This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.Adult AIDS Clinical Trials Group protocol A5223 is a multicenter, prospective study to evaluate the pharmacokinetics (PK) of lopinavir/ritonavir (Kaletra, LPV/RTV) in women and men. LPV is a protease inhibitor (PI) used in the treatment of HIV infection and is co-formulated with low dose RTV, a PI used to enhance the systemic exposure of LPV. HIV infected individuals who are taking LPV/RTV for at least 14 days (as part of their HIV treatment regimen) will be enrolled. Blood concentrations of LPV and RTV will be assessed immediately before and then following an observed oral dose of LPV/RTV (400mg/100mg) at 1, 2, 3, 4, 5, 6, 8, 10, and 12 hours post dose. These data will be used to derive standard PK parameters. There will be 78 subjects enrolled nationally (approximately 8 of these locally).

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000037-47
Application #
7603478
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-04-01
Project End
2007-09-16
Budget Start
2007-04-01
Budget End
2007-09-16
Support Year
47
Fiscal Year
2007
Total Cost
$979
Indirect Cost
Name
University of Washington
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
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