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.This study is a Phase II, randomized, placebo-controlled, double blind, multiple dose, dose-escalation study in HIV treatment experienced patients on a failing antiretroviral regimen, harboring key resistance mutations to at least one member of the anti-HIV medicaition classes. The antiviral activity, safety, and pharmacokinetics of up to five different dose levels of PA103001-04 (Bevirimat) will be compared following multiple oral doses when added to a failing antiretroviral regimen. Initially, a total of 48 patients will be randomized to evaluate the first three dose levels. If the doses are escalated beyond the initial three dose levels, an additional 32 patients may be randomized.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR000034-48
Application #
7718661
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2007-12-01
Project End
2008-05-31
Budget Start
2007-12-01
Budget End
2008-05-31
Support Year
48
Fiscal Year
2008
Total Cost
$3,499
Indirect Cost
Name
Ohio State University
Department
Administration
Type
Schools of Medicine
DUNS #
832127323
City
Columbus
State
OH
Country
United States
Zip Code
43210
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