The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by George Washington University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
George Washington University
ClinicalTrials.gov Identifier:
NCT01206933
First received: September 17, 2010
Last updated: January 3, 2014
Last verified: September 2010

September 17, 2010
January 3, 2014
July 2010
July 2014   (final data collection date for primary outcome measure)
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.
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Complete list of historical versions of study NCT01206933 on ClinicalTrials.gov Archive Site
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The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System
The Effect of HIV Tat Protein on HCV Replication in an In-vitro Model System.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

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)
  • Human Immunodeficiency Virus (HIV)
  • Hepatitis C, Chronic
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
July 2014
July 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Nicole Bisby 202-741-2230
United States
 
NCT01206933
GWUIRB #061012
No
George Washington University
George Washington University
Not Provided
Principal Investigator: David Parenti, MD George Washington University
George Washington University
September 2010

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