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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01206933

Enrollment

Registered

2010-09-22

Start date

2010-07-31

Completion date

2015-06-30

Last updated

2016-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic, Human Immunodeficiency Virus (HIV)

Keywords

HIV/HCV Coinfection, Tat Protein, HCV

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.

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Laboratory analysis of Tat Protein	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.

Countries

United States

Outcome results