Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00184951
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : October 22, 2008
Information provided by:
Radboud University

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.

Condition or disease Intervention/treatment Phase
HIV Infections Hyperlipidemia Drug: Rosuvastatin Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
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)
Study Start Date : April 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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

Secondary Outcome Measures :
  1. evaluation of lipid lowering activity on week 0,4,8,12
  2. endothelial function will be measured at week 0 & 12 (optional for patients from Leiden and Nijmegen)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00184951     History of Changes
Other Study ID Numbers: UMCN-AKF 03.01
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: October 22, 2008
Last Verified: October 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
Anticholesteremic Agents
Hypolipidemic Agents