Status:
COMPLETED
Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Abbott
AstraZeneca
Conditions:
HIV Infections
Hyperlipidemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 u...
Eligibility Criteria
Inclusion
- use of lopinavir 400mg/ritonavir 100mg bid \> 3months
- HIV-1 RNA \<400cop/mL
- fasting total cholesterol \> 6.2mmol/L
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00184951
Start Date
April 1 2004
End Date
July 1 2005
Last Update
November 12 2020
Active Locations (5)
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1
University of Bonn
Bonn, Germany
2
University of Cologne
Cologne, Germany
3
University of Amsterdam
Amsterdam, Netherlands
4
University of Leiden
Leiden, Netherlands