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

Primary Purpose

HIV Infections

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
KP-1461
Sponsored by
Koronis Pharmaceuticals.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections focused on measuring HIV, viral, Viral decay acceleration, ART, HAART, Treatment Experienced

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Health for Life Clinic
  • Living Hope Clinical Foundation
  • Light Source Medical/U. of Southern California
  • ACTU at CARES/UC Davis
  • UCSD Antiviral Research Center
  • Quest Clinical Research
  • Dupont Circle Physician's Group
  • Whitman-Walker Clinic
  • Comprehensive Care Center -- HIV Clinical Research
  • Wohlfeiler, Piperato and Associates, LLC
  • Orlando Immunology Center
  • Treasure Coast Infectious Disease Consultants
  • AIDS Research Consortium of Atlanta
  • Northstar Medical Center
  • University of Kansas School of Medicine - PriVia, The Research Centers of Via Christi
  • Institute of Human Virology, University of Maryland
  • Community Research Initiative of New England
  • Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
  • St. Michael's Medical Center
  • Southwest CARE Center
  • Albany Medical College
  • AIDS Community Research Initiative of America
  • Mount Sinai Medical Center
  • Duke University Medical Center
  • University of Cincinnati Medical Center
  • Thomas Jefferson University, Division of Infectious Disease
  • Charlton Methodist Hospital
  • University of Texas Health Science Center
  • CARE-ID
  • University of Washington AIDS Clinical Trials Unit
  • Clinical Research Puerto Rico, Inc.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To evaluate the antiviral activity (eg., CD4 count, HIV RNA count) of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects.

Full Information

First Posted
July 18, 2007
Last Updated
November 3, 2011
Sponsor
Koronis Pharmaceuticals.
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1. Study Identification

Unique Protocol Identification Number
NCT00504452
Brief Title
Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
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 Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Terminated
Why Stopped
Corroboration of supporting in vitro data - Data successfully corroborated 2009
Study Start Date
July 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Koronis Pharmaceuticals.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
HIV, viral, Viral decay acceleration, ART, HAART, Treatment Experienced

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
KP-1461
Intervention Description
Oral dosage, 1600 mg bid for 124 days
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Health for Life Clinic
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72207
Country
United States
Facility Name
Living Hope Clinical Foundation
City
Long Beach
State/Province
California
ZIP/Postal Code
90813
Country
United States
Facility Name
Light Source Medical/U. of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
ACTU at CARES/UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UCSD Antiviral Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Dupont Circle Physician's Group
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Whitman-Walker Clinic
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Comprehensive Care Center -- HIV Clinical Research
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33311
Country
United States
Facility Name
Wohlfeiler, Piperato and Associates, LLC
City
North Miami Beach
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Treasure Coast Infectious Disease Consultants
City
Vero Beach
State/Province
Florida
ZIP/Postal Code
32960
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northstar Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60657
Country
United States
Facility Name
University of Kansas School of Medicine - PriVia, The Research Centers of Via Christi
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Institute of Human Virology, University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Community Research Initiative of New England
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64106
Country
United States
Facility Name
St. Michael's Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07102
Country
United States
Facility Name
Southwest CARE Center
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87505
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
AIDS Community Research Initiative of America
City
New York
State/Province
New York
ZIP/Postal Code
10018
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Thomas Jefferson University, Division of Infectious Disease
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Charlton Methodist Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
University of Texas Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
CARE-ID
City
Annandale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
University of Washington AIDS Clinical Trials Unit
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Clinical Research Puerto Rico, Inc.
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0015135
Description
Results on drug activity in patients who completed treatment

Learn more about this trial

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

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