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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00504452
Recruitment Status : Terminated (

Corroboration of supporting in vitro data

- Data successfully corroborated 2009

First Posted : July 20, 2007
Last Update Posted : November 7, 2011
Information provided by (Responsible Party):
Koronis Pharmaceuticals.

Brief 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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: KP-1461 Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS
U.S. FDA Resources

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

Primary Outcome Measures :
  1. To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. [ Time Frame: 124 days ]

Secondary Outcome Measures :
  1. To evaluate the antiviral activity (eg., CD4 count, HIV RNA count) of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. [ Time Frame: 124 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00504452

  Hide Study Locations
United States, Arkansas
Health for Life Clinic
Little Rock, Arkansas, United States, 72207
United States, California
Living Hope Clinical Foundation
Long Beach, California, United States, 90813
Light Source Medical/U. of Southern California
Los Angeles, California, United States, 90036
Sacramento, California, United States, 95817
UCSD Antiviral Research Center
San Diego, California, United States, 92103
Quest Clinical Research
San Francisco, California, United States, 94115
United States, District of Columbia
Dupont Circle Physician's Group
Washington, District of Columbia, United States, 20009
Whitman-Walker Clinic
Washington, District of Columbia, United States, 20009
United States, Florida
Comprehensive Care Center -- HIV Clinical Research
Fort Lauderdale, Florida, United States, 33311
Wohlfeiler, Piperato and Associates, LLC
North Miami Beach, Florida, United States, 33169
Orlando Immunology Center
Orlando, Florida, United States, 32803
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States, 32960
United States, Georgia
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States, 30308
United States, Illinois
Northstar Medical Center
Chicago, Illinois, United States, 60657
United States, Kansas
University of Kansas School of Medicine - PriVia, The Research Centers of Via Christi
Wichita, Kansas, United States, 67214
United States, Maryland
Institute of Human Virology, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Community Research Initiative of New England
Boston, Massachusetts, United States, 02215
United States, Missouri
Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
Kansas City, Missouri, United States, 64106
United States, New Jersey
St. Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, New Mexico
Southwest CARE Center
Santa Fe, New Mexico, United States, 87505
United States, New York
Albany Medical College
Albany, New York, United States, 12208
AIDS Community Research Initiative of America
New York, New York, United States, 10018
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267
United States, Pennsylvania
Thomas Jefferson University, Division of Infectious Disease
Philadelphia, Pennsylvania, United States, 19107
United States, Texas
Charlton Methodist Hospital
Dallas, Texas, United States, 75204
University of Texas Health Science Center
Houston, Texas, United States, 77030
United States, Virginia
Annandale, Virginia, United States, 22003
United States, Washington
University of Washington AIDS Clinical Trials Unit
Seattle, Washington, United States, 98104
Puerto Rico
Clinical Research Puerto Rico, Inc.
San Juan, Puerto Rico, 00909
Sponsors and Collaborators
Koronis Pharmaceuticals.

Additional Information:
Responsible Party: Koronis Pharmaceuticals. Identifier: NCT00504452     History of Changes
Other Study ID Numbers: KP-1461-201
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: November 7, 2011
Last Verified: November 2008

Keywords provided by Koronis Pharmaceuticals.:
Viral decay acceleration
Treatment Experienced

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases