HIV-HCV Coinfection: Impact of Immune Dysfunction
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| ClinicalTrials.gov Identifier: NCT00575315 |
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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
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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.
| Condition or disease |
|---|
| HIV Infections Hepatitis |
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 |
| Actual Enrollment : | 634 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | HIV-HCV Coinfection: Impact of Immune Dysfunction |
| Study Start Date : | July 2004 |
| Actual Primary Completion Date : | August 2014 |
| Actual Study Completion Date : | August 2014 |
Resource links provided by the National Library of Medicine
Primary Outcome Measures :
- Changes in liver histology [ Time Frame: 5 years ]
Secondary Outcome Measures :
- Assessing the effect of confounding variables on hepatic fibrosis. [ Time Frame: 5 years ]
Biospecimen Retention: Samples With DNA
Sera
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| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
HIV-HCV Coinfection
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00575315
Locations
| United States, Virginia | |
| Virgnia Commonwealth University | |
| Richmond, Virginia, United States, 23298 | |
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
| Principal Investigator: | Richard K Sterling, MD MSc | VCU |
Publications:
| Responsible Party: | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier: | NCT00575315 |
| Other Study ID Numbers: |
VCU03488 K23-DK-066578-01 |
| First Posted: | December 18, 2007 Key Record Dates |
| Last Update Posted: | August 20, 2014 |
| Last Verified: | August 2014 |
Keywords provided by Virginia Commonwealth University:
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HIV-HCV Coinfection HIV Histology |
Additional relevant MeSH terms:
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Coinfection Immune System Diseases Infections |