This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. A5223 is a prospective evaluation of 78 (39 men and 39 women) HIV-1-infected subjects designed to determine the pharmacokinetics (PK) of lopinavir (LPV) in men and women ?18 years of age. Subjects must be currently receiving lopinavir 400 mg/ritonavir 100 mg po bid plus one or more of the following: nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir (a nucleotide RTI), and enfuvirtide (a fusion inhibitor). Subjects must be on the same regimen for at least 14 days prior to screening. The screening visit will occur within 30 days prior to the PK visit. Upon confirmation of eligibility, subjects will return for a registration/entry visit to enroll into the study and to be given a 48-hour medication diary. Subjects will be required to spend approximately 13 hours in the GCRC for the intensive PK blood sampling.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000750-34
Application #
7379155
Study Section
Special Emphasis Panel (ZRR1-CR-8 (01))
Project Start
2005-12-01
Project End
2006-11-30
Budget Start
2005-12-01
Budget End
2006-11-30
Support Year
34
Fiscal Year
2006
Total Cost
$8,772
Indirect Cost
Name
Indiana University-Purdue University at Indianapolis
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
603007902
City
Indianapolis
State
IN
Country
United States
Zip Code
46202
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