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

Stopped early · Phase 2

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00504452

Run by

Koronis Pharmaceuticals.

People needed

27

Starts

2007-07-01

Expected to finish

2009-06-01

Last updated by the study team

2011-11-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Health for Life Clinic — Little Rock, Arkansas, United States
• Living Hope Clinical Foundation — Long Beach, California, United States
• Light Source Medical/U. of Southern California — Los Angeles, California, United States
• ACTU at CARES/UC Davis — Sacramento, California, United States
• UCSD Antiviral Research Center — San Diego, California, United States
• Quest Clinical Research — San Francisco, California, United States
• Dupont Circle Physician's Group — Washington D.C., District of Columbia, United States
• Whitman-Walker Clinic — Washington D.C., District of Columbia, United States
• Comprehensive Care Center -- HIV Clinical Research — Fort Lauderdale, Florida, United States
• Wohlfeiler, Piperato and Associates, LLC — North Miami Beach, Florida, United States
• Orlando Immunology Center — Orlando, Florida, United States
• Treasure Coast Infectious Disease Consultants — Vero Beach, Florida, United States
• AIDS Research Consortium of Atlanta — Atlanta, Georgia, United States
• Northstar Medical Center — Chicago, Illinois, United States
• University of Kansas School of Medicine - PriVia, The Research Centers of Via Christi — Wichita, Kansas, United States
• Institute of Human Virology, University of Maryland — Baltimore, Maryland, United States
• Community Research Initiative of New England — Boston, Massachusetts, United States
• Dybedal Center for Clinical Research, Kansas City University of Medicine and Biosciences — Kansas City, Missouri, United States
• St. Michael's Medical Center — Newark, New Jersey, United States
• Southwest CARE Center — Santa Fe, New Mexico, United States
• Albany Medical College — Albany, New York, United States
• AIDS Community Research Initiative of America — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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