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

Sponsor:	Koronis Pharmaceuticals.
Information provided by:	Koronis Pharmaceuticals.
ClinicalTrials.gov Identifier:	NCT00504452

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 II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: AIDS

U.S. FDA Resources

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 titer) of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects. [ Time Frame: 124 days ] [ Designated as safety issue: Yes ]

Enrollment:	27
Study Start Date:	July 2007
Study Completion Date:	November 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Show 31 Study Locations

Sponsors and Collaborators

Koronis Pharmaceuticals.

More Information

No publications provided

Responsible Party:	Koronis Pharmaceuticals ( Jeff Parkins, VP, Clinical Development )
Study ID Numbers:	KP-1461-201
Study First Received:	July 18, 2007
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00504452 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Koronis Pharmaceuticals.:

HIV
antiretroviral
viral

ART
HAART
Treatment Experienced

Additional relevant MeSH terms:

Virus Diseases
Sexually Transmitted Diseases, Viral
RNA Virus Infections
Slow Virus Diseases
Immune System Diseases
HIV Infections

Sexually Transmitted Diseases
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Infection
Retroviridae Infections
Immunologic Deficiency Syndromes

ClinicalTrials.gov processed this record on November 27, 2009