Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

Sponsor

Radboud University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00184951

Collaborator

Abbott (Industry), AstraZeneca (Industry)

Enrollment

Locations

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

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 Design

Study Type:

Interventional

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 :

Apr 1, 2004

Actual Primary Completion Date :

Jul 1, 2005

Actual Study Completion Date :

Jul 1, 2005

Outcome Measures

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) []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country
1	University of Bonn	Bonn	Germany
2	University of Cologne	Cologne	Germany
3	University of Amsterdam	Amsterdam	Netherlands
4	University of Leiden	Leiden	Netherlands
5	University of Nijmegen	Nijmegen	Netherlands

Sponsors and Collaborators

Radboud University Medical Center
Abbott
AstraZeneca

Investigators

Principal Investigator: David M. Burger, Dr, Radboud University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00184951

Other Study ID Numbers:

UMCN-AKF 03.01

First Posted:

Sep 16, 2005

Last Update Posted:

Nov 12, 2020

Last Verified:

Nov 1, 2020

Keywords provided by , ,

HIV

Additional relevant MeSH terms:

Hyperlipidemias

Hyperlipoproteinemias

Rosuvastatin Calcium

Study Results

No Results Posted as of Nov 12, 2020