Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
NCT ID: NCT00504452
Last Updated: 2011-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
27 participants
INTERVENTIONAL
2007-07-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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KP-1461
Oral dosage, 1600 mg bid for 124 days
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Koronis Pharmaceuticals.
INDUSTRY
Responsible Party
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Locations
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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
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
Dupont Circle Physician's Group
Washington D.C., District of Columbia, United States
Whitman-Walker Clinic
Washington D.C., District of Columbia, United States
Comprehensive Care Center -- HIV Clinical Research
Fort Lauderdale, Florida, United States
Wohlfeiler, Piperato and Associates, LLC
North Miami Beach, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, United States
Northstar Medical Center
Chicago, Illinois, United States
University of Kansas School of Medicine - PriVia, The Research Centers of Via Christi
Wichita, Kansas, United States
Institute of Human Virology, University of Maryland
Baltimore, Maryland, United States
Community Research Initiative of New England
Boston, Massachusetts, United States
Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
Kansas City, Missouri, United States
St. Michael's Medical Center
Newark, New Jersey, United States
Southwest CARE Center
Santa Fe, New Mexico, United States
Albany Medical College
Albany, New York, United States
AIDS Community Research Initiative of America
New York, New York, United States
Mount Sinai Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Thomas Jefferson University, Division of Infectious Disease
Philadelphia, Pennsylvania, United States
Charlton Methodist Hospital
Dallas, Texas, United States
University of Texas Health Science Center
Houston, Texas, United States
CARE-ID
Annandale, Virginia, United States
University of Washington AIDS Clinical Trials Unit
Seattle, Washington, United States
Clinical Research Puerto Rico, Inc.
San Juan, , Puerto Rico
Countries
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Related Links
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Results on drug activity in patients who completed treatment
Other Identifiers
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KP-1461-201
Identifier Type: -
Identifier Source: org_study_id