Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

Radboud University Medical Center

Status and phase: Completed; Phase 2

Conditions: Hyperlipidemia; HIV Infections

Treatments: Drug: Rosuvastatin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00184951

UMCN-AKF 03.01

Details and patient eligibility

About

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

Full description

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)