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Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

This study has been completed.
Information provided by:
Radboud University Identifier:
First received: September 12, 2005
Last updated: October 21, 2008
Last verified: October 2008
open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.

Condition Intervention Phase
HIV Infections Hyperlipidemia Drug: Rosuvastatin Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-Infected Patients With Hyperlipidemia (ROSALKA)

Resource links provided by NLM:

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • pharmacokinetics on week 0,4,8 and 12

Secondary Outcome Measures:
  • 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)

Estimated Enrollment: 30
Study Start Date: April 2004
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00184951

University of Bonn
Bonn, Germany
University of Cologne
Cologne, Germany
University of Amsterdam
Amsterdam, Netherlands
University of Leiden
Leiden, Netherlands
University of Nijmegen
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Principal Investigator: David M. Burger, Dr Radboud University
  More Information Identifier: NCT00184951     History of Changes
Other Study ID Numbers: UMCN-AKF 03.01
Study First Received: September 12, 2005
Last Updated: October 21, 2008

Keywords provided by Radboud University:

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Rosuvastatin Calcium
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents processed this record on September 25, 2017