HIV-HCV Coinfection: Impact of Immune Dysfunction
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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.
Condition |
---|
HIV Infections Hepatitis |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | HIV-HCV Coinfection: Impact of Immune Dysfunction |
- Changes in liver histology [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Assessing the effect of confounding variables on hepatic fibrosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Sera
Estimated Enrollment: | 800 |
Study Start Date: | July 2004 |
Estimated Study Completion Date: | September 2015 |
Estimated Primary Completion Date: | September 2015 (Final data collection date for primary outcome measure) |
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:
- 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
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 |
No publications provided
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT00575315 History of Changes |
Other Study ID Numbers: | VCU03488, K23-DK-066578-01 |
Study First Received: | December 14, 2007 |
Last Updated: | June 19, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Virginia Commonwealth University:
HIV-HCV Coinfection HIV Histology |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Hepatitis Hepatitis A Immune System Diseases Hepatitis C Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Slow Virus Diseases Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on March 03, 2013