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Sponsored by: |
Virginia Commonwealth University |
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Information provided by: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00575315 |
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.
Condition |
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HIV Infections Hepatitis |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | HIV-HCV Coinfection: Impact of Immune Dysfunction |
Sera
Estimated Enrollment: | 400 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | August 2009 |
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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
HIV-HCV Coinfection
Inclusion Criteria:
Exclusion Criteria:
Contact: Richard K Sterling, MD, MSc | 804-828-4060 | rksterli@vcu.edu |
United States, Virginia | |
Virgnia Commonwealth University | Recruiting |
Richmond, Virginia, United States, 23298 | |
Contact: Richard K Sterling, MD MSc 804-828-4060 rksterli@vcu.edu | |
Contact: Paula Smith, RN, BSN 804-828-4060 pgsmith@VCU.edu |
Principal Investigator: | Richard K Sterling, MD MSc | VCU |
Responsible Party: | VCU ( Richard Sterling, MD ) |
Study ID Numbers: | VCU03488, K23-DK-066578-01 |
Study First Received: | December 14, 2007 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00575315 |
Health Authority: | United States: Institutional Review Board |
HIV-HCV Coinfection HIV Histology |
Virus Diseases Hepatitis Liver Diseases Sexually Transmitted Diseases, Viral Digestive System Diseases |
HIV Infections Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |