HIV-HCV Coinfection: Impact of Immune Dysfunction

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Virginia Commonwealth University

ClinicalTrials.gov Identifier:

NCT00575315

First received: December 14, 2007

Last updated: August 19, 2014

Last verified: August 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

December 14, 2007

Last Updated Date

August 19, 2014

Start Date ^ICMJE

July 2004

Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Changes in liver histology [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00575315 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Assessing the effect of confounding variables on hepatic fibrosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

HIV-HCV Coinfection: Impact of Immune Dysfunction

Official Title ^ICMJE

HIV-HCV Coinfection: Impact of Immune Dysfunction

Brief Summary

Effective therapy for human immunodeficiency virus (HIV) infection has markedly prolonged survival in infected individuals. As a result, other diseases are now becoming clinically significant. Approximately 30% of HIV infected patients are co-infected with hepatitis C virus (HCV) which is now the leading co-morbid disease in co-infected individuals. The histologic severity and natural history of HCV has been reported to be accelerated in those co-infected with HIV. It is hypothesized that 1) the severity and progression of HCV disease is related to the immune competence of the individual, 2) immune restoration associated with HIV therapy may further accelerate the progression of HCV disease which may explain the marked increase in HCV related morbidity and mortality observed in recent years, and 3) the virologic response to anti-HCV treatment is directly related to the degree of immunologic competence. The specific aims of the proposal are: 1) To obtain, through multi-disciplinary didactic teaching, the necessary skills of clinical research design, data collection, data analysis, and biostatistical methods and 2) To study the impact of HIV disease on HCV, the effect of the immune function and immune restoration during HIV therapy on the natural history of HCV, and the efficacy of HCV treatment in HIV co-infection.

Detailed Description

Approximately 30% of HIV infected patients are co-infected with hepatitis C virus (HCV) which is now the leading co-morbid disease in co-infected individuals. The histologic severity and natural history of HCV has been reported to be accelerated in those co-infected with HIV. It is hypothesized that 1) the severity and progression of HCV disease is related to the immune competence of the individual, 2) immune restoration associated with HIV therapy may further accelerate the progression of HCV disease which may explain the marked increase in HCV related morbidity and mortality observed in recent years, and 3) the virologic response to anti-HCV treatment is directly related to the degree of immunologic competence. The specific aims of the proposal are: 1) To obtain, through multi-disciplinary didactic teaching, the necessary skills of clinical research design, data collection, data analysis, and biostatistical methods and 2) To study the impact of HIV disease on HCV, the effect of the immune function and immune restoration during HIV therapy on the natural history of HCV, and the efficacy of HCV treatment in HIV co-infection.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

Sera

Sampling Method

Non-Probability Sample

Study Population

HIV-HCV Coinfection

Condition ^ICMJE

HIV Infections
Hepatitis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

634

Completion Date

August 2014

Primary Completion Date

August 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

HIV antibody positive
Positive HCV-RNA
Age > 18 years

Exclusion Criteria:

Coagulopathy (prothrombin time prolonged > 2 seconds from control)
Presence of ascites
Thrombocytopenia (platelet < 70,000)
Active or recent (within 3 months) opportunistic infection related to HIV
Advanced HIV disease with life expectancy less than 1 year
Renal failure
Hepatitis B surface antigen positive
Inability to give informed consent

Gender

Both

Ages

18 Years to 90 Years (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00575315

Other Study ID Numbers ^ICMJE

VCU03488, K23-DK-066578-01

Has Data Monitoring Committee

Yes

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Virginia Commonwealth University

Study Sponsor ^ICMJE

Virginia Commonwealth University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Richard K Sterling, MD MSc

VCU

Information Provided By

Virginia Commonwealth University

Verification Date

August 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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