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

Tracking Information

First Received Date ^ICMJE

September 17, 2010

Last Updated Date

February 8, 2013

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01206933 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

detectable HIV RNA (Ribonucleic Acid) and detectable HCV RNA
undetectable HIV RNA (treated) and detectable HCV RNA
undetectable HIV RNA (treated) and undetectable HCV RNA
undetectable HCV RNA (mono-infected)
detectable HCV RNA (mono-infected)
detectable HIV RNA (mono-infected)

Condition ^ICMJE

Human Immunodeficiency Virus (HIV)
Hepatitis C, Chronic

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2014

Estimated Primary Completion Date

July 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Nicole Bisby

202-741-2230

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01206933

Other Study ID Numbers ^ICMJE

GWUIRB #061012

Has Data Monitoring Committee

Responsible Party

George Washington University

Study Sponsor ^ICMJE

George Washington University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David Parenti, MD

George Washington University

Information Provided By

George Washington University

Verification Date

September 2010

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

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