Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
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ClinicalTrials.gov Identifier: NCT00184951 |
Recruitment Status :
Completed
First Posted : September 16, 2005
Last Update Posted : November 12, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
HIV Infections Hyperlipidemia | Drug: Rosuvastatin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 30 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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) |
Study Start Date : | April 2004 |
Actual Primary Completion Date : | July 2005 |
Actual Study Completion Date : | July 2005 |
- pharmacokinetics on week 0,4,8 and 12
- 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)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00184951
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 |
Principal Investigator: | David M. Burger, Dr | Radboud University Medical Center |
ClinicalTrials.gov Identifier: | NCT00184951 |
Other Study ID Numbers: |
UMCN-AKF 03.01 |
First Posted: | September 16, 2005 Key Record Dates |
Last Update Posted: | November 12, 2020 |
Last Verified: | November 2020 |
HIV |
Hyperlipidemias Hyperlipoproteinemias Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Rosuvastatin Calcium Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |