Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

Phase 2

Completed

• Conditions: Hyperlipidemia; HIV Infections

• Registration Number: NCT00184951
• Lead Sponsor: Radboud University Medical Center

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-09
• Last Update Posted: 2020-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
pharmacokinetics on week 0,4,8 and 12

Secondary Outcome Measures

Name	Time	Method
endothelial function will be measured at week 0 & 12 (optional for patients from Leiden and Nijmegen)
evaluation of lipid lowering activity on week 0,4,8,12

Trial Locations

Locations (5)

University of Leiden; 🇳🇱 Leiden, Netherlands

University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

University of Bonn; 🇩🇪 Bonn, Germany

University of Cologne; 🇩🇪 Cologne, Germany

University of Nijmegen; 🇳🇱 Nijmegen, Netherlands