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

George Washington University (GW)

Status: Completed

Conditions: Hepatitis C, Chronic; Human Immunodeficiency Virus (HIV)

Study type: Observational

Funder types: Other

Identifiers

NCT01206933

GWUIRB #061012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

20 participants in 6 patient groups

Detectable HIV RNA and HCV RNA

Description:

HIV and HCV co-infected with detectable HIV RNA and HCV RNA

Undetectable HIV and Detectable HCV

Description:

HIV and HCV infected, HIV RNA Undetectable(treated) and Detectable HCV RNA.

Undetectable HIV and HCV

Description:

HIV and HCV infected, Undetectable HIV RNA and HCV RNA

Undetectable HCV

Description:

HCV(mono-infected,) HCV RNA undetectable

Detectable HCV RNA

Description:

Monoinfected HCV, detectable RNA

Detectable HIV RNA

Description:

Monoinfected HIV, Detectable RNA