- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00184951
Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
November 9, 2020 updated by: Radboud University Medical Center
Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-infected Patients With Hyperlipidemia (ROSALKA)
open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Bonn, Germany
- University of Bonn
-
Cologne, Germany
- University of Cologne
-
-
-
-
-
Amsterdam, Netherlands
- University of Amsterdam
-
Leiden, Netherlands
- University of Leiden
-
Nijmegen, Netherlands
- University of Nijmegen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
pharmacokinetics on week 0,4,8 and 12
|
Secondary Outcome Measures
Outcome Measure |
---|
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)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David M. Burger, Dr, Radboud University Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (Actual)
July 1, 2005
Study Completion (Actual)
July 1, 2005
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Actual)
November 12, 2020
Last Update Submitted That Met QC Criteria
November 9, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Metabolic Diseases
- Lipid Metabolism Disorders
- Dyslipidemias
- Hyperlipidemias
- Hyperlipoproteinemias
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Rosuvastatin Calcium
Other Study ID Numbers
- UMCN-AKF 03.01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HIV Infections
-
University of MinnesotaWithdrawnHIV Infections | HIV/AIDS | Hiv | AIDS | Aids/Hiv Problem | AIDS and InfectionsUnited States
-
University of California, San DiegoUniversity of California, Los Angeles; University of Southern California; California... and other collaboratorsCompleted
-
National Institute of Allergy and Infectious Diseases...Eunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedHIV Infections | HIV SeronegativityUnited States, Puerto Rico
-
Erasmus Medical CenterCompletedHIV/AIDS | Opportunistic Infections, HIV RelatedNetherlands
-
University of WashingtonHealth Alliance International; Beira Operations Research Center, Mozambique...Completed
-
Brown UniversityCompleted
-
University of WashingtonSeattle Children's Hospital; University of NairobiCompleted
-
University of North Carolina, Chapel HillNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
University of California, BerkeleyNational Institute of Mental Health (NIMH); Ministry of Health and Social Welfare...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
Clinical Trials on Rosuvastatin
-
AstraZenecaCompletedDyslipidemia | Kidney DiseaseUnited States, Puerto Rico
-
Yuhan CorporationCompletedHypertension | HyperlipidemiaKorea, Republic of
-
Ottawa Hospital Research InstituteUnknownVenous ThromboembolismCanada, Norway
-
National Institute of Diabetes and Digestive and...National Institute on Alcohol Abuse and Alcoholism (NIAAA); National Cancer... and other collaboratorsRecruitingCirrhosis | Cirrhosis, Liver | Cirrhosis Due to Hepatitis B | Cirrhosis Due to Hepatitis C | Cirrhosis Early | Cirrhosis Advanced | Cirrhosis Infectious | Cirrhosis Alcoholic | Cirrhosis, Biliary | Cirrhosis Cryptogenic | Cirrhosis Due to Primary Sclerosing CholangitisUnited States
-
Kobe UniversityCompletedCoronary Artery Disease Progression
-
Gachon University Gil Medical CenterDaewoong Pharmaceutical Co. LTD.UnknownCoronary Artery DiseaseKorea, Republic of
-
Alvogen KoreaCompletedPrimary HypercholesterolemiaKorea, Republic of
-
Hanmi Pharmaceutical Company LimitedUnknownHealthyKorea, Republic of
-
Organon and CoCompleted