HIV-HCV Coinfection: Impact of Immune Dysfunction

HIV Infections Clinical Trial

Official title:

HIV-HCV Coinfection: Impact of Immune Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575315
• Other study ID #: VCU03488
• Secondary ID: K23-DK-066578-01
• Status: Completed
• Phase: N/A
• First received: December 14, 2007
• Last updated: August 19, 2014
• Start date: July 2004
• Est. completion date: August 2014

Study information

• Verified date: August 2014
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 634
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coinfection
• Hepatitis
• HIV Infections
• Immune System Diseases

Locations

Country	Name	City	State
United States	Virgnia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Shah AG, Smith PG, Sterling RK. Comparison of FIB-4 and APRI in HIV-HCV coinfected patients with normal and elevated ALT. Dig Dis Sci. 2011 Oct;56(10):3038-44. doi: 10.1007/s10620-011-1710-2. Epub 2011 Apr 28. — View Citation

Smith JO, Sterling RK. Hepatitis C and HIV. Curr Gastroenterol Rep. 2007 Mar;9(1):83-90. Review. — View Citation

Sterling RK, Brown RS Jr, Hofmann CM, Luketic VA, Stravitz RT, Sanyal AJ, Contos MJ, Mills AS, Smith V, Shiffman ML. The spectrum of chronic hepatitis C virus infection in the Virginia Correctional System: development of a strategy for the evaluation and treatment of inmates with HCV. Am J Gastroenterol. 2005 Feb;100(2):313-21. — View Citation

Sterling RK, Chiu S, Snider K, Nixon D. The prevalence and risk factors for abnormal liver enzymes in HIV-positive patients without hepatitis B or C coinfections. Dig Dis Sci. 2008 May;53(5):1375-82. Epub 2007 Oct 16. — View Citation

Sterling RK, Contos MJ, Sanyal AJ, Luketic VA, Stravitz RT, Wilson MS, Mills AS, Shiffman ML. The clinical spectrum of hepatitis C virus in HIV coinfection. J Acquir Immune Defic Syndr. 2003 Jan 1;32(1):30-7. — View Citation

Sterling RK, Contos MJ, Smith PG, Stravitz RT, Luketic VA, Fuchs M, Shiffman ML, Sanyal AJ. Steatohepatitis: Risk factors and impact on disease severity in human immunodeficiency virus/hepatitis C virus coinfection. Hepatology. 2008 Apr;47(4):1118-27. doi: 10.1002/hep.22134. — View Citation

Sterling RK, Lissen E, Clumeck N, Sola R, Correa MC, Montaner J, S Sulkowski M, Torriani FJ, Dieterich DT, Thomas DL, Messinger D, Nelson M; APRICOT Clinical Investigators. Development of a simple noninvasive index to predict significant fibrosis in patients with HIV/HCV coinfection. Hepatology. 2006 Jun;43(6):1317-25. — View Citation

Sterling RK, Wegelin JA, Smith PG, Stravitz RT, Luketic VA, Fuchs M, Puri P, Shiffman ML, Contos MA, Mills AS, Sanyal AJ. Similar progression of fibrosis between HIV/HCV-infected and HCV-infected patients: Analysis of paired liver biopsy samples. Clin Gastroenterol Hepatol. 2010 Dec;8(12):1070-6. doi: 10.1016/j.cgh.2010.08.004. Epub 2010 Aug 20. — View Citation

Sterling RK, Wilson MS, Sanyal AJ, Luketic VA, Stravitz RT, Contos MJ, Mills AS, Shiffman ML. Impact of highly active antiretroviral therapy on the spectrum of liver disease in HCV-HIV coinfection. Clin Gastroenterol Hepatol. 2004 May;2(5):432-9. — View Citation

Stravitz RT, Shiffman ML, Sanyal AJ, Luketic VA, Sterling RK, Heuman DM, Ashworth A, Mills AS, Contos M, Cotterell AH, Maluf D, Posner MP, Fisher RA. Effects of interferon treatment on liver histology and allograft rejection in patients with recurrent hepatitis C following liver transplantation. Liver Transpl. 2004 Jul;10(7):850-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in liver histology		5 years	No
Secondary	Assessing the effect of confounding variables on hepatic fibrosis.		5 years	No