NCT01206933

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 10, 2016

Status Verified

September 1, 2010

Enrollment Period

4.9 years

First QC Date

September 17, 2010

Last Update Submit

February 8, 2016

Conditions

Human Immunodeficiency Virus (HIV)Hepatitis C, Chronic

Keywords

HIV/HCV CoinfectionTat ProteinHCV

Outcome Measures

Primary Outcomes (1)

  • Laboratory analysis of Tat Protein

    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.

    Single sample analysis

Study Arms (6)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Four groups of subjects will be included in this study, with 5 participants in each group: 1. detectable HIV RNA (Ribonucleic Acid) 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)

You may qualify if:

  • Meets one of the following criteria:
  • detectable HIV RNA 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)
  • 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.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Washington University Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency SyndromeHepatitis C, Chronic

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System DiseasesHepatitis CHepatitis, Viral, HumanFlaviviridae InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David Parenti, MD

    George Washington University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2010

First Posted

September 22, 2010

Study Start

July 1, 2010

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

February 10, 2016

Record last verified: 2010-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)