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

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 Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Rosuvastatin calcium Lopinavir Rosuvastatin

Genetic and Rare Diseases Information Center resources: Sphingolipidosis

U.S. FDA Resources

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

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

No publications provided


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
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:


HIV

Additional relevant MeSH terms:


Hyperlipidemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Lopinavir Rosuvastatin Anti-HIV Agents Anti-Infective Agents Anti-Retroviral Agents Anticholesteremic Agents Antimetabolites	Antiviral Agents Enzyme Inhibitors HIV Protease Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protease Inhibitors Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015