Study Stopped
Corroboration of supporting in vitro data \- Data successfully corroborated 2009
Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
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
Other study identifiers
Sponsor study identifier
interventional
27
2 countries
31
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
June 2009
Actual (reported)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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- terminated
- Actual enrollment (reported)
- 27 participants
- Study completion date
June 2009
Actual (reported)- Listed locations
- 2 countries · 31 sites
Trial Relationships
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
First Submitted
July 18, 2007
Actual (reported)First Posted
July 20, 2007
Actual (reported)Primary Completion
September 2008
Actual (reported)Study Completion
June 2009
Actual (reported)
- Last Updated
- November 7, 2011
- Status Verified
- November 2008
- Last Update Submitted
- November 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects.
124 days
Secondary Outcomes (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.
124 days
Interventions
Oral dosage, 1600 mg bid for 124 days
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Koronis Pharmaceuticals.Industrylead
Study Sites (31)
Health for Life Clinic
Little Rock, Arkansas, 72207, United States
Living Hope Clinical Foundation
Long Beach, California, 90813, United States
Light Source Medical/U. of Southern California
Los Angeles, California, 90036, United States
ACTU at CARES/UC Davis
Sacramento, California, 95817, United States
UCSD Antiviral Research Center
San Diego, California, 92103, United States
Quest Clinical Research
San Francisco, California, 94115, United States
Dupont Circle Physician's Group
Washington D.C., District of Columbia, 20009, United States
Whitman-Walker Clinic
Washington D.C., District of Columbia, 20009, United States
Comprehensive Care Center -- HIV Clinical Research
Fort Lauderdale, Florida, 33311, United States
Wohlfeiler, Piperato and Associates, LLC
North Miami Beach, Florida, 33169, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Treasure Coast Infectious Disease Consultants
Vero Beach, Florida, 32960, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Northstar Medical Center
Chicago, Illinois, 60657, United States
University of Kansas School of Medicine - PriVia, The Research Centers of Via Christi
Wichita, Kansas, 67214, United States
Institute of Human Virology, University of Maryland
Baltimore, Maryland, 21201, United States
Community Research Initiative of New England
Boston, Massachusetts, 02215, United States
Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
Kansas City, Missouri, 64106, United States
St. Michael's Medical Center
Newark, New Jersey, 07102, United States
Southwest CARE Center
Santa Fe, New Mexico, 87505, United States
Albany Medical College
Albany, New York, 12208, United States
AIDS Community Research Initiative of America
New York, New York, 10018, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267, United States
Thomas Jefferson University, Division of Infectious Disease
Philadelphia, Pennsylvania, 19107, United States
Charlton Methodist Hospital
Dallas, Texas, 75204, United States
University of Texas Health Science Center
Houston, Texas, 77030, United States
CARE-ID
Annandale, Virginia, 22003, United States
University of Washington AIDS Clinical Trials Unit
Seattle, Washington, 98104, United States
Clinical Research Puerto Rico, Inc.
San Juan, 00909, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Enrollment
27 participants (actual enrollment reported by the registry).
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2007
First Posted
July 20, 2007
Study Start
July 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
June 2009
Actual (reported)Last Updated
November 7, 2011
Record last verified: 2008-11
Source record
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
- Registry identifier
- NCT00504452
- Data provider
- ClinicalTrials.gov
- Source updated
- 2011-11-07
- Normalization version
- ctgov-legacy-1
Source retrieved: