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

History of Changes

Tracking Information
First Received Date ^ICMJE	July 18, 2007
Last Updated Date	November 3, 2011
Start Date ^ICMJE	July 2007
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 30, 2007)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: July 19, 2007)	To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. [ Time Frame: 124 days ]
Change History	Complete list of historical versions of study NCT00504452 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 3, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: July 19, 2007)	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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
Official Title ^ICMJE	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
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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	HIV Infections
Intervention ^ICMJE	Drug: KP-1461 Oral dosage, 1600 mg bid for 124 days
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Terminated
Enrollment ^ICMJE	27
Completion Date	June 2009
Primary Completion Date	September 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Puerto Rico

Administrative Information
NCT Number ^ICMJE	NCT00504452
Other Study ID Numbers ^ICMJE	KP-1461-201
Has Data Monitoring Committee	Yes
Responsible Party	Koronis Pharmaceuticals.
Study Sponsor ^ICMJE	Koronis Pharmaceuticals.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Koronis Pharmaceuticals.
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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