HIV-HCV Coinfection: Impact of Immune Dysfunction

Completed

Conditions studied: HIV Infections, Hepatitis

In brief

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.

Key facts

Study ID

NCT00575315

Run by

Virginia Commonwealth University

People needed

634

Starts

2004-07-01

Expected to finish

2014-08-01

Last updated by the study team

2014-08-20

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• HIV antibody positive
• Positive HCV-RNA
• Age > 18 years

You may not qualify if…

• 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

Where it is running

• Virgnia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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