HIV-HCV Coinfection: Impact of Immune Dysfunction

Completed

• Conditions: HIV Infections; Hepatitis

• Registration Number: NCT00575315
• Lead Sponsor: Virginia Commonwealth University

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 Timeline

• Study Start: 2004-07
• Study First Submitted: 2007-12-14
• Study First Submitted QC: 2007-12-17
• Study First Posted: 2007-12-18
• Status Verified: 2014-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 634

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in liver histology	5 years

Secondary Outcome Measures

Name	Time	Method
Assessing the effect of confounding variables on hepatic fibrosis.	5 years

Trial Locations

Locations (1)

Virgnia Commonwealth University; 🇺🇸 Richmond, Virginia, United States