Clinical trial NCT00184951: Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
Official title: Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-infected Patients With Hyperlipidemia (ROSALKA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Hyperlipidemia
Keywords: HIV
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Abbott
name: AstraZeneca
First posted: 2005-09-16
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: pharmacokinetics on week 0,4,8 and 12
Secondary outcomes:
measure: evaluation of lipid lowering activity on week 0,4,8,12
measure: endothelial function will be measured at week 0 & 12 (optional for patients from Leiden and Nijmegen)
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: University of Bonn
city: Cologne
country: Germany
facility: University of Cologne
city: Amsterdam
country: Netherlands
facility: University of Amsterdam
city: Leiden
country: Netherlands
facility: University of Leiden
city: Nijmegen
country: Netherlands
facility: University of Nijmegen
Study officials:
affiliation: Radboud University Medical Center
name: David M. Burger, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: van der Lee M, Sankatsing R, Schippers E, Vogel M, Fatkenheuer G, van der Ven A, Kroon F, Rockstroh J, Wyen C, Baumer A, de Groot E, Koopmans P, Stroes E, Reiss P, Burger D. Pharmacokinetics and pharmacodynamics of combined use of lopinavir/ritonavir and rosuvastatin in HIV-infected patients. Antivir Ther. 2007;12(7):1127-32.