HIV-HCV Coinfection: Impact of Immune Dysfunction
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ClinicalTrials.gov Identifier: NCT00575315 |
Recruitment Status :
Completed
First Posted : December 18, 2007
Last Update Posted : August 20, 2014
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Sponsor:
Virginia Commonwealth University
Information provided by (Responsible Party):
Virginia Commonwealth University
Tracking Information | ||||
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First Submitted Date | December 14, 2007 | |||
First Posted Date | December 18, 2007 | |||
Last Update Posted Date | August 20, 2014 | |||
Study Start Date | July 2004 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Changes in liver histology [ Time Frame: 5 years ] | |||
Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures |
Assessing the effect of confounding variables on hepatic fibrosis. [ Time Frame: 5 years ] | |||
Original Secondary Outcome Measures | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | HIV-HCV Coinfection: Impact of Immune Dysfunction | |||
Official Title | HIV-HCV Coinfection: Impact of Immune Dysfunction | |||
Brief Summary | 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. | |||
Detailed Description | 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 Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Sera
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Sampling Method | Non-Probability Sample | |||
Study Population | HIV-HCV Coinfection | |||
Condition |
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Intervention | Not Provided | |||
Study Groups/Cohorts | Not Provided | |||
Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
634 | |||
Original Estimated Enrollment |
400 | |||
Actual Study Completion Date | August 2014 | |||
Actual Primary Completion Date | August 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 90 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00575315 | |||
Other Study ID Numbers | VCU03488 K23-DK-066578-01 |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Current Responsible Party | Virginia Commonwealth University | |||
Original Responsible Party | Richard Sterling, MD, VCU | |||
Current Study Sponsor | Virginia Commonwealth University | |||
Original Study Sponsor | Same as current | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Virginia Commonwealth University | |||
Verification Date | August 2014 |