Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
Information source: Radboud University
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: HIV Infections; Hyperlipidemia
Intervention: Rosuvastatin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Radboud University Official(s) and/or principal investigator(s):
David M. Burger, Dr, Principal Investigator, Affiliation: Radboud University
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.
Clinical Details
Official title: Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-Infected Patients With Hyperlipidemia (ROSALKA)
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: pharmacokinetics on week 0,4,8 and 12
Secondary outcome: evaluation of lipid lowering activity on week 0,4,8,12endothelial function will be measured at week 0 & 12 (optional for patients from Leiden and Nijmegen)
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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 and Contacts
University of Cologne, Cologne, Germany
University of Bonn, Bonn, Germany
University of Leiden, Leiden, Netherlands
University of Nijmegen, Nijmegen, Netherlands
University of Amsterdam, Amsterdam, Netherlands
Additional Information
Starting date: April 2004
Ending date: July 2005
Last updated: August 21, 2007
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