvastatin
• concomitant use of medications that interfere with rosuvastatin or lopinavir pharmacokinetics
• active hepatobiliary or hepatic disease
• hypothyroidism
• alcohol abuse
• japanese or chinese patients