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The Effect of Human Immunodeficiency Virus (HIV) Tat Protein on Hepatitis C Virus (HCV) Replication in an In-vitro Model System

This study is currently recruiting participants.
Verified September 2010 by George Washington University
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01206933
First received: September 17, 2010
Last updated: February 8, 2013
Last verified: September 2010
History of Changes
  Purpose

Investigators in the Division of Infectious Diseases and the Departments of Biochemistry and Molecular Biology of The George Washington University Medical Center are carrying out a research study to determine why patients with Human Immunodeficiency Virus (HIV) and Hepatitis C virus (HCV) co-infection (HIV/HCV) have a more rapid and progressive course of HCV infection, leading to fatty infiltration of the liver and cirrhosis. Samples will be collected from 4 groups of patients with HIV/HCV infection, identified by the virologic control of either HIV, HCV, or both. Sera will be used in an in-vitro hepatocyte model of hepatitis C infection to better understand the pathogenesis of HIV/HCV co-infection, and to gain insight into intracellular mechanisms.


Condition
Human Immunodeficiency Virus (HIV)
Hepatitis C, Chronic

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Laboratory analysis of Tat Protein [ Time Frame: Single sample analysis ] [ Designated as safety issue: No ]
    The validation that HIV Tat protein is a potent inducer of HCV in dual infected patients will likely lead to anti-tat therapy to manage HCV patients for whom treatment options are rather limited.


Estimated Enrollment: 30
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Detectable HIV RNA and HCV RNA
Undetectable HIV and Detectable HCV
HIV and HCV infected, HIV RNA Undetectable(treated) and Detectable HCV RNA.
Undetectable HIV and HCV
HIV and HCV infected, Undetectable HIV RNA and HCV RNA
Undetectable HCV
HCV(mono-infected,) HCV RNA undetectable
Detectable HCV RNA
Monoinfected HCV, detectable RNA
Detectable HIV RNA
Monoinfected HIV, Detectable RNA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Four groups of subjects will be included in this study, with 5 participants in each group:

  1. detectable HIV RNA (Ribonucleic Acid) and detectable HCV RNA
  2. undetectable HIV RNA (treated) and detectable HCV RNA
  3. undetectable HIV RNA (treated) and undetectable HCV RNA
  4. undetectable HCV RNA (mono-infected)
  5. detectable HCV RNA (mono-infected)
  6. detectable HIV RNA (mono-infected)
Criteria

Inclusion Criteria:

  • Meets one of the following criteria:

    1. detectable HIV RNA and detectable HCV RNA
    2. undetectable HIV RNA (treated) and detectable HCV RNA
    3. undetectable HIV RNA (treated) and undetectable HCV RNA
    4. undetectable HCV RNA (mono-infected)
    5. detectable HCV RNA (mono-infected)
    6. detectable HIV RNA (mono-infected)

Participants will be men and women, ages 18 and older, and who are patients being seen in the clinics of the Medical Faculty Associates, and meet the above criteria.

Exclusion Criteria:

  • None
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206933

Contacts
Contact: Nicole Bisby 202-741-2230

Locations
United States, District of Columbia
George Washington University Medical Faculty Associates Recruiting
Washington, District of Columbia, United States, 20037
Contact: Nicole Bisby     202-741-2230        
Principal Investigator: David Parenti, MD            
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: David Parenti, MD George Washington University
  More Information

No publications provided

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01206933     History of Changes
Other Study ID Numbers: GWUIRB #061012
Study First Received: September 17, 2010
Last Updated: February 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by George Washington University:
HIV/HCV Coinfection
Tat Protein
HCV

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

ClinicalTrials.gov processed this record on March 03, 2013