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

November 3, 2011 updated by: Koronis Pharmaceuticals.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

27

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
124 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koronis Pharmaceuticals.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

September 1, 2008

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

July 18, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (Estimate)

July 20, 2007

Study Record Updates

Last Update Posted (Estimate)

November 6, 2011

Last Update Submitted That Met QC Criteria

November 3, 2011

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KP-1461-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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