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

NCT ID: NCT01206933

Last Updated: 2016-02-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2015-06-30

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.

Conditions

Human Immunodeficiency Virus (HIV); Hepatitis C, Chronic

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Detectable HIV RNA and HCV RNA

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

No interventions assigned to this group

Undetectable HIV and Detectable HCV

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

No interventions assigned to this group

Undetectable HIV and HCV

HIV and HCV infected, Undetectable HIV RNA and HCV RNA

No interventions assigned to this group

Undetectable HCV

HCV(mono-infected,) HCV RNA undetectable

No interventions assigned to this group

Detectable HCV RNA

Monoinfected HCV, detectable RNA

No interventions assigned to this group

Detectable HIV RNA

Monoinfected HIV, Detectable RNA

No interventions assigned to this group

Eligibility 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

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Parenti, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, United States

Countries

United States

Other Identifiers

GWUIRB #061012

Identifier Type: -

Identifier Source: org_study_id