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Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

This study has been completed.
Sponsor:
Collaborators:
Abbott
AstraZeneca
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00184951
First received: September 12, 2005
Last updated: October 21, 2008
Last verified: October 2008
History of Changes

September 12, 2005
October 21, 2008
April 2004
July 2005   (final data collection date for primary outcome measure)
pharmacokinetics on week 0,4,8 and 12
* pharmacokinetics on week 0,4,8 and 12
Complete list of historical versions of study NCT00184951 on ClinicalTrials.gov Archive Site
  • 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)
  • * 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)
Not Provided
Not Provided
 
Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-Infected Patients With Hyperlipidemia (ROSALKA)

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • HIV Infections
  • Hyperlipidemia
Drug: Rosuvastatin
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2005
July 2005   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Netherlands
 
NCT00184951
UMCN-AKF 03.01
Not Provided
Not Provided
Radboud University
  • Abbott
  • AstraZeneca
Principal Investigator: David M. Burger, Dr Radboud University
Radboud University
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP