This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The goal of the project is to identify subjects who have recently (within a 9 month period) become infected with hepatitis C virus and to study the immune system is in its earliest stages of response. The duration of the collection period will be 3 years (10 study subjects per year, locally.) A total of 100 subjects will be recruited from sites around the country.Screened subjects with test results confirming recent infection will receive literature about HCV infection, and treatment options, and will be referred to the study to be consented if they so choose. The subject's option to choose treatment or refuse treatment will not effect their participation in the studyStudy subjects will be followed over a one year period with a pint of blood collected at baseline, 2, 4, 6, and 12 months. There will be a 9 month visit where six tubes of blood will be drawn, two for plasma analysis for viral load, two for T-cell analysis, one for liver function analysis and one to monitor white blood cell changes. At each visit liver function will be monitored with ALT, AST, and total Bilirubin. A complete blood count will be performed to provide information about changes in white blood count and leukocytes over the period of development of the virus. Questionnaires relating to lifestyle and risk factors will be self administered at baseline, 6 and 12 months. Questions about treatment for HCV will be asked at 6 and 12 months. The answers collected from the questionnaires will allow us to match risk factors, for instance, repeated exposures, to outcome of infection. Also, it will be important to know about antiviral treatment choices as we examine the individual immune responses.In an effort to successfully follow the subject for the entire year, telephone visits will be conducted in between clinic visits. These calls will confirm contact information and capture any adverse event that is related to the study.The acute phase of HCV poses particular problems in identifying human subjects, because symptoms of the infection rarely alert care providers to the presence of the virus. Symptoms of the HCV infection generally do not appear until the infection has reached the chronic stage, if they appear at all. Since subjects for the study of the acute phase of HCV are rarely identified in a clinic setting, this study presents a unique opportunity to identify and follow immune responses in a population that has until now rarely been examined. The immune response of individuals who spontaneously clear the infection or who receive antiviral treatment will be compared to the individuals whose immune responses are inadequate to resolve the infection (those who become chronically infected.) The results of the research conducted in this study will answer the important questions vital to the development of a vaccine and more effective treatment of the hepatitis C infection.
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