Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
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open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
Condition or disease
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
use of lopinavir 400mg/ritonavir 100mg bid > 3months
HIV-1 RNA <400cop/mL
fasting total cholesterol > 6.2mmol/L
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