Clinical trial NCT00504452: Safety and Efficacy Study of KP-1461 to Treat ART-Experienced HIV+ Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV
viral
Viral decay acceleration
ART
HAART
Treatment Experienced
Lead sponsor: Koronis Pharmaceuticals.
Sponsor class: INDUSTRY
First posted: 2007-07-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: To evaluate the safety and tolerability of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects.
timeFrame: 124 days
Secondary outcomes:
measure: To evaluate the antiviral activity (eg., CD4 count, HIV RNA count) of KP-1461 for 124 days in treatment-experienced, HIV-1-infected subjects.
timeFrame: 124 days
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Health for Life Clinic
state: Arkansas
city: Long Beach
country: United States
facility: Living Hope Clinical Foundation
state: California
city: Los Angeles
country: United States
facility: Light Source Medical/U. of Southern California
state: California
city: Sacramento
country: United States
facility: ACTU at CARES/UC Davis
state: California
city: San Diego
country: United States
facility: UCSD Antiviral Research Center
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Washington
country: United States
facility: Dupont Circle Physician's Group
state: District of Columbia
city: Washington
country: United States
facility: Whitman-Walker Clinic
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Comprehensive Care Center -- HIV Clinical Research
state: Florida
city: North Miami Beach
country: United States
facility: Wohlfeiler, Piperato and Associates, LLC
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Vero Beach
country: United States
facility: Treasure Coast Infectious Disease Consultants
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Chicago
country: United States
facility: Northstar Medical Center
state: Illinois
city: Wichita
country: United States
facility: University of Kansas School of Medicine - PriVia, The Research Centers of Via Christi
state: Kansas
city: Baltimore
country: United States
facility: Institute of Human Virology, University of Maryland
state: Maryland
city: Boston
country: United States
facility: Community Research Initiative of New England
state: Massachusetts
city: Kansas City
country: United States
facility: Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences
state: Missouri
city: Newark
country: United States
facility: St. Michael's Medical Center
state: New Jersey
city: Santa Fe
country: United States
facility: Southwest CARE Center
state: New Mexico
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: New York
country: United States
facility: AIDS Community Research Initiative of America
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Division of Infectious Disease
state: Pennsylvania
city: Dallas
country: United States
facility: Charlton Methodist Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas Health Science Center
state: Texas
city: Annandale
country: United States
facility: CARE-ID
state: Virginia
city: Seattle
country: United States
facility: University of Washington AIDS Clinical Trials Unit
state: Washington
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico, Inc.
Study officials:
References: