HIV-HCV Coinfection: Impact of Immune Dysfunction

This study is currently recruiting participants.
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
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assessing the effect of confounding variables on hepatic fibrosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Sera


Estimated Enrollment: 800
Study Start Date: July 2004
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: September 2018 (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

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00575315

Contacts
Contact: Richard K Sterling, MD, MSc 804-828-4060 rksterli@vcu.edu

Locations
United States, Virginia
Virgnia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Richard K Sterling, MD MSc    804-828-4060    rksterli@vcu.edu   
Contact: Paula Smith, RN, BSN    804-828-4060    pgsmith@VCU.edu   
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Richard K Sterling, MD MSc VCU
  More Information

Publications:

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT00575315     History of Changes
Other Study ID Numbers: VCU03488, K23-DK-066578-01
Study First Received: December 14, 2007
Last Updated: August 12, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Hepatitis
Hepatitis A
Immune System Diseases
Hepatitis C
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Slow Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 16, 2014