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HIV-HCV Coinfection: Impact of Immune Dysfunction

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ClinicalTrials.gov Identifier: NCT00575315
Recruitment Status : Completed
First Posted : December 18, 2007
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date December 14, 2007
First Posted Date December 18, 2007
Last Update Posted Date August 20, 2014
Study Start Date July 2004
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 17, 2007)
Changes in liver histology [ Time Frame: 5 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 17, 2007)
Assessing the effect of confounding variables on hepatic fibrosis. [ Time Frame: 5 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title HIV-HCV Coinfection: Impact of Immune Dysfunction
Official Title HIV-HCV Coinfection: Impact of Immune Dysfunction
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Sera
Sampling Method Non-Probability Sample
Study Population HIV-HCV Coinfection
Condition
  • HIV Infections
  • Hepatitis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 19, 2014)
634
Original Estimated Enrollment
 (submitted: December 17, 2007)
400
Actual Study Completion Date August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00575315
Other Study ID Numbers VCU03488
K23-DK-066578-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Virginia Commonwealth University
Original Responsible Party Richard Sterling, MD, VCU
Current Study Sponsor Virginia Commonwealth University
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Richard K Sterling, MD MSc VCU
PRS Account Virginia Commonwealth University
Verification Date August 2014