Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Infections, Hyperlipidemia

Intervention / Treatment
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* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rosuvastatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetics on week 0,4,8 and 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of lipid lowering activity on week 0,4,8,12 |  |  | 
| endothelial function will be measured at week 0 & 12 (optional for patients from Leiden and Nijmegen) |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV