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

HIV Infections Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129194
• Other study ID #: KP-1461-102
• Status: Completed
• Phase: Phase 1
• First received: August 9, 2005
• Last updated: December 30, 2007
• Start date: August 2005

Study information

• Verified date: December 2007
• Source: Koronis Pharmaceuticals.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• KP-1461

Locations

Country	Name	City	State
United States	Institute of Human Virology, University of Maryland	Baltimore	Maryland
United States	Bach and Godofsky	Bradenton	Florida
United States	Greenville Hospital System	Greenville	South Carolina
United States	Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences	Kansas City	Missouri
United States	University of Miami	Miami	Florida
United States	AIDS Community Research Initiative of America	New York	New York
United States	St. Michael's Medical Center	Newark	New Jersey
United States	Triple O Medical Services	West Palm Beach	Florida
United States	Research Centers of Via Christi	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Koronis Pharmaceuticals.

Country where clinical trial is conducted

United States,