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

February 8, 2016 updated by: George Washington University

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • George Washington University Medical Faculty Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Single sample analysis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Investigators

  • Principal Investigator: David Parenti, MD, George Washington University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

February 10, 2016

Last Update Submitted That Met QC Criteria

February 8, 2016

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GWUIRB #061012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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