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HIV-HCV Coinfection: Impact of Immune Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00575315
First Posted: December 18, 2007
Last Update Posted: August 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Virginia Commonwealth University
  Purpose
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

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

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

Enrollment: 634
Study Start Date: July 2004
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
  Contacts and Locations
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
  More Information

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

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00575315     History of Changes
Other Study ID Numbers: VCU03488
K23-DK-066578-01
First Submitted: December 14, 2007
First Posted: December 18, 2007
Last Update Posted: August 20, 2014
Last Verified: August 2014

Keywords provided by Virginia Commonwealth University:
HIV-HCV Coinfection
HIV
Histology

Additional relevant MeSH terms:
HIV Infections
Coinfection
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Infection
Parasitic Diseases


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