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Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens

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: NCT00129194
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : January 4, 2008
Information provided by:
Koronis Pharmaceuticals.

Brief Summary:
The primary purpose of the study is to assess the safety and pharmacokinetics of KP-1461 given every 12 hours for 14 days when administered to HIV+ patients who have failed multiple highly active antiretroviral therapy (HAART) regimens. Patients currently on HAART will be required to discontinue all HAART medications for up to 6 weeks after screening eligibility has been determined.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: KP-1461 Phase 1

Detailed Description:
KP-1461 is a carbamate prodrug of the active nucleoside, KP-1212. KP-1212 is incorporated into the proviral DNA. After multiple rounds of replication, KP-1212 increases the high inherent mutation rate of HIV beyond the threshold of viability, a process called "viral decay acceleration". KP-1212 is unique from conventional nucleoside reverse transcriptase inhibitors in that it inserts mutations randomly across the entire 10,000 nucleotide HIV genome and does not exert selective pressure by targeting a specific viral or cellular process, thus potentially avoiding drug resistance.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of KP-1461 in HIV+ Adults Who Have Failed Two or More Highly Active Antiretroviral Regimens (HAART)
Study Start Date : August 2005
Actual Primary Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • CD4 > 100 cells/mm3
  • Viral load 2,500 - 200,000 copies/mL
  • Exposure to at least 2 different HAART regimens containing NRTI(s), NNRTI(s), and 2 PI(s), excluding Ritonavir, for a minimum of 4 months or documented resistance to at least 3 of the 4 classes of approved antiretroviral drugs.
  • Few, if any, effective treatment options available

Exclusion Criteria:

  • HBsAb (hepatitis B) positive serology

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): NCT00129194

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United States, Florida
Bach and Godofsky
Bradenton, Florida, United States, 34205
University of Miami
Miami, Florida, United States, 33146
Triple O Medical Services
West Palm Beach, Florida, United States, 33401
United States, Kansas
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, Missouri
Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
Kansas City, Missouri, United States, 64106-1453
United States, New Jersey
St. Michael's Medical Center
Newark, New Jersey, United States, 07102
United States, New York
AIDS Community Research Initiative of America
New York, New York, United States, 10018
United States, South Carolina
Greenville Hospital System
Greenville, South Carolina, United States, 29605
Sponsors and Collaborators
Koronis Pharmaceuticals.

Layout table for additonal information Identifier: NCT00129194    
Other Study ID Numbers: KP-1461-102
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: January 4, 2008
Last Verified: December 2007
Keywords provided by Koronis Pharmaceuticals.:
Treatment Experienced
Additional relevant MeSH terms:
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HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases