Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
This study has been completed.
Sponsor:
Radboud University
Collaborators:
Abbott
AstraZeneca
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00184951
First received: September 12, 2005
Last updated: October 21, 2008
Last verified: October 2008
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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:
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) |
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 (Adult) |
| 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
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
| 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:
|
HIV Infections Hyperlipidemias Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Lopinavir Ritonavir |
Rosuvastatin Calcium HIV Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites |
ClinicalTrials.gov processed this record on September 26, 2016