Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Radboud University
• Collaborators: Abbott; AstraZeneca
• Treatments: Lopinavir; Ritonavir; Rosuvastatin Calcium

Criteria

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