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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
| AstraZeneca | INDUSTRY |
open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rosuvastatin | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| pharmacokinetics on week 0,4,8 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David M. Burger, Dr | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bonn | Bonn | Germany | ||||
| University of Cologne |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18018771 | Result | van der Lee M, Sankatsing R, Schippers E, Vogel M, Fatkenheuer G, van der Ven A, Kroon F, Rockstroh J, Wyen C, Baumer A, de Groot E, Koopmans P, Stroes E, Reiss P, Burger D. Pharmacokinetics and pharmacodynamics of combined use of lopinavir/ritonavir and rosuvastatin in HIV-infected patients. Antivir Ther. 2007;12(7):1127-32. |
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| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D006949 | Hyperlipidemias |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
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| ID | Term |
|---|---|
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
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| Cologne |
| Germany |
| University of Amsterdam | Amsterdam | Netherlands |
| University of Leiden | Leiden | Netherlands |
| University of Nijmegen | Nijmegen | Netherlands |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006845 |
| Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |