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

This study has been terminated.
(

Corroboration of supporting in vitro data

- Data successfully corroborated 2009

)
Sponsor:
Information provided by (Responsible Party):
Koronis Pharmaceuticals.
ClinicalTrials.gov Identifier:
NCT00504452
First received: July 18, 2007
Last updated: November 3, 2011
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
HIV Infections
Drug: KP-1461
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Koronis Pharmaceuticals.:

Primary Outcome Measures:
  • To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. [ Time Frame: 124 days ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 124 days ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: July 2007
Study Completion Date: June 2009
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: KP-1461
    Oral dosage, 1600 mg bid for 124 days
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504452

  Show 31 Study Locations
Sponsors and Collaborators
Koronis Pharmaceuticals.
  More Information

Additional Information:
No publications provided

Responsible Party: Koronis Pharmaceuticals.
ClinicalTrials.gov Identifier: NCT00504452     History of Changes
Other Study ID Numbers: KP-1461-201
Study First Received: July 18, 2007
Last Updated: November 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Koronis Pharmaceuticals.:
HIV
viral
Viral decay acceleration
ART
HAART
Treatment Experienced

Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome
HIV Infections
Immune System Diseases
Immunologic Deficiency Syndromes
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Viral
Slow Virus Diseases
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014