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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01206933
First Posted: September 22, 2010
Last Update Posted: February 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
George Washington University
  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.

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:


Further study details as provided by George Washington University:

Primary Outcome Measures:
  • Laboratory analysis of Tat Protein [ Time Frame: Single sample analysis ]
    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.


Enrollment: 20
Study Start Date: July 2010
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Detectable HIV RNA and HCV RNA
HIV and HCV co-infected with 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

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206933


Locations
United States, District of Columbia
George Washington University Medical Faculty Associates
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
Investigators
Principal Investigator: David Parenti, MD George Washington University
  More Information

Responsible Party: George Washington University
ClinicalTrials.gov Identifier: NCT01206933     History of Changes
Other Study ID Numbers: GWUIRB #061012
First Submitted: September 17, 2010
First Posted: September 22, 2010
Last Update Posted: February 10, 2016
Last Verified: September 2010
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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