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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KP-1461 | Drug |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bach and Godofsky | Bradenton | Florida | 34205 | United States | ||
| University of Miami |
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| Miami |
| Florida |
| 33146 |
| United States |
| Triple O Medical Services | West Palm Beach | Florida | 33401 | United States |
| Research Centers of Via Christi | Wichita | Kansas | 67214 | United States |
| Institute of Human Virology, University of Maryland | Baltimore | Maryland | 21201 | United States |
| Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences | Kansas City | Missouri | 64106-1453 | United States |
| St. Michael's Medical Center | Newark | New Jersey | 07102 | United States |
| AIDS Community Research Initiative of America | New York | New York | 10018 | United States |
| Greenville Hospital System | Greenville | South Carolina | 29605 | United States |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C522536 | KP 1461 |
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