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Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

Primary Purpose

HIV Infections, Hyperlipidemia

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Bonn
  • University of Cologne
  • University of Amsterdam
  • University of Leiden
  • University of Nijmegen

Outcomes

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)

Full Information

First Posted
September 12, 2005
Last Updated
November 9, 2020
Sponsor
Radboud University Medical Center
Collaborators
Abbott, AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00184951
Brief Title
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

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Radboud University Medical Center
Collaborators
Abbott, AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Hyperlipidemia
Keywords
HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Primary Outcome Measure Information:
Title
pharmacokinetics on week 0,4,8 and 12
Secondary Outcome Measure Information:
Title
evaluation of lipid lowering activity on week 0,4,8,12
Title
endothelial function will be measured at week 0 & 12 (optional for patients from Leiden and Nijmegen)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M. Burger, Dr
Organizational Affiliation
Radboud University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bonn
City
Bonn
Country
Germany
Facility Name
University of Cologne
City
Cologne
Country
Germany
Facility Name
University of Amsterdam
City
Amsterdam
Country
Netherlands
Facility Name
University of Leiden
City
Leiden
Country
Netherlands
Facility Name
University of Nijmegen
City
Nijmegen
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
18018771
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.
Results Reference
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Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

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