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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Koronis Pharmaceuticals.

Criteria

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