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

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:

MedlinePlus related topics: HIV/AIDS Hepatitis Hepatitis C

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.


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


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

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)

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	September 17, 2010
Last Updated:	February 8, 2016
Health Authority:	United States: Institutional Review Board
Individual Participant Data
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

ClinicalTrials.gov processed this record on September 29, 2016