HIV-HCV Coinfection: Impact of Immune Dysfunction

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Virginia Commonwealth University
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT00575315
First received: December 14, 2007
Last updated: August 12, 2013
Last verified: August 2013

December 14, 2007
August 12, 2013
July 2004
September 2018   (final data collection date for primary outcome measure)
Changes in liver histology [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00575315 on ClinicalTrials.gov Archive Site
Assessing the effect of confounding variables on hepatic fibrosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
HIV-HCV Coinfection: Impact of Immune Dysfunction
HIV-HCV Coinfection: Impact of Immune Dysfunction

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Sera

Non-Probability Sample

HIV-HCV Coinfection

  • HIV Infections
  • Hepatitis
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
September 2019
September 2018   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact: Richard K Sterling, MD, MSc 804-828-4060 rksterli@vcu.edu
United States
 
NCT00575315
VCU03488, K23-DK-066578-01
Yes
Virginia Commonwealth University
Virginia Commonwealth University
Not Provided
Principal Investigator: Richard K Sterling, MD MSc VCU
Virginia Commonwealth University
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP