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Clinical Trials

MainTitle

Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

This study has been completed
Sponsor
Radboud University

Collaborator
Abbott
AstraZeneca

Information provided by (Responsible Party)
Radboud University
ClinicalTrials.gov Identifier
NCT00184951

First received: September 12, 2005
Last updated: October 21, 2008
Last Verified: October 2008
History of Changes
Purpose

Purpose

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)

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)

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.

Eligibility

Eligibility

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

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00184951

Locations

Germany
University of Bonn
Bonn, Germany
University of Cologne
Cologne, Germany
Netherlands
University of Amsterdam
Amsterdam, Netherlands
University of Leiden
Leiden, Netherlands
University of Nijmegen
Nijmegen, Netherlands

Sponsors and Collaborators

Radboud University
Abbott
AstraZeneca

Investigators

Principal Investigator: David M. Burger, Dr Radboud University
More Information

More Information


Responsible Party: Radboud University  
ClinicalTrials.gov 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:

HIV

Additional relevant MeSH terms:
HIV Infections
Hyperlipidemias
Hyperlipoproteinemias
Ritonavir
Lopinavir
Rosuvastatin Calcium

ClinicalTrials.gov processed this data on October 18, 2017
This information is provided by ClinicalTrials.gov.