Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens
- Conditions
- HIV Infections
- Registration Number
- NCT00129194
- Lead Sponsor
- Koronis Pharmaceuticals.
- 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 10,000 nucleotide HIV genome and does not exert selective pressure by targeting a specific viral or cellular process, thus potentially avoiding drug resistance.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- HBsAb (hepatitis B) positive serology
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
University of Miami
🇺🇸Miami, Florida, United States
Institute of Human Virology, University of Maryland
🇺🇸Baltimore, Maryland, United States
St. Michael's Medical Center
🇺🇸Newark, New Jersey, United States
Triple O Medical Services
🇺🇸West Palm Beach, Florida, United States
Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
🇺🇸Kansas City, Missouri, United States
Bach and Godofsky
🇺🇸Bradenton, Florida, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Research Centers of Via Christi
🇺🇸Wichita, Kansas, United States
AIDS Community Research Initiative of America
🇺🇸New York, New York, United States