Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
Corroboration of supporting in vitro data
- Data successfully corroborated 2009)
The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label, Multicenter, Mechanism Validation Study to Evaluate the Safety, Efficacy and Tolerability of KP-1461 as Monotherapy for 124 Days in Antiretroviral-experienced, HIV-1-infected Subjects|
- To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. [ Time Frame: 124 days ] [ Designated as safety issue: Yes ]
- To evaluate the antiviral activity (eg., CD4 count, HIV RNA count) of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. [ Time Frame: 124 days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
KP-1461 is a prodrug of KP-1212 triphosphate, a unique nucleoside that is incorporated into the HIV viral genome resulting in an accumulation of nucleic substitutions that interfere with viral replication. The study is designed to investigate the safety and antiviral activity for 124 days in antiretroviral-experienced HIV-1-infected subjects. By inducing additional mutagenic events in the viral genome, viral decay accelerators such as KP-1212 may force the virus to exceed the threshold of nonviability.
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