View Clinical Trial (Medical Research Study)
HIV-HCV Coinfection: Impact of Immune Dysfunction
| City: |
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Richmond |
| State: |
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Virginia |
| Zip Code: |
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23298 |
| Conditions: |
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HIV Infections - Hepatitis |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00575315 |
| Primary Contact: |
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Principal Investigator
Richard K Sterling, MD MSc
VCU
Richard K Sterling, MD, MSc
Phone: 804-828-4060
Email: rksterli@vcu.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Richmond, Virginia 23298
United States
Richard K Sterling, MD MSc
Phone: 804-828-4060
Email: rksterli@vcu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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