Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129194
Status:
COMPLETED
Last Update Posted:
2008-01-04
First Post:
2005-08-09
Brief Title:
Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens
Sponsor:
Koronis Pharmaceuticals
Organization:
Koronis Pharmaceuticals
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Dose Escalation Study of the Safety Tolerability and Pharmacokinetics of Multiple Oral Doses of KP-1461 in HIV Adults Who Have Failed Two or More Highly Active Antiretroviral Regimens HAART
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary purpose of the study is to assess the safety and pharmacokinetics of KP-1461 given every 12 hours for 14 days when administered to HIV patients who have failed multiple highly active antiretroviral therapy HAART regimens Patients currently on HAART will be required to discontinue all HAART medications for up to 6 weeks after screening eligibility has been determined
Detailed Description:
KP-1461 is a carbamate prodrug of the active nucleoside KP-1212 KP-1212 is incorporated into the proviral DNA After multiple rounds of replication KP-1212 increases the high inherent mutation rate of HIV beyond the threshold of viability a process called viral decay acceleration KP-1212 is unique from conventional nucleoside reverse transcriptase inhibitors in that it inserts mutations randomly across the entire 10000 nucleotide HIV genome and does not exert selective pressure by targeting a specific viral or cellular process thus potentially avoiding drug resistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None