Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens

This study has been completed.
Sponsor:
Information provided by:
Koronis Pharmaceuticals.
ClinicalTrials.gov Identifier:
NCT00129194
First received: August 9, 2005
Last updated: December 30, 2007
Last verified: December 2007

August 9, 2005
December 30, 2007
August 2005
June 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00129194 on ClinicalTrials.gov Archive Site
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Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens
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)

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment
HIV Infections
Drug: KP-1461
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
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June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • HBsAb (hepatitis B) positive serology
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00129194
KP-1461-102
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Koronis Pharmaceuticals.
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Koronis Pharmaceuticals.
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP