HIV Infections Clinical Trial
Official title:
Pharmacodynamics and Pharmacokinetics of Combined Use of Rosuvastatin (Crestor) and Lopinavir/Ritonavir (Kaletra) in HIV-infected Patients With Hyperlipidemia (ROSALKA)
NCT number | NCT00184951 |
Other study ID # | UMCN-AKF 03.01 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | April 2004 |
Est. completion date | July 2005 |
Verified date | November 2020 |
Source | Radboud University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
open-label, multiple dose, single-group, 12 week trial in HIV-infected patients with hyperlipidemia while using lopinavir/ritonavir; both male or female subjects.
Status | Completed |
Enrollment | 30 |
Est. completion date | July 2005 |
Est. primary completion date | July 2005 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University of Bonn | Bonn | |
Germany | University of Cologne | Cologne | |
Netherlands | University of Amsterdam | Amsterdam | |
Netherlands | University of Leiden | Leiden | |
Netherlands | University of Nijmegen | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Radboud University | Abbott, AstraZeneca |
Germany, Netherlands,
van der Lee M, Sankatsing R, Schippers E, Vogel M, Fätkenheuer G, van der Ven A, Kroon F, Rockstroh J, Wyen C, Bäumer A, de Groot E, Koopmans P, Stroes E, Reiss P, Burger D. Pharmacokinetics and pharmacodynamics of combined use of lopinavir/ritonavir and — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pharmacokinetics on week 0,4,8 and 12 | |||
Secondary | evaluation of lipid lowering activity on week 0,4,8,12 | |||
Secondary | endothelial function will be measured at week 0 & 12 (optional for patients from Leiden and Nijmegen) |
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