This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Approximately 2% of the U.S. population is chronically infected with hepatitis C virus (HCV). Chronic HCV infections result in significant liver disease, including cirrhosis and liver cancer in approximately 20% of infected individuals. The current therapy of interferon and ribavirin does not result in viral clearance in the majority of cases. The development of improved antiviral strategies to treat HCV chronic infection is essential for the control of this disease. This study is designed to determine the antiviral efficacy of an immunotherapeutic administered as three, intravascular injections to chimpanzees chronically infected with hepatitis C Genotype 1 virus at an interval of 10 days. The drug is a novel cationic lipid and non-coding DNA (CLDC) under development for therapeutic vaccines for cancer and infectious diseases. The initial dose was selected to deliver a dose approximately the same as that tested previously in humans (1.6 ug/kg). If this dose is well tolerated, the second dose will be increased twofold (3.2 ug/kg). If that dose is well tolerated the third and final dose will then be increased twofold (6.4 ug/kg). Two chronically infected chimpanzees will be used in the study. The animals will be monitored closely for adverse events. The animals will be monitored for decline in viral load and markers of the innate immune response.
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