Status:
COMPLETED
Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens
Lead Sponsor:
Koronis Pharmaceuticals.
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 anti...
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...
Eligibility Criteria
Inclusion
- CD4 \> 100 cells/mm3
- Viral load 2,500 - 200,000 copies/mL
- Exposure to at least 2 different HAART regimens containing NRTI(s), NNRTI(s), and 2 PI(s), excluding Ritonavir, for a minimum of 4 months or documented resistance to at least 3 of the 4 classes of approved antiretroviral drugs.
- Few, if any, effective treatment options available
Exclusion
- HBsAb (hepatitis B) positive serology
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00129194
Start Date
August 1 2005
Last Update
January 4 2008
Active Locations (9)
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1
Bach and Godofsky
Bradenton, Florida, United States, 34205
2
University of Miami
Miami, Florida, United States, 33146
3
Triple O Medical Services
West Palm Beach, Florida, United States, 33401
4
Research Centers of Via Christi
Wichita, Kansas, United States, 67214