Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of the study is to investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Koronis Pharmaceuticals.

Criteria

Inclusion Criteria:

• Asymptomatic HIV-1-infected individuals who are treatment-experienced and who have not been on ART for at least 16 weeks.

• Have documented prior non-suppressive ART including at least 1 NRTI, 1 NNRTI and 2 PIs; or have documented prior ART resistance to at least 1 NRTI, 1 NNRTI and 1 PI; AND in the opinion of the investigator, have few, if any, effective treatment options available.

• Have >2,500 copies/mL of HIV-1 RNA at screening.

• Have a stable CD4 cell count while off ART and >250 cells/mL at screening.

• Have no clinically significant findings on screening evaluations.

Exclusion Criteria:

• Have a current or recent opportunistic infection that, in the opinion of the investigator, is not being controlled by medication.

• Have any condition that, in the opinion of the investigator, could compromise subject safety or adherence to the protocol.

• Have a documented positive test for hepatitis B surface antigen, or have received any antiviral therapy for hepatitis C <6 weeks prior to study drug administration.