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

HIV Infections Clinical Trial

Official title:

An Open-Label, Multicenter, Mechanism Validation Study to Evaluate the Safety, Efficacy and Tolerability of KP-1461 as Monotherapy for 124 Days in Antiretroviral-experienced, HIV-1-infected Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00504452
• Other study ID #: KP-1461-201
• Status: Terminated
• Phase: Phase 2
• First received: July 18, 2007
• Last updated: November 3, 2011
• Start date: July 2007
• Est. completion date: June 2009

Study information

• Verified date: November 2008
• 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 investigate the safety and efficacy of KP-1461 given every 12 hours for 124 days to HIV+ patients who have failed multiple antiretroviral regimens.

Description:

KP-1461 is a prodrug of KP-1212 triphosphate, a unique nucleoside that is incorporated into the HIV viral genome resulting in an accumulation of nucleic substitutions that interfere with viral replication. The study is designed to investigate the safety and antiviral activity for 124 days in antiretroviral-experienced HIV-1-infected subjects. By inducing additional mutagenic events in the viral genome, viral decay accelerators such as KP-1212 may force the virus to exceed the threshold of nonviability.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: June 2009
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• HIV Infections

Intervention

Drug:
• KP-1461
Oral dosage, 1600 mg bid for 124 days

Locations

Country	Name	City	State
Puerto Rico	Clinical Research Puerto Rico, Inc.	San Juan
United States	Albany Medical College	Albany	New York
United States	CARE-ID	Annandale	Virginia
United States	AIDS Research Consortium of Atlanta	Atlanta	Georgia
United States	Institute of Human Virology, University of Maryland	Baltimore	Maryland
United States	Community Research Initiative of New England	Boston	Massachusetts
United States	Northstar Medical Center	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Charlton Methodist Hospital	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Comprehensive Care Center -- HIV Clinical Research	Fort Lauderdale	Florida
United States	University of Texas Health Science Center	Houston	Texas
United States	Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences	Kansas City	Missouri
United States	Health for Life Clinic	Little Rock	Arkansas
United States	Living Hope Clinical Foundation	Long Beach	California
United States	Light Source Medical/U. of Southern California	Los Angeles	California
United States	AIDS Community Research Initiative of America	New York	New York
United States	Mount Sinai Medical Center	New York	New York
United States	St. Michael's Medical Center	Newark	New Jersey
United States	Wohlfeiler, Piperato and Associates, LLC	North Miami Beach	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	Thomas Jefferson University, Division of Infectious Disease	Philadelphia	Pennsylvania
United States	ACTU at CARES/UC Davis	Sacramento	California
United States	UCSD Antiviral Research Center	San Diego	California
United States	Quest Clinical Research	San Francisco	California
United States	Southwest CARE Center	Santa Fe	New Mexico
United States	University of Washington AIDS Clinical Trials Unit	Seattle	Washington
United States	Treasure Coast Infectious Disease Consultants	Vero Beach	Florida
United States	Dupont Circle Physician's Group	Washington	District of Columbia
United States	Whitman-Walker Clinic	Washington	District of Columbia
United States	University of Kansas School of Medicine - PriVia, The Research Centers of Via Christi	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Koronis Pharmaceuticals.

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects.		124 days	Yes
Secondary	To evaluate the antiviral activity (eg., CD4 count, HIV RNA count) of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects.		124 days	No

External Links

•   Results on drug activity in patients who completed treatment