Pharmacokinetic Study of Rosuvastatin and Lopinavir/Ritonavir in HIV Patients
NCT ID: NCT00184951
Last Updated: 2020-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2004-04-30
2005-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Rosuvastatin
Eligibility Criteria
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Inclusion Criteria
* HIV-1 RNA \<400cop/mL
* fasting total cholesterol \> 6.2mmol/L
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Abbott
INDUSTRY
AstraZeneca
INDUSTRY
Radboud University Medical Center
OTHER
Principal Investigators
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David M. Burger, Dr
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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University of Bonn
Bonn, , Germany
University of Cologne
Cologne, , Germany
University of Amsterdam
Amsterdam, , Netherlands
University of Leiden
Leiden, , Netherlands
University of Nijmegen
Nijmegen, , Netherlands
Countries
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References
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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.
Other Identifiers
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UMCN-AKF 03.01
Identifier Type: -
Identifier Source: org_study_id