Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients

This study has been completed.
Sponsor:
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
  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)
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:
Acquired Immunodeficiency Syndrome
HIV Infections
Hyperlipidemias
Dyslipidemias
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Lipid Metabolism Disorders
Metabolic Diseases
RNA Virus Infections
Retroviridae Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus 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

ClinicalTrials.gov processed this record on November 20, 2014