Sponsored by Virginia Commonwealth University

Phase	Quota	Distance
Phase N/A		Near

Effective therapy for human immunodeficiency virus (HIV) infection has markedly prolonged survival in infected individuals. As a result, other diseases are now becoming clinically significant. Approximately 30% of HIV infected patients are co-infected with hepatitis C virus (HCV) which is now the leading co-morbid disease in co-infected individuals. The histologic severity and natural history of HCV has been reported to be accelerated in those co-infected with HIV. It is hypothesized that 1) the severity and progression of HCV disease is related to the immune competence of the individual, 2) immune restoration associated with HIV therapy may further accelerate the progression of HCV disease which may explain the marked increase in HCV related morbidity and mortality observed in recent years, and 3) the virologic response to anti-HCV treatment is directly related to the degree of immunologic competence. The specific aims of the proposal are: 1) To obtain, through multi-disciplinary didactic teaching, the necessary skills of clinical research design, data collection, data analysis, and biostatistical methods and 2) To study the impact of HIV disease on HCV, the effect of the immune function and immune restoration during HIV therapy on the natural history of HCV, and the efficacy of HCV treatment in HIV co-infection.

Study Start Date: July 2004

Estimated Completion Date: August 2014

Specialties: Infectious Disease: HIV/Immunodeficiency,Hepatitis Gastroenterology: GI Infectious Disease,Hepatology Allergy/Immunology: Gastrointestinal/Hepatic,HIV/Immunodeficiency

Interventions

No interventions cited

Inclusion criteria

• HIV antibody positive
• Positive HCV-RNA
• Age > 18 years

Exclusion criteria

• Coagulopathy (prothrombin time prolonged > 2 seconds from control)
• Presence of ascites
• Thrombocytopenia (platelet < 70,000)
• Active or recent (within 3 months) opportunistic infection related to HIV
• Advanced HIV disease with life expectancy less than 1 year
• Renal failure
• Hepatitis B surface antigen positive
• Inability to give informed consent

Study Locations And Contact Information

• Virgnia Commonwealth University, Richmond Virginia