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Sponsors and Collaborators: |
Radboud University Abbott AstraZeneca |
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Information provided by: | Radboud University |
ClinicalTrials.gov Identifier: | NCT00184951 |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | David M. Burger, Dr | Radboud University |
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) |
HIV |
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 |
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 |