Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

Radboud University Medical Center30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

HIV Infections Hyperlipidemia

Interventions

RosuvastatinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (5)

University of Bonn

Bonn, Germany

University of Cologne

Cologne, Germany

University of Amsterdam

Amsterdam, Netherlands

University of Leiden

Leiden, Netherlands

University of Nijmegen

Outcomes

Primary Outcomes

pharmacokinetics on week 0,4,8 and 12

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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