Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens

Completed · Phase 1

Conditions studied: HIV Infections

In brief

The primary purpose of the study is to assess the safety and pharmacokinetics of KP-1461 given every 12 hours for 14 days when administered to HIV+ patients who have failed multiple highly active antiretroviral therapy (HAART) regimens. Patients currently on HAART will be required to discontinue all HAART medications for up to 6 weeks after screening eligibility has been determined.

Key facts

Study ID

NCT00129194

Run by

Koronis Pharmaceuticals.

People needed

40

Starts

2005-08-01

Last updated by the study team

2008-01-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• CD4 > 100 cells/mm3
• Viral load 2,500 - 200,000 copies/mL
• Exposure to at least 2 different HAART regimens containing NRTI(s), NNRTI(s), and 2 PI(s), excluding Ritonavir, for a minimum of 4 months or documented resistance to at least 3 of the 4 classes of approved antiretroviral drugs.
• Few, if any, effective treatment options available

You may not qualify if…

• HBsAb (hepatitis B) positive serology

Where it is running

• Bach and Godofsky — Bradenton, Florida, United States
• University of Miami — Miami, Florida, United States
• Triple O Medical Services — West Palm Beach, Florida, United States
• Research Centers of Via Christi — Wichita, Kansas, United States
• Institute of Human Virology, University of Maryland — Baltimore, Maryland, 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
• AIDS Community Research Initiative of America — New York, New York, United States
• Greenville Hospital System — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.