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

July 18, 2007
November 3, 2011
July 2007
September 2008   (final data collection date for primary outcome measure)
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 ]
To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. [ Time Frame: 124 days ]
Complete list of historical versions of study NCT00504452 on ClinicalTrials.gov Archive Site
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 ]
To evaluate the antiviral activity (eg., CD4 count, HIV RNA titer) of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. [ Time Frame: 124 days ]
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
HIV Infections
Drug: KP-1461
Oral dosage, 1600 mg bid for 124 days
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
June 2009
September 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Puerto Rico
 
NCT00504452
KP-1461-201
Yes
Koronis Pharmaceuticals.
Koronis Pharmaceuticals.
Not Provided
Not Provided
Koronis Pharmaceuticals.
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP