Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients - Full Text View

Sponsors and Collaborators:	Radboud University Abbott AstraZeneca
Information provided by:	Radboud University
ClinicalTrials.gov Identifier:	NCT00184951

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 II

MedlinePlus related topics: AIDS

Drug Information available for: Rosuvastatin Rosuvastatin calcium Ritonavir Lopinavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics/Dynamics Study
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)

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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

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

Locations

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

Sponsors and Collaborators

Radboud University

Abbott

AstraZeneca

Investigators

Principal Investigator:

David M. Burger, Dr

Radboud University

More Information

Study ID Numbers:	UMCN-AKF 03.01
Study First Received:	September 12, 2005
Last Updated:	October 21, 2008
ClinicalTrials.gov Identifier:	NCT00184951
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:

HIV

Study placed in the following topic categories:

Sexually Transmitted Diseases, Viral
Hyperlipidemias
Metabolic Diseases
Acquired Immunodeficiency Syndrome
Immunologic Deficiency Syndromes
Virus Diseases
Rosuvastatin
Lopinavir

HIV Infections
Ritonavir
Sexually Transmitted Diseases
Metabolic disorder
Retroviridae Infections
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Antimetabolites
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Enzyme Inhibitors

Anticholesteremic Agents
Infection
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Therapeutic Uses
Lentivirus Infections

ClinicalTrials.gov processed this record on January 14, 2009